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REZIZFILM-COATED

Contains
  • Indication

    Chloroquine resistant falciparum malaria acute attack

  • Dosage

    Oral Chloroquine resistant falciparum malaria acute attack Adult: Per tab contains pyrimethamine 25 mg and sulfadoxine 500 mg: 2-3 tabs as a single dose. Do not repeat for at least 7 days.  Child: Pyrimethamine 25mg + Sulfadoxine 500mg (Tablet): <2 yr (5-10 kg): ½ tab as a single dose; 2-5 yr (>10-20 kg): 1 tab as a single dose; 5-10 yr (< 20-30 kg): 1½ tab as a single dose; 10-14 yr (> 30-45 kg): 2 tab as a single dose. Do not repeat for at least 7 days.  Renal impairment: Dose reduction may be needed. Severe: contra-indicated. Hepatic impairment: Dose reduction may be needed. Severe: contra-indicated.

  • Overdosage

    Symptoms: Headache, nausea, anorexia, vomiting, CNS stimulation, megaloblastic anaemia, leukopenia, thrombocytopenia, glossitis and crystalluria. Management: Treatment is symptomatic and supportive. Emesis and gastric lavage to reduce drug absorption. Ensure that patient is adequately hydrated to prevent kidney damage. Monitor renal, hepatic, and haematopoietic systems for at least 1 month after overdosage. Folinic acid may be admin for depressed platelet or WBC counts.

  • Contraindications

    Severe renal or hepatic impairment, blood dyscrasias, hypersensitivity to components, megaloblastic anaemia due to folate deficiency, pregnancy at term and during lactation, infants = 2 mth old.

  • Special precautions

    Severe renal or hepatic impairment, blood dyscrasias, hypersensitivity to components, megaloblastic anaemia due to folate deficiency, pregnancy at term and during lactation, infants = 2 mth old.

  • Adverse drug reactions

    Urticaria, serum sickness, photosensitisation, arthralgia, nausea, vomiting, abdominal pain, diarrhoea, headache, peripheral neuritis, ataxia, tinnitus, vertigo, convulsions, toxic nephrosis and pulmonary infiltrates resembling eosinophilic or allergic alveolitis. Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, blood dyscrasias, anaphylactoid reactions.

  • Drug interaction

    Increased halofantrine and chlorpromazine levels. Increased effects of warfarin. Potentially Fatal: Increased risk of myelosupression with zidovudine, clozapine.

  • Pregnancy category

    Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus

  • Mech of action

    Pyrimethamine, a folic acid antagonist, inhibits the reduction of dihydrofolic acid to tetrahydrofolic acid (folinic acid). Sulfadoxine, a structural analog of p-aminobenzoic acid (PABA), competitively inhibits dihydrofolic acid synthesis which is important for PABA conversion to folic acid. This combination results in a synergistic action against susceptible plasmodia. Both have prolonged half-lives enabling single dose admin. Absorption: Peak plasma concentration: 4 hr. Distribution: Volume of distribution: 0.14 L/kg (sulfadoxine); 2.3 L/kg (pyrimethamine). Protein binding: 90% (for both drugs). Both drugs cross placenta and passes into breast milk. Metabolism: Sulfadoxine: 5% appear in blood as acetylated metabolite, 2-3% as glucuronide. Pyrimethamine converted to several metabolites. Excretion: Elimination half life: 100 hr (pyrimethamine); 200 hr (sulfadoxine). Excreted mainly via kidneys.

  • CIMS class

    Antimalarials

  • ATC class

    P01BD01 - pyrimethamine; Belongs to the class of diaminopyrimidine antimalarials. Used in the management of malarial infections.

  • Additional Info

    *sulfadoxine + pyrimethamine information: Note that there are some more drugs interacting with sulfadoxine + pyrimethamine sulfadoxine + pyrimethamine sulfadoxine + pyrimethamine brands available in India Always prescribe with Generic Name : sulfadoxine +

 
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