Clinical medicine profile
Sulphadoxine / Pyrimethamine
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
This profile needs source confirmation
Some sections contain general class guidance rather than medicine-specific evidence. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Pregnancy at term, newborn/premature babies below 2 months, hypersensitivity to pyrimethamine or sulfonamides
- patients with megaloblastic anaemia due to folate deficiency.
Precautions
- Obtain allergy and medication history.
- Adjust for renal/hepatic impairment, pregnancy, lactation, extremes of age and interacting drugs.
- Use the lowest effective dose for the shortest appropriate duration.
- Monitor for expected class adverse effects.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- Prophylaxis against Plasmodium falciparum malaria in pregnancy.
- Clinical selection for Sulphadoxine / Pyrimethamine should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Therapeutic agent (verify pharmacological class).
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- Adverse reactions vary by agent.
- Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
- Report suspected ADRs via national pharmacovigilance channels.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Sulphadoxine / Pyrimethamine, Pyrimethamine.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
The combination is a folic acid antagonist.
Read complete mechanism
The combination is a folic acid antagonist. Sulfadoxine and sulpamethoxypyridazine inhibit the activity of dihydropteroate synthase whereas pyrimethamine inhibits dihydrofolate reductase
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
[From component Pyrimethamine] Pregnancy Teratogenic Effects : Pyrimethamine has been shown to be teratogenic in rats when given in oral doses 2.5 times the human dose for treatment of toxoplasmosis. At these doses in rats, there was a significant increase in abnormalities such as cleft palate, brachygnathia, oligodactyly, and microphthalmia. Pyrimethamine has also been shown to produce terata such as meningocele in hamsters and cleft palate in miniature pigs when given in oral doses 5 times the human dose for the treatment of toxoplasmosis. There are no adequate and well-controlled studies in pregnant women. Pyrimethamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Concurrent administration of folinic acid is strongly recommended when used during pregnancy.
[From component Pyrimethamine] Nursing Mothers Pyrimethamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pyrimethamine and from concurrent use of a sulfonamide with pyrimethamine for treatment of some patients with toxoplasmosis, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS and PRECAUTIONS : Pregnancy ).
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| FANLAR TABS 25*3 | Not recorded | — | KES 671.88Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| MALODAR TABS 3*S | Not recorded | — | KES 36.55Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.