Sulfasalazine delayed-release tabletsPronunciation
Generic Name: sulfasalazine (SUL-fa-SAL-a-zeen)
Brand Name: Azulfidine EN-tabs
Sulfasalazine delayed-release tablets are used for:
Treating ulcerative colitis, rheumatoid arthritis, or polyarticular-course juvenile rheumatoid arthritis in certain patients. It may be used along with other medicines. It is also used to increase the time between attacks of ulcerative colitis. It may also be used for other conditions as determined by your doctor.
Sulfasalazine delayed-release tablets are a salicylate. It decreases inflammation. Exactly how it works to treat ulcerative colitis is not known.
Do NOT use sulfasalazine delayed-release tablets if:
- you are allergic to any ingredient in sulfasalazine delayed-release tablets or to a salicylate (eg, aspirin) or a sulfonamide (eg, sulfisoxazole)
- you have the blood disorder porphyria or a stomach, bowel, or urinary tract blockage
- the patient has systemic-course juvenile rheumatoid arthritis
Contact your doctor or health care provider right away if any of these apply to you.
Before using sulfasalazine delayed-release tablets:
Some medical conditions may interact with sulfasalazine delayed-release tablets. 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 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, asthma, severe allergies, blood problems (eg, anemia, low white blood cell levels), thyroid problems, or rheumatoid arthritis
- if you have glucose-6-phosphate dehydrogenase deficiency
- if you have an infection (eg, strep throat), an infection that keeps coming back, or a history of infections
Some MEDICINES MAY INTERACT with sulfasalazine delayed-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) or methotrexate because the risk of their side effects may be increased by sulfasalazine delayed-release tablets
- Beta-blockers (eg, propranolol), digoxin, or folic acid because their effectiveness may be decreased by sulfasalazine delayed-release tablets
- Methenamine because the risk of crystals in the urine is increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if sulfasalazine delayed-release tablets 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 sulfasalazine delayed-release tablets:
Use sulfasalazine delayed-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take sulfasalazine delayed-release tablets by mouth after meals.
- Take sulfasalazine delayed-release tablets with a full glass of water (8 oz [240 mL]).
- Swallow sulfasalazine delayed-release tablets whole. Do not break, crush, or chew before swallowing.
- Drinking extra fluids while you are taking sulfasalazine delayed-release tablets is recommended. Check with your doctor for instructions.
- Take sulfasalazine delayed-release tablets on a regular schedule to get the most benefit from it.
- Continue to take sulfasalazine delayed-release tablets even if you feel well. Do not miss any doses.
- If you miss a dose of sulfasalazine delayed-release tablets, 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 sulfasalazine delayed-release tablets.
Important safety information:
- Sulfasalazine delayed-release tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use sulfasalazine delayed-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Sulfasalazine delayed-release tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to sulfasalazine delayed-release tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Sulfasalazine delayed-release tablets may discolor the urine or skin to an orange-yellow color. This is normal and not a cause for concern.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Severe and sometimes fatal allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, blood problems, and permanent nerve or muscle problems have happened in patients taking sulfasalazine delayed-release tablets. Talk with your doctor for more information.
- If you see the tablet in your stool, contact your doctor right away.
- Some men taking sulfasalazine delayed-release tablets have developed a decreased number of sperm and infertility. These effects usually went away after sulfasalazine delayed-release tablets was stopped. Discuss any questions or concerns with your doctor.
- Diabetes patients - Sulfasalazine delayed-release tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Sulfasalazine delayed-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking sulfasalazine delayed-release tablets.
- LAB TESTS, including liver function, kidney function, complete blood cell counts, or urine tests, may be performed while you use sulfasalazine delayed-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use sulfasalazine delayed-release tablets with caution in the ELDERLY; they may be more sensitive to its effects.
- Sulfasalazine delayed-release tablets should not be used in CHILDREN younger than 2 years 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 sulfasalazine delayed-release tablets while you are pregnant. Sulfasalazine delayed-release tablets are found in breast milk. If you are or will be breast-feeding while you use sulfasalazine delayed-release tablets, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of sulfasalazine delayed-release tablets:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; loss of appetite; mild stomach upset or pain; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody diarrhea; bluish discoloration of the skin or nails; chest pain; decreased urination; hearing loss; irregular heartbeat; mental or mood changes; muscle pain; numbness or tingling in the fingers or toes; seizures; severe or persistent dizziness, drowsiness, headache, or trouble sleeping; severe or persistent stomach pain; shortness of breath; swelling or soreness of the mouth or tongue; swollen glands; symptoms of infection (eg, fever, chills, cough, or sore throat; difficult or painful urination); symptoms of liver problems (eg, yellowing if the skin or eyes, dark urine, pale stools, severe or persistent nausea or vomiting, persistent loss of appetite); trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of sulfasalazine delayed-release tablets:
Store sulfasalazine delayed-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep sulfasalazine delayed-release tablets out of the reach of children and away from pets.
- If you have any questions about sulfasalazine delayed-release tablets, please talk with your doctor, pharmacist, or other health care provider.
- Sulfasalazine delayed-release tablets are 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take sulfasalazine delayed-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sulfasalazine delayed-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sulfasalazine delayed-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using sulfasalazine delayed-release tablets.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: 5-aminosalicylates