Fansidar

FANSIDAR (SULFADOXINE + PYRIMETHAMINE)

Complete information including dosage, side effects, interactions and pregnancy & breast feeding warnings for patient and professional use.

Overview and uses

Sulfadoxine – Pyrimethamine (Fansidar) combination is used for the treatment of chloroquine resistant P. falciparum.

Indication (uses):

  • Treatment of acute malaria.
  • Prevention of malaria in areas where chloroquine-resistant falciparum malaria is endemic and sensitive to this combination, and when alternative drugs are not available or are contraindicated.

Pharmacological classification: anti bacterial and anti malarial.

Brand names: Fansidar

Dosage form:

  • Available as tablets containing Sulfadoxine 500 mg and pyrimethamine 25 mg.

Mechanism of action:

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

Dosage of Fansidar

  • ADULT DOSE
    • For the treatment of acute malaria
      • 2 or 3 tablets taken as a single dose.
    • For the prevention of malaria
      • The first dose of Sulfadoxine – pyrimethamine combination should be taken 1 or 2 days before arrival in an endemic area; administration should be continued during the stay and for 4 to 6 weeks after return. Dose should be 1 tablet once a week or 2 tablets once every 2 weeks.
  • PEDIATRIC DOSE (for the treatment of acute malaria): can be used in children with more than 2 months of age to less than 18 years of age. Dose calculations on the basis of body weight is mentioned below:
    • Body weight more than 45 kg
      • 3 tablets to be taken as a single dose.
    • Body weight more than 30 kg but less than or equal to 45 kg
      • 2 tablets to be taken as a single dose.
    • Body weight more than 20 kg but less than or equal to 30 kg
      • 5 (one and half) tablets to be taken as a single dose.
    • Body weight more than 10 kg but less than or equal to 20 kg
      • 1 tablet to be taken as a single dose.
    • Body weight more than 5 kg but less than or equal to 10 kg
      • Half tablet to be taken once a day.
  • PEDIATRIC DOSE (for the prevention of malaria): can be used in children with more than 2 months of age to less than 18 years of age. Dose calculations on the basis of body weight is mentioned below:
    • Body weight more than 45 kg
      • 5 (one and a half) tablets to be taken as a single dose.
    • Body weight more than 30 kg but less than or equal to 45 kg
      • 1 tablet to be taken as a single dose.
    • Body weight more than 20 kg but less than or equal to 30 kg
      • 3/4th (three fourth of the tablet) tablet to be taken as a single dose.
    • Body weight more than 10 kg but less than or equal to 20 kg
      • ½ (half) tablet to be taken as a single dose.
    • Body weight more than 5 kg but less than or equal to 10 kg
      • 1/4th (one fourth of the tablet) tablet to be taken once a day.

Pediatric dose adjustments

Sulfadoxine – pyrimethamine combination should not be given to infants less than 2 months of age because of inadequate development of the glucuronide-forming enzyme system.

Elderly patients

Sufficient data regarding the safety and efficacy of Sulfadoxine – pyrimethamine combination usage in patients above 65 years of age is not available.

Overdosage

  • Symptoms of overdosage includes headache, nausea, anorexia, vomiting and central nervous system stimulation (including convulsions), followed by megaloblastic anemia, leukopenia, thrombocytopenia, glossitis and crystalluria.
  • In cases of acute intoxication, emesis and gastric lavage followed by purges may be beneficial.
  • Patient should be adequately hydrated to prevent renal damage.
  • Renal, hepatic, and hematopoietic systems should be monitored for at least 1 month after an overdosage. If the patient is having convulsions, the use of parenteral diazepam or a barbiturate is indicated.
  • For depressed platelet or white blood cell counts, folinic acid (leucovorin) should be administered in a dosage of 5 mg to 15 mg intramuscularly daily for 3 days or longer.

Side effects or unwanted effects of Fansidar

Hypersensitivity reactions

Hypersensitivity reactions have included 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 pericarditis. Fatalities due to severe hypersensitivity reactions have been reported.

  • Fever, itchy skin, joint aches, multiple skin lesions, swelling of the face, swelling of the tongue, urticaria or hives, skin pain, red or purple colored skin rash, blistering of the skin, shedding of the skin, puffiness around the eyes are some of the symptoms of the above mentioned condition.
  • Consult your doctor as soon as possible if you observe any of the above mentioned symptoms. This may require immediate medical attention and probably discontinuation of the therapy.

Dermatologic side effects

Dermatologic side effects have frequently included phototoxicity, rash, dermatitis, and hair loss.

Hematologic side effects

Agranulocytosis, leucopenia, Aplastic anemia, megaloblastic anemia, thrombocytopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, eosinophilia and macrocytic anemia have also been reported.

  • Sudden fever, sore throat, chills, weakness in limbs, mouth ulcers, bleeding gums, loss of appetite, nausea, feeling of tiredness, rapid heartbeat, shortness of breath, pale skin, leg cramps and insomnia are some of the symptoms of the above mentioned condition. However, above mentioned condition can only be confirmed by suitable blood reports.
  • Consult your doctor as soon as possible. This may require immediate medical attention.

Gastrointestinal side effects

Abdominal pain, vomiting, digestive intolerance, anorexia, diarrhea, nausea, glossitis, stomatitis, and pancreatitis have been reported.

  • Swelling of the tongue, change in the color of tongue, sore and tender tongue, difficulty with chewing, swallowing or speaking, canker sores, cold sores, bloating, diarrhea, nausea, vomiting, loss of appetite, bruising around the belly button and fast hear rate are some of the symptoms of the above mentioned condition.
  • Ask your pharmacist to recommend a suitable medicine and consult your doctor.

Hepatic side effects

Hepatic side effects have included hepatitis, hepatocellular necrosis and liver enzyme elevations.

  • Fatigue, nausea, loss of weight, low grade fever, yellowing of the skin and whites of the eye, dark colored urine are some of the symptoms of hepatitis. Consult your doctor as soon as possible. This may require immediate medical attention.
  • Fatigue, nausea, vomiting, upper right quadrant abdominal pain and tenderness, loss of sex drive, mental changes and itchiness are some of the symptoms of elevated liver enzymes when it is caused by acute liver disease. Consult your doctor as soon as possible.

Renal side effects

Renal failure, interstitial nephritis, toxic nephrosis with oliguria and anuria, crystalluria, and increases in BUN and serum creatinine has also been reported.

Respiratory side effects

Cough, pulmonary infiltrates and shortness of breath have been reported.

Nervous system side effects

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

Other side effects

Other side effects have included drug fever, chills, periarteritis nodosa, and lupus erythematosus phenomenon.

Weight gain, dieresis and hypoglycemia have also been reported.

Contraindications

  • Sulfadoxine-pyrimethamine combination is contraindicated in patients with renal or hepatic failure or blood dyscrasias.
  • Infants less than 2 months of age.
  • Prophylactic use of Sulfadoxine-pyrimethamine combination in pregnancy at term and during nursing.
  • Patients with documented megaloblastic anemia due to folate deficiency.

Pregnancy and breast feeding

Pregnancy: Category C, which means animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Nursing:

  • Both pyrimethamine and Sulfadoxine are excreted in human breast milk.
  • The American academy of pediatrics considers pyrimethamine to be compatible with breast milk.
  • Sulfadoxine can be used in a mother if the breast feeding baby was born healthy and at full term.
  • Sulfadoxine should be avoided if the breast feeding baby is ill, premature, hyperbilirubinemia or glucose – 6 – phosphate dehydrogenase deficiency.
  • However, due to risk of Kernicterus, Sulfadoxine-pyrimethamine combination is contraindicated to use in breast feeding mothers.

Interactions

Drug – drug interactions of Fansidar

  • Concomitant administration of Sulfadoxine-pyrimethamine combination with chloroquine may increase the occurrence and severity of adverse effects.
  • Sulfadoxine-pyrimethamine combination is compatible with quinine and anti-biotics.
  • Sulfadoxine-pyrimethamine combination has not been reported to interfere with anti diabetics.
  • Concomitant use of Sulfadoxine-pyrimethamine combination with sulfonamides, Trimethoprim or sulfonamide – Trimethoprim combination should be avoided.

Drug – food interactions

  • Sulfadoxine-pyrimethamine combination should be taken after meals.

how long does Fansidar stay in the body?

I have shared some of the technical data that should help to answer the above question.

  • The elimination half life of pyrimethamine is 96 hours and that of sulfadoxine is about 200 hours.
  • The duration of action of a drug is known as its half life. This is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. We usually consider the half life of a drug in relation to the amount of the drug in plasma. A drug’s plasma half-life depends on how quickly the drug is eliminated from the plasma. A drug molecule that leaves plasma may have any of several fates. It can be eliminated from the body, or it can be translocated to another body fluid compartment such as the intracellular fluid or it can be destroyed in the blood. The removal of a drug from the plasma is known as ‘clearance and the distribution of the drug in the various body tissues is known as the ‘volume of distribution’. Both of these pharmacokinetic parameters are important in determining the half life of a drug.

How should I take Fansidar?

  • Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
  • Take the pyrimethamine and sulfadoxine tablet after a meal, with plenty of water or other fluid. Swallow the tablet whole, do not break or chew it.
  • Drink plenty of water to keep your kidneys working and prevent kidney stones while taking this medication.
  • To treat malaria, this medication is usually given as a single dose of 1/2 to 3 tablets. Follow your doctor’s instructions.
  • If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for 4 to 6 weeks after you leave.
  • You should not take pyrimethamine and sulfadoxine for longer than 2 years without a doctor’s advice.
  • In addition to taking pyrimethamine and sulfadoxine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.
  • If you take this medication for longer than 3 months, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.
  • Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.
  • No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.
  • Store pyrimethamine and sulfadoxine at room temperature away from moisture and heat.

Click here to go to Sulfadoxine + pyrimethamine (Fansidar) forums.

Fansidar wikipedia page

Reference:

“Product information. Fansidar (Sulfadoxine-pyrimethamine combination).” Roche laboratories, Nutley, NJ.

Note: The sole purpose of every information shared on this article is to bring awareness. Do not use this information as a medical advice or prescription advice or as a tool for the treatment, diagnosis or prevention of the disease.

By |2018-12-29T07:07:59+00:00May 2nd, 2017|medicines|Comments Off on Fansidar

About the Author:

B. Pharm (K.L.E. society's S.V.V. Patil College of Pharmacy, Bengaluru) M. Pharm (Maharishi Arvind Institute of Pharmacy, Jaipur)

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