International generic name

Isoniazid

Drug form and composition

Tablets. One tablet contains 100 mg Isoniazid. Solution for injection. One ampoule of 2 ml contains 50 mg Isoniazid (25 mg/ml).

Indications

Rimicid is a tuberculostatic agent of first order and it is used in all forms of tuberculosis in combination with other antimicrobial agents. In patients susceptible to this disease (diabetics, patients on systemic corticosteroid treatment), Rimicid can be used for chemoprophylaxis of tuberculosis.

Dosage and administration

In adults: Preventive administration - the drug is given as a single agent intramuscularly or orally route in a dose of 300 mg once daily. For a treatment in combination with other tuberculostatic drugs (orally or intramuscularly) in a dose of 5 - 10 mg/kg body weight daily, but not exceeding 600 mg daily. In children: Preventive administration - Rimicid is given as a single agent intramuscularly or orally in a dose of 10 mg/kg body weight, up to 300 mg daily. For a treatment in combination with other tuberculostatic drugs using orally or intramuscularly in a dose of 10 - 20 mg/kg body weight, up to 500 mg daily.

Contraindications

Rimicid is not used in cases of hypersensitivity to this drug, alcoholism, hepatic dysfunction, renal failure, epilepsy and other seizure states.

Special warnings and precautions

Because the drug disturbs the liver function, during the treatment it is necessary to perform regular checks of the hepatic function using serum transaminase levels. The people showing hypersensitivity to ethionamide, pyrazinamide, hiacin, and other drugs, shows higher risk of development of hypersensitivity manifestations because of cross allergy. In patients regularly using great quantities of alcohol, patients suffering form epilepsy, or with severe renal diseases, the dosing regimen should be modified according to the creatinine clearance. During pregnancy and lactation Rimicid can be used only after careful assessment of the indications and risks for the fetus. During the treatment with Rimicid, increased attention during car driving and working with machines is necessary because of the possibility of development of dizziness and psychic disturbances in some patients.

Drug interactions

The drugs containing aluminum hydroxide decrease intestinal absorption of Rimicid. Combination with rifampicin, streptomycin, or ethambutol leads to avoiding selection of resistant tuberculosis strains. Rimicid elevates the plasma levels and the toxicity of the hydantoin antiepileptic drugs. In cases of concurrent administration with disulfiram psychotic reactions and ataxia have been observed.

Adverse reactions

Rimicid is a drug with wide therapeutic spectrum. The adverse drug reaction most commonly are from the central nervous system and the liver: symmetric polyneuritis, dizziness, headache, ataxia, psychic disturbances, mental problems, susceptibility to seizures, paresthesia, muscle cramps; risk of development of severe hepatitis. There is a possibility of gastrointestinal disturbances: nausea, vomiting, pain in epigastrium, vitamin B6-deficiency; endocrine disorders: hyperglycemia, galactorrhea; allergic reactions: skin rash, fever, exfoliative dermatitis, lymphadenopathy, vasculitis, Quincke’s edema. Lupus erythematodes like syndrome, arthralgia, and rheumatic syndrome are observed relatively rarely.

Pharmacological mechanisms

Rimicid is an antituberculosis drug with a wide spectrum of its bacteriostatic action and low toxicity. It exerts a fast bactericidal action on the mycobacteria in the stage of replication and bacteriostatic action against mycobacteria in latent state. Its activity is weaker than that of rifampicin and pyrazinamide. It acts both on the intracellular and extracellular mycobacteria. It is transformed into isonicotine acid which is incorporated in a defective NAD. It binds into a helate complex the copper ions, which are necessary for the vitality of the mycobacteria. It disturbs catalase and peroxidase in the mycobacteria, and inhibits synthesis of DNA and secondarily RNA synthesis. In this process the bacteria are subjected to great morphologic changes at the level of the lipid membrane.

Supplied

100 tablets of 100 mg. 10 or 50 ampoules of 2 ml (50 mg).

Expiry

Solution for injection and tablets-5 years