Composition, form of production and packaging
The tablets covered with a film membrane of red-brown color, round, biconcave.
isoniazid 100 mg
Rifampicin 150 mg
Auxiliary substances: microcrystalline cellulose - 11.785 mg, kopividone - 4 mg, croscarmellose sodium - 19.58 mg, crospovidone - 1.055 mg, hypromellose - 2.2 mg, magnesium stearate (vegetable) - 3.89 mg, colloidal dioxide silicon 2.9 mg, sorbitol 99.7 mg , talc - 3.89 mg.
The composition of the membrane: hypromellose - 7.25 mg, macrogol 6000 - 0.76 mg, propylene glycol - 0.83 mg, iron oxide red (E172) - 0.42 mg, iron oxide yellow (E172) - 0.42 mg, titanium dioxide (E171) 0.32 mg.
100 pieces. - polypropylene containers (1) - cardboard packs.
The tablets covered with a film membrane of red-brown color, round, biconcave, with a notch on one side.
isoniazid 150 mg
rifampicin 300 mg
Excipients: microcrystalline cellulose - 20.17 mg, kopividone - 6 mg, croscarmellose sodium - 38 mg, crospovidone - 2.1 mg, hypromellose - 3.333 mg, magnesium stearate (vegetable) - 7.6 mg, silicon dioxide colloid - 5.8 mg, sorbitol - 199.4 mg , talc - 7.6 mg.
The composition of the coating: hypromellose - 10.88 mg, macrogol 6000 - 1.14 mg, propylene glycol - 1.24 mg, iron oxide red (E172) - 0.63 mg, iron oxide yellow (E172) - 0.63 mg, titanium dioxide (E171) - 0.48 mg.
100 pieces. - polypropylene containers (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
[I] - Instruction on medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on June 27, 2000
Iso-Eremfat contains a combination of two anti-tuberculosis drugs - rifampicin and isoniazid.
Rifampicin and isoniazid are most active against fast-growing extracellularly distributed microorganisms, but also have a bactericidal effect on intracellular pathogens.
Rifampicin is also active against slowly and intermittently growing forms of Mycobacterium tuberculosis. The mechanism of action of rifampicin is the inhibition of DNA-dependent RNA polymerase. With tuberculosis, rifampicin has a bactericidal effect on both intracellular and extracellular microorganisms.
Isoniazid has a bactericidal effect on the actively dividing cells of Mycobacterium tuberculosis. The mechanism of its action is to inhibit the synthesis of mycolic acids, which are a component of the cell wall of mycobacteria. For Mycobacterium tuberculosis, the minimum inhibitory concentration of isoniazid is 0.05-0.025 mg / L. Resistance to isoniazid arises quickly.
After taking Iso-Eremfat inside, its active components are quickly and completely absorbed from the digestive tract. C max of the active components in plasma is reached by the second hour and remains at a detectable level up to 8 hours.
In case of reception together with food, the absorption of rifampicin, which is part of Iso-Erefmat, is reduced by 30%.
C max rifampicin in plasma is achieved after 2 hours. Rifampicin is widely distributed in the body. Approximately 80% of the dose is associated with plasma proteins.Rifampicin is metabolized in the liver to deacetyltrifampicin; this metabolite is active. Rifampicin is excreted from the body with urine (up to 30% of the dose taken).
After taking Iso-Erefmat in healthy adults, C max isoniazid in plasma reaches 2 hours after T.sub.I 1/2 of isoniazid from the plasma is 2-6 hours. Isoniazid undergoes severe pre-systemic metabolism in the wall of the small intestine and liver, resulting in its concentration in the plasma patients with a rapid acetylation process is half the concentration in patients with a slow acetylation process.
Up to 95% of the dose of isoniazid is excreted in the urine in the first 24 hours. Less than 10% of the dose taken is excreted with feces.
The main products of urinary excretion are N-acetylisosodium and isonicotinic acid.
- treatment of the initial stage of pulmonary tuberculosis;
- treatment of the initial stages of extrapulmonary tuberculosis.
The drug is administered to adults . The daily dose is set taking into account the patient's body weight. It is possible to use the following schemes of prescribing the drug in the continuation phase. (The initial phase involves the assignment of iso-eremfat + streptomycin / ethambutol for 2 months).
Short course of treatment:
The continuation phase (4 months or more): Isoniazid and rifampicin (Iso-Eremfat) are prescribed every day or 2-3 times a week.
Therapy of tuberculosis should continue for 6 months and at least 3 more months after the cessation of bacterial release.
Long course of treatment:
Patients with resistance or extrapulmonary forms of tuberculosis may require a longer course of therapy (continuation phase).
In the case of HIV infection, treatment should be continued for 9 months and at least 6 more months after the bacteriophage has ceased. A tablet containing 150 mg of rifampicin and 100 mg of isoniazid is taken orally 1 to 4 hours before meals, once a day, with patients weighing less than 50 kg, for 2 months.
A tablet containing 300 mg of rifampicin and 150 mg of isoniazid is taken orally 1 to 2 hours before meals, once a day, with patients weighing at least 60 kg for 2 months.
It is possible to use the drug in combination with other anti-tuberculosis drugs, such as streptomycin.
It is recommended simultaneous administration of pyridoxine to elderly patients, persons with a predisposition to neuropathy (patients with diabetes mellitus).
The side effects of Iso-Eremfat are determined by the active ingredients in the formulation.
Rifampicin can cause side effects from the gastrointestinal tract, such as heartburn, epigastric discomfort, anorexia, vomiting, intestinal colic and diarrhea. Some patients experience headache, drowsiness, weakness, ataxia, dizziness, confusion, visual disorders, muscle weakness, fever, pain in the limbs, itching, urticaria, skin rashes and eosinophilia, sore throat and soreness of the tongue. Men occasionally experience toxic liver damage, which usually develops in the first two weeks after the start of treatment.
Long-term use of isoniazid causes peripheral neuropathy in 3.5-17% of patients. There is a feeling of tingling and numbness in the fingers and toes, some patients have muscle weakness, headache, dizziness, nausea, vomiting, drug-induced hepatitis, gynecomastia in men and menorrhagia in women. Prophylactic and therapeutic use of isoniazid in the form of monotherapy or in combination with anti-tuberculosis drugs is associated with a significant risk of toxic damage to the liver.
- increased sensitivity to any ingredient of the drug;
- epilepsy and penchant for seizures, in the case of a previous history of poliomyelitis;
- violations of the liver and kidneys;
- severe atherosclerosis;
- children's age till 12 years;
- body weight less than 45 kg;
- I trimester of pregnancy;
- the period of breastfeeding.
PREGNANCY AND LACTATION
Iso-Eremfat can not be used in the first trimester of pregnancy and also with breastfeeding. The possibility of using Iso-Eremfat during further pregnancy can only be resolved by a doctor after assessing the degree of risk / effect. When used in the last weeks of pregnancy, Iso-Eremfat can cause postpartum bleeding in the mother or newborn, for which vitamin K is used.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated: impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated: liver dysfunction.
Caution is given to Iso-Eremfat patients with liver disease.
APPLICATION FOR CHILDREN
Contraindicated: children under 12 years.
APPLICATION IN ELDERLY PATIENTS
Be wary appoint Iso-Eremfata to elderly patients.
During treatment with Iso-Eremfat, the control of the kidney, liver and blood function is necessary.
When appointing Iso-Eremfat, it should be borne in mind that urine, feces, saliva and tears can be dyed orange.
Caution is given to Iso-Eremfat patients with liver diseases, elderly and emaciated patients, as well as patients suffering from chronic alcoholism.
It is known that rifampicin induces certain enzymes of the cytochrome P450 system. It has been established that rifampicin accelerates the metabolism of phenytoin, quinidine, oral anticoagulants and antifungal agents.
Isoniazid enhances the effects of phenytoin, such as drowsiness and ataxia.
Prednisolone can significantly reduce the concentration of isoniazid in blood plasma in slow and fast acetylators, but this effect is more pronounced in slow acetylators.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Protect from moisture and light. Keep out of the reach of children.
Shelf life - 3 g. After the expiry date of the drug can not be used.