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|Sulfamethoxazole/Trimethoprim Tablets

Sulfamethoxazole/Trimethoprim

Sulfamethoxazole/Trimethoprim is used for:

Treating infections caused by certain bacteria.

Sulfamethoxazole/Trimethoprim is an antibiotic combination containing a sulfonamide antibiotic. It works by killing sensitive bacteria.

Do NOT use Sulfamethoxazole/Trimethoprim if:

• you are allergic to any ingredient in Sulfamethoxazole/Trimethoprim or to similar medicines
• you had a severe allergic reaction to any other sulfonamide (sulfa) medicine (eg, glipizide, hydrochlorothiazide)
• you are taking dofetilide
• you have anemia caused by low levels of folate in the blood or urinary blockage
• you are in week 38 of pregnancy or later (full-term) or you are breast-feeding
• the patient is a child younger than 2 months old

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sulfamethoxazole/Trimethoprim:

Some medical conditions may interact with Sulfamethoxazole/Trimethoprim. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription (especially seizure medications) or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver or kidney problems, blood problems (eg, anemia, porphyria), asthma, or AIDS
• if you have severe allergies, glucose-6-phosphate dehydrogenase deficiency, or an enzyme deficiency
• if you at risk for low levels of folate in the blood (eg, you have alcoholism, are elderly, you do not absorb nutrients from food properly, you are in a poor nutritional state, you are taking medicine for seizures)

Some MEDICINES MAY INTERACT with Sulfamethoxazole/Trimethoprim. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Leucovorin because it may decrease Sulfamethoxazole/Trimethoprim"s effectiveness
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, hydrochlorothiazide) because they may increase the risk of Sulfamethoxazole/Trimethoprim"s side effects
• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Dofetilide because the risk of severe heart problems may be increased
• Digoxin, methotrexate, phenytoin, sulfones (eg, dapsone), or sulfonylureas (eg, glipizide) because their actions and side effects may be increased
• Cyclosporine because its effectiveness may be decreased and the risk of liver side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfamethoxazole/Trimethoprim may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sulfamethoxazole/Trimethoprim:

Use Sulfamethoxazole/Trimethoprim as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sulfamethoxazole/Trimethoprim by mouth with or without food.
• Sulfamethoxazole/Trimethoprim works best if it is taken at the same time each day.
• Take Sulfamethoxazole/Trimethoprim with a full glass of water (8 oz/240 mL). Drink several extra glasses of water a day unless otherwise directed by your doctor.
• To clear up your infection completely, take Sulfamethoxazole/Trimethoprim for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Sulfamethoxazole/Trimethoprim, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sulfamethoxazole/Trimethoprim.

Important safety information:

• Sulfamethoxazole/Trimethoprim may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sulfamethoxazole/Trimethoprim. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Be sure to use Sulfamethoxazole/Trimethoprim for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Sulfamethoxazole/Trimethoprim only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Sulfamethoxazole/Trimethoprim may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Diabetes patients - Sulfamethoxazole/Trimethoprim may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Sulfamethoxazole/Trimethoprim may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sulfamethoxazole/Trimethoprim.
• Lab tests, including complete blood cell counts and kidney function tests, may be performed while you use Sulfamethoxazole/Trimethoprim. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sulfamethoxazole/Trimethoprim with caution in the ELDERLY; they may be more sensitive to its effects, especially severe skin reactions, bone marrow suppression, or high blood potassium levels.
• Use Sulfamethoxazole/Trimethoprim with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
• Sulfamethoxazole/Trimethoprim should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfamethoxazole/Trimethoprim while you are pregnant. Do not use Sulfamethoxazole/Trimethoprim if you are in week 38 of pregnancy or later (full-term). Sulfamethoxazole/Trimethoprim is found in breast milk. Do not breast-feed while taking Sulfamethoxazole/Trimethoprim.

Possible side effects of Sulfamethoxazole/Trimethoprim:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; diarrhea; nausea; skin sensitivity to sunlight; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistered, peeling, red, or swollen skin; bloody or black, tarry stools; chest pain; chills, fever, or sore throat; decreased urination; depression; hallucinations; irregular heartbeat; joint or muscle pain; painful or stiff neck; purple patches under the skin; seizures; severe diarrhea; severe or persistent cough; severe or persistent headache; severe or persistent nausea or vomiting; shortness of breath; stomach cramps/pain; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; vaginal irritation or discharge; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blood in urine; confusion; depression; dizziness; drowsiness; loss of consciousness; severe nausea or vomiting; severe or prolonged headache; unusual bruising or bleeding.

Store Sulfamethoxazole/Trimethoprim at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep Sulfamethoxazole/Trimethoprim out of the reach of children and away from pets.

General information:

• If you have any questions about Sulfamethoxazole/Trimethoprim, please talk with your doctor, pharmacist, or other health care provider.
• Sulfamethoxazole/Trimethoprim is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sulfamethoxazole/Trimethoprim. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.