Generic name: Sulfadoxine and Pyrimethamine tablets USP & Sulfadoxine and Pyrimethamine Oral suspension.
Sulphadar is indicated for the Intermittent Preventive Therapy of malaria in pregnancy (IPTp). The aim of IPTp is to prevent the worst effect of malaria infection I pregnancy rather than to cure.
Dosage regimen and directions for use
As directed by the physician (DOT-Direct observed treatment) OR
The first IPTp dose is administered between 20-24 weeks of gestational age. The second IPTp dose should be administered at 28-32 weeks.
FOR PREGNANT WOMEN ONLY
Direction for reconstitution
Shake the bottle before adding water. Measure 25ml of previously boiled and cooled water and add it o the powder of oral solution in 2 portions and agitate vigorously immediately after each addition.
Sulfadoxine and Pyrimethamine (SP) tablets should be used during pregnancy only if the expected benefit justifies the potential risk to foetus. If at all possible, usage during first trimester should be avoided. It is also contraindicated in infants under 6 weeks due to risk of kernicterus, hyphosphataemia and in renal and hepatic failure, jaundice, patients with documented megaloblastic anaemia due to folate deficiency, Glucose 6-phosphate Dehydrogenase deficiency and to patients hypersensitive to either of the drugs.
Side effects and adverse reactions
Depression of Haemopoiesis with prolonged treatment and skin rashes.
Severe reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Blood adverse effects enhanced by drugs which interfere with folic acid metabolism such as Trimethoprim and Methotrexate.
Precautions and warnings
To be used with caution in hepatic or renal impairment. In case of prophylaxis with this therapy, the treatment should be immediately discontinued if lesions of the skin or mucous membrane appear or if there is itching or sore throat. Blood count monitoring is required.
Caution to be taken when Pyrimethamine and Sulfadoxine combination is administered in patients with deficiency of glucose 6-Phosphate Dehydrogenase activity. Maintain adequate fluid intake.
Keep the medicine out of reach of children.
Symptoms and treatment of overdose
Symptoms: Vomiting, visual and mental disorders, patechiae, purpura and jaundice
Treatment: The stomach should be emptied induce emesis or gastric lavage if ingested within few hours. Convulsions should be controlled by injection of Diazepam 5-10 mg and injection of Calcium folinate should be given to counter the folinate deficiency. Respiration may require assistance. Hypersensitivity reactions are treated with corticosteroid. Alkalisation of urine by administration of alkalizing solution may favor the excretion of Sulfadoxine and symptomatic treatment shall be given.