Treatment of both pulmonary and extrapulmonary tuberculosis in the intensive initial phase of treatment.
Theropeutic Class
Combined anti- Tubercular Preparations
Pharmacology
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.
Dosage & Administration of Rimstar 4-FDC
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.
Dosage of Rimstar 4-FDC
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.
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.
Rifampicin: Since rifampicin has been reported to cross the placental barrier and appear in cord blood and in maternal milk, neonates and newborns of rifampicin-treated mothers should be carefully observed for any evidence of untoward effects.Ethambutol: While administration of ethambutol to pregnant human patients has produced no detectable effect upon the fetus, the possible teratogenic potential in women capable of bearing children would be weighed carefully against the benefits of therapy. There are published reports of 5 women who received ethambutol during pregnancy without apparent adverse effect upon the fetus.
Precautions & Warnings
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.
Storage Conditions
Store at temperatures not exceeding 30°C.
Use In Special Populations
Use in children: Ethambutol is not recommended for use in children <13 years since safe conditions for use have not been established.
Drug Classes
Combined anti- Tubercular Preparations
Mode 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.
Pregnancy
Rifampicin: Since rifampicin has been reported to cross the placental barrier and appear in cord blood and in maternal milk, neonates and newborns of rifampicin-treated mothers should be carefully observed for any evidence of untoward effects.Ethambutol: While administration of ethambutol to pregnant human patients has produced no detectable effect upon the fetus, the possible teratogenic potential in women capable of bearing children would be weighed carefully against the benefits of therapy. There are published reports of 5 women who received ethambutol during pregnancy without apparent adverse effect upon the fetus.
Pediatric Uses
Use in children: Ethambutol is not recommended for use in children <13 years since safe conditions for use have not been established.
Frequently Asked Questions
What is Rimstar 4-FDC used for?
Treatment of both pulmonary and extrapulmonary tuberculosis in the intensive initial phase of treatment.
What is the dosage of Rimstar 4-FDC?
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.
What are the side effects of Rimstar 4-FDC?
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, hematologic…
Who should not take Rimstar 4-FDC?
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.
What precautions should be taken with Rimstar 4-FDC?
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 & m…
Is Rimstar 4-FDC safe during pregnancy and breastfeeding?
Rifampicin: Since rifampicin has been reported to cross the placental barrier and appear in cord blood and in maternal milk, neonates and newborns of rifampicin-treated mothers should be carefully observed for any evidence of untoward effects.Ethambutol: While administration of ethambutol to pregnant human patients has produced no detectable effect upon the fetus, the possible teratogenic potentia…
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.
