Sulfadoxine/pyrimethamine

Brands of Sulfadoxine/pyrimethamine in Kenya

Falcidin SP, Cosmos Limited

Falcigo, Biodeal Laboratories Ltd

Fanlar,Dawa Limited

G-Cospe, Guilin Pharmaceutical Co. Ltd

Malacide, Square Pharmaceuticals Ltd.

Malodar, Laboratory & Allied Ltd

Sulphadar, Shelys Pharmaceuticals Ltd.

MODE OF ACTION

Sulfadoxine and pyrimethamine,the constituents of this drug,are folic acid antagonists.
Sulfadoxine inhibits the activity of dihydropteroate synthase whereas pyrimethamine inhibits dihydrofolate reductase.

INDICATIONS

Treatment of Acute Malaria

This drug is indicated for the treatment of acute, uncomplicated P. falciparum malaria for those patients in whom chloroquine resistance is suspected. However, strains of P. falciparum may be encountered which have developed resistance to (sulfadoxine and pyrimethamine) , in which case alternative treatment should be administered.

Prevention of Malaria

Malaria prophylaxis with (sulfadoxine and pyrimethamine) is not routinely recommended and should only be considered for travelers to areas where chloroquine-resistant P. falciparum malaria is endemic and sensitive to (sulfadoxine and pyrimethamine) , and when alternative drugs are not available or are contraindicated . However, strains of P. falciparum may be encountered which have developed resistance to (sulfadoxine and pyrimethamine)

CONTRAINDICATIONS

  • Repeated prophylactic (prolonged) use of  (sulfadoxine and pyrimethamine) is contraindicated in patients with renal or hepatic failure or with blood dyscrasias;
  • Hypersensitivity to pyrimethamine, sulfonamides, or any other ingredient of (sulfadoxine and pyrimethamine) ;
  • Patients with documented megaloblastic anemia due to folate deficiency;
  • Infants less than 2 months of age;
  • Prophylactic use of (sulfadoxine and pyrimethamine) in pregnancy at term and during the nursing period.

DRUG INTERACTIONS

There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with (sulfadoxine and pyrimethamine) as compared to the use of (sulfadoxine and pyrimethamine) alone.sulfadoxine and pyrimethamine) is compatible with quinine and with antibiotics. However, antifolic drugs such as sulfonamides, trimethoprim, or trimethoprim-sulfamethoxazole combinations should not be used while the patient is receiving (sulfadoxine and pyrimethamine) for antimalarial prophylaxis.

This drug (sulfadoxine and pyrimethamine) has not been reported to interfere with antidiabetic agents.

If signs of folic acid deficiency develop, (sulfadoxine and pyrimethamine) should be discontinued.

When recovery of depressed platelets or white blood cell counts in patients with drug-induced folic acid deficiency is too slow, folinic acid (leucovorin) may be administered in doses of 5 to 15 mg intramuscularly daily for 3 days or longer.

ADVERSE EFFECTS

Hematological Changes

Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, and eosinophilia.

Skin and Miscellaneous Sites Allergic Reactions

Erythema multiforme, Stevens-Johnson syndrome, generalized skin eruptions, toxic epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, slight hair loss, Lyell’s syndrome,

Gastrointestinal Reactions

Glossitis, stomatitis, nausea, emesis, abdominal pains, hepatitis, hepatocellular necrosis, diarrhea, pancreatitis, feeling of fullness, and transient rise of liver enzymes.

Central Nervous System Reactions

Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo, insomnia, apathy, fatigue, muscle weakness, nervousness, and polyneuritis.

Respiratory Reactions

Pulmonary infiltrates resembling eosinophilic or allergic alveolitis.

Genitourinary

Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, and crystalluria.

Miscellaneous Reactions

Drug fever, chills, periarteritis nodosa and LE phenomenon have occurred.

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has produced thyroid malignancies in the species.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:

Sulfadoxine/pyrimethamine in Kenya
Sulfadoxine/pyrimethamine in Kenya
Sulfadoxine/pyrimethamine in Kenya
Sulfadoxine/pyrimethamine in Kenya
Sulfadoxine/pyrimethamine in Kenya
Sulfadoxine/pyrimethamine in Kenya

Clinical | Pharmacokinetic data

Pregnancy Category: C (Risk not ruled out)
Routes of Administration: Oral
Bioavailability: Not Available
Protein Binding: Not Available
Metabolosim: Hepatic
Onset of Action: N/A
Elimination Half life: Pyrimethamine : 111 hours | Sulfadoxine: 169
Excretion: Pyrimethamine : Renal (16-30%) | Sulfadoxine: Renal (30%)

Legal Status | Dosage forms & Strengths

Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:

Drug Indentifiers:


Drug Images

References/ Citation:

What was the patient being treated for