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Sulfadoxine / Pyrimethamine

Pronouncation: (SULL-fah-DOX-een/pihr-ih-METH-ah-meen)
Class: Antimalarial preparation

Trade Names:
Fansidar
- Tablets 500 mg sulfadoxine and 25 mg pyrimethamine

Pharmacology

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Compare with other drugs.

The 2 components sequentially block 2 enzymes involved in the biosynthesis of folinic acid within the parasites.

Indications and Usage

Treatment of Plasmodium falciparum malaria for those patients in whom chloroquine resistance is suspected; prophylaxis of malaria for travelers to areas where chloroquine-resistant P. falciparum malaria is endemic.

Contraindications

Patients with severe renal insufficiency; marked liver parenchymal damage; blood dyscrasias; documented megaloblastic anemia caused by folate deficiency; infants less than 2 mo; pregnancy at term; during the nursing period; hypersensitivity to pyrimethamine, sulfonamides, or any component of the product.

Dosage and Administration

Acute Attack of Malaria
Adults

PO Single dose of 2 to 3 tablets.

Children 9 to 14 yr

PO Single dose of 2 tablets.

Children 4 to 8 yr

PO Single dose of 1 tablet.

Children under 4 yr

PO Single dose of ½ tablet.

Malaria Prophylaxis

Take first dose 1 or 2 days before departure to an endemic area; continue administration during the stay and for 4 to 6 wk after returning.

Adults

PO 1 tablet once/wk or 2 tablets once every 2 wk.

Children 9 to 14 yr

PO ¾ tablet once/wk or 1½ tablets once every 2 wk.

Children 4 to 8 yr

PO ½ tablet once/wk or 1 tablet once every 2 wk.

Children under 4 yr

PO ¼ tablet once/wk or ½ tablet once every 2 wk.

Storage/Stability

Store tablets at controlled room temperature (59° to 77°F).

Drug Interactions

Antifolic drugs (eg, sulfonamides, trimethoprim-sulfamethoxazole)

Should not be taken by patients receiving sulfadoxine/pyrimethamine.

Chloroquine

Incidence and severity of adverse reactions may be increased compared with taking sulfadoxine/pyrimethamine alone.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; peripheral neuritis; mental depression; convulsions; ataxia; hallucinations; insomnia; apathy; fatigue; muscle weakness; nervousness; vertigo.

EENT

Tinnitus.

GI

Glossitis; stomatitis; nausea; emesis; abdominal pain; diarrhea; pancreatitis.

Genitourinary

Toxic nephrosis with oliguria and anuria.

Hematologic

Agranulocytosis; aplastic anemia; megaloblastic anemia; thrombopenia; leukopenia; hemolytic anemia; purpura; hypoprothrombinemia; methemoglobinemia; eosinophilia.

Hepatic

Hepatitis; hepatocellular necrosis.

Respiratory

Pulmonary infiltrates.

Miscellaneous

Allergic reactions including 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 and allergic myocarditis; drug fever; chills; periarteritis nodosa; lupus erythematosus.

Precautions

Warnings

Fatalities have occurred because of severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Discontinue sulfadoxine and pyrimethamine prophylaxis at the first appearance of skin rash, if a significant reduction in the count of any formed blood elements is noted, or upon the occurrence of active bacterial or fungal infections.

Pregnancy

Category C . Contraindicated in pregnancy at term (may cross placenta, causing kernicterus).

Lactation

Secreted in breast milk (may cause kernicterus).

Children

Should not be given to infants under 2 mo because of inadequate development of glucuronide-forming enzyme system.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Special Risk Patients

Use with caution in patients with renal or hepatic function impairment, possible folate deficiency, severe allergy or bronchial asthma, or glucose-6-phosphate dehydrogenase deficiency.

Severe reaction

Fatalities have occurred because of fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.

Overdosage

Symptoms

Anorexia, vomiting, CNS stimulation (including convulsions), megaloblastic anemia, leukopenia, thrombocytopenia, glossitis, crystalluria.

Patient Information

Advise patient to maintain adequate fluid intake (eg, 8 glasses of water/day) while taking medication.
Instruct patient taking medication for prophylaxis that first dose should be taken 1 to 2ߙdays prior to arrival in malaria-infected area and that subsequent doses should be taken on the same day of the week (or every other week if ordered) while in the malaria-infected area and for 4 to 6 wk after leaving the malaria-infected area.
Advise patient that protective clothing, insect repellents, and bednets are important components of malaria prophylaxis.
Advise patient to discontinue therapy and notify health care provider immediately if any of the following occur: skin rash; fever or other signs of infection (eg, sore throat); joint pain; unexplained cough or shortness of breath; paleness; skin discoloration; yellowing of skin or eyes; tongue inflammation.
Advise patient to notify health care provider if severe or persistent vomiting or diarrhea develop, other bothersome side effects occur, or if therapy is prematurely discontinued for any reason.
Advise women of childbearing potential to use effective contraception while taking medication for malaria prophylaxis.
Advise patient if a febrile illness develops during or after return from a malaria-endemic area to seek health care and inform health care provider of possible exposure to malaria.