Fansidar (Oral)

Sulfadoxine, a sulfa medicine, and pyrimethamine combination is used to treat malaria. This medicine may also be used to prevent malaria in people who live in, or will be traveling to, an area where there is a chance of getting malaria. Sulfadoxine and pyrimethamine combination may also be taken with other medicines for malaria or may be used for other issues as determined by your doctor.

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

This medicine is available only with your doctor's prescription.

If this medicine causes a skin rash, itching, redness, sores in the mouth or on the genitals (sex organs), or a sore throat, contact your doctor right away. These may be early warning signs of more serious skin or related issues that could develop later.

Malaria is spread by mosquitoes. If you live in or are traveling to an area where there is a risk of getting malaria, the following mosquito-control measures can help prevent infection:

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

For patients taking this medicine to prevent malaria:

• It is very important that your doctor checks your progress at regular visits. This medicine may cause blood problems, especially if taken for a long time.
• If this medicine causes anemia, your doctor may suggest you take leucovorin (e.g., folinic acid, Wellcovorin) to help resolve the anemia. If so, it is important to take the leucovorin every day while you are taking this medicine. Do not miss any doses.
• The sulfadoxine and pyrimethamine combination may cause blood problems. These problems may lead to a higher chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be cautious when using regular toothbrushes, dental floss, and toothpicks. Delay any dental work until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
• The sulfadoxine and pyrimethamine combination may make your skin more sensitive to sunlight than usual. Exposure to sunlight, even for short periods, may cause a skin rash, itching, redness or other discoloration of the skin, or severe sunburn. When you start taking this medicine: Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m. if possible. Wear protective clothing, including a hat. Also, wear sunglasses. Apply a sunblock product with a skin protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, ask your health care professional. Apply a sunblock lipstick with an SPF of at least 15 to protect your lips. Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction to the sun, contact your doctor.

For patients taking this medicine to self-treat presumed malaria:

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

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Sulfadoxine and pyrimethamine combination should not be used in infants up to 2 months of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of sulfadoxine and pyrimethamine combination in the elderly with other age groups.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used even if there could be an interaction. In these situations, your doctor may adjust the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aurothioglucose

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Carbamazepine
• Cholera Vaccine, Live
• Methotrexate
• Sapropterin
• Sulfamethoxazole
• Trimethoprim
• Zidovudine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Aminolevulinic Acid
• Lorazepam

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime, as interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Anemia or other blood problems—Patients with these issues may experience increased side effects related to the blood.

• Kidney disease or
• Liver disease—Patients with kidney and/or liver disease may have a higher risk of side effects.

• Porphyria—This medicine may trigger an attack of porphyria.

• Seizure disorders, such as epilepsy—High doses of this medicine may increase the risk of convulsions (seizures).

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

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

More common

• Fever
• increased sensitivity of skin to sunlight
• irritation or soreness of tongue
• skin rash

Less common

• Black, tarry stools
• bleeding or crusting sores on lips
• blood in urine or stools
• chest pain
• chills
• cough or hoarseness
• loss of appetite
• lower back or side pain
• muscle cramps or pain
• nausea
• painful or 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 abdominal area
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Rare

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

Symptoms of overdose

• Bleeding or bruising (severe)
• clumsiness or unsteadiness
• convulsions (seizures)
• fever and sore throat
• irritation or soreness of tongue
• loss of appetite
• unusual tiredness or weakness
• trembling
• vomiting (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Anxiety
• diarrhea
• drowsiness
• headache
• nervousness

Less common

• Pain in joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Fansidar

Pharmacologic Class: Folic Acid Antagonist

Chemical Class: Sulfonamide

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

Sulfa-containing medicines are best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects (e.g., kidney stones) of this medicine. If this medicine upsets your stomach or causes vomiting, it may 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 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for 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 area and for 4 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important that you keep taking this medicine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.
• 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 the same day each week. Do not miss any doses. If you 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 presumed malaria:

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of malaria: Adults and teenagers: 3 tablets as a single dose on the third day of quinine therapy. Children: Dose is based on body weight and must be determined by your doctor.
• For self-treatment of presumed malaria: Adults and teenagers: 3 tablets as a single dose when you get a fever and medical care is not available. Children 2 months of age and older: Dose is based on body weight and must be determined by your doctor. The dose may range from ½ tablet to 3 tablets taken as a single dose.
• For prevention of malaria: Adults and teenagers: 1 tablet once every seven days, or 2 tablets once every fourteen days. Children 2 months of age and older: Dose is based on body weight and must be determined by your doctor. The dose may range from ¼ tablet to ¾ tablet taken once every seven days, or ½ tablet to 1½ tablets taken once every fourteen days.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.