GENERIC NAME: SULFADOXINE/PYRIMETHAMINE - ORAL (sull-fuh-DOX-een/pir-ih-METH-uh-meen)
BRAND NAME(S): Fansidar
WARNING: Sulfadoxine/pyrimethamine has caused severe, sometimes fatal allergic reactions. These severe reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) usually start with a skin rash. Stop taking sulfadoxine/pyrimethamine at the first sign of a rash and seek immediate medical attention.
Sulfadoxine/pyrimethamine can cause severe bleeding, low red blood cell count (anemia), or serious infections. If you experience unusual bruising/bleeding, signs of low red blood cell count (such as severe tiredness, pale lips/nails/skin, fast heartbeat, rapid breathing at rest), or symptoms of a severe infection (such as high fever, severe chills, persistent sore throat), stop this medication and seek immediate medical attention.
USES: This medication contains 2 medicines: sulfadoxine and pyrimethamine. This combination may be used to treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in other body tissues. Both medications may be needed for a complete cure and to prevent the return of infection (relapse). Sulfadoxine/pyrimethamine belongs to a class of drugs known as antimalarials.The United States Centers for Disease Control and Prevention (CDC) does not recommend using this medication to prevent malaria (prophylaxis while traveling or living in areas where malaria is common) because severe (sometimes fatal) reactions are more common when this medication is used for prophylaxis. The CDC provides updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.This medication should not be used in infants younger than 2 months. Consult your doctor for more details.
HOW TO USE: Take this medication by mouth after a meal, as a single dose, exactly as directed by your doctor to treat malaria. Do not crush or chew the tablets. Take this drug with at least a full glass of fluid (8 ounces or 240 milliliters). Drink lots of fluids (6 to 8 glasses a day) for the next 7 to 10 days to prevent severe kidney problems (such as kidney stones).Dosage is based on your weight, medical condition, and response to treatment.If needed, primaquine can be taken for 14 days starting immediately after you have finished sulfadoxine/pyrimethamine treatment.Do not take more or less of this drug than prescribed. Doing so may cause treatment to work less well, cause the amount of parasites to increase, make the infection more difficult to treat (resistant), or worsen side effects.It is important to prevent mosquito bites (such as by using appropriate insect repellents, wearing clothes that cover most of the body, remaining in air-conditioned or well-screened areas, using mosquito nets and insect-killing sprays). Buy insect repellent before traveling. The most effective insect repellents contain diethyltoluamide (DEET). Ask your doctor or pharmacist to recommend the appropriate strengths of mosquito repellent for you/your children.No drug treatment is completely effective in preventing malaria. Seek immediate medical attention if you develop symptoms of malaria (such as fever, chills, headache, other flu-like symptoms). Malaria can return, even months after completing prevention/treatment. Quick treatment of malaria infection is needed to prevent serious, possibly fatal, outcomes.Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section.Nausea, vomiting, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen/painful tongue, mental/mood changes (such as depression, hallucinations, nervousness), unusually quick sunburn (photosensitivity).Tell your doctor immediately if any of these rare but very serious side effects occur: lower abdominal/back pain, bloody/pink urine, change in amount of urine, painful urination, chest pain, irregular heartbeat, signs of severe liver problems (such as severe tiredness, persistent nausea/vomiting, yellowing skin/eyes, abdominal pain, dark urine).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking sulfadoxine/pyrimethamine, tell your doctor or pharmacist if you are allergic to either sulfadoxine or pyrimethamine; or to other "sulfa" drugs (such as sulfamethoxazole, sulfisoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as low platelets), low red blood cell count (anemia), low white blood cell count, severe allergy or breathing problems (asthma), seizures, kidney problems, liver problems, low folic acid levels (such as problems with absorption of food, alcoholism), a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), a certain blood disorder (porphyria).This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.This drug passes into breast milk. Due to the possibility of severe side effects in your nursing infant, avoid breast-feeding while taking sulfadoxine/pyrimethamine. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin), chloroquine, cyclosporine, drugs that lower folate levels (such as phenytoin, "sulfa" antibiotics, trimethoprim), methenamine, penicillamine, live vaccines such as typhoid vaccine taken by mouth, drugs that may cause a decrease in white blood cells (such as chemotherapy drugs like methotrexate).This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, fainting, dangerously slowed breathing, inability to wake up.
NOTES: Do not share this medication with others.If you take this medication for longer than 3 months, laboratory and/or medical tests (such as blood cell counts, liver tests, kidney tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.