Precautions and warnings

Rifampin is usually taken every day to treat tuberculosis. Taking large doses of rifampin (over 600 mg) only once or twice a week increases the risk of side effects. These side effects can include flu-like symptoms (fever, chills, feeling unwell), blood problems (such as low white blood cells, low platelets, or anemia), skin, stomach, and liver issues, trouble breathing, allergic shock, or even kidney failure. Recent studies show that taking 600 mg of rifampin with 15 mg/kg of isoniazid twice a week is much safer and easier for patients to tolerate.

Rifampin should not be used for “off-and-on” or intermittent treatment. Patients should not skip doses or stop and restart the medication, as this may cause rare but serious kidney allergic reactions.

Drug Interactions

- **Rifampicin:** Speeds up the breakdown of many medicines by the liver, which can make these drugs less effective. This includes methadone, blood thinners, steroids, female hormones (like those in birth control), diabetes medicines, heart drugs (such as digitoxin and antiarrhythmics), theophylline, epilepsy drugs, beta-blockers, antifungal medicines, and cyclosporin.

- **INH (Isoniazid):** Slows down the breakdown of antiepileptics, benzodiazepines, warfarin, and theophylline, which can cause higher levels of these drugs in the body. It also increases the breakdown of enflurane. INH can interact with alcohol, aspirin, antacids with aluminum, steroids, ketoconazole, and propranolol.

- **Pyrazinamide (PZA):** Can reduce the effectiveness of medicines used to treat gout.

- **Ethambutol:** May have harmful effects when taken with other drugs that affect the nerves (neurotoxic agents).

Contraindications

This medicine should not be taken by anyone who has had an allergic reaction to rifampin, isoniazid, pyrazinamide, any ingredients in the medicine, or any rifamycin antibiotics.

Mode of actions

Rifampicin, isoniazid, and pyrazinamide are strong antibiotics used to treat tuberculosis (TB). Rifampicin and isoniazid work well against TB bacteria that grow quickly both outside and inside cells. Rifampicin also blocks an enzyme needed for the bacteria to make RNA and is effective against TB bacteria that grow slowly or only sometimes.

Pyrazinamide mainly works inside cells, especially in acidic conditions found in macrophages, and is active against TB bacteria hiding there. Using these drugs together helps attack TB bacteria living in different conditions in the body.

Ethambutol stops TB bacteria from making RNA, which slows down their growth. It works mainly by stopping fast-growing bacteria in lung cavities but is also effective against those that grow slowly. Ethambutol can also help treat some other types of mycobacteria, like M. kansasii and the M. avium complex (MAC).

Dosage & Administration

Rimstar 4-FDC presents- Rifampicin 150mg + Isoniazid 75mg + Pyrazinamide 400mg + Ethambutol 275mg tablet. Patients should be given the following single daily dose of either 1 hour before or 2 hours after a meal with a full glass of water.

The total dosage requirement of rifampicin is 10 (8 to 12) mglkg/day, of isoniazid 5 (4 to 6) mglkglday, of pyrazinamide 25 (20 to 30) mglkg/day and of ethambutol 15 (15-20) mglkg/day.

New patients:
Body weight < 50kg, initial 2•months- Rimstar 4-FDC 3 tablets at a time daily; next 4 months- continuation dose Rifampicin 450mg + Isoniazid 300mg daily.

Body weight >50kg, initial 2 months- Rimstar 4-FDC 4 tablets at a time daily; next 4 months- continuation dose Rifampicin 600mg + Isoniazid 300mg at a time daily.

Re-treatment patients:
Body weight < 50kg, initial 2 months- Rimstar 4-FDC 3 tablets at a time daily, & Streptomycin 15mg/kg daily; next 1 month Rimstar 4-FDC 3 tablets at a time daily; next 5 months- continuation dose Rifampicin 450mg + Isoniazid 300mg daily, & Ethambutol 400mg 2 tablets (800mg) at a time daily.

Body weight >50kg, initial 2 months- Rimstar 4-FDC 4 tablets at a time daily, & Streptomycin 15mg/kg daily; next 1 month Rimstar 4-FDC 4 tablets at a time daily; next 5 months- continuation dose Rifampicin 600mg + Isoniazid 300mg at a time daily, & Ethambutol 400mg 2 1/2 tablets (1000mg) at a time daily.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required despite potential risks.

Mothers with a newborn baby who have used this drug during the last 3 months of pregnancy may seldom create symptoms including drowsiness, muscle stiffness or shakiness, feeding or breathing troubles, constant crying. If you notice any of these symptoms of your baby's particularly during their first month, tell the doctor immediately.

This medicine passes into breast milk. Talk to your doctor before breastfeeding.

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