Sulfadoxine/ Pyrimethamine

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Mild to moderately severe chloroquine resistant malaria due to Plasmodium falciparum

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sulfadoxine
Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product 
• Hypersensitivity to sulphonamides
• Term pregnancy 
• Severe renal impairment
• Severe hepatic impairment
• Megaloblastic anaemia 
• Premature infants
• Infants below 2 months 

Cautions

• Pregnancy 
• Breastfeeding 
• Elderly 

Pyrimethamine
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Megaloblastic anaemia
• Dehydration
• Patients predisposed to folate deficiency
• History of seizures

Additional contraindications for this combination product

• Blood dyscrasias

Forms avail. in SA and covered in this monograph: tab

Infections caused by: Plasmodium falciparum

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Malaria
- Mild to moderate
- Chloroquine resistant

Sulfadoxine/ Pyrimethamine
500/25 (mg)

• Oral (tab): 2-3 tab, as a single dose

Complicated malaria (additional agent required)
Emergency malaria self-treatment
- When prompt medical attention is unavailable

• Oral (tab): 2-3 tab, as a single dose

Paed. forms avail. in SA and covered in this monograph: tab

Infections caused by: Plasmodium falciparum

General dosing range

Sulfadoxine/ Pyrimethamine
500/25 (mg)

• Younger than 4 years: Oral (tab): 0.5 tab, as a single dose
• Between 4-6 years: Oral (tab): 1 tab, as a single dose
• Between 7-9 years: Oral (tab): 1.5 tab, as a single dose
• Between 10-14 years: Oral (tab): 2 tab, as a single dose
• Older than 14 years: See adult dosage

 Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Contraindicated

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Pyrimethamine)
• Severe: Contraindicated (Sulfadoxine)

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Pyrimethamine)
• Severe: Contraindicated (Sulfadoxine)

Elderly

• Caution; no dose adjustment recommended (Sulfadoxine)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sulfadoxine
Central Nervous System Disorders

• Fatigue
• Headache
• Dizziness
• Polyneuritis

Gastrointestinal Disorders

• Nausea and vomiting 
• Feeling of fullness
• Diarrhoea
• Stomatitis

Hepatobiliary Disorders

• Transient increased hepatic enzymes 
• Hepatitis 

Genitourinary Disorders

• Interstitial nephritis
• Flank pain 
• Haematuria
• Oliguria

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Photosensitisation
• Hair loss
• Erythema multiforme
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Fixed drug eruption
• Purpura

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Megaloblastic anaemia
• Leucopenia
• Agranulocytosis
• Fever

Pyrimethamine
Central Nervous System Disorders

• Headache
• Dizziness
• Seizures

Respiratory Disorders

• Pneumonia with cellular and eosinophilic pulmonary infiltration 

Gastrointestinal Disorders

• Nausea and vomiting 
• Diarrhoea
• Colic
• Buccal ulceration

Skin and Subcutaneous Tissue Disorders

• Rash
• Abnormal skin pigmentation
• Dermatitis

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Leucopenia
• Thromboctopenia
• Pancytopenia
• Fever

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sulfadoxine

• Cotrimoxazole
• Sulphonylureas
• Procaine
• Benzocaine
• Tetracaine
• Zidovudine
• Aminolevulinic acid

Pyrimethamine

• Folate inhibitors 
• Daunorubicin
• Cytosine arabinoside 
• Trimethoprim 
• Methotrexate
• Antimalarial agents
• Quinine 
• Warfarin
• Lorazepam
• Antacid salts 
• Kaolin

• Full blood count
• Hepatic function
• Renal function

Sulfadoxine
Sulfadoxine is a long acting sulphonamide which is an analogue para-aminobenzoic acid. The combination of sulfadoxine and pyrimethamine has synergistic effect of inhibiting the plasmodium falciparum folate biosynthetic pathway via inhibition of dihydropteroate synthetase by sulfadoxine and dihydrofolate reductase by pyrimethamine. Sulfadoxine activity is against the blood asexual form P.falciparum in uncomplicated malaria.

Pyrimethamine
Pyrimethamine binds to and reversibly inhibits the protozoa enzyme dihydrofolate reductase. This depletes folate, an essential cofactor in biosynthesis of nucleic acids.

Spectrum of activity: Plasmodium falciparum

COMBINATION PREPARATIONS

Sulfadoxine/ Pyrimethamine

Tablet 500mg/25mg

• Fansidar (Roche) originator