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معلومات الدواء

التفاصيل الكاملة
عن الدواءAbout the medicine

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.

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.

دواعي الاستعمالUses
  • Initial treatment of tuberculosis according to WHO guidelines.electronic medicines compendium (emc)
  • Initial treatment of tuberculosis according to WHO guidelines.electronic medicines compendium (emc)
الآثار الجانبيةSide effects
  • 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)
  • 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).International label, equivalent formulation · electronic medicines compendium (emc)
  • Rare but serious: thrombocytopenia, haemolytic anaemia, severe hepatitis, retrobulbar optic neuritis (ethambutol), severe skin reactions.International label, equivalent formulation · electronic medicines compendium (emc)
موانع الاستعمالContraindications
  • 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)
عرض الكل (6)
  • Hypersensitivity to rifamycins, isoniazid, pyrazinamide, ethambutol or excipients.International label, equivalent formulation · electronic medicines compendium (emc)
  • History of drug-induced hepatitis or acute liver disease.International label, equivalent formulation · electronic medicines compendium (emc)
  • Porphyria.International label, equivalent formulation · electronic medicines compendium (emc)
Show all (6)
تحذيرات واحتياطاتWarnings & precautions
  • 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)
عرض الكل (5)
  • 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).International label, equivalent formulation · electronic medicines compendium (emc)
  • Ocular toxicity from ethambutol: check visual acuity, colour discrimination and visual fields before and during treatment.International label, equivalent formulation · electronic medicines compendium (emc)
  • Severe cutaneous adverse reactions (SJS, TEN, DRESS, AGEP) can be fatal; withdraw immediately and never restart.International label, equivalent formulation · electronic medicines compendium (emc)
Show all (5)
التداخلات الدوائيةDrug interactions
  • 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)
  • 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)
الحمل والرضاعةPregnancy & breastfeeding
  • 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)
  • May be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus; pyridoxine supplementation recommended.International label, equivalent formulation · 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.International label, equivalent formulation · electronic medicines compendium (emc)

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