Flexeril

Flexeril Drug Uses

Flexeril is a muscle relaxant, used to treat the pain and stiffness of muscle injuries, including strains, sprains and muscle spasms. The active ingredient in Flexeril is cyclobenzaprine.

How Taken Flexeril

Flexeril comes in 10 mg tablets, and the normal dose in adults is one 10 mg tablet three times daily. You should not exceed a total dosage of 60 mg of Flexeril per day. It might be taken with food if stomach upset occurs. Take Flexeril as directed. Do not increase your dose or take it more often than prescribed.

Warnings/Precautions

Flexeril may not be suitable for all individuals. If you have had any of the following conditions in the past, or are being treated for them now, please inform your doctor. In some cases side effects may be minimized by following your doctor's advice, but you may be advised not to take Flexeril. Before taking this drug, tell your doctor if you have: glaucoma, an overactive thyroid gland, heart disease, difficulty urinating or any allergies. Inform your doctor if you are pregnant or breast-feeding before taking this drug.

Missed Dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Possible Side Effects

May cause stomach upset, heartburn, constipation, headache, dizziness or drowsiness or dry mouth the first few days as your body adjusts to the medication. If these symptoms persist or become severe, notify your doctor. Inform your doctor if you develop: muscle stiffness, skin rash, itching, rapid heart rate, swelling of the face, difficulty urinating. When rising quickly from a sitting or lying position, dizziness or lightheadedness may occur. Change positions slowly and use caution on stairs. Avoid activities requiring alertness if dizziness or drowsiness occurs. If you notice other effects not listed above, contact your doctor or pharmacist.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) and out of reach of children.

Overdose

The following symptoms indicate an overdose, get medical help immediately: difficulty breathing, extreme nervousness or restlessness, flushed skin, hallucination, racing or irregular heartbeat, seizure, shortness of breath, tiredness (extreme), unstable temperature, unusual muscle stiffness, vomiting (in combination with these other symptoms).

More Information about Flexeril

Flexeril may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

Cialis

Composition, structure and packing

Tablets, film-coated yellow, almond-shaped, with the inscription "From 20" on one side.
1 tab.
Tadalafil 20 mg



Excipients: lactose monohydrate, croscarmellose sodium, gidroksipropiltsellyuloza, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, a mixture of dye Opadry II yellow.

1 pc. - Blisters (1) - packs cardboard.

2 pcs. - Blisters (1) - packs cardboard.

4 pcs. - Blisters (1) - packs cardboard.

8 pcs. - Blisters (1) - bundle pasteboard.

Clinico-pharmacological group: Drug for treatment of erectile dysfunction. PDE-5 inhibitor

Registration № №:
Tab., cover. membranous sheath, 20 mg: 1, 2, 4 or 8 pieces. - P № 014761/01-2003, 17.02.03 outage

Pharmacological action

The drug for the treatment of erection. Is a reversible selective inhibitor of specific phosphodiesterase type 5 (PDE-5) cGMP. When sexual stimulation causes local release of nitric oxide, inhibition of PDE-5 tadalafilom leads to increased levels of cGMP in the cavernous body of penis. The result is relaxation of smooth muscles of arteries and blood flow to the tissues of the penis that causes erections. Tadalafil has no effect without sexual stimulation.

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE-5. PDE-5 - an enzyme found in smooth muscles of cavernous bodies in the vascular smooth muscles of internal organs, skeletal muscle, platelets, kidney, lung cerebellum.

Effects of tadalafil for PDE-5 is more active than other phosphodiesterase. Tadalafil 10 000 times more active against PDE-5 than for FDE1, FDE2, FDE4, FDE7, which are located in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle and other organs. Tadalafil 10 000 times more active blocks PDE-5 than FDE3 - an enzyme that is found in the heart and blood vessels. This selectivity against PDE-5 compared with FDE3 is important, because FDE3 is an enzyme involved in the reduction of the heart muscle. In addition, tadalafil is approximately 700 times more active against PDE-5 than in respect FDE6 found in the retina and is responsible for fotoperedachu.

Tadalafil is also shown in action 9000 times more potent against PDE-5, compared with its effect on FDE8, 9 and 10 and 14 times more potent against PDE-5, compared with FDE11. Distribution in tissues and physiological effects of inhibition FDE8-FDE11 so far not been clarified.

Tadalafil improves erection and the possibility of successful sexual intercourse.

The drug acts within 36 h. The effect is manifested as little as 16 minutes after taking the drug in the presence of sexual stimulation.

Tadalafil in healthy individuals causes no significant change in systolic and diastolic blood pressure compared with placebo in the supine position (mean maximum decrease of 1.6/0.8 mm Hg, respectively) and standing (mean maximum decrease of 0.2/4.6 mm Hg, respectively ). Tadalafil does not cause significant change in heart rate.

Tadalafil does not cause changes in the recognition of color (blue / green), which explains its low affinity for FDE6. In addition, no marked effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.

Tadalafil does not cause changes in the level of testosterone, LH and FSH in blood plasma.

There were no clinically significant effect on the characteristics of sperm in men taking tadalafil at daily doses over 6 months in placebo-controlled studies.

Pharmacokinetics

Absorption

After oral tadalafil is rapidly absorbed. C max achieved after an average of 2 hours speed and extent of absorption do not depend on the meal. Time of drug administration (morning or evening) has no clinically significant effect on the rate and extent of absorption.

Tadalafil pharmacokinetics in healthy individuals is linear with respect to time and dose. At doses ranging from 2.5 to 20 mg AUC increased proportionally to dose. C ss in plasma are attained within 5 days while taking the drug 1 times / day.

The pharmacokinetics of tadalafil in patients with erectile dysfunction is similar to the pharmacokinetics of the drug in patients without erectile dysfunction.

Distribution

The average V d is about 63 liters, indicating that tadalafil is distributed in the tissues of the body. At therapeutic concentrations, 94% tadalafil bound to plasma proteins. In healthy persons less than 0.0005% of the administered dose was found in semen.

Metabolism

Metabolised involving isoenzyme CYP3A4. The main circulating metabolite is metilkateholglyukuronid. He is 13000 times less active against PDE-5 than tadalafil. Therefore, this metabolite is unlikely to be clinically significant.

Withdrawal

In healthy individuals the average clearance of tadalafil ingestion of 2.5 l / h and an average T 1 / 2 - 17.5 hours Tadalafil appears mostly as inactive metabolites mainly in the faeces (61%) and to a lesser extent in the urine (about 36%).

Pharmacokinetics in special clinical situations

Healthy elderly (65 years and over) have lower clearance tadalafil, which was reflected in increased AUC by 25% compared with healthy people aged 19 to 45 years. This distinction is not clinically significant and does not require selection of a dose.

In patients with renal insufficiency, including patients on hemodialysis, AUC greater than in healthy individuals. Protein binding is not altered by disrupting kidney function.

The pharmacokinetics of tadalafil in patients with mild or moderate hepatic insufficiency comparable to that in healthy individuals. For patients with severe hepatic insufficiency (class C according to Child-Pugh scale) data are not available.

Patients with diabetes mellitus during treatment with tadalafil AUC was lower by about 19% lower than in healthy individuals. This distinction is not clinically significant and does not require changing the dose.

Statement
erectile dysfunction

Dosage regimen

Drugs are taken by mouth.

The recommended maximum dose of Cialis is 20 mg. The maximum recommended frequency of reception - 1 times / day.

Cialis take at least 16 minutes before the anticipated sexual activity.

Patients may attempt to carry out a sexual act at any time within 36 hours after taking the drug in order to establish the optimal response time to receive the drug.

Side effect

The most frequently: headache (11%), dyspepsia (7%).

Side effects are usually minor or medium severity, transient and diminish with continued treatment.

Perhaps: back pain, myalgia, nasal congestion, flushing of the face.

Rare: edema of the eyelids, eye pain, hyperaemia of conjunctiva, dizziness.

Very rare: hypersensitivity reactions (including rash, urticaria and face edema, Stevens-Johnson syndrome and exfoliative dermatitis), hypotension (in patients who have already received antihypertensive drugs), hypertension, syncope, abdominal pain and gastro-reflux, hyperhydrosis ( excessive sweating), and the delay erection priapism, blurred vision, nearterialnaya anterior ischemic optic neuropathy, retinal vein occlusion, the violation of fields of view.

Since the cardiovascular system: patients with cardiovascular risk factors - myocardial infarction, sudden cardiogenic death, stroke, chest pain, palpitations and tachycardia. However, it is impossible accurately to determine whether these phenomena directly with these risk factors, with tadalafilom, with sexual arousal, or with a combination of these or other factors.

Contraindications
simultaneous reception of preparations containing any organic nitrates
use in persons aged 18 years
Hypersensitivity to the drug's components

Application of pregnancy and breastfeeding

The product is not intended for use in women.

Application for violations of liver function

Patients with impaired renal function of the liver of a special selection of a dose is not required. Since there is no evidence of controlled clinical studies on safety and efficacy of Cialis in patients with severe hepatic insufficiency, and use the drug in this category of patients should take special caution and only when absolutely necessary.

Application for violations of renal function

Patients with impaired renal function (spacecraft more than 30 ml / min) of a special selection of a dose is not required. The treatment Cialis in patients with renal insufficiency moderately (QC from 31 to 50 ml / min) were observed more frequently of back pain compared to patients with renal insufficiency mild (QC from 51 to 80 ml / min) or healthy volunteers . Patients with CC less than 50 ml / min, the drug should be prescribed with caution. Since there is no evidence of controlled clinical studies on safety and efficacy of Cialis in patients with renal failure severe (CC less than 30 ml / min) used the drug in this category of patients should take special caution and only when absolutely necessary.

Cautions

Precautions should be prescribed to patients with severe hepatic insufficiency (class C according to Child-Pugh scale), since the data of controlled clinical studies on safety and efficacy of Cialis in this group of patients lacking.

Need care in prescribing Cialis to patients receiving α1-blockers, such as doxazosin, as the simultaneous application, in some cases can lead to symptomatic arterial hypotension. In a study of clinical pharmacology in 18 healthy volunteers who received a single dose of tadalafil were observed symptomatic arterial hypotension, while the introduction of α1-blocker tamsulosin.

The treatment Cialis in patients with renal insufficiency moderately (QC from 31 to 50 ml / min) were observed more frequently of back pain compared to patients with renal insufficiency mild (QC from 51 to 80 ml / min) or healthy volunteers . Patients with CC less than 50 ml / min, the drug should be prescribed with caution.

The sexual activity has a potential risk for patients with cardiovascular diseases. Therefore, treatment of erectile dysfunction, including using Cialis, you should not hold for men with heart disease, in which sexual activity is not recommended.

Keep in mind the potential risk of complications in sexual activity in patients with diseases of the cardiovascular system:
myocardial infarction within the last 90 days
unstable angina or angina occurring during sexual intercourse
Chronic heart failure (II functional class and higher classification of NYHA), which developed over the last 6 months
uncontrolled arrhythmias
hypotension (BP less than 90/50 mm Hg) or uncontrolled hypertension
stroke, transferred within the last 6 months

Precautions should be applied Cialis in patients with predisposition to priapism (eg sickle cell anemia, multiple myeloma or leukemia) or in patients with anatomical deformation of the penis (such as triangulation, cavernous fibrosis or Peyronie's disease).

Patient should be informed about the need for an immediate visit to a doctor in the event of an erection, lasting 4 hours or more. Delayed treatment for priapism causes damage to the tissues of the penis, as a result of this can occur a long-term loss of potency.

Against the background of the drug Cialis cases priapism were reported.

Safety and efficacy of a combination of Cialis with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

As with other PDE-5 inhibitors, tadalafil has a systemic vasodilating properties, which can lead to transient blood pressure decrease. Prior to the appointment of Cialis physicians should carefully consider the question - not whether the patients with their existing cardiovascular disease subjected to unwanted effects due to these vasodilator effects.

Use in Pediatrics

Cialis is not used in patients younger than 18 years.

Effects on ability to drive vehicles and management mechanisms

Specific recommendations are not available.

Overdose

For a single appointment healthy volunteers at a dose of 500 mg / day and patients with erectile dysfunction - many times up to 100 mg / day, adverse effects were the same as when using the drug at lower doses.

Treatment: conducting standard symptomatic therapy. In hemodialysis tadalafil virtually no output.

Drug Interactions

The influence of other drugs on tadalafil

Tadalafil is mainly metabolized with the participation of the enzyme CYP3A4. Selective CYP3A4 inhibitor ketoconazole at a dose of 400 mg / day increases the AUC of a single dose of tadalafil in 312% and C max - 22%, and ketoconazole 200 mg / day increases the effects of tadalafil, taken in a single dose of 107% and C max - 25%, relative to the AUC and C max values for only one tadalafil.

Ritonavir (200 mg 2 times / day), an inhibitor of CYP3A4, 2C9, 2S19, and 2D6, increases the impact of a single dose of tadalafil (AUC) at 524% without changing the C max. Despite the fact that the specific interactions have not been studied, we can assume that protease inhibitors such as ritonavir and saquinavir, as well as inhibitors of CYP3A4, such as erythromycin and itraconazole, increase the activity of tadalafil.

Selective CYP3A4 inducer rifampin (rifampicin, 60/mg/sut), reduces the impact of a single dose of tadalafil (AUC) by 88% and C max by 46%, relative to the AUC and C max values for only one tadalafil. It is assumed that the simultaneous administration of other inducers of CYP3A4 should also reduce the concentration of tadalafil in plasma.

At the same time taking an antacid (magnesium hydroxide / aluminum hydroxide) and tadalafil reduced the rate of absorption of the latter without changing its AUC.

Increasing the pH of gastric juice as a result of receiving blocker histamine H 2-receptor nizatidina no effect on the pharmacokinetics of tadalafil.

Effect of tadalafil on other drugs

Tadalafil enhances the hypotensive effect of nitrates. This is due to the additive action of nitrates and tadalafil on the metabolism of nitric oxide and cGMP. Therefore, the appointment of Cialis during treatment with nitrates is contraindicated.

Tadalafil has no clinically significant effect on clearance of drugs, the metabolism of which occurs with the participation of cytochrome P 450 isozymes. Studies have confirmed that tadalafil does not inhibit or induce isozymes CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9, CYP2C19.

Tadalafil has no clinically significant effect on the pharmacokinetics of S-and R-warfarin. Tadalafil does not affect the action of warfarin with respect to prothrombin time.

Tadalafil does not increase the duration of bleeding on the background of acetylsalicylic acid.

Tadalafil has a systemic vasodilating properties and may exacerbate the effects of antihypertensive drugs to lower blood pressure. Additionally, patients taking several antihypertensive agents, in which hypertension, poorly controlled, were observed several large blood pressure reduction. The vast majority of these patients reduction was not associated with hypotensive symptoms. Patients receiving treatment antngipertenzivnymi drugs and receiving tadalafil, should be given appropriate clinical recommendations.

There were no significant BP reduction when using tadalafil simultaneously with the selective alpha 1 A-blocker tamsulosin.

When using tadalafil healthy volunteers who took alpha 1-blocker doxazosin (8 mg / day) were increased hypotensive effect of doxazosin. Some patients experienced dizziness. No cases of syncope were not observed. Lower doses of doxazosin were not studying.

Tadalafil did not affect the concentration of ethanol, as ethanol does not affect the concentration of Tadalafil. At high doses of ethanol (0.7 g / kg) receiving tadalafil did not cause a statistically significant decrease in the mean arterial pressure. Some patients showed postural dizziness and orthostatic hypotension. With the introduction of tadalafil in combination with lower doses of ethanol (0.6 g / kg) hypotension was not observed, and dizziness occurred with the same frequency that the admission of only one alcohol.

Tadalafil has no clinically significant effect on pharmacokinetics and pharmacodynamics of theophylline.

To the top

Drug prescription.

Terms and Conditions of storage

The product should be stored out of reach of children, in their original packaging at a temperature not above 30 ° C. Shelf life - 3 years.

Zyrtec

Composition, structure and packing

Tablets, coated in white, oblong, scored and marked with "Y / Y" with one hand. 1 tab. cetirizine dihydrochloride 10 mg. Excipients: microcrystalline cellulose, lactose, colloidal silicon dioxide, magnesium stearate, gipromelloza, titanium dioxide, polyethylene glycol-400 (macrogol),.

Drops for oral colorless, transparent. 1 ml of cetirizine hydrochloride 10 mg. Other ingredients: glycerol, propylene glycol, sodium saccharinato, metilparabenzol, propilparabenzol, sodium acetate, glacial acetic acid, purified water.

Clinico-pharmacological group: blocker histamine H1-receptors. Antiallergic drug.

Pharmacological action

Antiallergic drug. Blocker histamine H1-receptor-Hydroxyzine metabolite. Prevents the development and facilitates during allergic reactions, has antipruritic and antiexudative action. Influences on the early stage gistaminozavisimuyu allergic reactions, limits the release of inflammatory mediators in the late phase allergic reactions, reduces the migration of eosinophils, neutrophils and basophils, stabilizing the membrane of mast cells.

Decreases capillary permeability, prevents the development of edema, relieves spasm of smooth muscles. Eliminates skin reaction to the introduction of histamine, specific allergens, as well as cooling (when the "cold" urticaria). It reduces histamine-induced bronchial asthma bronhokonstriktsiyu lung flow. Almost no anticholinergic and antiserotoninovogo action. In therapeutic doses, has almost no sedative effect. Start effect after single dose of 10 mg cetirizine observed after 20 min (50% of patients) and 60 min (95% of patients), the effect lasts more than 24 hours on the background of a course of treatment tolerance to antihistaminic action of cetirizine is not developed. After the cessation of treatment effect persists up to 3 days.

Pharmacokinetics

Absorption

Once inside quickly absorbed. Cmax is achieved through 1 pm Admission drug with food did not affect the magnitude of absorption, but the rate of absorption is somewhat reduced (the time to reach Cmax increased by 1 h). Distribution of Cetirizine binds to plasma proteins by 93%. Vd - 0.5 L / kg. Provided with breast milk. Not cumulative.

Metabolism

In small quantities, is metabolized in the liver by O-dezalkirovaniya with the formation of pharmacologically inactive metabolite (in contrast to other blockers of histamine H1-receptors, metabolised in the liver with the participation of cytochrome P450).

Putting 2 / 3 of the drug excreted unchanged in the urine and about 10% - with the feces. Systemic clearance - 53 ml / min. T1 / 2 7-10 pm practice is not removed during hemodialysis.

Pharmacokinetics in special clinical situations

T1 / 2 in children aged 6-12 years - 6 h in children 2-6 years old - 5 h in children aged 6 months to 2 years - 3.1 hours in elderly patients T1 / 2 increased by 50% , systemic clearance - up to 40%.

Statement

The drug used in adults and children aged 6 months and older.

Treatment of symptoms:
year-round and seasonal allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia;
hay fever (pollen disease);
urticaria (including chronic idiopathic urticaria);
Quincke's edema;
other allergic dermatitis (including atopic dermatitis), accompanied by itching and rash.

Dosage regimen

The drug is prescribed inside.

Children aged 6 months to 1 year appoint 2.5 mg (5 drops) 1 times / day.

Children aged 1 to 2 years appoint 2.5 mg (5 drops) up to 2 times per day.

Children aged 2 to 6 years appoint 2.5 mg (5 drops) 2 times / day or 5 mg (10 drops) 1 times / day.

Adults and children over 6 years is prescribed in doses of 10 mg (1 tab. Or 20 drops) per day.

Adults - 10 mg 1 time / d; children - 5 mg 2 times / day or 10 mg 1 time / day. Sometimes the initial dose of 5 mg may be sufficient to achieve a therapeutic effect. In renal failure dose is reduced depending on the spacecraft.

Side effect
On the part of the CNS: drowsiness, headache, rarely - dizziness, headache.
On the part of the digestive system: dry mouth, seldom - diarrhea.
Allergic reactions: seldom - angioedema, itching, rash, urticaria.

Contraindications
Pregnancy
Lactation (breastfeeding);
Children under 6 months;
hypersensitivity to the drug's components or hydroxizine.

Precautions should be prescribed the drug in patients with chronic renal failure (moderate or severe degree of severity), as well as elderly patients (due to a possible decrease in the glomerular filtration).

Pregnancy and lactation

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

Application for violations of renal function

Precautions should be prescribed the drug in patients with chronic renal insufficiency (moderate or severe severity), as well as elderly patients (in connection with a possible decrease in glomerular filtration). In renal failure dose is reduced depending on the spacecraft.

Cautions

Not received data on the interaction of the drug Zirtek when it is applied in recommended doses of alcohol (at a concentration of ethanol in the blood of 0.5 g / l), are nevertheless encouraged to abstain from alcohol during the application Zirteka.

Effects on ability to drive vehicles and management mechanisms

Objective methods of studying the capacity for studies of potentially dangerous activities were not significantly identify any adverse events when using the drug at the recommended dose of 10 mg, nonetheless recommended caution.

Overdose

When receiving a single dose of the drug in doses exceeding 50 mg may experience the following symptoms: sleepiness, restlessness, irritability, urinary retention, dry mouth, constipation, mydriasis, tachycardia. Treatment: removal of the drug, gastric lavage, the appointment of activated charcoal, symptomatic therapy.

Drug Interactions

At a joint appointment Zirteka with theophylline at a dose of 400 mg 1 time per day was decreased by 16% QC. At a joint appointment with the macrolides and ketoconazole were observed changes in the ECG. Clinically meaningful interactions, while the appointment of the drug Zirtek with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizidom not observed.

Terms and Conditions of storage

Tablets should be stored in a dry, away from children at or above 25 ° C. Solution-drops for oral administration should be stored at temperatures not above 25 ° C. Shelf life of the drug - 5 years.

Risperdal

Risperdal Overdosage Products Liability Risperdal, also known as Ridal, is an orally administered atypical antipsychotic drugs are produced and sale of pharmaceutical Jansen.


The overall composition of Risperdal is known as Risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Risperdal antipsychotic effect occurs due to a decrease of secretion of dopamine in the brain called a neurotransmitter is regulated by the balance of chemicals in the brain. Risperdal was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia. In fact, Risperdal is the only USFDA approved drug to treat schizophrenia and bipolar disorder in children aged 10-18. Risperdal is also recommended for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.

Risperdal is not recommended for elderly patients with dementia-related psychosis. This is explained by the fact that the atypical antipsychotic drugs such as Risperdal lead to increased risk of death of such persons. The most common side effects of Risperdal similar to other atypical antipsychotic drugs. These include drowsiness, increased appetite, fatigue, weakness, runny nose, vomiting, excessive coughing, uncontrollable urination, increased saliva, low blood pressure, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dry mouth, dizziness and upset stomach.

Like all other antipsychotics, Risperdal can lead to potentially dangerous and incurable side effects, such as slow Dyskinesia (TD), extrapyramidal symptoms (EPS) and neuroleptic malignant syndrome (NMS). Risperdal can also cause diabetes, hypertension and other serious conditions of glucose metabolism including Ketoacidosis and hyperosmolar coma. Risperdal is strictly not recommended for pregnant and lactating women.

Despite potential risks, the drug continues to be a blockbuster drug to market during the last 8 years, primarily due to the requirements of physicians who remain unaware of their potential danger and risk, and not in search of safer alternatives. Recently, manufacturers warn of the potential side effects of the drug in patients. You can file a product liability lawsuit against Janssen Pharmaceutical, if he suffers from the dangerous side effects, which include Risperdal stroke, NMS and TD.

Somatuline

Composition, structure and packing

Lyophilisates for suspension for a / m the introduction of long acting white or white with kremovatym color dispersed in the attached solvent to form a suspension of white or white with kremovatym color.
1 vial.
lanreotida acetate 40 mg
which corresponds to the content lanreotida 30 mg



Excipients: copolymers (laktid-glycolide and galaxies-glikolik), mannitol, sodium carboxymethylcellulose, polysorbate 80.

Thinner: mannitol, water, d / and (2 ml).

Glass Bottles (1) together with the solvent (amp. 1 pc.) - Blister packs (1) disposable polypropylene syringes, needles for injection (2 pcs.) - Pack carton.

Clinical and pharmacological groups: An analogue of somatostatin

Registration № №:
lyophilisates d / prepara. sus. d / i / m administration prolongs. of 30 mg: PL. 1 pc. in compl. with the solvent, syringe and 2 needles - P № 010212/01, 29.07.05

Pharmacological action

Synthetic peptide, which is an analog of the natural hormone somatostatin.

Like natural somatostatin, lanreotid inhibits pathologically increased secretion of growth hormone, and secretion of many peptide and other biologically active substances produced in the gastro-entero-pancreatic endocrine system (including gastrin, insulin, glucagon, digestive enzymes, hydrochloric acid, vazointestinalny peptide, serotonin).

He has more pronounced in peripheral somatostatinovym tropic receptors (pituitary and pancreatic) than to the central. This is due to its selectivity with respect to the secretion of growth hormone and exocrine secretion of pancreas and intestinal glands.

Pharmacokinetics

Absorption

Absorption lanreotida characterized the first phase of rapid release of peptide, located on the surface of microspheres, which is replaced by a slow second phase of release. C max of the first phase, amounting to 6.8 ± 3.8 mg / l, observed in 1.4 ± 0.8 h and C max of the second phase, amounting to 2.5 ± 0.9 mg / l, observed in 1.9 ± 1.8 days. The absolute bioavailability of 46.1 ± 16.7%.

Distribution

Study of binding lanreotida blood components showed that this interaction is unlikely at this level.

Patients with acromegaly and in healthy individuals similar pharmacokinetics. At the same concentration of growth hormone and insulin-like growth factor (IGF-1) decreased for at least 14 days after a single injection of the drug. With a constant injection of the drug for several months cumulation is not marked.

Withdrawal

The average retention time of 8 ± 1 days and T1 / 2 5.2 ± 2.5 days. These figures confirm the prolonged release of the drug.

Statement
acromegaly;
carcinoid tumor (as a symptomatic therapy).

Dosage regimen

Application Somatulina possible only in specialized institutions. The drug is introduced only in / m.

Treatment starts with the introduction of the test (if it is ineffective further therapy is impractical), and evaluate the response (the dynamics of secretion of growth hormone, growth, symptoms associated with carcinoid tumor).

Dosage regimen and duration of therapy set individually.

The drug is prescribed in the / m in a dose of 30 mg 1 time in 14 days. With the lack of effectiveness can increase the frequency of drug administration up to 1 injection every 10 days.

Dissolution lyophilizate in the attached solvent must be performed immediately before injection by smooth shaking the contents of vial to obtain a homogeneous suspension of white or white with kremovatym color. Preparation of the suspension should not be mixed with other drugs.

Side effect

Local reactions: itching, burning, mild transient pain at the injection site, sometimes accompanied by hyperemia.

On the part of the digestive system: diarrhea or soft stool, steatorrhea, abdominal pain, flatulence, nausea, vomiting and in rare cases, prolonged use may form gall stones (asymptomatic cholelithiasis).

On the part of metabolism: in rare cases - raising the level of glucose in the blood, impaired glucose tolerance.

Contraindications
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components.

Application of pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation.

Patients who receive therapy Somatulinom should be warned of a possible violation of the reproductive function, as well as whether to use contraception during treatment Somatulinom and within 3 months after treatment.

Application for violations of liver function

If abnormal liver function should be adjusted dose.

Application for violations of renal function

In case of violation of renal function should be adjusted dose.

Cautions

In appointing Somatulina patients with diabetes (both type 1 and type 2) should be regular monitoring of blood glucose and, if necessary, to adjust the dose of hypoglycemic drugs.

When gastrointestinal carcinoid tumors treated Somatulinom appointed after the removal of the existing intestinal obstruction by tumor.

In the treatment of acromegaly should be careful monitoring of the pituitary gland.

Prolonged treatment every 6 months should be performed ultrasound of the gallbladder.

If any function of the liver or kidneys should adjust the dose of the drug.

In case of simultaneous appointment with cyclosporine (oral), it is necessary to adjust the dose of cyclosporine.

Overdose

Symptoms: possible manifestations of increased side effects from the digestive system, electrolyte disturbances.

Treatment: perform symptomatically.

Drug Interactions

When applied simultaneously with insulin increases its hypoglycemic effect, which requires correction insulin.

To the top

Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored out of reach of small children at a temperature of 2 ° to 8 ° C (refrigerated). Shelf life - 2 years.

Expiration preparation of suspensions of 6 h when stored at room temperature.

Symbicort turbuhaler

Dosage form, composition and packaging

Powder for inhalation dose in the form of granules from white to almost white, mostly round shape.

1 dose (delivered) - budezonid - 80 micrograms - of formoterol fumarate dihydrate - 4.5 micrograms.

Excipients: lactose monohydrate.

Pharmacological action

Combined medication for the treatment of bronchial asthma. It contains formoterol and budesonide, which have different mechanisms of action and show additive effect in reducing the frequency of exacerbations of asthma. Budesonide - GCS, after inhalation of anti-inflammatory effect on the airways, which lasts several hours and is dose-dependent. Reduces severity of symptoms and frequency of exacerbations of asthma. In the appointment of inhaled budesonide in the form of notes lower incidence of serious side-effects than with systemic SCS. Decreases edema of the mucous membrane of the bronchi, mucus production, education, sputum and airway hyperreactivity. The exact mechanism of anti-inflammatory action of GCS is not known.

Formoterol - a selective ß2-adrenoceptor agonist. Causes relaxation of smooth muscles of the bronchi in patients with reversible respiratory obstruction. Bronchodilator effect is dose-dependent, occurs within 1-3 minutes after inhalation and is kept for at least 12 hours after receiving a single dose. In clinical studies found that the combined use of formoterol and budesonide reduced the severity of symptoms of asthma, improving lung function and reduced the frequency of exacerbations of the disease.

Effects of Symbicort turbuhaler on lung function corresponds to the action monotherapies, the combination of budesonide and formoterol and budesonide than one action. Not mentioned reduction of asthma over time. The drug has a good tolerability.

During the course of turbuhaler Symbicort as maintenance therapy for 12 weeks in children aged 6 to 11 years (two inhalations of 80 / 4,5 mcg / inhalation 2 times / day) improves lung function and was awarded with a good tolerability, according to compared with the corresponding dose of budesonide turbuhaler.

In patients with severe chronic obstructive pulmonary disease (baseline FEV | - 36%) in the intake of Symbicort turbuhaler showed a significant decrease in the frequency of exacerbations of the disease compared with patients receiving therapy just as formoterol or placebo (mean frequency of exacerbations compared with 1.4, 1 8-1,9 in the placebo / formoterol). There was no difference between the reception and Symbicort Formoterol against the values of FEV1.

Farmakokinektika

Absorption

Symbicort turbuhaler bioekvivalenten respective monotherapies (budesonide and formoterol) in respect of their systemic action. Despite this, there was a slight increased suppression of cortisol after administration of Symbicort turbuhaler compared with monotherapies. This difference does not affect the clinical safety of Symbicort turbuhaler. Evidence of pharmacokinetic interaction between budesonide and formoterol are not available. Pharmacokinetic parameters of budesonide and formoterol were comparable after their admission as monotherapies and as part of Symbicort turbuhaler.

When using the combined formulation of budesonide AUC was slightly more is absorbed faster and the magnitude of C max was higher, C max formoterol coincide with those for monotherapies. Nebulised budesonide is rapidly absorbed, reaching C max after 30 min. The average dose of budesonide, got into the lungs after inhalation via turbuhaler is 32-44% of the delivered dose. Systemic bioavailability of approximately 49% of the delivered dose. In children aged 6 to 16 years, the average dose of budesonide that has entered the lungs after inhalation via turbuhaler does not differ from that of adult patients (final concentration of the drug in blood plasma was not determined).

Inhaled formoterol is rapidly absorbed, reaching C max within 10 min after inhalation. Studies have shown that the average dose of formoterol, got into the lungs after inhalation via turbuhaler is 28-49% of the delivered dose. Systemic bioavailability - about 61% of the delivered dose.

Distribution

Plasma protein binding of formoterol is approximately 50%, budesonide - 90% Vd formoterol is about 4 L / kg, budesonide - 3 l / kg.

Metabolism

Formoterol is metabolized in the liver by conjugation with the formation of active O-demethylated metabolites, but mostly - inactivated conjugates. Budesonide undergoes intensive biotransformation (90%) in the "first pass" through the liver with the formation of metabolites with low glucocorticoid activity. The metabolism of budesonide is carried out mainly with the participation of the enzyme CYP3A4. Glucocorticoid activity of the major metabolite - 6-ß-gidroksibudesonida and 16-alpha-gidroksiprednizolona - less than 1% of similar activity of budesonide. There is no evidence of interaction of metabolites or substitution reaction between budesonide and formoterol.

Withdrawal

After inhalation of 8-13% of delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l / min);

T1 / 2 is an average of 17 hours

Budesonide is excreted in the urine as metabolites or in the form of conjugates, and only in small quantities - unchanged. Budesonide has a high systemic clearance (approximately 1.2 l / min).

Pharmacokinetics in special clinical situations

The pharmacokinetics of formoterol in children and in patients with renal insufficiency has not been studied. The concentration of budesonide and formoterol in blood plasma may be elevated in patients with liver zabolevniyami.

Statement
bronchial asthma (not controlled by inhaled GCS and beta2-sympathomimetics as a short-acting therapy on demand, or adequately controlled with inhaled GCS and ß2-adrenoagonists long-acting) - as a maintenance therapy and cupping;
symptomatic therapy in patients with severe chronic obstructive pulmonary disease (FEV <50% of the estimated current level) and repeated exacerbations in history, in the presence of pronounced symptoms, despite treatment with bronchodilators long-lasting.

Dosage regimen

Bronchial asthma

Symbicort turbuhaler not intended for initial treatment of bronchial asthma and lung persistiruyushego intermittent flow. Selection of doses comprising Symbicort turbuhaler, conducted individually, and depending on the severity of the disease. It is necessary to consider not only at the beginning of combination therapy, but after changing the dose. In the event that certain patients require different doses of a combination of active substances than in the drug Symbicort turbuhaler should designate a separate betagadrenomimetiki and / or MCS in separate inhalers. The dose should be reduced to the lowest against which remains the optimal control of symptoms of bronchial asthma. Patients should be under constant medical supervision for the proper selection of a dose Symbicort turbuhaler. When the full control of asthma symptoms on a background of the minimum recommended dose, the next step you can try the appointment of monotherapy with inhaled GCS.

There are two approaches to the appointment of therapy Symbicort turbuhaler.

A. turbuhaler Symbicort as maintenance therapy: a drug prescribed as maintenance therapy in combination with a separate betag-adrenostimulyatorov short action for relief of attacks. The patient must always carry an inhaler with a separate betag-adrenostimulyatorov short action for relief of attacks.

Adults (18 years and older) designate turbuhaler Symbicort 80/4.5 mcg / dose and 160/4.5 mcg / dose for 1-2 inhalations 2 times / day. If necessary, the dose can be increased to 4 inhalations 2 times / day.

Teens (12-17 years) designate turbuhaler Symbicort 80/4.5 mcg / dose and 160/4.5 mcg / dose for 1-2 inhalations 2 times / day.

Children under the age of 6 prescribe Symbicort turbuhaler 80/4.5 mcg / dose for 1-2 inhalations 2 times / day.

After achieving optimal control of asthma symptoms on a background of taking the medication 2 times per day is recommended to titrate the dose to the smallest effective up to receive a once a day, in those cases where the opinion of the doctor patient requires supportive therapy in combination with long-acting bronchodilators.

Increasing the frequency of beta 2-adrenostimulyatorov short-acting is an indicator of the deterioration of overall control of the disease and requires a revision of anti-asthma therapy.

B. Symbicort turbuhaler as maintenance therapy for relief of seizures: the drug can be prescribed as continuous as maintenance therapy, as well as treatment on demand in case of attacks. The patient must always carry turbuhaler Symbicort for relief of attacks.

Turbuhaler Symbicort as maintenance therapy and cupping is particularly indicated for patients with inadequate asthma control and the need to frequently use the drug to treat seizures, and specifying a history of bronchial asthma exacerbations requiring medical intervention.

Need to monitor closely the appearance of dose-dependent side effects in patients using a large number of inhalations for relief of attacks.

Adults (18 years and older) designate Symbicort turbuhaler 80 / 4,5 mcg / dose and 160/4.5 mcg / dose, the recommended dose - 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time / day only in the morning or evening. If you experience symptoms should be the appointment of 1 additional inhalation. With further increase of symptoms within a few minutes appoint another 1 additional inhalation, but no more than 6 inhalations for relief of an attack. Usually does not require the appointment of more than 8 inhalations per day, but you can increase the number of inhalations to 12 per day for a short time. Patients who use more than 8 inhalations per day is recommended revision of therapy. COPD

Adults prescribed Symbicort turbuhaler 160/4.5 mcg / dose of 2 inhalations 2 times / day. No need for a special selection of the dose for elderly patients.

No data on the use of Symbicort Turbuha ¬ Teller in patients with renal or hepatic insufficiency. As budesonide and formoterol are derived primarily involving liver metabolism, the patients with severe cirrhosis of the liver can be expected to slow the rate of excretion of the drug.

Terms of Use turbuhaler

The mechanism of action turbuhaler is such that when a patient inhales through the mouthpiece, the flow of air carries with it a medicinal substance in the respiratory tract.

Should instruct the patient:
carefully examine the "Instruction on the Application ¬ tion" turbuhaler;
breathe heavily and deeply through the mouthpiece to ensure getting the optimal dose of the drug into the lungs;
never exhale into the mouthpiece;
in order to minimize the possibility of fungal infections of oropharynx, rinse your mouth with water after each inhalation. It is also necessary to rinse your mouth with water after inhalation to edema and symptoms of the case of candidiasis of the oral mucosa and pharynx.

The patient may not taste or feel the product after use turbuhaler, due to a small amount of delivered material.

Instructions for use turbuhaler

Turbuhaler - multidose inhaler, which allows dose and inhale the drug in very tiny doses. If you inhale the powder from turbuhaler delivered to the lungs, so it is important that the patient is strong and deep breaths through the mouthpiece.

Before first use turbuhaler need to prepare for work:
Unscrew and remove the cap.
Hold the inhaler upright red feeder bottom. Do not keep the inhaler in the mouthpiece during the rotation dosing. Turn the dispenser until it stops in one direction, and then also the way - in the opposite direction.

Perform this procedure twice. Now the inhaler ready for use, repeat this. procedure for the preparation turbuhaler to work before each use is not required.

To receive a single dose of the patient must perform the following procedures:
Unscrew and remove the cap.
Hold the inhaler upright red feeder bottom. Do not keep the inhaler in the mouthpiece during the rotation dosing. In order to measure out the dose, dosing turn to lock in one direction, and then also the way - in the opposite direction.
Exhale. Do not exhale through the mouthpiece.
Carefully place the mouthpiece between your teeth, your lips and inhale strongly and deeply through your mouth. The mouthpiece does not chew and do not compress your teeth.
Before you exhale, pull out the inhaler from the mouth.
If you want to inhalation of more than one dose, repeat paragraphs. 2-5.
Close inhaler cap, check that the inhaler cap was thoroughly screwed.
Rinse mouth with water without swallowing.

It is impossible to remove the mouthpiece, because He is enshrined in the inhaler and not withdrawn. Mouthpiece turbuhaler rotates, but do not turn it unnecessarily. As the number of inhaled powder is very small, you can not taste the powder after inhalation. It is absolutely accurate compliance manual provides inhalation (ingalirovanie) required dose. If before taking the drug by mistake was repeated the procedure for loading the inhaler more than once, the inhalation of patients will still receive one dose of the drug. This indicator shows the total number of doses calibrated doses. The sound which is heard when shaking the inhaler, is made desiccating agent, and not drugs.

The need to replace the inhaler

The indicator shows the approximate number of doses of doses remaining in the inhaler, calculated doses to fill turbuhaler begins with the 60 th or 120 th dose (depending on the total number of doses purchased turbuhaler). The indicator shows the interval in 10 doses, so it does not show every metered (loaded) dose. Turbuhaler deliver the required dose of the drug, even if no noticeable change in the window display of doses.

The appearance of a red background in the window display of doses means that turbuhaler still have 10 doses of the drug. When the number 0 on a red background in the middle of the window dose inhaler should be discarded. It should be noted that even when the window indicator shows the number 0, dispenser continues to turn. However, the dose indicator stops to record the number of doses (ceases to move) and in the window dose inhaler remains the number 0.

Cleaning

Regularly (1 time per week) should be cleaned outside of the mouthpiece with a dry cloth. Do not use water or other liquid to clean the mouthpiece.

Utilization

Caution must be exercised when handling used inhaler and remember that within the inhaler may be a certain amount of the drug.

Side effect

Against the backdrop of a joint appointment of two drugs, there has been increasing the frequency of adverse reactions. The most common adverse reactions associated with drug intake, are such pharmacologically expected to betagadrenomimetikov unwanted side effects, like tremors and tachycardia, which usually have a moderate degree of severity and pass a few days after starting treatment.

In the application of budesonide in patients with COPD bruises and pneumonia occurred at a frequency of 10% and 6% respectively, compared to 4% and 3% in the group with placebo.

Quired for central nervous system: often - head ¬ Nye pain, less often - psychomotor agitation, anxiety, nausea, dizziness, sleep disorders are very rare - depression, behavioral disturbances (mainly in children), breach of taste.

Since the cardiovascular system: often - heartbeat; less frequently - tachycardia rarely - atrial fibrillation, supraventricular tachycardia, extrasystoles, very rarely - angina, blood pressure fluctuations.

From the kostnomyshechnoy system: often - tremor, less often - muscle cramps.

In the respiratory sistemy.chasto (> 1 / 100, but - candidiasis of the oral mucosa and pharynx, lung irritation in the throat, cough, hoarseness; rarely - bronchospasm.

Dermatological reactions: less often - bruises; rare - exanthema, rash, itching, dermatitis, angioedema.

Metabolic Disorders: rare - hypokalemia, very rarely - hyperglycemia, symptoms of systemic effects of GCS (including hypoadrenalism). Systemic effects of inhaled GCS may occur while taking the drug in high doses for long periods. The use of beta 2-sympathomimetics may result in an increase in blood insulin, free fatty acids, glycerol, ketone derivatives.

Contraindications
Children under 6 years
Hypersensitivity to budesonide, formoterol or inhaled lactose.

Precautions should be applied turbuhaler Symbicort in patients with pulmonary tuberculosis (active or inactive form), fungal, viral or bacterial infections of the respiratory system in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortalnym stenosis, severe hypertension, aneurysm of any location or other serious cardiovascular diseases (coronary heart disease, tachy-arrhythmia or heart failure, severe), with lengthening of the interval QT (formoterol may cause lengthening of the interval QTC).

Pregnancy and lactation

No clinical data on the use of Symbicort turbuhaler or combined use of formoterol and budesonide in pregnancy. If pregnancy should be prescribed Symbicort turbuhaler only when the expected benefit of therapy to the mother outweighs the potential risk to the fetus. Should be applied budesonide in the lowest effective dose needed to maintain adequate control of symptoms of asthma.

It is not known whether formoterol allocated and budesonide through breast milk in humans. Symbicort turbuhaler can be assigned to nursing mothers unless the expected benefit of therapy to the mother outweighs the potential risk to the child.

Cautions

We recommend gradually reducing the dose before discontinuation of treatment and is not recommended to abruptly stop therapy.

Turbuhaler Symbicort (80/4.5 mg / dose) was not intended to treat patients with severe bronchial asthma.

Symbicort turbuhaler not intended for the initial selection of therapy in the early stages of treatment of bronchial asthma.

For lack of effectiveness of therapy or exceeding the maximum recommended doses of Symbicort turbuhaler need to review the tactics of treatment. Sudden and progressive deterioration in control of symptoms of asthma or COPD is potentially life-threatening condition and requires urgent medical intervention. In this situation, should consider the possibility of increasing the dose of GCS, ie, the appointment of the course of oral antibiotic treatment GCS, or in case of infection.

Patients should always carry emergency medications, or Symbicort turbuhaler (for patients with asthma using turbuhaler Symbicort maintenance therapy and cupping), betagadrenomimetikm short-acting (for all patients using Symbicort turbuhaler only for maintenance therapy).

Attention is drawn to a patient's need for regular maintenance dose of Symbicort reception turbuhaler in accordance with the chosen therapy, even in the absence of symptoms. Inhalation Symbicort turbuhaler for cupping should be conducted only when there symptoms, but the use of the drug is not indicated for routine prophylactic use, ie before exercise. In these cases demonstrates the use of a separate short-acting bronchodilator.

Treatment Symbicort turbuhaler should not begin during the exacerbation of bronchial asthma. As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate intensification of wheezing after taking the dose. In this connection, it should discontinue therapy Symbicort turbuhaler to reconsider the tactics of treatment and, if necessary, appoint an alternative therapy

Systemic effects may occur when taking any inhaled GCS, especially when taking high doses of drugs over a long period of time. The manifestation of systemic effects are less likely during inhalation therapy than with oral GCS. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

It is recommended to regularly monitor the growth of children receiving long-term inhaled GCS. In case of growth retardation should reconsider therapy to reduce the dose of inhaled GCS. Should be carefully weighed against the benefits of SCS therapy for a possible risk of growth retardation. When selecting therapy is recommended consultation pediatric pulmonology.

Based on the limited research data on the chronic administration of GCS, we can assume that most children and adolescents receiving treatment by inhaled budesonide ultimately achieve normal adult rate of growth. However, the reported low (about 1 cm), short-term growth retardation, mainly in the first year of treatment. Because of potential actions of inhaled GCS on bone mineral density should pay particular attention to patients taking the drug in high doses for long periods with the presence of risk factors for osteoporosis. Studies of prolonged use of nebulised budesonide in children of average daily dose of 400 micrograms or adults in an average daily dose of 800 mg showed no significant effect on bone mineral density. No data on the action of high doses of the drug on bone mineral density.

If estosnovaniya believe that against the background of previous systemic therapy SCS was disturbed adrenal function, should take precautions when transferring patients to treatment Symbicort turbuhaler.

The advantages of budesonide inhalation therapy, usually minimizes the need for receiving oral GCS, but the patients discontinuing therapy with oral GCS, for a long time may continue adrenal insufficiency. Patients who in the past were in need of urgent admission of high doses of GCS may also be in this risk group. In extreme cases, and any situations that may cause stress, you should always keep in mind the possibility of residual dysfunction of the adrenal glands in these patients. In such situations need to provide adequate treatment of the SCS. Depending on the degree of dysfunction of the adrenal glands may need to consult a specialist prior to the recommended procedures.

It should reconsider the need for and dose inhaled GCS in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system.

Should observe special precautionary measures in patients with unstable asthma, short-acting bronchodilators applying for withdrawal seizures in patients with acute severe asthma, because the risk of hypokalemia increases against the background of hypoxia and other conditions where increased likelihood of developing symptoms gipokaliemicheskogo action. In such cases, it is recommended to control the content of potassium in serum.

Admission of patients with acute bronchial obstruction formoterol in a dose of 90 mcg for 3 hours is safe. During the period of treatment should control the concentration of glucose in the blood of patients with diabetes.

Symbicort turbuhaler contains lactose (less than 1 mg / dose). Typically, this amount does not cause problems in patients with lactose intolerance.

Use in Pediatrics

Symbicort turbuhaler not recommended for use in COPD in children younger than 6 years. Turbuhaler Symbicort is not recommended as maintenance therapy and cupping for children and adolescents under the age of 18 years.

Effects on ability to drive vehicles and management mechanisms

Symbicort turbuhaler not affect the ability to drive motor vehicles and management mechanisms. May influence the ability to drive motor vehicles and management mechanisms in the development of side effects.

Overdose

Symptoms: an overdose of formoterol - tremor, headache, tachycardia, in some cases - hyperglycemia, hypokalemia, prolongation of the interval QTC, arrhythmias, nausea, vomiting. In acute overdose of budesonide, even in large doses, is not expected clinically significant symptoms. In chronic receive budesonide in excessive doses can manifest systemic effects SCS, such as hypercorticoidism and adrenal suppression.

In acute bronchial obstruction receiving formoterol in a dose of 90 mcg for 3 h was safe.

Treatment: supportive and shown symptomatic treatment. In case of need to cancel due to an overdose turbuhaler Symbicort Formoterol, incoming and composition of the combined drug, should consider the appointment of the SCS.

Drug Interactions

In simultaneous ingestion of ketoconazole in a dose of 200 mg 1 time / effect of budesonide in a dose of 3 mg budesonide concentration in plasma increased by an average of 6 times. When receiving ketoconazole at 12 h after administration of budesonide in plasma concentration of the latter increased on average 3 times. The information about such interactions with budesonide inhalation administration is absent, but should expect a noticeable increase in concentration of the drug in blood plasma. Since there is currently no information for recommendations on the selection of doses should be avoided given combination of drugs. If not, then the intervals between doses of ketoconazole and budesonide should be maximized. You should also consider reducing the dose of budesonide. Other potent inhibitors of CYP3A4, may also be significantly increased the content of budesonide in plasma. We do not recommend the appointment of turbuhaler Symbicort as maintenance therapy and cupping the patients receiving potent inhibitors of CYP3A4. 3-adrenoceptor blockers can weaken or inhibit the action of formoterol. Symbicort turbuhaler should not be given simultaneously with beta-blockers (including eye drops), except in cases of extreme necessity. With simultaneous use of Symbicort turbuhaler and quinidine, dizopiramid, procainamide, phenothiazines, antihistamines (terfenadina), MAO inhibitors and tri-cyclic antidepressants may be lengthening the QT interval and increase the risk of ventricular arrhythmias. In addition, levodopa, levothyroxine, oxytocin, and ethanol can reduce the tolerance of the heart muscle to betagadrenomimetikam. In case of simultaneous appointment of MAO inhibitors and drugs with similar characteristics (furazolidone, procarbazine), may increase blood pressure. In the conduct of anesthesia drugs halides ized hydrocarbons during treatment Symbicort turbuhaler there is an increased risk of arrhythmias in patients. At the same time taking Symbicort turbuhaler and other agonists (5-adrenergic receptors may be increased side effects of formoterol. Gipokaliemicheskoe action betag-sympathomimetics may be increased, while the appointment of xanthine derivatives, minerals, derivatives of the SCS and diuretics. Hypokalemia increases the susceptibility to the development of arrhythmias in patients receiving cardiac glycosides . There was no interaction of budesonide with other drugs used to treat asthma.

Terms and Conditions of storage

The drug should be stored at temperatures not above 30 ° C in the reach of children. Shelf life - 2 years.

Glucophage

Composition, structure and packing

Tablets, coated in white, film, round, biconvex, transverse section of - homogeneous white mass. 1 tab. metformin hydrochloride 500 mg. Excipients: povidone, magnesium stearate. The composition of the shell membrane: gipromelloza.

Tablets, coated in white, film, round, biconvex, transverse section of - homogeneous white mass. biconvex. 1 tab. metformin hydrochloride 850 mg. Excipients: povidone, magnesium stearate. The composition of the shell membrane: gipromelloza.

Tablets, coated in white, film, oval, biconvex, with risks on both sides and engraved "1000" on one side, and on cross section - a homogeneous white mass. 1 tab. metformin hydrochloride 1000 mg. Excipients: povidone, magnesium stearate. The composition of the shell membrane: opadray net (gipromelloza, macrogol 400, macrogol 8000).

Clinico-pharmacological group: oral hypoglycemic drug.

Pharmacological action

Oral hypoglycemic drug from the biguanide group. Glyukofazh reduces hyperglycemia, does not cause hypoglycemia. Does not stimulate insulin secretion and does not have hypoglycemic action in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and stimulates glucose uptake by muscle cells. Hinders gluconeogenesis in the liver. Delays absorption of carbohydrates in the intestines. Has a beneficial effect on lipid metabolism: reduces total cholesterol, triglycerides and LDL.

Pharmacokinetics

Absorption

After taking the drug inside metformin adequately absorbed from the gastrointestinal tract. At the same time food intake and decreased absorption of metformin delayed. The absolute bioavailability of 50-60%. In the plasma Cmax is approximately 2 ug / ml or 15 uM and reached through 2.5 hours

Distribution

Metformin rapidly distributed in body tissues. Practically not bound to plasma proteins.

Metabolism

In a very small extent exposed to metabolic and displayed by the kidneys.

Withdrawal

Clearance of metformin in healthy subjects is 440 ml / min (4 times greater than CC), indicating that active tubular secretion. T1 / 2 approximately 6.5ch.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency T1 / 2 increases, there is a risk of metformin accumulation in the body.

Statement
Type 2 diabetes in adults;
in combination with insulin in diabetes mellitus type 2, especially in obese with secondary insulin resistance;
Type 2 diabetes in children older than 10 years (monotherapy, in combination with insulin).

Dosage regimen

Monotherapy and combination therapy with other oral hypoglycemic means the adult starting dose is 500 mg 2-3 times / day after or during meals.

Perhaps a further gradual increase in the dose depending on the level of glucose in the blood. Maintenance daily dose of 1500-2000 mg / day. To reduce the side effects on the gastrointestinal dose should be divided into 2-3 reception. The maximum daily dose is 3000 mg / day, divided into 3. The slow increase in dose may improve gastrointestinal tolerability.

Patients taking metformin at doses of 2000-3000 mg / day, may be transferred to the reception Glyukofazha 1000 mg. The maximum recommended dose is 3000 mg / day, divided into 3. In the case of planning for the transition to therapy with other hypoglycemic Glyukofazhem funds should stop taking the other way and start accepting Glyukofazha in a dose above. Combination with insulin to achieve better control of blood glucose levels with metformin and insulin may be used as combination therapy. The initial dose of the drug Glyukofazh a dose of 500 mg and 850 mg of 1 tab. 2-3 times / day; Glyukofazh drug at a dose of 1000 mg of 1 tab. 1 times / day. Insulin is selected on the basis of measurement of blood glucose.

In children older than 10 years of age Glyukofazh can be used as a monotherapy and in combination with insulin. The initial dose is 500 mg 2-3 times / day after or during meals. After 10-15 days, the dose should be adjusted based on the results of measurement of blood glucose. The maximum daily dose is 2000 mg, divided into 2-3 reception. Elderly patients due to a possible reduction in kidney function dose of metformin should be selected for regular monitoring indicators of renal function (creatinine level control serum no less than 2-4 times per year). Do not use the drug in patients aged over 60 years of performing heavy physical work.

Side effect

Frequency of side effects was estimated as follows: very common (≥ 1 / 10), often (≥ 1 / 100, <1 / 10), infrequently (≥ 1 / 1000, <1 / 100), rare (≥ 1 / 10000, < 1 / 1000), very rarely (<1 / 10000). Side effects presented in order of decreasing importance.
From the side of the central nervous system: often - breach of taste.
On the part of the digestive system: very often - nausea, vomiting, abdominal pain, loss of appetite. Most symptoms occur in the initial period of treatment and in most cases spontaneously resolve.

Allergic reactions: seldom - erythema, pruritus, rash.
On the part of metabolism: very often - laktatsidoz (requires discontinuation of the drug), with prolonged use - vitamin deficiencies of vitamin B12 (malabsorption). These effects are rapidly reversible with the abolition of metformin and usually clinically insignificant (<0.01%). Reduced vitamin B12 should be taken into account in patients with megaloblastic anemia.
From the hepato-biliary system: isolated cases - violation indicators of liver function, hepatitis. After the abolition of metformin adverse effects completely disappear. Published data, potsmarketingovye data and the data controlled clinical studies in limited populations of children aged 10 to 16 years show that the adverse effects on nature and gravity similar to those in adult patients.

Contraindications
diabetic ketoacidosis;
diabetic precoma;
diabetic coma;
renal dysfunction (CC <60 ml / min);
acute diseases in which there is the risk of renal dysfunction: dehydration (vomiting, diarrhea), fever, severe infections, the state of hypoxia (shock, sepsis, renal disease, broncho-pulmonary disease);
symptomatic manifestations of acute and chronic diseases that can lead to tissue hypoxia (respiratory failure, heart failure, acute myocardial infarction);
major surgical operations and injuries, and (when shown an insulin);
liver problems;
chronic alcoholism and acute ethanol poisoning;
laktatsidoz (including history);
period of not less than 2 days before and within 2 days after the radioisotope, or radiological investigations with the introduction of iodine contrast agents;
compliance with the hypocaloric diet (<1000 kcal / day);
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components. Do not use the drug in patients aged over 60 years of performing heavy physical work.

Pregnancy and lactation

The drug is contraindicated during pregnancy and during breastfeeding. When planning a pregnancy or Glyukofazh should be abolished and appoint insulin. The patient should notify the need to notify the doctor in case of pregnancy. For the mother and child should be placed under observation.

It is not known whether metformin is allocated with breast milk. If necessary, use during lactation should stop breastfeeding.

Application for violations of liver function

Contraindicated in liver problems.

Application for violations of renal function

Contraindicated in renal events.

Cautions

Patients should notify the need to stop taking the drug and consult a doctor if vomiting, abdominal pain, muscle pain, general weakness and severe malaise. These symptoms may be a sign of incipient laktatsidoza. Glyukofazh should be abolished for 48 h before and during the period of 48 hours after the radiographic examination (including urography, in / in angiography) using X-ray facilities.

As shown in the urine metformin, before drug treatment and regularly thereafter to be determined levels of serum creatinine. Particular caution should be exercised in violation of renal function, for example, in the initial period of therapy of antihypertensive therapy, diuretics, NSAIDs.

It should inform the patient about the need for treatment to the doctor with symptoms of bronchopulmonary infection or infectious disease urinary organs. Against the background of the drug Glyukofazh should refrain from taking alcohol.

Use in Pediatrics

In children older than 10 years of age Glyukofazh can be used as a monotherapy and in combination with insulin.

Effects on ability to drive vehicles and management mechanisms

As monotherapy, the drug does not cause hypoglycemia Glyukofazh and therefore does not affect your ability to drive and operate machinery. However, patients should be treated with caution to the risk of hypoglycemia when using metformin in combination with other hypoglycemic agents (including derivatives sulfanilmocheviny, insulin, repaglinidom).

Overdose

Symptoms: Using Glyukofazha a dose of 85 g of hypoglycemia was not observed, but noted the development laktatsidoza. Early symptoms laktatsidoza are nausea, vomiting, diarrhea, fever, abdominal pain, muscle pain, in the future possibly rapid breathing, dizziness, impaired consciousness, the development of coma.

Treatment: immediate cancellation Glyukofazha, urgent hospitalization, the definition of the concentration of lactate in blood, if necessary, carry symptomatically. For the excretion of lactate and metformin is most effective hemodialysis.

Drug Interactions

Deprecated when used with a combination drug Glyukofazh with danazol may develop hyperglycemic effect. If necessary, treatment of danazol after the termination of his admission required dosage adjustment Glyukofazha under the control of blood glucose levels.

With simultaneous use of the drug with alcohol and Glyukofazh etanolsoderzhaschimi drugs increases the risk of laktatsidoza during acute alcohol intoxication, especially during fasting or low calorie diet compliance, as well as in liver failure. Combinations which require special care Chlorpromazine in high doses (100 mg / day) reduces the release of insulin and increases the level of glucose in the blood.

When applied simultaneously with neuroleptics and after the termination of their admission require dosage adjustment Glyukofazha under the control of blood glucose levels. GCS (for systemic and topical) reduce glucose tolerance and increased blood glucose levels, in some cases causing ketosis.

If necessary, use of such a combination, and after stopping GCS requires dosage adjustment Glyukofazha under the control of blood glucose.

With simultaneous use of the "loop" diuretics and a risk of Glyukofazha laktatsidoza because of the possible occurrence of functional renal insufficiency. You should not assign Glyukofazh if CC <60 ml / min. Radiological study using iodine radiopaque agents may cause the development laktatsidoza in patients with diabetes against the background of functional renal failure.

Application Glyukofazha should be abolished for 48 h before and did not reopen after 2 days after the X-ray studies using X-ray facilities. Appointment in the form of injections beta2-sympathomimetic reduce hypoglycemic effect Glyukofazha due β2-adrenoceptor stimulation. In this case, should monitor blood glucose and insulin, if necessary, appoint. ACE inhibitors and other antihypertensive drugs may reduce the level of glucose in the blood.

If necessary, adjust the dose of metformin. With simultaneous application Glyukofazha with derivatives sulfonylureas, insulin, acarbose, and salicylates may be increased hypoglycemic action.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 25 ° C. Shelf life for tablets 500 mg and 850 mg - 5 years. Shelf life for tablets 1000 mg - 3 years.

Meridia

Composition, structure and packing

Hard gelatin capsules, with a yellow body and blue cap, surcharged "10", the contents of capsules - white or almost white, easy-flowing powder. 1 capsule. hydrochloride monohydrate sibutramine 10 mg. Excipients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, indigodin (E132), titanium dioxide (E171), sodium lauryl sulfate, black (gray), quinoline yellow.

Hard gelatin capsules with a white body and blue cap, surcharged "15", the contents of capsules - white or almost white, easy-flowing powder. 1 capsule. sibutramine hydrochloride monohydrate 15 mg. Excipients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, indigotine (E132), titanium dioxide (E171), gelatin, sodium lauryl sulfate, black (gray), quinoline yellow.

Clinico-pharmacological group: Drug for treatment of obesity central action.

Pharmacological action

The drug for the treatment of obesity. Sibutramine is a prodrug and exerts its effect in vivo by metabolites (primary and secondary amines), which inhibit reuptake of monoamines (especially serotonin and norepinephrine). Increased content of neurotransmitters in synapses increases the activity of central 5-HT-serotonin and adrenergic receptors, which increases feelings of satiety and reduce the need for food, as well as increase termoproduktsii. Indirectly activating the β3-adrenergic receptors, sibutramine acts on the brown adipose tissue. Sibutramine and its metabolites do not affect the release of monoamines, not inhibit MAO, do not have the affinity to a large number of neurotransmitter receptors, including serotonin (5-HT1, 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2C), adrenergic (β1 , β2, β3, α1, α2), dopamine (D1, D2), muscarinic, histamine (H1), benzodiazepine and NMDA-receptors.

Pharmacokinetics

Absorption, distribution, metabolism

After taking the drug inside sibutramine is rapidly absorbed from the digestive tract. Time to reach Cmax was 1.2 hours sibutramine Sibutramine almost completely metabolized in the liver, with the participation isoenzyme CYP 3A4 with the formation of mono-(dismetilsibutramin) and di-dismetil (di-dismetilsibutramin) forms active metabolites (M1 and M2), and by hydroxylation and conjugation with the formation of inactive metabolites. After a single dose of the drug orally at a dose of 15 mg Cmax of M1 and M2 is 4 ng / ml (3.2-4.8 ng / ml) and 6.4 ng / ml (5.6-7.2 ng / ml), respectively. Reception with food increases the time to reach and reduces the value of Cmax dismetil metabolites at 3 h and 30%, respectively, no influence on the AUC dismetil metabolites. Fast and well distributed in tissues.

Protein binding sibutramine - 97%, M1 and M2 - 94%.

Withdrawal

T1 / 2 sibutramine - 1.1 h, M1 - 14 h, M2 - 16 hours is derived primarily by the kidneys in the form of inactive metabolites.

Pharmacokinetics in special clinical situations

In renal insufficiency, the main pharmacokinetic parameters (Cmax, T1 / 2 and AUC) did not significantly change.

Statement
alimentary obesity with a body mass index (BMI) 30 kg/m2 or more;
alimentary obesity with a BMI of 27 kg/m2 or more in combination with diabetes mellitus type 2 (insulin-dependent) or dyslipoproteinemia.

Dosage regimen

Dose was set individually, depending on tolerability and clinical effectiveness. The initial dose is 10 mg. In case of insufficient efficacy (weight loss less than 2 kg in 4 weeks), but only if well tolerated daily dose may be increased to 15 mg. If, after increasing dose efficacy is insufficient (weight loss less than 2 kg per 4 weeks), continuation of treatment impractical. Capsules Meridia should be taken in the morning, without chewing, and drinking plenty of fluids (water glass).

The drug can be taken on an empty stomach and combine with the meal. We should not continue treatment for more than 3 months to patients who during this time (3 months) could not be reached to reduce body weight by 5% from baseline. Treatment should not continue if the therapy Meridia after weight-loss achieved patients gain body weight of 3 kg or more. The duration of treatment Meridia should not exceed 2 years as against a longer period of drug administration data on the effectiveness and safety of missing.

Side effect

The most common side effects occur early in treatment (in the first 4 weeks). Their severity and frequency over time, weaken. Side effects are usually slight and reversible. Side effects, depending on the impact on the organs and systems are presented in the following order: often -> 10%, sometimes - 1-10%, rare - "1%.
From the central nervous system and peripheral nervous system: often - insomnia, sometimes - headache, dizziness, anxiety, paresthesias, changes in taste.
Since the cardiovascular system: sometimes - tachycardia (increased heart rate by 3-7 bpm), a sense of palpitations, increased blood pressure (at rest by 1-3 mm Hg), vasodilatation.

In some cases, does not exclude a more pronounced increase of blood pressure and heart rate. Clinically significant changes in the level of blood pressure and heart rate are recorded mainly in the beginning of treatment (in the first 4-8 weeks).
On the part of the digestive system: often - dry mouth, loss of appetite, constipation, and sometimes - nausea, aggravation of hemorrhoids. Other: Sometimes - increased sweating. In individual cases, describes the following clinically significant side effects: dysmenorrhea, edema, influenza-like syndrome, skin itching, backache, abdominal pain, a paradoxical increase in appetite, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, purpura Henoch's, seizures, thrombocytopenia, transient increase in liver enzymes in blood plasma.

One patient with schizoaffective disorder which supposedly existed before treatment, after treatment, developed acute psychosis.

Contraindications
presence of organic causes of obesity (eg, hypothyroidism);
serious eating disorders (anorexia nervosa or bulimia nervosa);
mental illness;
Syndrome Gilles de la Tourette (chronic generalized tick);
simultaneous reception of MAO inhibitors (eg, phentermine, fenfluramina, deksfenfluramina, etilamfetamina, ephedrine), or using them for 2 weeks prior to the appointment Meridia; serotonin reuptake inhibitors, sleeping pills, medicines that contain tryptophan, other drugs of central action to reduce body weight;
CHD, chronic heart failure in the stage of decompensation, congenital heart disease, occlusive peripheral arterial disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient ischemic attacks);
uncontrolled hypertension (blood pressure above 145/90 mm Hg);
thyrotoxicosis;
severe disorders of liver function and / or kidneys;
benign prostate hyperplasia;
pheochromocytoma;
angle-closure glaucoma;
established drug, drug or alcohol addiction;
Pregnancy
Lactation (breastfeeding);
childhood and adolescence to 18 years;
age 65;
Hypersensitivity to sibutramine or to other components of the drug.

Precautions should be prescribed the drug if a history of arrhythmias, congestive heart failure, coronary artery disease (including history), cholelithiasis, hypertension (controlled and history), neurological disorders (including mental retardation and seizures (in m . hours in history), abnormal liver function and / or kidney mild to moderate severity, motor and verbal ticks in history.

Pregnancy and lactation

Do not take the drug Meridia during pregnancy and lactation (breastfeeding), because so far there is no sufficient research on the safety of Meridia impact on the fetus. Women of childbearing age who take the drug Meridia should use methods of contraception.

Application for violations of liver function

With caution is prescribed for violations of the liver function mild to moderate severity. In severe liver problems drug contraindications

Application for violations of renal function

With caution is prescribed for violations of renal function with mild and moderate severity. In severe renal dysfunction drug contraindications

Cautions

The drug Meridia should be applied only in cases where non-drug interventions to reduce body weight (diet and physical activity) are ineffective (weight loss for 3 months was less than 5 kg). Treatment Meridia should be carried out within the framework of comprehensive therapy for weight loss under medical supervision, which has practical experience in the treatment of obesity. Comprehensive therapy includes a change in dietary habits and lifestyles, and increasing physical activity.

Patients need to change your lifestyle and habits so that after completion of treatment to ensure that the achieved reduction of body weight. Patients should be made clear that failure to comply with these requirements will lead to repeated weight gain and the need for retreatment. During the administration of the drug Meridia should control the level of BP and HR: in the first 2 months - every 2 weeks and then monthly.

In patients with hypertension control should be implemented very carefully and at shorter intervals. If a control measure blood pressure twice higher than the level of 145/90 mm Hg, reception Meridia should be suspended.

Precautions should be prescribed Meridia in conjunction with drugs, extending the interval QT, including blockers of histamine H1-receptor (astemizol, terfenadin), antiarrhythmics (amiodarone, quinidine, flekainid, meksiletin, propafenone, sotalol), tsizapridom, pimozidom, sertindolom and tricyclic antidepressants. This applies to states, which may result in a lengthening of the interval QT (eg, gipomagniemiya). The interval between administration of MAO inhibitors (including furazolidone, procarbazine, selegiline) and Meridia should not be less than 2 weeks. Although not establish a link between the intake of sibutramine and the development of primary pulmonary hypertension, but the application of the drug Meridia is necessary to pay attention to the emergence of progressive respiratory failure, chest pain and swelling in the legs.

When there are missing doses of Meridia should not be taken in the following method double dose of the drug, further encouraged to continue taking the drug scheme. Reactions to the abolition of the drug (headache, increased appetite) are rare. There is no evidence that after the withdrawal of the drug observed withdrawal syndrome, withdrawal, or mood disorder.

During the drug should not take alcoholic drinks, because intake of alcohol is absolutely not compatible with the recommended while taking Meridia dietary interventions.

The impact on the ability to drive vehicles and machinery ypravleniyu

Drugs affecting the CNS, may limit mental activity, memory and reaction speed. Although studies sibutramine did not affect these functions, yet taking the drug Meridia may limit the ability to drive motor vehicles and management mechanisms.

Overdose

There are very limited data about the overdose sibutramine. Specific signs of overdose are not known, however, should consider the possibility of a more pronounced manifestation of side effects. The patient must notify the attending physician in case of alleged overdose. Treatment: There is no specific antidote; should ensure free breathing, observe the state of the cardiovascular system, the need for a symptomatic therapy. The following appointment of activated charcoal, gastric lavage, with an increase in blood pressure and tachycardia - beta-blockers. The effectiveness of forced diuresis or hemodialysis is not installed.

Drug Interactions

Simultaneous reception from Meridia isoenzyme CYP3A4 inhibitors (ketoconazole, erythromycin, troleandomitsin, cyclosporine) increases the concentration of metabolites of sibutramine with an increase in heart rate and clinically insignificant prolongation of the interval QT. Rifampicin, a macrolide antibiotics, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate the metabolism of sibutramine.

With simultaneous use of Meridia with selective serotonin reuptake inhibitors (antidepressants), with preparations for the treatment of migraine (sumatriptan, dihydroergotamine), a potent analgesics (pentazocine, pethidine, fentanyl), with antitussive drugs (dextromethorphan) in rare cases may develop serotonin syndrome.

Drug Interactions Meridia medication with drugs that increase blood pressure and heart rate, with antitussives, anti-allergic drugs are currently not fully understood. Meridia does not affect the validity of oral contraceptives. At the same time receiving sibutramine and ethanol, there has been a tightening of the latter.

Terms and Conditions of storage

List B. The drug should be kept dry and away from children at or above 25 ° C. Shelf life - 3 years.