Vegeto-vascular dystonia. Symptoms. Diagnosis. Treatment. Prevention.

Vegeto-vascular dystonia (VVD) - the diverse clinical manifestations of symptoms affecting various organs and systems and developing as a result of abnormalities in the structure and function of the central and / or peripheral autonomic nervous system.

Vegeto-vascular dystonia - not an independent nosological form, but in combination with other contributory factors, it can promote the development of many diseases and pathological conditions, often having a psychosomatic component (arterial hypertension, ischemic heart disease, asthma, peptic ulcer, etc.). Autonomic changes determine the development and course of many diseases of childhood. In turn, the somatic and any other diseases can exacerbate autonomic disorders.

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Symptoms of vascular dystonia detected in 25-80% of children, primarily among urban residents. They can be found in any age period, but more often observed in children 7-8 years and adolescents. Most often this syndrome is observed in girls.

Vegeto-vascular dystonia. Causes.

The reasons for the formation of vegetative disorders are numerous. The main importance are the primary, inherited due to abnormalities in the structure and functions of various divisions of the autonomic nervous system, often traced through the maternal line. Other factors tend to play the role of triggers that cause the manifestation already existing latent autonomic dysfunction.
The formation of vegetative-vascular dystonia have contributed significantly to perinatal CNS, leading to cerebral vascular disorders, liquorodynamics, hydrocephalus, damage to the hypothalamus and other parts of limbic-reticular complex. Damage to the central parts of the autonomic nervous system leads to emotional imbalance, neurotic and psychotic disorders in children, inadequate responses to stressful situations, which also influences the formation and course of vascular dystonia.
In the development of vascular dystonia is very large role of various traumatic effects (conflict situations in the family, school, family alcoholism, broken families, isolation, excessive protection of the child or his parents), leading to psychological maladjustment of children, contributing to the implementation and strengthening of autonomic disorders. Equally important are repetitive acute emotional overload, chronic stress, mental tension.

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By provoking factors include a variety of somatic, endocrine and neurological diseases, abnormalities of the constitution, allergic conditions, adverse or drastically changing weather conditions, especially climate, ecological trouble, upsetting the balance of trace elements, physical inactivity or excessive physical stress, hormonal changes of puberty, failure to comply with diet and etc.

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The unquestionable importance are age-appropriate rate of maturation of sympathetic and parasympathetic autonomic nervous system instability metabolism of the brain, as well as the child's inherent body the ability to develop generalized reactions in response to local irritation, which determines a higher polymorphism and the severity of syndrome in children compared to adults. Violations arising from the autonomic nervous system, leading to various changes in the functions of the sympathetic and parasympathetic systems in violation of the allocation of neurotransmitters (norepinephrine, acetylcholine), adrenal cortex hormones and other endocrine glands, a number of biologically active substances (polypeptides, prostaglandins), as well as to violations sensitivity of vascular a-and ß-adrenergic receptors.



This is a great diversity and varying severity of subjective and objective manifestations of vegetative-vascular dystonia in children and adolescents, depending on the age of the child. Autonomic changes they are often multi-organ nature of the predominance of dysfunction in any one system, often in the cardiovascular.

Classification of vegetative-vascular dystonia

To date, standard classification vegetative-vascular dystonia has not been developed. In formulating the diagnosis into account:
etiological factors;
variant of autonomic disorders (vagotonichesky, sympathicotonic, mixed);
prevalence of autonomic disorders (generalized, systemic or local form);
of the organs most involved in the pathological process;
functional state of the autonomic nervous system;
severity (mild, mid-weight, heavy);
nature of the flow (latent, permanent, paroxysmal).

Symptoms of vegetative-vascular dystonia

For vegetative-vascular dystonia is characterized by multiple, often bright subjective symptoms that do not meet much less pronounced objective manifestations of any organ pathology. The clinical picture of vascular dystonia is largely dependent on the direction of autonomic disorders (prevalence of vago-or sympathic).

Vagotonia

Children with typical vagotonia many hypochondriacal complaints, fatigue, decreased performance, impaired memory, sleep disturbances (difficulty falling asleep, sleepiness), apathy, indecision, fearfulness, tendency to depression.

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Characterized by reduced appetite, coupled with excess body weight, poor tolerance to cold intolerance stuffy room, a sense of chilliness, a feeling of lack of air, periodic deep breaths, feeling "a lump in my throat, and vestibular disorders, vertigo, pain in the legs (usually at night time), nausea, abdominal pain, unmotivated, marbling of the skin, acrocyanosis pronounced red dermographism, high flux, sebaceous excretions and a tendency to fluid retention, transient swelling under the eyes, frequent urination, hyperptyalism, spastic constipation, and allergic reactions.

Cardiovascular disorders manifest pain in the heart, bradyarrhythmia, the tendency to decrease blood pressure, increased heart size by reducing the tone of the heart muscle, subdued heart sounds. The ECG reveal sinus bradycardia (bradyarrhythmia), there are beats, prolongation of the interval P-Q (until atrioventricular block I-II degree), as well as the displacement of ST segment above the contour and an increase in wave amplitude T.

Sympathicotony

Children with sympathic inherent temperament, temper, mood variability, increased sensitivity to pain, quick distraction, distraction, and various neurotic state. They often complain of feeling hot, feeling the heartbeat. When sympathicotonia asthenic physique often watching against the backdrop of increased appetite, pallor, dry skin, pronounced white dermographism, cold extremities, numbness and paresthesia in them in the morning, unexplained fever, poor tolerance to heat, polyuria, atonic constipation. Respiratory disorders are absent, are not characteristic of vestibular. Cardiovascular disorders manifest a tendency to tachycardia and increased blood pressure at normal heart size and its loud colors. The ECG often reveal sinus tachycardia, shortening of the interval P-Q, the displacement of ST segment below the contour, flattened prong T.

Cardiopsychoneurosis

With the prevalence of cardiovascular disorders in the complex of existing vegetative disorders is permissible to use the term "neurocirculatory dystonia. However, please note that cardiopsychoneurosis is an integral part of the broader concept of vegetative-vascular dystonia.

Andriol

Composition, structure and packing

Capsules 1 capsule. testosterone undecanoate 40 mg.

Clinico-pharmacological group: androgenic drug.

Mechanism of action Andriol is a drug testosterone, active ingestion. The active ingredient is testosterone undecanoate, ether natural testosterone. Testosterone in a pure form ingestion is inactive.

In contrast, testosterone undecanoate, due to its high fat soluble, and the availability of a special solvent - oleic acid, is absorbed with chylomicrons through the lymphatic system of the small intestine, enters the thoracic lymphatic duct and then through the superior vena cava immediately gets into the systemic circulation.

Thus, a sufficient amount of testosterone passes initial passage through the liver and inactivation in it, and in the systemic circulation rapidly achieved therapeutic concentrations of this hormone. In applying Andrioli in plasma level rises as testosterone and its active metabolite, which accounts for stable therapeutic effect. Andriol, unlike active after oral application of C-17-methylated derivatives of testosterone, has no effect on liver function.

Pharmacokinetics

Absorption

After ingestion of the small intestine absorbs 45-48% of the dose. Cmax in plasma obtained between 2.5 h and 5 h after a single dose.

Metabolism

Testosterone undecanoate is hydrolyzed with the formation of testosterone, the effect is similar to the effect of endogenous testosterone. Later formed active metabolites of testosterone: 5-alpha-dihydrotestosterone, androstenedione and estradiol, which by binding to corresponding receptors, cause a full spectrum of androgenic activity Andrioli. Putting T1 / 2 - 3-4 pm derive mainly from the urine as metabolites (two drugs and sulfates) in the first 24 hours - about 40%, and in one week - 50-70%.

A small amount of the active substance is excreted in the feces.

Statement

Hormone replacement therapy for disorders associated with testosterone deficiency:
postcastration syndrome syndrome;
evnuhoidizme;
hypopituitarism;
endocrine impotence;
climacteric disorders in males such as reduced libido and decrease in mental and physical activity.

In addition, testosterone can be shown with osteoporosis.

Dosage regimen

Typically, the dose should be set individually depending on the clinical effect. The recommended starting dose is 120-160 mg / day for 2-3 weeks. Maintenance dose - 40-120 mg / day. Andriol capsules should be taken after meals, washed down with a small amount of liquid swallowed whole without chewing. It is advisable to take half the dose in the morning and afternoon - evening. If the patient takes an odd number of capsules, the higher dose should be taken in the morning.

Side effect

On the part of the reproductive system: priapism, increased sexual arousal, premature puberty boys, increased frequency of erections, increase the size of the penis, oligospermia, reduced volume of ejaculate. From the water-electrolyte balance: sodium and water retention. Other: premature closure of growth zones of bones, dizziness, nausea.

Contraindications
verified or suspected carcinoma of the prostate or breast cancer.

Cautions

In the case of androgenozavisimyh side effects treatment should be discontinued. After their disappearance should resume treatment with lower doses.

Treatment of patients with latent or pronounced cardiac failure, impaired renal function, hypertension, epilepsy or migraine (or the notes on the history of these conditions) should be under constant surveillance, since androgens may occasionally induce sodium and water retention. Perhaps reducing belkovosvyazannogo iodine, but it has no clinical significance.

Use in Pediatrics

The boys in the prepubertal period, androgens should be used with caution to avoid premature closure of epiphyses and accelerated sexual development.

Overdose

Currently, cases of overdosing Andriol not reported.

Drug Interactions

Drug Interactions preparation Andriol is not described.

Terms and Conditions of storage

The drug should be stored in a dry place protected from light.

Shelf life at room temperature - 90 days. Shelf life at a constant temperature of 2 ° to 8 ° C - 3 years.

Andante

Composition, structure and packing

Hard gelatin capsules with opaque blue cap and light blue opaque body, the contents of capsules - powder light blue with a grayish tint.

1 capsule. zaleplon 5 mg.

Excipients: starlak (a mixture of lactose and corn starch), microcrystalline cellulose, magnesium stearate, indigo, titanium dioxide, sodium lauryl sulfate, colloidal silicon dioxide.

The composition of the shell capsules: indigo, titanium dioxide, gelatin. Hard gelatin capsules with opaque blue cap and blue opaque body, the contents of capsules - powder light blue with a grayish tint.

1 capsule. zaleplon 10 mg.

Excipients: starlak (a mixture of lactose and corn starch), microcrystalline cellulose, magnesium stearate, indigo, titanium dioxide, sodium lauryl sulfate, colloidal silicon dioxide.

The composition of the shell capsules: indigo, titanium dioxide, gelatin.

Clinico-pharmacological group: sleeping pills.

Pharmacological action

Sleeping pills pyrazolo-pyrimidine type, the chemical structure differs from the benzodiazepines and other hypnotics. Selectively binds to benzodiazepine receptors type 1 (ω-1). Significantly reduces the latency time of falling asleep, prolongs sleep (in the first half of the night), does not cause changes in the ratio of the different phases of sleep. When used in a dose of 5 mg and 10 mg for 2-4 weeks does not cause pharmacological tolerance. In addition, has sedative, slightly pronounced anxiolytic, anticonvulsant and central miorelaksiruyuschee action. Excited benzodiazepine receptor (ω) GABA receptor complexes of type A.

Interaction with ω-receptors leads to the discovery of neuronal ionoformnyh channels for chloride ions, the development of hyperpolarization and increase of inhibitory processes in the CNS.

Pharmacokinetics

Absorption

Once inside quickly and almost completely (about 71%) absorbed from the gastrointestinal tract, Cmax in the blood is achieved after 1 h. As a result presistemnogo metabolism absolute bioavailability of 30%. Plasma concentration is directly proportional to the dose. Acceptance of the drug immediately after a meal may, at 2 h delay the time to reach Cmax, without affecting the absorbability of the drug. Distribution is fat-soluble compound. Vd after i / v administration of 1.4 ± 0.3 L / kg. Plasma protein binding of about 60% (the probability of interaction with other drugs is very low). Provided with breast milk.

Metabolism

In the primary metabolism involved aldegidoksidaza and leads to the formation of 5-oksozaleplona. CYP3A4 is also involved in the metabolism zaleplona with the formation dezetil-zaleplona, which in turn, with the help aldegidoksidazy transformed into 5-oxo-dezetil-zaleplon. Further oxidation products are subjected to conjugation with glucuronic acid. All metabolites are inactive. When used in doses of 30 mg / day accumulation is not observed. T1 / 2 zaleplona - about 1 h.

Withdrawal

Outputs in the form of inactive metabolites mainly in urine (71%) and feces (17%). Up to 57% of applied dose found in urine in the form of 5-oksozaleplona or its metabolite, 9% of the dose - in the form of 5-oxo-dezetil zaleplona or its metabolites, the remainder of the dose - as less important metabolites. Among the metabolites that are derived through the intestine, the prevailing 5-oksozaleplon. Rapidly excreted from the body.

Pharmacokinetics in special clinical situations

Pharmacokinetics in elderly patients (including older than 75 years) is not significantly different from that of younger persons. Zaleplona pharmacokinetics in patients with renal failure is not significantly different from that of healthy, although the level of inactive metabolites is higher. Indications - severe sleep disturbances (difficulty falling asleep), leading to excessive fatigue, hindering daily activities and reduce efficiency.

Dosage regimen

Duration of therapy should not exceed 2 weeks. The drug, taken orally immediately before bedtime, after 2 hours after meals or after the patient feels that he can not sleep. The recommended dose for adults - 10 mg. The maximum daily dose of 10 mg (patients should be alert about the dangers of taking repeated doses in one night). Elderly drug administered in a dose of 5 mg (for greater sensitivity to the soporific).

When liver failure light and moderate daily dose is 5 mg (due to delayed removal from the body).

In renal insufficiency, mild and moderate dose adjustment is required. Data on the safety of the drug in renal failure severe absent. Safety of the drug in children under the age of 18 is not installed, so the patients in this age group, zaleplon is not indicated.

Side effect

On the part of the digestive system: stomach pain, nausea, vomiting, diarrhea.

From the side of the central nervous system and peripheral nervous system: the most common - headache, fatigue, increased sleepiness, dizziness, anterograde amnesia (accompanied by a breach of conduct), depression, paradoxical and mental reactions (mostly elderly patients): anxiety, irritability, aggressiveness, paresthesia, rage, nightmares, hallucinations, psychosis, behavioral disorders, the development of physical dependence with withdrawal symptoms, even when used in therapeutic doses (the appearance of initial symptoms of sleep disturbance in a more severe form, as well as changes in mood, anxiety, agitation), withdrawal syndrome (headache, myalgia, irritability, confusion), the development of psychological dependence, leading to drug abuse, ataxia, tremor, irritability, violations of perception. In severe cases: autoaggression, depersonalization, hearing loss, increased reaction to visual, auditory and physical stimuli, seizures. Allergic reactions: skin rash, itching.

Contraindications
severe hepatic impairment;
sleep apnea syndrome;
severe pulmonary insufficiency;
severe myasthenia gravis;
Pregnancy
lactation;
children's age (18 years);
Hypersensitivity to any component of the drug.

With caution is prescribed for chronic obstructive pulmonary disease, hepatic and / or renal failure, chronic alcoholism, drug dependence (including history), and depression.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding). In the appointment of the drug to women of childbearing age should warn patients about the need for immediate treatment to the doctor in case of conception or when planning pregnancy.

In the case of zaleplona in the III trimester of pregnancy or use of the drug at high doses of the drug during delivery of the newborn may develop hypothermia, muscular hypotonia, mild respiratory insufficiency resulting from the pharmacological action of the drug. Babies whose mothers regularly took benzodiazepines or benzodiazepinopodobny drug in the last weeks of pregnancy may develop physical dependence and the risk of withdrawal symptoms.

Application for violations of liver function

When liver failure light and moderate daily dose is 5 mg (due to delayed removal from the body). Contraindicated in severe liver failure due to the risk of encephalopathy

Application for violations of renal function

In renal insufficiency, mild and moderate dose adjustment is required. Data on the safety of the drug with severe renal insufficiency are absent. Cautions Patients must notify that the drug is not intended for long-term therapy and the possibility of withdrawal symptoms after the drug Andante. The course is taking the drug should be short and in no case exceed 2 weeks. To extend the treatment is possible only after a thorough clinical examination of the patient.

The drug can be considered in patients older (including older than 75 years). Sleep disturbance may be the result of disease (including mental health). If, after a brief use of the drug Andante sleep is normal, or sleep disturbance progresses, you should re-evaluate the clinical situation. If the patient wakes up shortly after midnight (because of the short T1 / 2 zaleplona) may require the appointment of another drug with a longer T1 / 2.

It should warn patients about the need for no more than 1 tab. overnight. Acceptance of benzodiazepines and short-acting drugs benzodiazepinopodobnyh within a few weeks may be accompanied by lower soporific effect. Acceptance of benzodiazepines and benzodiazepinopodobnyh drugs may lead to the development of physical and psychic dependence, the probability of which increases with the use of high-dose, prolonged therapy, chronic alcoholism and drug addiction in the history of the patient.

When formed of physical dependence abrupt withdrawal of the drug leads to development of withdrawal symptoms: headache, myalgia, a pronounced anxiety, increased tension and irritability, psychomotor agitation, confusion. In severe cases, possible autoaggression, depersonalization, hearing loss, paresthesia in the extremities, increased reaction to visual, auditory and physical stimuli, hallucinations and seizures.

After the cessation of the use of benzodiazepines and benzodiazepinopodobnyh drug may cause transient and more pronounced than at the beginning of treatment, symptoms of insomnia (withdrawal symptoms). It is possible to develop other related phenomena (change of mood, anxiety, sleep disorders or anxiety). Benzodiazepines and benzodiazepinopodobnye drugs can cause the development of anterograde amnesia and a violation of psychomotor functions. In order to avoid the development of these symptoms the drug should be taken only when the patient can sleep uninterrupted, at least within 4 h after administration of the drug.

Zaleplonom Treatment should be discontinued in case of increased excitability, irritability, aggressiveness, disorders of perception, nightmares, hallucinations, psychotic disorders, particularly behavioral disorders.

Children and elderly patients are more likely to develop such symptoms. The product is not intended to treat depression and / or anxiety, because can be used for the implementation of suicidal intent, often accompany depressive disorders. Patients with depression drug can be given a minimum dose to avoid deliberate overdose. Do not appoint a drug to patients with severe hepatic insufficiency due to the risk of encephalopathy. If lactose intolerance should be noted that in the tablet containing 5 mg zaleplona, comprises 67 mg of lactose, 10 mg -134 mg. Effects on ability to drive vehicles and management mechanism during use of the drug should refrain from driving motor vehicles, and training activities that require high concentration and quickness of psychomotor reactions, because sedative effect, amnesia, reduced concentration and muscle strength may adversely affect the ability to engage in such activities.

Overdose

Data on acute drug overdose a bit. Zaleplona concentration in the blood of an overdose was not measured. Like other benzodiazepines and benzodiazepinopodobnym drug overdose does not cause life-threatening conditions, when zaleplon was not taken in combination with other drugs, depressant drug (including ethanol). In case of overdose should never forget about the possibility of combined poisoning.

Symptoms: symptoms of CNS depression, manifested in sleepiness until coma. In case of overdose mild - drowsiness, confusion, lethargy, in more severe cases - ataxia, decrease blood pressure, respiratory failure, rarely coma (in very rare cases, fatal).

Treatment: According to preclinical studies flumazenil is an antagonist zaleplona, although clinical studies did not confirm the efficacy of flumazenil in overdose Andante. Flumazenil can be used as an antidote.

If the patient is conscious, then during the first hour after taking the drug should induce vomiting. If the patient is unconscious, then carry out gastric lavage, activated charcoal designate. Monitoring of cardiac and respiratory activity conducted in the intensive care unit.

Drug Interactions

Simultaneous reception of ethanol or etanolsoderzhaschih drugs increases sedative effect zaleplona.

The simultaneous use of antipsychotic (neuroleptics), other hypnotics, anxiolytic, sedative, antidepressant, antiepileptic, antihistamine drugs, means for anesthesia, opioid analgesics leads to increased sedative effect zaleplona. With the simultaneous use of opioid analgesics may be a manifestation of euphoric effect of the latter, leading to the development of drug dependence.

With simultaneous application of cimetidine (an inhibitor of aldegidoksidazy and CYP3A4) increases the concentration of zaleplona in plasma by 85%. With simultaneous application of selective inhibitors of CYP3A4 (ketoconazole, erythromycin) increase the concentration of zaleplona in plasma and enhance its sedative effect (when using this combination can sometimes require dosage adjustment zaleplona).

With simultaneous application of inducers of CYP3A4 (rifampicin, carbamazepine, phenobarbital derivatives) may reduce the effectiveness of zaleplona by 25%. With simultaneous use of zaleplon did not affect the pharmacodynamics and pharmacokinetics of digoxin and warfarin (dosage adjustment of these drugs is not required). Interactions of ibuprofen with zaleplonom not revealed.

Terms and Conditions of storage

The drug should be stored in their original packaging away from children at a temperature of 15 ° to 30 ° C. Shelf life - 2 years.

Angiozil Retard

Enteric coating, coated pink, round, biconvex.

1 tab. Trimetazidine dihydrochloride 35 mg.

Excipients: gipromelloza, microcrystalline cellulose, colloidal silicon dioxide (aerosil), magnesium stearate, Opadry II (gipromelloza, lactose monohydrate, Polydextrose, macrogol, titanium dioxide, iron oxide yellow, iron oxide red).

Clinico-pharmacological group: The drug that improves myocardial metabolism and neurosensory organs in conditions of ischemia.

Pharmacological action

The drug, which improves myocardial metabolism and neurosensory organs in ischemia. Has antianginalnoe, antihypoxia action. Directly affecting the cardiomyocytes and neurons of the brain, improves their metabolism and function. Cytoprotective effect explained by rising energy potential, activation of oxidative decarboxylation and the rationalization of consumption of oxygen (increased aerobic glycolysis and the blockade of fatty acid oxidation). Supports myocardial contractility, prevents reduction of intracellular ATP content and fosfokreatinina.

In acidosis, normalizes the function of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and phosphate levels, due to myocardial ischemia and reperfusion.

It prevents the damaging action of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic area, increases the duration of the electric potential, reduces the yield of CK from the cells and the severity of ischemic myocardial damage.

When angina reduces the frequency of attacks (which lowers the consumption of nitrates). After 2 weeks of treatment increased exercise tolerance, reduced blood pressure drops. Against the background of the drug in patients improves hearing and results of vestibular tests, decreased dizziness and tinnitus.

In vascular pathology eye on the background of the drug restored the functional activity of the retina.

Pharmacokinetics

Absorption after taking the drug inside trimetazidine quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability - 90%. Time to reach Cmax in blood plasma - 5 hours after a single administration of trimetazidine 35 mg Cmax in blood plasma is about 115 ng / ml.

Distribution

Binding to plasma proteins - 16%. Easily penetrates through histohematogenous barriers.

Withdrawal

T1 / 2 was 6.5 hours excreted by the kidneys (about 60% - unchanged).

Statement
Coronary heart disease: prevention of angina attacks (in the complex therapy);
chorioretinal circulatory disorders;
Vertigo of vascular origin;
kohleo-vestibular disorders of ischemic nature (tinnitus, hearing loss).

Dosage regimen

Assign to 35 mg (1 tab.) 2 times / day. Tablets are taken orally, during a meal in the morning and evening. Duration of therapy is determined individually.

Side effect

On the part of the digestive system: rarely - stomachalgia, nausea, vomiting.

Allergic reactions: itching.

Other: rarely - headache, feeling of palpitations.

Contraindications
renal failure (CC <15 ml / min);
marked disturbances of liver function;
Pregnancy
Lactation (breastfeeding);
childhood and adolescence to 18 years (efficacy and safety of the drug not established);
Hypersensitivity to the drug's components.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindications disturbancies liver

Application for violations of renal function

Contraindicated in renal insufficiency (CC <15 ml / min).

Cautions

The product is not intended for relief of angina attacks. In the case of an attack of angina should be correction of treatment.

Effects on ability to drive vehicles and management mechanisms

The product has no effect on the ability to occupations potentially hazardous activities requiring attention and speed of psychomotor reactions.

Overdose

Currently, cases of overdosing Angiozil retard not reported.

Drug Interactions

Drug Interactions drug Angiozil retard not described.

Terms and Conditions of storage

List B. The drug should be stored out of reach of children, dry, dark place at temperatures not above 25 ° C. Shelf life - 2 years.

Anvifen

Composition, structure and packing

Hard gelatin capsules, № 3, white; content capsules - a mixture of powder and / or granules of white or white with a yellowish tint.

1 capsule. aminofenilbutirovoy acid hydrochloride 25 mg.

Excipients: giproloza, colloidal silicon dioxide, lactose, magnesium stearate.

Composition of hard gelatin capsules: gelatin, titanium dioxide (E171), water.

Hard gelatin capsules, № 3, body in white, blue cap, the contents of capsules - a mixture of powder and / or granules of white or white with a yellowish tint.

1 capsule. aminofenilbutirovoy acid hydrochloride 50 mg.

Excipients: giproloza, colloidal silicon dioxide, lactose, magnesium stearate.

Composition of hard gelatin capsules: gelatin, food coloring azorubin (E122), colorant brilliant blue (E133), quinoline yellow (E104), titanium dioxide (E171), water.

Hard gelatin capsules, № 2, body in white, blue cap, the contents of capsules - a mixture of powder and / or granules of white or white with a yellowish tint.

1 capsule. aminofenilbutirovoy acid hydrochloride 125 mg.

Excipients: giproloza, colloidal silicon dioxide, lactose, magnesium stearate.

Composition of hard gelatin capsules: gelatin, food coloring azorubin (E122), colorant brilliant blue (E133), titanium dioxide (E171), water.

Hard gelatin capsules, № 0, body white cap, dark blue; content capsules - a mixture of powder and / or granules of white or white with a yellowish tint.

1 capsule. aminofenilbutirovoy acid hydrochloride 250 mg.

Excipients: giproloza, colloidal silicon dioxide, lactose, magnesium stearate.

Composition of hard gelatin capsules: gelatin, food coloring azorubin (E122), colorant brilliant blue (E133), titanium dioxide (E171), water.

Clinico-pharmacological group

Nootropic drugs.

Pharmacological action

Nootropic drugs. Facilitates GABA-mediated transmission of nerve impulses in the central nervous system (a direct effect on GABA-ergic receptors). Tranquilizing effect is combined with an activating effect. Also has antiplatelet, antioxidant and some anticonvulsant activity.

It improves the functional state of the brain due to the normalization of its metabolism and effects on cerebral blood flow (increases the volume and linear velocity, reduces vascular resistance, improves microcirculation, has antiplatelet effect). Lengthens the latency period and shortens the duration and severity of nystagmus.

No effect on holino-and adrenoreceptors. Reduces vazovegetativnye symptoms (including headaches, feeling of heaviness in the head, sleep disturbances, irritability, emotional lability). In exchange you receive increases physical and mental abilities (attention, memory, speed and accuracy of sensory-motor reactions).

Reduces manifestations of asthenia (state of health improves, increases the interest and initiative (motivation activities)) with no sedation or excitation.

Reduces feelings of anxiety, tension and anxiety, normalizes sleep.

The elderly does not cause CNS depression, muscle-relaxing after-effect often absent.

Pharmacokinetics

Absorption and distribution

Absorption is high.

Good penetrates all body tissues and through the BBB (in the brain tissue penetrates about 0.1% of the administered dose, and in young and elderly to a greater extent). Evenly distributed in the liver and kidneys.

Metabolism and excretion

Metabolised in the liver - 80-95%, metabolites are pharmacologically inactive. Not cumulative.

After 3 h begins with urine, with a concentration in the brain tissue is not reduced and is found even within 6 h. About 5% is excreted in the urine in unchanged form and partly in the bile.

Indications for use of the drug
asthenic and anxious-neurotic condition;
stuttering, tics and enuresis in children;
insomnia and nocturnal anxiety in the elderly;
Meniere's disease;
dizziness associated with dysfunction of the vestibular apparatus of various origins;
prevention of motion sickness when kinetozah;
in complex therapy of alcohol withdrawal syndrome for relief of psychopathological and somatovegetativnyh disorders.

Dosage regimen

The drug is prescribed by mouth after eating. The course of treatment - 2-3 weeks.

Adults and children over 14 years appoint 250-500 mg of 3 (maximum daily dose 2.5 g).

Children aged 3 to 8 years appoint 50-100 mg 3; in age from 8 to 14 years - 250 mg 3 maximum single dose for adults and children over 14 years of age is 750 mg in patients over 60 years - 500 mg in children up to 8 years - 150 mg, in children from 8 to 14 years - 250 mg.

When alcohol withdrawal syndrome appoint 250-500 mg 3 and 750 mg at night, with a gradual decrease in daily dose to normal for adults.

For the treatment of vertigo vestibular dysfunction and Meniere's disease drug is prescribed 250 mg of 3 for 14 days.

For prevention of motion sickness appoint 250-500 mg dose 1 hour prior to expected start rolling or when the first symptoms of seasickness. Step Anvifena increases with increasing dose. When the express manifestation of sea-sickness (vomiting, etc.) Appointment Anvifena ineffective even at doses of 750-1000 mg.

Side effect

From the CNS: drowsiness, increased irritability, agitation, anxiety, dizziness, headache (at first admission).

Other: nausea, allergic reactions.

Contraindications to the use of the drug
Pregnancy
lactation (breastfeeding);
Children under 3 years;
Hypersensitivity to the drug's components.

Precautions should be prescribed medication for erosive and ulcerative lesions of the gastrointestinal tract, liver failure.

Pregnancy and lactation

Use of the drug Anvifen contraindicated during pregnancy and lactation.

Application for violations of liver function

Precautions should be prescribed the drug for hepatic failure

Cautions

Prolonged use is necessary to periodically monitor the performance of liver function and pattern of peripheral blood.

Effects on ability to drive vehicles and management mechanisms

During the period of drug administration should refrain from potentially hazardous activities requiring higher concentration.

Overdose

Symptoms: marked drowsiness, nausea, vomiting, fatty liver (receiving more than 7 g), eosinophilia, decrease blood pressure, renal dysfunction.

Treatment: gastric lavage, activated charcoal method and conduct of symptomatic therapy.

Drug Interactions

Anfiven while the application extends and enhances the action of hypnotic drugs, opioid analgesics, neuroleptics, antiparkinsonian, and anticonvulsants.

To the top

Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored in dry, protected from light, away from children at or above 25 ° C. Expiration -3 years.

Anvistat

Composition, structure and packing

Tablets, film-coated white or white with a slight yellowish tint, oblong shape, with risks on one side.

1 tab. atorvastatin calcium trihydrate 10,823 mg, which corresponds to the content of atorvastatin 10 mg.

Other ingredients: silicon dioxide colloidal, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The composition of the shell membrane: gipromelloza, talc, titanium dioxide (E171).

Tablets, film-coated white or white with a slight yellowish tint, oblong shape, with risks on one side.

1 tab. atorvastatin calcium trihydrate 21,646 mg, which corresponds to the content of atorvastatin 20 mg.

Other ingredients: silicon dioxide colloidal, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The composition of the shell membrane: gipromelloza, talc, titanium dioxide (E171).

Tablets, film-coated white or white with a slight yellowish tint, oblong shape, with risks on one side.

1 tab. - Atorvastatin calcium trihydrate 43,293 mg, which corresponds to the contents of atorvastatin 40 mg.

Other ingredients: silicon dioxide colloidal, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

The composition of the shell membrane: gipromelloza, talc, titanium dioxide (E171).

Clinico-pharmacological group

Lipid lowering drugs.

Pharmacological action

Synthetic lipid lowering drugs. Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase - the enzyme that determines the ultimate speed of cholesterol biosynthesis, responsible for the transformation of 3-hydroxy-3-methyl-glyutaril-coenzyme A to mevalonate, the precursor of sterols, including cholesterol.

In the liver, triglycerides and cholesterol are included in the very low density lipoproteins (VLDL), enter the blood plasma and transported to peripheral tissues. Because VLDL formed low-density lipoprotein (LDL), which kataboliziruyutsya primarily through interaction with the high affinity LDL.

Atorvastatin reduces levels of cholesterol and lipoproteins in blood plasma by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver, as well as by increasing the number of "liver" of LDL receptors on the cell surface, which increases the capture and katabolizatsiyu LDL.

Atorvastatin decreases the production of LDL and LDL particle number. Atorvastatin is pronounced and persistent increase in LDL receptor activity coupled with favorable changes in the quality of circulating LDL particles.

Dose-dependent manner reduces the level of LDL in patients with homozygous hereditary hypercholesterolemia, resistant to therapy with other lipid-lowering drugs.

Research dose ratio and the reaction showed that atorvastatin reduced total cholesterol (by 30-46%), LDL cholesterol (by 41-61%), apolipoprotein B (by 34-50%) and triglycerides (by 14-33%), simultaneously causing, in varying degrees, increased levels of HDL cholesterol and apolipoprotein A. These results were similar in patients with heterozygous familial hypercholesterolemia, non-family forms of hypercholesterolemia and mixed hyperlipidemia, including patients with insulin-dependent diabetes mellitus.

In connection with the reduction in total cholesterol, LDL cholesterol and apolipoprotein B decreased risk of cardiovascular disease and, consequently, decreases the risk of death. Study the impact of atorvastatin on morbidity and mortality has not yet been completed.

Pharmacokinetics

Absorption and distribution

Absorption - high. Cmax plasma levels achieved in 1-2 hours on a meal reduces the rate and duration of the absorption of the drug (25% and 9% respectively), but the decrease in LDL cholesterol similar to that in the application of atorvastatin without food. The concentration of atorvastatin when used in the evening is lower than in the morning (approximately 30%). Revealed a linear relationship between absorption rate and dose of the drug.

Bioavailability - 12%, systemic bioavailability of inhibitory activity against HMG-CoA reductase - 30%. The low systemic bioavailability due presistemnym metabolism in the mucosa of the gastrointestinal tract and the first passage through the liver.

The average Vd - 381 hp, the relationship with blood plasma proteins - 98%.

Metabolism

Metabolised mainly in the liver under the influence of isoenzymes CYP 3A4, CYP 3A5 and CYP 3A7 to the formation of pharmacologically active metabolites (ortho-and paragidroksilirovannyh derivatives, products of beta-oxidation). In vitro ortho-and paragidroksilirovannye metabolites exert an inhibitory effect on HMG-CoA reductase, comparable with that of atorvastatin. Inhibitory effect of the drug on HMG-CoA reductase by about 70% is determined by the activity of circulating metabolites.

Withdrawal

Is derived from the bile after liver and / or extrahepatic metabolism (not subject to pronounced enterohepatic recirculation). T1 / 2 - 14 hours inhibitory activity against HMG-CoA reductase saved about 20-30 h due to the presence of active metabolites. Less than 2% of the accepted oral dose of the drug determined in the urine. Not shown in the course of hemodialysis.

Pharmacokinetics in special clinical situations

Cmax in women above 20%, and AUC - below 10%.

Cmax in patients with alcoholic liver cirrhosis in 16 times, and the AUC - 11 times above normal.

Indications for use of the drug
in combination with diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides and raising HDL-cholesterol in patients with primary hypercholesterolemia, heterozygous familial and non-family hypercholesterolemia and combined (mixed) hyperlipidemia (Types IIa and IIb of Fredrickson) .
in combination with diet for treatment of patients with elevated serum levels of triglycerides (type IV according to Fredrickson) and patients with disbetalipoproteinemiey (type III according to Fredrickson), in which nutritional therapy does not provide an adequate effect;
to reduce the levels of total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological treatments are not sufficiently effective.

Dosage regimen

Is the inside at any time regardless of the meal. Before therapy with Anvistat ® should try to control hypercholesterolemia with diet, exercise and weight loss in patients with obesity, as well as treating the underlying disease.

Prior to the use of the drug the patient should be transferred to a standard diet, lowers cholesterol, and should continue to respect this diet during drug treatment.

The initial dose is 10 mg 1 time / daily dose ranges from 10 to 80 mg. The dose should be selected individually based on the initial level of LDL cholesterol, the goals of therapy and patient response to treatment. The maximum daily dose - 80 mg when receiving 1 time / At the beginning and / or while increasing the dose every 2-4 weeks is necessary to control lipid levels in blood plasma and to adjust dose.

At intervals of not less than 4 weeks should be corrected dose.

For patients with established CHD and other patients with high risk of coronary attacks, we recommend setting the following goals correction lipid levels: LDL-cholesterol below 3.0 mmol / l (or less than 115 mg / dL) and total cholesterol less than 5.0 mmol / l (or less 190 mg / dL).

When the primary hypercholesterolemia and combined (mixed) hyperlipidemia necessary control lipid levels in most patients provided 10 mg of the drug 1 times. The therapeutic effect was observed within 2 weeks and usually reaches a maximum within 4 weeks.

In heterozygous familial hypercholesterolemia patients treated should begin with the appointment of 10 mg. Through individual dose adjustment every 4 weeks, you should bring it up to 40 mg. You can then increase the dose to a maximum level equal to 80 mg / or use a combination of the appointment of 40 mg of the drug Anvistat ® and sekvestranta bile acids.

In homozygous familial hypercholesterolemia prescribed a dose of 80 mg 1 time.

There was no dose adjustment in patients with renal insufficiency is not required because renal dysfunction does not affect the concentration of atorvastatin in plasma or the degree of reduction of Tc-LDL in the treatment of drug Anvistat.

When liver failure dose should be reduced under the constant supervision of the activity of hepatic transaminases (ACT and ALT).

When using the drug in elderly patients differences in the safety, efficacy or goal lipid-lowering therapy compared with the general population is not mentioned, dose adjustment is required.

If necessary, a joint application with cyclosporine dose Anvistat ® should not exceed 10 mg.

Side effect

The most common (≥ 1%)
From the CNS: insomnia, headache, asthenia syndrome.
On the part of the digestive system: nausea, diarrhea, abdominal pain, dyspepsia, flatulence, constipation.
The part of the musculoskeletal system: myalgia.

Less frequently (<1%)
From the CNS: malaise, dizziness, amnesia, paresthesia, peripheral neuropathy, hypoesthesia.
On the part of the digestive system: vomiting, anorexia, hepatitis, pancreatitis, jaundice holestatitcheskaya.
On the part of the musculoskeletal system: back pain, muscle cramps, myositis, myopathy, myalgia, arthralgia, rhabdomyolysis.

Allergic reactions: rash, itching, rash, anaphylactic reactions, bullous eruption, polymorphic exudative erythema multiforme (including Stevens-Johnson syndrome), Lyell syndrome (toxic epidermal necrolysis).
The part of the hemopoietic system: thrombocytopenia.
From the Metabolic: hypo-or hyperglycemia, increased activity of serum CK.

Other: impotence, peripheral edema, weight gain, chest pain, secondary renal failure, alopecia, tinnitus, fatigue.

Contraindications to the use of the drug
active liver disease or increased activity of hepatic transaminases (more than 3 times compared with FHG) of unknown origin;
hepatic impairment (severity of A and B on the classification of Child-Pugh);
Pregnancy
Lactation (breastfeeding);
the age of 18 years (effectiveness and safety have not been established);
Hypersensitivity to the drug's components.

C should be used cautiously in patients who abuse alcohol, with indications in the history of the disease of the liver.

Pregnancy and lactation

Anvistat contraindicated in pregnancy. Women of reproductive age during treatment should use reliable methods of contraception.

The drug can be given to women of childbearing age only if the probability of pregnancy among them is very low, and the patient informed of the risks of treatment for the fetus.

The drug is contraindicated during breastfeeding. It is not known whether the drug is derived from breast milk. Given the possibility of adverse effects in infants, if necessary, use during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

The drug is contraindicated in active liver disease or increased activity of hepatic transaminases (more than 3 times compared to FHG) of unknown origin, with liver failure (severity of A and B on the classification of Child-Pugh).

C caution should be used when specifying a history of the disease of the liver.

Application for violations of renal function

Dosage adjustment in patients with renal insufficiency is not required.

Cautions

Before therapy with Anvistat ® patient must assign standard hypolipidemic diet, which he must comply during the whole period of treatment.

The use of inhibitors of HMG-CoA reductase to reduce the level of lipids in the blood can lead to changes in biochemical parameters reflecting liver function. Liver function should be monitored before starting therapy, after 6 weeks, 12 weeks after starting the drug and after each increasing dose, and periodically, eg every 6 months. Increased activity of liver enzymes in blood serum can be observed during drug therapy. Patients in whom there is an increase of enzyme activity should be under control until the return of enzyme levels back to normal. In the case of a persistent increase the activity of ALT or ACT to a level that exceeds more than 3 times the upper FHG, it is recommended to reduce the dose or stop treatment.

Anvistat should be used with caution in patients who abuse alcohol and / or have liver disease. Active liver disease or a persistent increase in liver transaminases of unknown origin is a contraindication to the use of the drug. Treatment of drug, like other inhibitors of HMG-CoA reductase may cause myopathy. The diagnosis of myopathy (pain and weakness in the muscles, combined with increased activity of CK more than 10 times compared to FHG) should be discussed in patients with widespread myalgia, tenderness or weakness of muscles and / or a pronounced increase in the activity of CK.

Patients need to warn that they should immediately inform your doctor about the appearance of unexplained pain or weakness in muscles, if they are accompanied by malaise or fever.

Drug therapy should be discontinued in the event of a pronounced increase in the activity of CK or in the presence of confirmed or suspected myopathy. The risk of myopathy during treatment with other drugs of this class increased, while use of cyclosporine, fibrates, erythromycin, nicotinic acid lipidsnizhayuschih doses or azolnyh antifungals. Many of these drugs inhibit the metabolism mediated by cytochrome P450 3A4, and / or transport of drugs. Atorvastatin biotransformiruetsya under the action of isoenzyme CYP3A4.

Appointing Anvistat drug in combination with fibrates, erythromycin, immunosuppressive means azolnymi antifungal medicines or nicotinic acid in lipidsnizhayuschih doses should carefully weigh the potential benefits and risks of treatment and regularly monitor patients to identify pain or weakness in muscles, especially during the first months of treatment and during increasing doses of any drug. In such situations, you can recommend a periodic determination of CK activity, although such control does not prevent the development of severe myopathy.

In applying the drug Anvistat, as other tools of this class, described cases of rhabdomyolysis with acute renal failure caused mioglobinuriey. Drug therapy should be suspended or completely cancel when the signs of a possible myopathy or presence of risk factors for renal insufficiency on the background of rhabdomyolysis (eg severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disturbances and uncontrolled seizures).

Effects on ability to drive vehicles and management mechanisms

Data on the adverse effect of the drug on driving ability and engage in potentially hazardous activities that require high concentration and speed of psychomotor reactions, no.

Overdose

Treatment: No specific antidote; spend symptomatic and supportive therapy as needed. Required monitoring of liver function and levels of CK in serum. Hemodialysis is ineffective.

Drug Interactions

The risk of myopathy during treatment of inhibitors of HMG-CoA reductase is increased when used in combination with cyclosporine, fibrates, macrolide antibiotics (including erythromycin, clarithromycin), antifungal medicines azolnymi or nicotinic acid in the lipid-lowering doses. In some rare cases, these combinations cause rhabdomyolysis, accompanied by renal failure in connection with mioglobinuriey. In this connection, the need to carefully assess the ratio of risks and benefits of combined treatment.

Metabolism of atorvastatin carried out with the participation of CYP3A4 isoenzyme. When using atorvastatin in combination with the CYP3A4 isoenzyme inhibitors (eg, cyclosporine, macrolide antibiotics such as erythromycin and clarithromycin, nefazodonom, azolnymi antifungal agents, for example, itraconazole, and inhibitors of HIV protease) may have drug interactions. With the combined use of drugs may be elevated concentrations of atorvastatin in plasma. In this regard, it should be particularly cautious when using atorvastatin in combination with the aforementioned means.

The simultaneous use of drugs, which reduce the concentration of endogenous steroid hormones (including cimetidine, ketoconazole, spironolactone), increases the risk reduction of endogenous steroid hormones (caution).

Atorvastatin and its metabolites are substrates for P-glycoprotein. Inhibitors of P-glycoprotein (eg, cyclosporine) can increase the bioavailability of atorvastatin.

With simultaneous use of atorvastatin and erythromycin (500 mg 4) or clarithromycin (500 mg, 2), which inhibit the CYP3A4 isoenzyme, there was an increased concentration of atorvastatin in plasma.

With simultaneous use of atorvastatin (10 mg 1 time /) and azithromycin (500 mg 1 time /), the concentration of atorvastatin in plasma did not change.

With the combined use of atorvastatin at a dose of 40 mg and itraconazole in a dose of 200 mg 1 time / increase in AUC were found to levels that exceeded the rate of 3 times.

The simultaneous use of atorvastatin with inhibitors of proteases, known as inhibitors of CYP3A4 isoenzyme, was accompanied by an increase in the concentration of atorvastatin in plasma (with simultaneous application with erythromycin Cmax of atorvastatin increased by 40%).

The combined use of atorvastatin 40 mg with diltiazem 240 mg leads to increased concentrations of atorvastatin in plasma.

Grapefruit juice contains at least one ingredient, is an inhibitor of isoenzyme CYP3A4, and may cause an increase in plasma concentrations of those drugs that are metabolized by isoenzymes CYP 3A4. Daily consumption of 240 ml grapefruit juice increased the AUC of atorvastatin by 37% and AUC of active metabolite ortogidroksi-20.4%. Consuming large quantities of grapefruit juice (more than 1.2 l / 5 days) increased the AUC of atorvastatin 2.5-fold, a AUC of the active inhibitor of HMG-CoA reductase inhibitors (atorvastatin + its metabolites) - 1.3 times. Consumption of large quantities of grapefruit juice during treatment with atorvastatin is not recommended.

Effects of drugs that induce CYP3A4 (eg, rifampin or efavirenz) for atorvastatin is unknown. Interaction with atorvastatin and other substrates of this isoenzyme is not known, but the possibility of this interaction should be considered when using drugs with low therapeutic index - in particular, class III antiarrhythmics, such as amiodarone.

The risk of myopathy caused by atorvastatin may increase with concomitant use of fibrates. Studies in vitro suggest that gemfibrozil may also interact with atorvastatin through inhibition of its glyukuronirovaniya that can cause increasing concentrations of atorvastatin in plasma.

If readmission of digoxin and atorvastatin 10 mg equilibrium concentrations of digoxin in the blood plasma did not change. However, the application of digoxin in combination with atorvastatin at a dose of 80 mg / concentration of digoxin increased by about 20%. Patients receiving digoxin in combination with atorvastatin, require appropriate monitoring.

Acceptance of atorvastatin in combination with oral contraceptives containing norethisterone and ethinylestradiol caused an increase in the concentrations of norethisterone and ethinyl estradiol in the blood plasma. These increasing concentrations should be considered when choosing doses of oral contraceptives. With simultaneous use of atorvastatin and contraceptives for oral administration containing norethisterone and ethinylestradiol showed a significant increase in AUC norethisterone and ethinyl estradiol by approximately 30% and 20% respectively. This effect should be considered when selecting oral contraceptive for women receiving atorvastatin.

When receiving colestipol in combination with atorvastatin had decreased concentrations of atorvastatin in plasma by approximately 25%. However, the combined use of atorvastatin and colestipol effects on lipids was more pronounced than when using each of these drugs individually.

With simultaneous use of atorvastatin at a dose of 10 mg 1 time / and azithromycin 500 mg 1 time / concentration of atorvastatin in plasma did not change.

With simultaneous use of atorvastatin and terfenadina clinically significant changes in pharmacokinetic parameters were found.

In simultaneous ingestion of atorvastatin, and the suspension containing magnesium hydroxide and aluminum, the concentration of atorvastatin in plasma decreased by about 35%, but the degree of reduction of Tc-LDL is not changed.

When receiving atorvastatin in combination with warfarin noted a slight decrease in prothrombin time in the first days of receiving atorvastatin, but, in the next 15 days measure prothrombin time returned to normal. Nevertheless, in the case of joint use of atorvastatin and warfarin, patients should be carefully monitored.

With simultaneous use of atorvastatin does not affect the pharmacokinetics fenazona, so interaction with other drugs, is metabolized by the same cytochrome isoenzymes are not expected.

The study combined the introduction of cimetidine and atorvastatin did not reveal significant interaction between these drugs.

In the combined administration of atorvastatin 80 mg and 10 mg of amlodipine changes in pharmacokinetic parameters of atorvastatin in the equilibrium state has been identified.

There was no clinically significant undesirable interactions of atorvastatin and antihypertensive agents. Studies of interaction with all the specific drugs were not conducted.

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Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored in dry, protected from light, away from children at or above 25 ° C. Shelf life - 3 years.

Anaerocef

Composition, structure and packing

Powder for solution for in / and / m the introduction of white or white with a yellowish tint.

1 vial. - Tsefoksitin (in the form of sodium salt) 500 mg - - 1 g

Solvent: water w / and (5 ml).

Clinico-pharmacological group

II generation cephalosporin

Pharmacological action

Cephalosporin antibiotic II generation of group cephamycin for parenteral administration. Bactericidal action due to blocking of bacterial transpeptidase, which leads to a breach of the final stages of synthesis of cell walls of microorganisms. It has a wide spectrum of antimicrobial action both against aerobic and anaerobic bacteria. Molecular structure tsefoksitina determines its high resistance to bacterial β-lactamases.

It is active against Gram-positive aerobes: Staphylococcus aureus, Staphylococcus epidermidis (including producing strains and neprodutsiruyuschie penicillinase), beta-hemolytic group A streptococci (Streptococcus pyogenes), beta-hemolytic streptococcus group B (Streptococcus agalactiae), Streptococcus pneumoniae; gram aerobes: Escherichia coli, Haemophilus influenzae, Eikenella corrodens (strains that do not produce β-lactamase), Klebsiella pneumoniae, Neisseria gonorrhoeae (including strains producing and neprodutsiruyuschie penicillinase), Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia spp. (Including Providencia rettgeri), Salmonella spp., Shigella spp.; Anaerobes: Actinomyces spp., Clostridium spp. (Except for Clostridium difficile), Peptococcus niger, Peptostreptococcus spp., Microaerophilic streptococci, Bacteroides spp. (Including Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron), Prevotella bivia.

Tsefoksitin not active against metitsillinoustoychivyh Staphylococcus spp., Enterococcus spp., Listeria monocytogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Mycobacterium spp., Rickettsia spp., Chlamydia spp., Mycoplasma spp., Ureaplasma spp.

Pharmacokinetics

Distribution

After 5 min after the bolus in / tsefoksitina administration at a dose of 1 g and 2 g Cmax of 110 mg / l and 244 mg / l, respectively. After 4 h after i / in a dose of 1 g of serum concentrations of less than 1 mg / liter.

After a / m administration tsefoksitina a dose of 1 g Cmax is achieved within 20 min and 30 mg / liter.

Well into the various fluids and tissues of the body: in the pleural, ascitic and synovial fluid bactericidal concentrations are determined in the bile. Vd - 0.16 L / kg. Binding to plasma proteins - 70-80%. Provided with breast milk in low concentrations.

Withdrawal

Write mainly in the kidneys in unchanged form (85% by glomerular filtration, 6% - due to tubular secretion), while in the urine are high concentrations of the drug. In the form of inactive metabolites derived only 0.2-5% of the administered dose. T1 / 2 with a / in the introduction of 41-59 min.

Pharmacokinetics in special clinical situations

T1 / 2 for i / v administration in elderly patients is 51-90 minutes.

Indications for use of the drug

Infections caused by susceptible microorganisms:
Infection of lower respiratory tract (including pneumonia, empyema, lung abscess);
abdominal infections (including peritonitis, abscess of the abdominal cavity);
infectious and inflammatory diseases of the pelvic organs (including endometritis, pelvioperitonit, salpingoophoritis);
urinary tract infections (pyelitis, pyelonephritis);
infections of skin and soft tissues;
infections of bones and joints;
uncomplicated gonorrhea;
septicemia.

Prevention of postoperative infectious complications.

Dosage regimen

Depending on the dose and the severity of infection, Anaerotsef ® can be entered in / in (jet or drip) or / m.

Adult sredneterapevticheskaya dose of 1-2 g every 6-8 hours

For uncomplicated urinary tract infection drug prescribed in / m and 1 g 2

In uncomplicated gonorrhea, including caused by penicillinase-producing strains of Neisseria gonorrhoeae, a drug injected once a / m in a dose of 2 g; simultaneously or 1 h later appointed interior 1 g probenecid.

In severe infections in / route of administration is preferable. Assign to 2 g every 4 hours or 3 g every 6 hours daily dose should not be more than 1912

Tsefoksitin excreted primarily by the kidneys, so patients with renal failure require adjustment in dosage regimen depending on the values of creatinine clearance.

Creatinine clearance Dose interval between doses
30-50 ml / min 1-2 g 8-12 h
10-29 ml / min 1-2 g 12-24 h
5-9 ml / min 0.5-1 g 12-24 h
<5 ml / min 0.5-1 g 24-48 h

Patients who are on hemodialysis is recommended after each hemodialysis introduce additional 1-2 g Anaerotsefa.

Children older than 1 month Anaerotsef injected at the rate of 30-40 mg / kg every 6-8 hours (maximum daily dose should not exceed 12 g). In mild and moderate infections possibly / m injection of the drug, in severe infections are preferable in / injection or in / infusion of the drug. Children up to 3 months Anaerotsef ® introduced only in /.

Babies first week of life in preterm infants weighing over 1500 g is introduced into / in a single dose of 30-40 mg / kg every 12 h; infants 1-4 weeks of life - in / on 30-40 mg / kg every 8 h .

Adults for the prevention of postoperative infectious complications introduced into / in a dose of 2 g for 30 min before the operation; on the testimony of the first day postoperative period - 2 g every 6 hours

In carrying out Cesarean operation Anaerotsef enter in / at a dose of 2 g immediately after clamping the umbilical cord.

Babies and children under 12 years Anaerotsef introduced into / in 30 minutes before the start of the operation at a dose of 30-40 mg / kg. According to testimony, the first postoperative days in addition introduce the drug in doses of 30-40 mg / kg every 6-8 hours (neonates - 8-12 h).

Terms of preparing and implementing solutions

Do not use solutions containing preservatives (eg benzyl alcohol in bacteriostatic water for injection) for preparation of solutions Anaerotsefa used in neonates.

For iv administration we recommend jet dissolving 1 g Anaerotsefa in 10 ml water for injection. The resulting solution should be injected into / in slowly for 3-5 minutes, possibly through the introduction of site for injection systems for in / infusion transfusion of compatible solutions.

When using a long / v infusion of 1 g Anaerotsefa dissolved in 3-5 ml of sterile water for injection, and after complete dissolution of the resulting solution added to 200-400 ml of a compatible infusion medium: 0.9% sodium chloride, 5% dextrose (glucose) aqueous solution containing 5% dextrose (glucose) and 0.9% sodium chloride. Enter in / drip, use the system for to / in infusions.

To prepare the solution for i / m administration, 1 g Anaerotsefa dissolved in 2-3 ml of one of the following solvents: water for injection, 0.5% lidocaine hydrochloride, 1% lidocaine hydrochloride. Enter deeply into the / m in area with a distinct muscular layer (upper-outer quadrant of the buttocks), previously holding an aspiration test, to avoid the introduction of a blood vessel.

Side effect
From the urinary system: increasing serum creatinine, interstitial nephritis, renal failure.
On the part of the digestive system: nausea, vomiting, dry mouth, decreased appetite, diarrhea, pseudomembranous enterocolitis, increase in liver transaminases.
The part of the hemopoietic system: leukopenia, granulocytopenia, neutropenia, anemia, thrombocytopenia, bone marrow suppression, hemolytic anemia.
Since the cardiovascular system: arterial hypotension.

Allergic reactions: rash, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, fever, shortness of breath; rare - anaphylactic reaction, angioedema.

Local reactions: thrombophlebitis after i / v injection; pain, induration in the ground / m injections.

Other: aggravation flow myastenia gravis, patients with azotemia possible false-positive Coombs' reaction.

Contraindications to the use of the drug
Hypersensitivity to tsefoksitinu and other cephalosporin antibiotics.

Precautions should be prescribed to patients with allergic reactions to penicillin in history as possible cross allergy between penicillins and cephalosporins, with guidance on the history of ulcerative colitis in renal insufficiency.

Pregnancy and lactation

Application Anaerotsefa pregnant possible in cases where the intended benefits to the mother outweighs the potential risk to the fetus, and must be supervised by a specialist.

During treatment tsefoksitinom breastfeeding should be discontinued.

Application for violations of renal function

Tsefoksitin excreted primarily by the kidneys, so patients with renal insufficiency requires the introduction of correction mode, depending on the values of creatinine clearance.

Creatinine clearance Dose interval between doses
30-50 ml / min 1-2 g 8-12 h
10-29 ml / min 1-2 g 12-24 h
5-9 ml / min 0.5-1 g 12-24 h
<5 ml / min 0.5-1 g 24-48 h

Patients who are on hemodialysis is recommended after each hemodialysis introduce additional 1-2 g Anaerotsefa.

Cautions

Anaerotsef used for monotherapy for the treatment of mixed aerobic-anaerobic infections of various sites, including caused by strains of bacteria that are resistant to penicillins, other cephalosporins, and aminoglycosides Lincosamides.

Patients who had a history of allergic reactions to penicillin, may have heightened sensitivity to cephalosporin antibiotics.

For the treatment of newborns should use a solvent without preservatives.

Use of the drug in high doses in children accompanied by an increase in frequency of eosinophilia and increased activity of AST.

Anaerotsef not recommended for treatment of bacterial meningitis.

Using the method of Jaffe may falsely inflated the concentration of creatinine in serum, therefore, not recommended to collect blood samples for determination of creatinine within 2 h after injection tsefoksitina.

Overdose

Data on drug overdose Anaerotsef not available.

Drug Interactions

With the simultaneous use of aminoglycosides observed synergy of antimicrobial action, mainly in respect of Enterobacteriaceae.

Drugs that block tubular secretion, increase the concentration of drug in the blood and the duration of its action.

The simultaneous use of aminoglycosides and other cephalosporins increases the risk of nephrotoxicity.

At the same time / in the introduction of the solution Anaerotsefa possible with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose (glucose), 10% dextrose (glucose), an aqueous solution containing 5% dextrose (glucose) and 0.9% sodium chloride , Ringer's solution, 2.5%, 5% and 10% mannitol solution.

Because pharmacological incompatibility, do not mix in same syringe, or single infusion medium solutions Anaerotsefa and aminoglycosides.

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Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored in dry, protected from light, away from children at or above 25 ° C. Shelf life - 2 years.

Anafranil

Composition, structure and packing

Solution for in / and / m the introduction of transparent, colorless.

1 ml. clomipramine hydrochloride 12.5 mg.

1 amp. clomipramine hydrochloride 25 mg.

Other ingredients: glycerol, water, d / and.

Clinico-pharmacological group: Antidepressants.

Pharmacological action

Antidepressant drug (tricyclic antidepressant). Also has some analgesic (of central genesis), H2-gistaminoblokiruyuschee and antiserotoninovoe action helps eliminate bed-wetting and reduces appetite. It has a strong peripheral and central anticholinergic effects associated with high affinity for m-cholinergic receptors, a strong sedative effect connected with affinity for the H1-histamine receptors, and alpha-adrenoceptor blocking action. Has the properties of anti-arrhythmic drugs subgroups Ia, like quinidine in therapeutic doses, slows ventricular conduction (in overdose can cause severe intraventricular block).

The mechanism of antidepressant action is associated with an increase in the concentration of noradrenaline in the synapses and / or serotonin in the CNS. The accumulation of these neurotransmitters is the result of inhibition of reuptake of presynaptic membranes of neurons (reuptake of serotonin is reduced to a greater extent than on the background of other tricyclic antidepressants).

Prolonged use reduces the functional activity of beta-adrenergic and serotonin receptors of the brain, normalizes adrenergic and serotonergic transmission, restores the balance of these systems are impaired in depressive states. Eliminates psychomotor retardation, depressed mood, anxiety. Has analgesic action, which is believed to be associated with changes in concentrations of monoamines in the CNS, especially serotonin, and the impact on the endogenous opioid system.

The mechanism of anxiolytic action associated with a decrease in the rate of excitation of locus ceruleus by regulating the functions of alpha2-and beta-adrenergic receptors and norepinephrine turnover.

The mechanism of action for bulimia nervosa is unclear (perhaps similar to those with depression). Revealed a distinct effect of the drug in patients with bulimia as without depression, and if available, to the reduction of bulimia may occur without a concomitant weakening of the most depressed.

Antidepressant effect is already at 1 week of application.

Psychostimulant action is expressed to a lesser extent than imipramine, and sedative - weaker than amitriptyline. In attacks narcoleptic sleepiness effect is weak or absent.

Statement
depressive states of various etiologies and with various symptoms (endogenous, reactive, neurotic, organic, masked and involutional depression);
depressive symptoms in schizophrenia and personality disorders;
presenile and senile depression;
depression during long-term pain syndrome and chronic somatic diseases;
reactive depressive disorders, neurotic and psychopathic nature, including their somatic equivalents in children;
obsessive-compulsive syndromes (phobia), panic panic attacks, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic diseases, atypical facial pain, postherpetic neuralgia, posttraumatic neuropathy, diabetic or other peripheral neuropathy), the narcolepsy is accompanied by catalepsy;
headache, migraine (prevention).

Dosage regimen

Inside, during or immediately after a meal (to reduce the irritation of the gastric mucosa) in / m in / in. If possible, seek the appointment of the drug as possible at lower doses, especially in the treatment of elderly patients and adolescents with depression.

Depression, obsessive-compulsive syndromes and phobias - inside, and 25 mg 2-3 times daily or 1 tablet of long-acting (75 mg) 1 times a day, preferably in the evening. Within 1 week of treatment the daily dose gradually increased to 100-150 mg (2 tablets retard 75 mg).

If necessary, you can assign and large doses.

After reaching effect in the prescribed maintenance dose on average 50-100 mg or 1 tablet 75 mg. V / m: initial dose - 25-50 mg, then every day should be administered at 25 mg more, until the dose reaches 100-150 mg / day.

After improving gradually reduce the number of injections, and then transferred to oral maintenance dose.

In / in the introduction begin with a single drop infusion during 1.5-3 h 50-75 mg (contents of dissolved and thoroughly mixed with 250-500 ml 0.9% NaCl solution or 5% dextrose).

Given the daily fluctuations of the state of depressive patients, it is preferable to infusion in the morning. Outpatients after i / v infusion should be under strict supervision.

After achieving a noticeable effect (usually within the first 7 days) infusion continued for a further 3-5 days.

To maintain the achieved effect is necessary to continue ingestion. The gradual transition from / v injections to receive the inside can be facilitated by resorting to the intermediate phase in / m injection. In narcolepsy, accompanied by catalepsy, - inside, at a dose of 25-75 mg / day.

In chronic pain syndromes - inside, at a dose of 10-150 mg / day, given the concurrent appointment of a patient analgesics, as well as the possibility of reducing the injected dose of the latter.

Panic attacks: an initial dose - 10 mg / day, possibly in combination with benzodiazepines. Depending on the tolerability of the drug dose is increased to obtain the desired result, gradually stop taking the benzodiazepine. Do not discontinue treatment earlier than 6 months. During this time, should gradually reduce the dose supportive.

Geriatrics: an initial dose - 10 mg / day. Gradually (over 10 days) dose increased to the optimum (30-50 mg / day) and stick to this dose until the end of treatment.

Pediatrics: initial dose - 10 mg per day, within 10 days of daily dose increased: in children aged 5-7 years - up to 20 mg, aged 8-14 years - up to 20-50 mg, and children over 14 years - to 50 mg and above.

Side effect

Anticholinergic effects: blurred vision ("a veil before the eyes), paresis of accommodation, mydriasis, increased intraocular pressure (only in the eyes of the local anatomic predisposition - a narrow angle of anterior chamber), tachycardia, dry mouth, confusion, delirium or hallucination, constipation, paralytic ileus, difficulty urinating, reduced sweating.

Of the nervous system: drowsiness, asthenia, anxiety, disorientation, hallucinations (especially in elderly patients and patients with Parkinson's disease), anxiety, agitation, restlessness, manic state, hypomanic state, aggression, memory impairment, depersonalization, increased depression , reduced ability to concentrate, insomnia, nightmares, dreams, yawning, fatigue, activation of the symptoms of psychosis, headache, myoclonus, dysarthria, tremor of small muscles, especially the hands, arms, head and tongue, peripheral neuropathy (paresthesias), myasthenia gravis , myoclonus, ataxia, extrapyramidal syndrome, increased seizures, EEG changes, hyperpyrexia.

From the CCC: sinus tachycardia, palpitations, dizziness, orthostatic hypotension, collapse, clinically insignificant ECG changes (ST interval and T wave) in patients not suffering from heart disease, arrhythmia, blood pressure lability (decreased or increased blood pressure), violation of intraventricular conduction (expansion of the complex QRS, change the interval PQ, bundle branch block feet, AV block).

On the part of the digestive system: nausea, rarely - hepatitis (including a change in the functional "liver" tests and cholestatic jaundice), indigestion, vomiting, stomachalgia, increased appetite and body weight, or decreased appetite and weight loss, stomatitis, glossitis, dental caries, a change of taste , diarrhea, darkening of the tongue.

On the part of the endocrine system: an increase in size (swelling) of testicles, gynecomastia, enlargement of the mammary glands, hyperprolactinemia, galactorrhea, decreased or increased libido, reduced potency, hypo-or hyperglycemia, hyponatremia (decreased production of vasopressin), a syndrome of inappropriate secretion of ADH.

From the side of hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia, purpura, eosinophilia. Allergic reactions: skin rash, itching, rash, photosensitivity, angioedema.

Other: hair loss, tinnitus, edema, petechiae, "tides" of blood to the skin of the face, sensation of heat or cold, urinary retention, frequent urination, hypoproteinemia, hyperpyrexia. Symptoms of the syndrome of "cancellation" (after the sudden cancellation of long-term treatment): nausea, vomiting, diarrhea, headache, malaise, sleep disturbances, unusual dreams, unusual excitement, with the gradual abolition after long-term care - irritability, restlessness, sleep disturbances, unusual dreams.

Local reaction to / in the introduction: thrombophlebitis, lymphangitis, burning sensation, allergic skin reactions.

Overdose.

Symptoms: developed 4 hours after the overdose, reach a maximum after 24 h and lasts 4-6 days. If you suspect an overdose, especially in children, the patient should be hospitalized.

From the CNS: drowsiness, stupor, coma, ataxia, insomnia, hallucinations, anxiety, psychomotor agitation, reduced ability to concentrate, confusion, hyperreflexia, muscular rigidity, choreoathetosis, seizures.

From the CCC: lowering blood pressure, tachycardia, arrhythmia, a violation of intracardiac conduction (intraventricular block, AV block), characteristic of tricyclic antidepressants intoxication, ECG changes (especially the QRS), shock, CH, in very rare cases - cardiac arrest.

Other: respiratory depression, apnea, cyanosis, apnea, vomiting, hyperthermia, mydriasis, increased sweating, oliguria or anuria.

Treatment: oral uptake - gastric lavage, the appointment of activated charcoal, symptomatic and supportive therapy, in severe anticholinergic effects (lowering of blood pressure, arrhythmias, coma, myoclonic epileptic seizures) - the introduction of cholinesterase inhibitors (application Physostigmine is not recommended because of the increased risk of convulsions ) maintenance of blood pressure and water and electrolyte balance. Showing the control functions of SSA (including ECG) within 5 days (relapse can occur after 48 h and later), anticonvulsant therapy, mechanical ventilation and other resuscitation. Hemodialysis and forced diuresis are ineffective.

Contraindications
hypersensitivity
used in conjunction with MAO inhibitors and for 2 weeks before treatment,
myocardial infarction (acute and subacute periods)
acute alcohol intoxication,
acute intoxication with hypnotics,
analgesic and psychoactive drugs,
-closure glaucoma,
severe conduction disturbances (bundle branch block feet, AV block II Art.)
lactation,
children's age (10 years - for obsessive states, up to 12 years - with depression).

C carefully. Chronic alcoholism, asthma, manic-depressive psychosis, depression of bone marrow hemopoiesis, pregnancy (especially the I term), diseases of the CAS (angina, arrhythmias, heart block, CHF, myocardial infarction, hypertension), stroke, gastrointestinal disturbances in motor function (the risk of paralytic ileus), intraocular hypertension, liver and / or renal failure, hyperthyroidism, prostatic hyperplasia, urinary retention, schizophrenia (possible activation of psychosis), epilepsy, old age.

Pregnancy and lactation

Drugs are taken with caution.

Cautions

Before treatment is necessary to monitor blood pressure (in patients with low or labile blood pressure, it can be reduced even more) during treatment - control peripheral blood (in some cases may develop agranulocytosis, and therefore it is recommended to monitor blood picture, especially when increase in body temperature, the development of influenza-like symptoms and sore throat), with long-term therapy - control functions of the SSA and the liver.

In elderly and patients with diseases of the SSA shows control of heart rate, blood pressure, ECG. The ECG may appear clinically insignificant changes (smoothing of the T wave, depression of segment ST, the expansion of the complex QRS).

Parenteral application is possible only in hospital under medical supervision, compliance with bed rest in the first days of therapy. Caution is necessary when a dramatic shift in the vertical position from the position of "lying" or "sitting". In the period of treatment should be excluded use of ethanol. Assign no earlier than 14 days after discontinuation of MAO inhibitors, beginning with small doses.

At the reception after the sudden cessation of long-term treatment may develop the syndrome of "cancellation". Dose-dependent manner lowers the threshold of convulsive readiness (used with caution in patients with epilepsy, as well as the presence of other predisposing factors, the emergence of convulsant disorders, such as traumatic brain injury of any etiology, the simultaneous use of antipsychotic drugs (neuroleptics) in the period of non-ethanol or cancel drugs with anticonvulsant properties, such as benzodiazepines). Pronounced depression of the peculiar risk of suicidal actions, which may persist until a substantial remission. In this regard, early treatment can be shown with a combination of drugs from the group of benzodiazepines, or antipsychotic drugs and constant medical control (charging proxies storage and issuing of drugs).

Many patients with panic attacks in the early treatment of increased anxiety. Such a paradoxical anxiety enhancement is most marked in the first days of therapy and usually subsides within 2 weeks. Patients with cyclic affective disorders during the depressive phase of the therapy may develop manic or hypomanic (required dose reduction or withdrawal of the drug and the appointment of antipsychotic drugs). After coping with these states, if there are indications, treatment at low doses can be reopened.

Because of the possible cardiotoxic effects need to be careful when treating patients with thyrotoxicosis or patients receiving thyroid hormone drugs. In conjunction with electroconvulsive therapy shall be appointed only with careful medical supervision.

In predisposed patients and elderly patients may provoke the development of drug psychoses, mainly at night (after the withdrawal of the drug are within a few days). Can cause paralytic ileus, mainly in patients with chronic constipation, elderly, or patients who are forced to comply with bed rest. Before general or local anesthesia should warn the anesthesiologist that the patient takes clomipramine. Because anticholinergic actions may reduce watery, and the relative increase in the number of mucus in the tear fluid, which can cause damage to the corneal epithelium in patients using contact lenses.

Prolonged use of an increase in the incidence of dental caries. The study of reproduction in animals showed adverse effects on the fetus, and adequate and strictly controlled studies in pregnant women has not been conducted.

Pregnant women should use the drug only if the intended benefits to the mother outweighs the potential risk to the fetus. Penetrates into breast milk and may cause drowsiness in infants. In order to avoid the development of the syndrome of "cancellation" in neonates (proyavlyaetya shortness of breath, drowsiness, intestinal colic, increased nervous excitability, hypotension or hypertension, tremor or spastic phenomena) receiving clomipramine gradually canceled at least 7 weeks prior to delivery.

Children compared with adults are more sensitive to acute overdosage, which should be considered dangerous and potentially lethal to them.

During the period of treatment must be careful when driving and other lesson potentially dangerous activities which require high concentration and speed of psychomotor reactions.

Drug Interactions

When the joint application of ethanol and drugs which depress the central nervous system (including other antidepressants, barbiturates, benzodiazepines and general anesthetics) may be a considerable increase in inhibitory action on the CNS, respiratory depression and hypotensive effect. Increases sensitivity to drinks containing ethanol. Increases anticholinergic effects of amantadine and other drugs with anticholinergic activity (eg phenothiazines, antiparkinsonian drugs, atropine, biperidena, antihistamine drugs), which increases the risk of side effects (from the central nervous system, eyes, intestines and bladder).

When combined with the use of antihistamine drugs, clonidine - increased inhibitory action on CNS, with atropine - increases the risk of paralytic ileus, with drugs causing extrapyramidal reactions - the severity and frequency of extrapyramidal effects.

With simultaneous application of clomipramine and indirect anticoagulants (coumarin derivatives or indadiona) may increase anticoagulant activity of the latter. Clomipramine may exacerbate depression caused by SCS.

When combined with the use of anticonvulsant drugs may be increased inhibitory action on the central nervous system, reducing the threshold of seizure activity (when used in high doses) and reduced the effectiveness of the latter. Drugs for the treatment of thyrotoxicosis increase the risk of agranulocytosis. Reduces the effectiveness of phenytoin and alpha-blockers. Inhibitors of microsomal oxidation (cimetidine), extend T1 / 2, increase the risk of toxic effects of clomipramine (may require dose reduction clomipramine 20-30%), inducers of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotine, oral contraceptives) reduce the concentration in plasma and reduce the effectiveness of clomipramine. Fluoxetine and fluvoxamine increase the concentration of clomipramine in plasma (may require dose reduction clomipramine 50%).

In a joint application with holinoblokatorami, phenothiazines and benzodiazepines - are mutually reinforcing sedative and central anticholinergic effects and increased risk of epileptic seizures (threshold decrease seizure activity), phenothiazines, in addition, may increase the risk of neuroleptic malignant syndrome.

With simultaneous application of clomipramine with clonidine guanetidinom, betanidinom, reserpine and methyldopa - reduction of the hypotensive effect of the latter; with cocaine - the risk of cardiac arrhythmias. Estrogensoderzhaschie oral contraceptive drugs and estrogens may increase the bioavailability of clomipramine, antiarrhythmic drugs (such as quinidine) - the risk of arrhythmias (possibly slowing metabolism clomipramine).

Combined use of disulfiram and other inhibitors atsetaldegidrogenazy provokes delirium. Incompatible with MAO inhibitors (possible increase in the frequency of periods hyperpyrexia, severe convulsions, hypertensive crises, and the patient's death). Pimozid and probucol may increase cardiac arrhythmia, which is manifested by the lengthening of the QT interval on ECG. Enhances the effect of the SCA epinephrine, norepinephrine, isoprenaline, ephedrine and phenylephrine (including when these drugs are part of local anesthetics), and increases the risk of cardiac arrhythmia, tachycardia, severe hypertension.

Combined use of alpha-adrenostimulyatorov for intranasal administration, or for use in ophthalmology (with significant systemic absorption) can be amplified vasoconstrictor action of the latter.

In a joint reception with thyroid hormones - the mutual reinforcement of therapeutic effects and toxic effects (including cardiac arrhythmia and a stimulating effect on the CNS). M-holinoblokatory and antipsychotic drugs (neuroleptics) increase the risk of hyperpyrexia (especially during hot weather). Solution for injection is incompatible with diclofenac solution for injection.

At a joint appointment with other drugs may gain gematotoksichnymi gematotoksichnosti.

Terms and Conditions of storage

Store in a dark place at temperatures not above 30 ° C.

Shelf life 5 years

Anaferon for kids

Composition, structure and packing

Tablets homoeopathic from white to white with kremovatym color, round, flat surfaces, with the risk, with full margins, with a smooth, homogeneous surface.

1 tab. mixture of homeopathic dilutions of affinely purified antibodies to human interferon gamma C12, C30, C50.

Excipients: calcium stearate, microcrystalline cellulose, lactose, aerosil.

Clinico-pharmacological group: Homeopathic medicine for activating antiviral immunity.

Pharmacological action

The drug with immunomodulating and antiviral properties. Anaferon child is ultralow doses affinely purified antibodies to human interferon gamma, obtained by homeopathic technology. The drug stimulates the humoral and cellular immunity.

Increases the production of antibodies (including secretory IgA), reduces the level of IgE, activates the function of T effector and T-helper (Th), normalize their relationship.

Increases functional reserve Th and other cells involved in immune response.

Induces the formation of endogenous early interferons (alpha / beta) and interferon gamma. An inducer of mixed (Th1, Th2-type) immune response: increased cytokine production and Th1 (interferon gamma, interleukin 2) and Th2 (interleukin 4 and 10), normalizes the balance of Th1/Th2 activity.

Increases phagocytic activity of macrophages and neutrophils. Reduces the concentration of virus in infected tissues. Has antimutagenic properties. The drug reduces the severity and duration of the main manifestations of viral infections of upper respiratory tract (coughing, runny nose, sore throat, fever, headache, herpetic lesion of the skin and mucous membranes), reduces the likelihood of septic foci, and the risk of bacterial complications.

Pharmacokinetics

Carrying out the kinetic studies is not possible, because active substance can not be traced with the help of markers or bioissledovany.

Statement
prevention and treatment of influenza, SARS, viral infections of upper respiratory tract (rhinitis, pharyngitis, laryngitis, tracheobronchitis), herpes and cytomegalovirus infections, other acute and chronic viral infections;
treatment of secondary immunodeficient states of various etiologies;
in the complex therapy of bacterial infections;
prevention and treatment of complications of viral infections.

Dosage regimen

Acceptance of the drug should be started at the first signs of respiratory disease, as follows: in the first 2 hours take 1 tablet. every 30 minutes, then during the first days 3 more pills. at regular intervals.

On the second day and then be taken on 1 tab. 3 times / day until recovery. After the relief of acute conditions for prevention of bacterial complications of a drug should be taken on 1 tab. 1 time per day on an empty stomach for 8-12 days (up to a full recovery). The tablet should be kept in the mouth until completely dissolved.

Administration of these drugs to young children tablet should be dissolved in a small amount of warm water (room temperature).

Side effect

When applying for the indications and recommended doses side effects have been identified.

Contraindications
Hypersensitivity to the drug.

Cautions

Results from clinical studies show that Anaferon children has significantly proven preventive and therapeutic efficacy against SARS in children aged 6 months to 14 years. In the absence of clinical improvement on day 3 taking the drug should consult a doctor.

The drug can be used as part of combination therapy with analgesics, antipyretics and NSAIDs, thereby reducing the dose and shorten the duration of reception of the latter.

Overdose

So far, cases of overdose Anaferon not been described.

Drug Interactions

Cases of incompatibility with other pharmacological agents were observed.

Terms and Conditions of storage

The drug should be stored in a dry, protected from light and away from children at or above 25 ° C. Shelf life - 3 years.

Anauran

Composition, structure and packing

Ear Drops

1 ml.

polymyxin B sulfate, 10 thousand m

neomycin sulfate equivalent to neomycin 3.75 thousand m (5 mg)

Lidocaine hydrochloride 40 mg.

Excipients: benzalkonium chloride, propylene glycol, glycerol, purified water.

Clinico-pharmacological group: The product with antimicrobial and mestnoanesteziruyuschee effect for local use in ENT-practice

Pharmacological action

Combined tool for local use, has antibacterial and mestnoanesteziruyuschee effect. Neomycin sulfate - aminoglycoside antibiotics of broad-spectrum, bactericidal effect against Gram-positive (Staphylococcus spp., Streptococcus pneumoniae) and Gram-negative (Escherichia coli, Shigella dysenteria spp., Shigella flexneri spp., Shigella boydii spp., Shigella sonnei spp., Proteus spp .) microorganisms; against Streptococcus spp. - Maloaktiven. Polymyxin B - a polypeptide antibiotic. It is active against Gram-negative microorganisms: Escherichia coli, Shigella dysenteria spp., Shigella flexneri spp., Shigella boydii spp., Shigella sonnei spp., Salmonella typhi and Salmonella paratyphi; Pseudomonas aeruginosa. Inactive against Proteus spp., Mycobacterium spp., Gram-positive cocci and fungi. It provides a weak local irritating action. Lidocaine - mestnoanesteziruyuschee tool that quickly removes the pain and itching.

Statement
Acute and chronic external otitis,
chronic acute otitis media before and after perforation,
chronic otitis media with gnoetecheniem;
postoperative purulent complications after radical mastoidektomii,
tympanoplasty,
antrotomii,
fenestration.

Dosage regimen

Local. Adults - 4-5 cap into the outer ear canal, 2-4 times a day, children - 2-3 cap 3-4 times a day

Side effect

Hyperemia, itching and skin peeling ear canal.

Contraindications
hypersensitivity.

C carefully. Pregnancy, Infancy (under 1 year).

Pregnancy and lactation

The drug is taken with caution.