2010/12/16

Baralgin M

Release form, composition and packing Baralgin M 

Tablets

1 tab. metamizol sodium 500 mg.

Solution for injection

1 ml. metamizol sodium 500 mg.

1 amp. metamizol sodium was 2.5

Capsules, rectal [for children], tablets [for children]

Clinico-pharmacological group: analgesic-antipyretic

Pharmacological action

NSAIDs, pyrazolone derivatives, mechanism of action is practically no different from other NSAIDs (non-selectively block COX and reduces the formation of Pg from arachidonic acid). Hinders the extra pain and proprioceptive impulses on beams Gaulle and Burdach, raises the threshold of excitability of thalamic centers in pain sensitivity, increases heat transfer. A distinctive feature is a minor manifestation anti-inflammatory effect, which causes a slight effect on water-salt metabolism (delay of Na + and water) and gastrointestinal mucosa.

Has analgesic, antipyretic and some antispasmodic (for the smooth muscle of urinary and biliary) effect.

The action develops within 20-40 minutes after ingestion and reaches a maximum after 2 hours

Statement
febrile syndrome (infectious and inflammatory diseases, insect bites - mosquitoes, bees, gadfly, and others, post-transfusion complications);

pain (mild to moderate severity):
neuralgia,
myalgia,
arthralgia,
biliary colic,
intestinal colic,
renal colic,
trauma,
burns,
decompression sickness,
zoster,
orchitis,
sciatica,
myositis,
postoperative pain,
headache,
toothache
algomenorrhea.

Dosing regimen

Oral, 250-500 mg 2-3 times per day, maximum single dose - 1 g daily - 3 g.

Single dose for children

2-3 years - 50-100 mg;

4-5 years - 100-200 mg

6-7 years - 200 mg

8-14 years - 250-300 mg

Multiplicity of purposes - 2-3 times a day.

V / m or / (especially in severe pain): adults - 250-500 mg 3 times a day.

The maximum single dose - 1 g daily - 2 years

Children designate the rate of 5-10 mg / kg 2-3 times per day.

Children under 1 year of medication is administered only in V / m. Injectable solution for injection should have their body temperature. Doses over 1 g should be administered IV.

You must have the conditions for antishock therapy.

The most common reason for the sharp decrease of blood pressure is too high rate of injection, in connection with which intravenous should be done slowly (at a rate not exceeding 1 ml / min), the position of the patient "lying", under the control of blood pressure, heart rate and the number of breaths.

Rectal use - for adults - 300, 650 and 1000 mg.

The dose for children depends on the child's age and the nature of the disease, it is recommended to use the children's candles to 200 mg:

from 6 months to 1 year - 100 mg;

from 1 to 3 years - 200 mg

from 3 to 7 years - 200-400 mg

8 to 14 years - 200-600 mg.

After the introduction of the suppository child should be in bed.

Side effect

With the urinary system: Renal, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red. Allergic reactions: urticaria (including the conjunctiva and mucous membranes of nose and throat), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronhospasticheskih syndrome, anaphylactic shock.

For part of the blood: agranulocytosis, leukopenia, thrombocytopenia.

Other: blood pressure reduction.

Local reaction: when i / m administration may infiltrate at the injection site.

Overdose.

Symptoms: nausea, vomiting, stomachodynia, oliguria, hypothermia, decreased blood pressure, tachycardia, dyspnea, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or liver failure, convulsions, paralysis of respiratory muscles.

Treatment: gastric lavage, saline laxatives, activated carbon, conducting forced diuresis, hemodialysis, during the development of seizures - in intravenous diazepam and speed of barbiturates.

Contraindications
hypersensitivity to components of ptreparata,
inhibition of blood (agranulocytosis, neutropenia, infectious or cytostatic)
hepatic and / or renal failure,
hereditary hemolytic anemia,
associated with deficiency of glucose-6-phosphate dehydrogenase,
"Aspirin" asthma,
anemia,
leukopenia,
pregnancy (especially in I trimester and in the last 6 weeks)
lactation.

C care. The neonatal period (up to 3 months), kidney (pyelonephritis, glomerulonephritis - including history), prolonged abuse of ethanol. In the intravenous in patients with systolic blood pressure below 100 mm Hg or circulatory instability (eg against myocardial infarction, multiple trauma, starting shock).

Pregnancy and lactation

Use of the drug is contraindicated, especially in the I trimester and in the last 6 weeks.

Be wary of pregnancy (especially in the first trimester and in the last 6 weeks).

When used in the medium therapeutic doses of pyrazolone derivatives are excreted in breast milk in very small amounts.

Cautions

In the treatment of children under 5 years of age and patients receiving cytotoxic drugs, receiving metamizol sodium should be done only under medical supervision. Intolerance occurs very rarely, but the threat of anaphylactic shock after iv injection is relatively higher than after administration of the drug inside.

In patients with atopic asthma and hay fever have an increased risk of allergic reactions.

In patients receiving metamizol sodium may develop agranulocytosis, in connection with which the detection of unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of the phenomena of vaginitis or proctitis require immediate removal of the drug.

With prolonged use is necessary to control the peripheral blood picture.

Never use to relieve acute pain in the abdomen (to determine the cause).

For IM injection is necessary to use a long needle. Possible staining of urine into the red due to excretion of metabolites (irrelevant).

Drug Interactions

Because of the high likelihood of developing a pharmaceutical incompatibility can not be mixed with other drugs in the same syringe.

Strengthens the effects of ethanol, the simultaneous application of chlorpromazine and other phenothiazine derivatives may lead to severe hyperthermia.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with metamizol.

When concomitant administration of cyclosporine decreased concentration of the latter in the blood. Metamizol, displacing from its association with protein oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin, increase their activity. Phenylbutazone, barbiturates and other gepatoinduktory while appointing reduce the effectiveness of metamizol.

Baraclude

Release form, composition and packing Baraclude 

Tablets, film-coated white or nearly white, triangular, with the marking "Bms" on one side and "1611" on the other side. 1 tab. entecavir 500 mcg. Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, Opadry white colorant (titanium dioxide, hypromellose 6cP, hypromellose 3cP, macrogol 400, polysorbate 80).

Tablets, film-coated pink, triangular, with the marking "Bms" on one side and "1612" on the other side. 1 tab. entecavir 1 mg. Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, Opadry pink dye (6sR hypromellose, titanium dioxide, macrogol 400, iron oxide red dye).

Clinico-pharmacological group: antiviral drugs.

Pharmacological action

Antiviral drug, is a nucleoside guanosine analogue with a strong and selective activity against hepatitis B virus polymerase B (HBV). Entecavir is phosphorylated to form the active triphosphate (TP), which has an intracellular half-life of 15 hours the intracellular concentration of HF is directly related to the extracellular level of entecavir, not noted a significant accumulation of the drug after the initial level of the plateau.

By competition with the natural substrate, deoksiguanozina-FF-FF entecavir inhibits all three functional activity of the viral polymerase: (1) HBV polymerase priming, (2) reverse transcription of the negative threads from pregenomnoy mRNA and (3) synthesis of HBV DNA positive thread. Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β and δ with Ki 18-40 uM. In addition, high concentrations of entecavir-TP and entecavir are not marked adverse effects on the polymerase γ and DNA synthesis in the mitochondria of cells HepG2.

Pharmacokinetics

Suction

In healthy people, absorption of entecavir fast, Cmax in blood plasma determined by 0.5-1.5 h. The re-admission of entecavir at a dose of 0.1 to 1 mg dose is proportional to the observed increase in Cmax and AUC. The equilibrium state is achieved after 6-10 days intake 1 time per day, while the plasma concentration increases by a factor of 2. Cmax and Cmin in plasma at steady state were 4.2 and 0.3 ng / ml, respectively, while taking the drug at a dose of 500 micrograms, 8.2 and 0.5 ng / ml, respectively, when receiving a dose of 1 mg.

When comparing the bioavailability in healthy humans tablets and oral solution, it turned out to be equivalent, ie These two formulations are interchangeable.

If ingestion of entecavir at a dose of 500 mcg as a food high in fat and low-observed minimum delay absorption (1-1.5 hours at the reception with food and 0.75 hours at the reception on an empty stomach), decreased Cmax by 44-46% and decrease AUC by 18-20%.

Distribution

Vd entecavir exceeded total body water, indicating good penetration of the drug in the tissue. Binding of entecavir to human plasma proteins in vitro is about 13%.

Metabolism

Entecavir is not a substrate, inhibitor or inducer of isozymes of P450. After the introduction of 14C-labeled entecavir man and rats have not been determined oxidized or acetylated metabolites, and metabolites of phase II (glucuronide and sulfate) were found in small quantities.

Breeding

After reaching Cmax plasma concentrations of entecavir decreased biexponential, with T1 / 2 was 128-149 h. When you receive a time / day there was an increase of concentration (accumulation) of the drug in 2 times, that is effective T1 / 2 was approximately 24 hours entecavir primarily excreted by the kidneys, and in equilibrium unchanged in the urine is determined by the 62-73% of the dose.

Renal clearance is not dose dependent and ranges from 360 to 471 ml / min, indicating glomerular filtration and tubular secretion of the drug.

Statement
chronic hepatitis B in adults with evidence of viral replication and increase the activity level of serum transaminases (ALT or ACT) or the presence of histological signs of inflammation in the liver.

Dosing regimen

The drug is taken orally on an empty stomach (ie, not less than 2 hours after meals and at least 2 hours before the next meal). Recommended dose is 500 mcg Baraklyud 1 time per day.

If there is resistance to lamivudine (ie, when specifying a history of viremia with HBV, continuing on therapy with lamivudine, or in the case confirmed that resistance to lamivudine) are encouraged to nominate entecavir 1 mg 1 time per day.

In patients with renal failure the clearance of entecavir decreases with KK. In patients with hepatic impairment dose adjustment of entecavir is not required.

Side effect
From the digestive system: rare (> 1 / 1000, <1 / 100) - diarrhea, indigestion, nausea, and vomiting.
CNS: frequent (> 1 / 100, <1> 1 / 1000, <1 / 100) - insomnia, dizziness, drowsiness.

Contraindications
age 18;
hypersensitivity to entecavir or any component of the drug.

Pregnancy and lactation

Adequate and well controlled clinical studies on the safety of the drug during pregnancy has not been carried out.

Application Baraklyuda during pregnancy only in cases where the expected benefits of therapy to the mother justifies the potential risk to the fetus. Data on the penetration of entecavir in human milk is not.

Using the drug breastfeeding is not recommended.

Use in hepatic dysfunction

In patients with hepatic impairment dose adjustment of entecavir is not required.

Use in renal impairment

In patients with renal failure the clearance of entecavir decreases with KK. With CC <50 ml / min, including patients in hemodialysis and long-term ambulatory peritoneal dialysis, recommended dosage adjustment Baraklyuda.

Cautions

In the treatment of nucleoside analogues, alone and in combination with antiretroviral drugs are described cases of lactic acidosis and severe hepatomegaly with steatosis, leading sometimes to death of the patient. There are cases of acute hepatitis B after discontinuation of antiviral therapy, including entecavir. Most of these exacerbations were held without treatment. However, there may develop severe exacerbations, including fatal.

The causal relationship between these exacerbations with the abolition of therapy has not been established. After discontinuation of treatment should be periodically monitor liver function.

If necessary, antiviral therapy may be resumed. Safety and efficacy of entecavir in patients who underwent liver transplantation, are unknown.

Should carefully monitor renal function before and during treatment with entecavir in patients who underwent liver transplantation and receiving immunosuppressive drugs, which may affect renal function, such as cyclosporine and tacrolimus.

Overdose

Entecavir overdose cases are not registered.

Treatment: with an overdose requires careful medical supervision of a medical condition and if necessary, standard supportive therapy.

Drug Interactions

Since entecavir is excreted mainly by the kidneys, while the introduction of entecavir and drugs that cause impaired renal function or compete at the level of tubular secretion may increase serum concentrations of entecavir and these drugs.

When concomitant administration of entecavir with lamivudine, adefovir or tenofovir is not revealed clinically significant drug interactions. Interaction of entecavir with other drugs that affect the kidneys or kidney function, has not been studied. When concomitant administration of entecavir with such drugs the patient requires careful medical supervision.

Conditions and terms of

The drug should be stored in a place inaccessible to children at a temperature not exceeding 25 ° C. Shelf life - 2 years.

Baneocin

Release form, composition and packing

Ointment for external use yellowish, homogenous, with a weak characteristic odor. 1 g bacitracin (in the form of bacitracin zinc) 250 IU of neomycin (in the form of sulfate) 5000 IU. Other ingredients: lanolin, white soft paraffin.

Powder for external use finely divided, from white to yellowish. 1 g bacitracin (in the form of bacitracin zinc) 250 IU of neomycin (in the form of sulfate) 5000 IU. Excipients: Basis sterilized powder (corn starch, contains less than 2% magnesium oxide).

Clinico-pharmacological group: drug with antibacterial activity for outdoor use.

Pharmacological action

Combination antibiotic for topical use. Contains two antibiotics that have bactericidal activity, neomycin and bacitracin. Bacitracin is a polypeptide antibiotic that inhibits cell wall synthesis. Neomycin is an aminoglycoside antibiotic that inhibits protein synthesis of bacteria.

Bacitracin is active against gram-positive (Streptococcus spp. / Including hemolytic streptococcus /, Staphylococcus spp.) And some Gram-negative microorganisms. Resistance to bacitracin is rare. It has good tissue tolerability, the inactivation of biological products, blood and tissue components are not marked. Neomycin is active against gram-positive and Gram-negative bacteria. Through the use of a combination of these two antibiotics achieved a wide range of drug action and synergy of action against a number of microorganisms such as staphylococci.

Pharmacokinetics

Active ingredients are generally not absorbed (even broken skin), however, present in the skin of their high concentrations. When applying the product to large areas of skin lesions should take into account the possibility of systemic absorption of the drug.

Statement

Treatment of infectious and inflammatory skin diseases caused by microorganisms susceptible to the drug:

Powder
bacterial skin infections limited distribution, including moist contagious impetigo, infected trophic ulcers of the lower limbs, infected eczema, bacterial diaper dermatitis, secondary bacterial infection of diseases caused by Herpes simplex, Varicella zoster (including varicella);
prevention of umbilical infections in newborns;
Prevention of infection after surgery (including dermatological) procedures: in the postoperative period (after the excision of tissue, cauterization, episiotomy, treatment of cracks, weeping wounds, and sutures).

Ointment
foci of infection of the skin, t.ch.furunkuly, carbuncles (after surgery), staphylococcal sycosis, a deep folliculitis, purulent hydradenitis, paronychia;
bacterial skin infections limited distribution, including contagious impetigo, infected ulcers of the lower extremities, secondary infected eczema and secondary infection with dermatosis, cuts, bruises, burns, cosmetic surgery and skin transplantation (also for prevention and to impregnate bandages);
prevention of infection after surgery (as part of combination therapy in the postoperative period).

Dosing regimen

The drug is applied thinly to the affected areas: powder - 2-4 times a day, ointment - 2-3 times / day (in order to enhance the effectiveness of possible application of the ointment under the bandage). Application of ointment with bristles, preferably at the local treatment of infected wounds and cavities (including bacterial infections of the ear canal without perforating the eardrum, wounds or surgical incisions healing by secondary intention).

With burns over 20% of body powder should be applied no more than 1 time per day, especially in the case of reduction of renal function (because it is possible absorption of the active ingredient). When applied externally dose of neomycin should not exceed 1 g / day (equivalent to 200 grams of powder or ointment) for 7 days. When you know the maximum dose - less than 100 g.

Side effect

Allergic reactions: a long-term use - redness, dry skin, skin rash, itching. Most allergic reactions are the type of contact eczema (50% of cases are associated with cross-allergy to other aminoglycosides), and rare.

Systemic effects: with extensive lesions of the skin should consider the possibility of absorption of the drug and the development of mapping and nephrotoxic effects and disorders of neuromuscular conduction.

When applied topically Baneotsin generally well tolerated.

Contraindications
marked impairment of renal function (due to cardiac or renal failure);
disease kohleo-vestibular system;
extensive skin lesions (risk of Valium effect it if systemic absorption);
diseases of the eye (for application of powder);
Hypersensitivity to bacitracin, neomycin, or to other aminoglycosides.

Pregnancy and lactation

Use of the drug Baneotsin during pregnancy and lactation is possible only if the intended benefits to the mother outweighs the potential risk to the fetus or infant.

Use in hepatic dysfunction

Because the risk of toxic effects increases with a decrease in liver function in patients with liver failure should be blood and urine tests, together with audiometric studies before and during therapy with Baneotsin.

Use in renal impairment

When used in doses far exceeding the recommended, due to possible absorption should pay attention to symptoms suggestive of nephro-or ototoxic reactions. Because the risk of toxic effects increases with a decrease in renal function in patients with renal failure should be blood and urine tests, together with audiometric studies before and during therapy with Baneotsin.

Cautions

Avoid getting product into eyes. When used in doses far exceeding the recommended, due to possible absorption should pay attention to symptoms suggestive of nephro-or ototoxic reactions.

Because the risk of toxic effects increases with a decrease in liver function and / or renal function in patients with hepatic and / or renal failure should be blood and urine tests, together with audiometric studies before and during therapy with Baneotsin.

With the possible removal (extensive violation of the integrity of the skin), it is necessary to monitor the possible emergence of signs of neuromuscular blockade, especially in patients with acidosis, myasthenia gravis (myasthenia gravis) or other neuromuscular diseases.

With the development of neuromuscular blockade shows calcium supplements or neostigmine. With prolonged use of the drug should be monitored closely for excessive growth of resistant organisms.

If necessary, appropriate treatment. In the case of the drug in children, patients with impaired liver function and kidney, as well as a large work surface area, prolonged use, and deep skin lesions should consult a physician. With the development of allergic reactions and superinfection with the drug should be discontinued.

Overdose

Currently, cases of drug overdose Baneotsin were reported.

Drug Interactions

If there is systemic absorption, then the simultaneous prescription of antibiotics or cephalosporins, aminoglycosides increases the risk of nephrotoxic reactions. While the application Baneotsina with ethacrynic acid or furosemide increases the risk of mapping and nephrotoxic reactions.

In the case of systemic absorption, while the application Baneotsina with opioid analgesics, anesthetics and muscle relaxants increases the risk of neuromuscular blockade. There were no cases of incompatibility, bacitracin and neomycin.

Conditions and terms of

The drug should be stored in a place inaccessible to children at a temperature below 25 ° C. The drug in powder form should be kept in the dark and dry place. Shelf life - 3 years.