دواعي استعمال ريمستار 150 مجم 30 قرص

Rimstar (4-drug fixed-dose combination of rifampicin, isoniazid, pyrazinamide and ethambutol; 30 tablets) by Sandoz, used in the initial intensive phase of tuberculosis treatment.

• Initial treatment of tuberculosis according to WHO guidelines.electronic medicines compendium (emc)

• Common: tiredness, headache, dizziness, nausea, anorexia, abdominal pain, flushing, pruritus, asymptomatic liver enzyme rises, reddish discoloration of body fluids (rifampicin); peripheral neuropathy (isoniazid); hyperuricaemia and arthralgia (pyrazinamide).نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Rare but serious: thrombocytopenia, haemolytic anaemia, severe hepatitis, retrobulbar optic neuritis (ethambutol), severe skin reactions.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)

• Hypersensitivity to rifamycins, isoniazid, pyrazinamide, ethambutol or excipients.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• History of drug-induced hepatitis or acute liver disease.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Porphyria.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Acute gouty arthritis.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Severe renal impairment (creatinine clearance below 30 ml/min).نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Concomitant voriconazole and protease inhibitors (except full-dose ritonavir), and lurasidone, sofosbuvir, cabotegravir, fostemsavir or lenacapavir.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)

• Hepatotoxicity from all four components; monitor liver function, and stop isoniazid at jaundice or transaminases above 3 times ULN (replace the combination with separate drugs).نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Ocular toxicity from ethambutol: check visual acuity, colour discrimination and visual fields before and during treatment.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Severe cutaneous adverse reactions (SJS, TEN, DRESS, AGEP) can be fatal; withdraw immediately and never restart.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Gout and hyperuricaemia (pyrazinamide, ethambutol); peripheral neuropathy and seizures (isoniazid); pyridoxine may help prevent neuropathy.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• Rifampicin reduces hormonal contraceptive efficacy; use additional non-hormonal contraception; avoid alcohol.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)

• CYP3A/CYP2C substrates (e.g. coumarins, antiretrovirals, azole antifungals, immunosuppressants, hormonal contraceptives)Rifampicin induction can lower their levels and effect; monitor and adjust doses during and 2-3 weeks after treatment.electronic medicines compendium (emc)
• AntacidsReduce bioavailability of rifampicin, isoniazid and ethambutol; take Rimstar at least 1 hour before antacids.electronic medicines compendium (emc)
• Tyramine/histamine-rich foodsIsoniazid inhibits MAO/DAO, causing headache, sweating, palpitations, flushing, hypotension.electronic medicines compendium (emc)

• May be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus; pyridoxine supplementation recommended.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)
• All four drugs pass into breast milk; breast-feeding is not recommended because of a theoretical risk of neurotoxicity from isoniazid and ethambutol.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)

• Full blood count, liver function tests, renal function and serum uric acid before and at regular intervals; ocular examinations during ethambutol treatment.نشرة دولية لتركيبة مكافئة · electronic medicines compendium (emc)