Rimstar 4-FDC
Daily Dose:
Duration:
Cheaper & Alternative Brands (150 mg+75 mg+400 mg+275 mg)
Same active generic (Rifampicin + Isoniazid + Pyrazinamide + Ethambutol), same form (Tablet), exact same strength (150 mg+75 mg+400 mg+275 mg)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Treatment of both pulmonary and extrapulmonary tuberculosis in the intensive initial phase of treatment.
Dosage & Administration
Adults:
3 tablets/day for an average body weight of 50 kg.
Patients weighing-
>70 kg
: 5 tablets
55-70 kg
: 4 tablets
38-54 kg
: 3 tablets
30-37 kg
: 2 tablets
All doses to be taken once daily for 2 months on intensive phase.
Contraindications
Hypersensitivity to rifampicin, isoniazid, pyrazinamide or ethambutol.
Isoniazid
: Previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid eg, fever, chills and arthritis; acute liver disease of any etiology, a history of previous hypersensitivity reaction to isoniazid including drug-induced hepatitis.
Side Effects & Adverse Reactions
Rifampicin:
Reddish discolouration of body fluids, asymptomatic increase in liver enzymes, elevations of BUN & uric acid, hemolysis, hematuria, intestinal nephritis, renal insufficiency, Gl discomfort, CNS effects, hematological changes, skin rash, endocrine effects.
Isoniazid:
Disturbances of liver function, hepatitis, Gl disturbances, peripheral neuropathy, dizziness, lightheadedness, hematological changes, allergic reactions.
Pyrazinamide:
Transient rise in serum transaminases, hepatotoxicity, hepatomegaly, jaundice, hyperuricemia, intestinal nephritis, dysuria, Gl disturbances, hematological changes, allergic reactions.
Ethambutol:
Confusion, disorientation, headache, visual disturbances, jaundice, transient liver dysfunction, Gl disturbances, hematological changes, allergic effects, acute gout (rare).
Warnings & Precautions
Impaired renal or liver function, DM, chronic alcoholism, undernourishment, history of gout, patients with convulsive disorders, acute porphyria. Elderly. Pregnancy & lactation. Perform periodic blood counts & liver function tests. Avoid use with soft contact lenses.
Children <8 year or patients who are not able to communicate visual disturbances. Check visual ability before starting treatment & monitor during treatment.
Pharmacology & Mechanism of Action
Rifampicin:
It is a semisynthetic derivative of rifamycin, suppresses bacterial RNA synthesis by binding to the β-subunit of DNA-dependent RNA polymerase, thus inhibiting the attachment of the enzyme to DNA, blocking RNA transcription and elongation. It does not inhibit the counterpart mammalian enzyme.
Rifampicin has a bactericidal action and a potent sterilizing effect against both intracellular and extracellular tubercle bacilli. Cross-resistance has been shown only with other rifamycin derivatives.
Isoniazid:
It kills actively growing tubercle bacilli by inhibiting the biosynthesis of mycolic acids, which are the major components of the bacterial cell wall of Mycobacterium tuberculosis.
Pyrazinamide:
Pyrazinamide, an antituberculous drug, is the pyrazine analog of nicotinamide. The precise mechanism of action of pyrazinamide is not known. Its metabolite, pyrazinoic acid, which is less active in vitro may possibly be involved in the in vivo activity of pyrazinamide.
Ethambutol:
Ethambutol diffuses slowly into actively growing Mycobacteria cells eg, tubercle bacilli. It inhibits the synthesis of 1 or more metabolites, thus causing impaired cell metabolism, arrest cell multiplication and induce cell death. No cross-resistance with other agents has been demonstrated.
Spectrum of Activity:
Rifampicin, isoniazid, pyrazinamide, and ethambutol, at therapeutic levels, have demonstrated bactericidal activity against both intracellular and extracellular Mycobacterium tuberculosis organism.