SULFADOXINEAND PYRIMETHAMINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Fansidar

In Canada?

• Fansidar

Category

• Antiprotozoal

Description

Sulfadoxine (sul-fa-DOX-een), a sulfa medicine, and pyrimethamine (peer-i-METH-a-meen) combination is usedto treat malaria. This medicine may also be used to prevent malaria in peoplewho are living in, or will be traveling to, an area where there is a chanceof getting malaria. Sulfadoxine and pyrimethamine combination may also betaken with other medicines for malaria, or may be used for other problemsas determined by your doctor.

Since sulfadoxine and pyrimethamine combination may cause some seriousside effects, it generally is used only to prevent or treat serious malariainfections in areas where it is known that other medicines may not work.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For sulfadoxine andpyrimethamine combination, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to sulfa medicines, furosemide (e.g., Lasix) or thiazidediuretics (water pills), oral antidiabetics (diabetes medicine you take bymouth), glaucoma medicine you take by mouth (acetazolamide [e.g., Diamox],dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane]), or pyrimethamine(e.g., Daraprim). Also tell your health care professional if you are allergicto any other substances, such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in pregnant women. However,use is not recommended during pregnancy. Studies in rats have shown that sulfadoxineand pyrimethamine combination may cause birth defects and anemia. Also, womenwho travel to an area where there is a chance of getting malaria, and whomay be taking sulfadoxine and pyrimethamine combination, should avoid becomingpregnant.

Breast-feeding?Sulfadoxine and pyrimethamine pass into the breastmilk. This medicine is not recommended for use during breast-feeding. It maycause liver problems, anemia, and other unwanted effects in nursing babies.

Children?Sulfadoxine and pyrimethamine combination shouldnot be used in infants up to 2 months of age.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof sulfadoxine and pyrimethamine combination in the elderly with use in otherage groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingsulfadoxine and pyrimethamine combination, it is especially important thatyour health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Other anti-infectives by mouth or by injection (medicine for infection)or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Valproic acid (e.g., Depakene)?Use of sulfadoxine and pyrimethaminecombination with these medicines may increase the chance of side effects affectingthe liver

• Acetohydroxamic acid (e.g., Lithostat) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicines) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Dapsone or
• Flucytosine (e.g., Ancobon) or
• Furazolidone (e.g., Furoxone) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Nitrofurantoin (e.g., Furadantin) or
• Primaquine or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Quinine or
• Sulfoxone (e.g., Diasone) or
• Vitamin K (e.g., AquaMEPHYTON, Synkayvite) or
• Zidovudine (e.g., AZT, Retrovir)?Use of sulfadoxine and pyrimethaminecombination with these medicines may increase the chance of side effects affectingthe blood

• Antithyroid agents (medicine for overactive thyroid) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Plicamycin (e.g., Mithracin)?Use of sulfadoxine and pyrimethaminecombination with these medicines may increase the chance of side effects affectingthe liver and the blood

Other medical problems?The presence of other medicalproblems may affect the use of sulfadoxine and pyrimethamine combination.Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or other blood problems?Patients with these problemsmay have an increase in side effects involving the blood

• Kidney disease or
• Liver disease?Patients with kidney and/or liver disease mayhave an increased chance of side effects

• Porphyria?This medicine may cause an attack of porphyria

• Seizure disorders, such as epilepsy?High doses of this medicinemay increase the chance of convulsions (seizures)

Proper Use of This Medicine

Do not give this medicine to infants younger than 2 months of age unlessotherwise directed by your doctor. Also, keep this medicineout of the reach of children. Overdose is especially dangerous in children.

Sulfa-containing medicines are best taken with a fullglass (8 ounces) of water. Several additional glasses of water should be takenevery day, unless otherwise directed by your doctor. Drinking extrawater will help to prevent some unwanted effects (e.g., kidney stones) ofthis medicine. If this medicine upsets your stomach or causes vomiting, itmay be taken with meals or a snack.

For patients taking this medicine to prevent malaria:

• Your doctor may want you to start taking this medicine 1 to 2 weeksbefore you travel to an area where there is a chance of getting malaria. Thiswill help you to see how you react to the medicine. Also, it will allow timefor your doctor to change your medicine if you have a reaction to this medicine.
• Also, you should keep taking this medicine while you are in the areaand for 4 weeks after you leave the area. No medicine will protect you completelyfrom malaria. However, to protect you as completely as possible, it is important that you keep taking this medicine for the full time yourdoctor ordered. Also, if fever develops during your travels or within2 months after you leave the area, check with your doctorimmediately.
• This medicine works best when you take it on a regular schedule.For example, if you are to take it once a week, it is best to take it on thesame day each week. Do not miss any doses. Ifyou have any questions about this, check with your health care professional.

For patients taking this medicine to treat malaria:

• To help clear up your infection completely, take this medicine exactly as directed by your doctor.

For patients taking this medicine to self-treat presumedmalaria:

• After you take this medicine to self-treat presumed malaria, youshould continue to take your other medicine for malaria once a week.

Dosing?The dose of sulfadoxine and pyrimethamine combinationwill be different for different patients. Follow yourdoctor's orders or the directions on the label. The following informationincludes only the average doses of sulfadoxine and pyrimethamine combination. If your dose is different, do not change it unlessyour doctor tells you to do so.

• For treatment of malaria:
  • Adults and teenagers: 3 tablets as a single dose on the third dayof quinine therapy.
  • Children: Dose is based on body weight and must be determined byyour doctor.
• For self-treatment of presumed malaria:
  • Adults and teenagers: 3 tablets as a single dose when you get a feverand medical care is not available.
  • Children 2 months of age and older: Dose is based on body weightand must be determined by your doctor. The dose may range from 1/2 tabletto 3 tablets taken as a single dose.
• For prevention of malaria:
  • Adults and teenagers: 1 tablet once every seven days, or 2 tabletsonce every fourteen days.
  • Children 2 months of age and older: Dose is based on body weightand must be determined by your doctor. The dose may range from 1/4 tabletto 3/4 tablet taken once every seven days, or 1/2 tablet to 11/2tablets taken once every fourteen days.

Missed dose?For patients taking this medicine to prevent malaria: If you do miss a dose of this medicine, take itas soon as possible. This will help to keep you taking your medicine on aregular schedule. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose of sulfadoxine and pyrimethaminecombination is very dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If this medicine causes skin rash, itching, redness, sores inthe mouth or on the genitals (sex organs), or sore throat, check with yourdoctor immediately. These may be early warning signs of more serious skinor related problems that could develop later.

Malaria is spread by mosquitoes. If you are living in, or will be travelingto, an area where there is a chance of getting malaria, the following mosquito-controlmeasures will help to prevent infection:

• If possible, sleep under mosquito netting to avoid being bitten bymalaria-carrying mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protectyour arms and legs, especially from dusk through dawn when mosquitoes areout.
• Apply mosquito repellant to uncovered areas of the skin from duskthrough dawn when mosquitoes are out.

For patients taking this medicine to prevent malaria:

• It is very important that your doctor check yourprogress at regular visits. This medicine may cause blood problems,especially if it is taken for a long time.
• If this medicine causes anemia, your doctor may want you to takeleucovorin (e.g., folinic acid, Wellcovorin) to help clear up the anemia.If so, it is important to take the leucovorin every day while you are takingthis medicine. Do not miss any doses.
• Sulfadoxine and pyrimethamine combination may cause blood problems.These problems may result in a greater chance of certain infections, slowhealing, and bleeding of the gums. Therefore, you should be careful when usingregular toothbrushes, dental floss, and toothpicks. Dental work should bedelayed until your blood counts have returned to normal. Check with your medicaldoctor or dentist if you have any questions about proper oral hygiene (mouthcare) during treatment.
• Sulfadoxine and pyrimethamine combination may cause your skin tobe more sensitive to sunlight than it is normally. Exposure to sunlight, evenfor brief periods of time, may cause a skin rash, itching, redness or otherdiscoloration of the skin, or a severe sunburn. When you begin taking thismedicine:
  • Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block product that has a skin protection factor (SPF)of at least 15. Some patients may require a product with a higher SPF number,especially if they have a fair complexion. If you have any questions aboutthis, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check withyour doctor.

For patients taking this medicine to self-treat presumedmalaria:

• Seek medical help as soon as possible, especially if your symptomsdo not improve within 48 hours.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Fever; increased sensitivity of skinto sunlight; irritation or soreness of tongue; skin rash

Less common

Black, tarry stools; bleeding or crustingsores on lips; blood in urine or stools; chest pain; chills; cough or hoarseness; loss of appetite; lower back or side pain; muscle crampsor pain; nausea; painfulor difficult urination; pinpoint red spots on skin; redness, blistering, peeling, or loosening of skin; sore mouth; sore throat; sores, ulcers, and/or white spots in mouth; sores on lips; swelling in upper abdominalarea; unusual bleeding or bruising; unusual tiredness or weakness; vomiting; yellow eyes or skin

Rare

Abdominal or stomach pain; changes infacial skin color; constipation; fast or irregular breathing; tenderness, itching,or burning of skin; puffiness or swelling of theeyelids or around the eyes; shortness of breath,troubled breathing, tightness in chest, and/or wheezing; swelling of front part of neck

Symptoms of overdose

Bleeding or bruising (severe); clumsinessor unsteadiness; convulsions (seizures); fever and sore throat; irritation orsoreness of tongue; loss of appetite; unusual tiredness or weakness; trembling; vomiting (severe)

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

More common

Anxiety; diarrhea; drowsiness; headache; nervousness

Less common

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,sulfadoxine and pyrimethamine combination is used in certain patients withthe following medical condition:

• Isosporiasis (prevention)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.