Rimstar 4-FDC

• Pulmonary and Extrapulmonary Tuberculosis: Used in the intensive initial phase of treatment for pulmonary and extrapulmonary tuberculosis.

Rifampicin: It is a semisynthetic derivative of rifamycin, suppresses bacterial RNA synthesis by binding to the beta-subunit of DNA-dependent RNA polymerase. Isoniazid: Kills actively growing tubercle bacilli by inhibiting the biosynthesis of mycolic acids. Pyrazinamide: An antituberculous drug, the pyrazine analog of nicotinamide. Ethambutol: Inhibits the synthesis of 1 or more metabolites, causing impaired cell metabolism, arrest cell multiplication and induce cell death.

Adult Dose (FDC Tablets):

• New patient (Initial 2 months): 2-5 tablets of 4-FDC (Rifampicin 150mg + Isoniazid 75mg + Pyrazinamide 400mg + Ethambutol 275mg) daily based on body weight.
• New patient (Continuation 4 months): 2-5 tablets of 2-FDC (Rifampicin 600mg + Isoniazid 300mg) daily based on body weight.
• Retreatment patient (Initial 3 months): 4-FDC tablets + Streptomycin (500mg-1g) daily; next 5 months: 2-FDC + Ethambutol 400mg.

Average body weight (50 kg): 3 tablets/day.

Common Side Effects:

• Nausea
• Vomiting
• Rash
• Fever
• Dark colored urine
• Sweating
• Salivation
• Watery eyes
• Peripheral neuropathy
• Increased liver enzymes
• Jaundice
• Increased uric acid level in blood
• Visual impairment

Use in Pregnancy: This combination may be unsafe to use during pregnancy. Animal studies have shown harmful effects on the developing baby.

Precautions:

• This combination may cause sight problems and tingling or numbness in hand or feet; do not drive until you know how it affects you.
• Take on an empty stomach and preferably at the same time every day.
• Try not to forget a dose (increases risk of bacterial resistance and side effects).
• It may discolor urine, sweat, saliva and tears reddish/orange (normal and harmless).
• Your doctor may check liver function before and regularly after starting treatment.
• Inform doctor if yellowing of eyes or skin, dark urine, or stomach pain occurs.
• Avoid alcohol (increases risk of side effects on the liver).
• May cause vitamin B6 deficiency; doctor may prescribe supplements.
• Hormonal contraceptives may be less effective; use other methods.
• Do not take antacids within at least two hours of taking this medicine.

Overdose: In case of overdose, symptomatic treatment should be given and seek immediate medical attention.

Storage: Store at temperatures not exceeding 30 degree C.