Azulfidine 500mg Tablets

Sulfasalazine is a prodrug that is poorly absorbed from the gastrointestinal tract. In the colon, it is metabolized by bacterial azoreductases into two main components: sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA, also known as mesalamine). The 5-ASA component is thought to exert its anti-inflammatory effects locally in the colon by inhibiting prostaglandin and leukotriene synthesis, scavenging free radicals, and modulating immune cell function. The sulfapyridine component is largely responsible for the systemic effects, particularly in rheumatoid arthritis, though its precise mechanism is not fully understood but may involve immunomodulatory actions.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Feeling extremely tired or weak
Pale skin
Unexplained bruising or bleeding
Swollen glands
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; other skin irritation (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:

Headache
Stomach pain or heartburn
Upset stomach or vomiting
Decreased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A known allergy to sulfa, as this may impact your ability to take this medication safely.
Certain health conditions, including:
+ Bowel blockage
+ Porphyria, a group of rare genetic disorders
+ Difficulty urinating

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or supplements you use
Vitamins you take
* Existing health problems

Carefully review this information with your doctor to confirm that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have asthma, consult with your doctor, as you may be more susceptible to the effects of this drug.

Individuals with low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD) should exercise caution when taking this medication, as it may increase the risk of anemia. People of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.

Regular blood tests and urine checks should be performed as directed by your doctor. It is crucial to discuss your test results with your doctor and inform all healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests.

This medication may cause a harmless change in the color of your urine or skin, turning it yellow or orange. However, it can also cause severe and potentially life-threatening side effects, including allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, and blood disorders. Additionally, nerve or muscle problems that do not resolve may occur. If you experience any of these symptoms, consult with your doctor.

Men taking this medication may experience sperm problems, which could affect their ability to father a child. Although these issues may resolve after stopping the medication, it is essential to discuss any concerns with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.

• Digoxin (decreased absorption of digoxin)
• Folic acid (impaired absorption and metabolism of folic acid, leading to deficiency)
• Warfarin (potentiates anticoagulant effect, increased bleeding risk)
• Methotrexate (increased risk of myelosuppression and hepatotoxicity)
• Azathioprine/Mercaptopurine (increased risk of myelosuppression)

• Iron supplements (may chelate sulfasalazine, reducing absorption)
• Oral contraceptives (may reduce efficacy of oral contraceptives)
• Phenytoin (may increase phenytoin levels)
• Thiopurine methyltransferase (TPMT) inhibitors (increased risk of myelosuppression with azathioprine/mercaptopurine)

• Antacids (may alter absorption, separate administration)

• Rash (including severe skin reactions like SJS/TEN)
• Fever
• Sore throat
• Unusual bleeding or bruising
• Jaundice (yellowing of skin/eyes)
• Dark urine
• Pale stools
• Persistent nausea, vomiting, abdominal pain
• Fatigue, weakness
• Shortness of breath
• Swelling of face, lips, tongue (signs of allergic reaction)

Sulfasalazine is generally considered safe for use during pregnancy (Category B). However, it can interfere with folic acid absorption and metabolism, which is crucial for fetal development. Therefore, pregnant women taking sulfasalazine should receive high-dose folic acid supplementation (e.g., 2 mg/day) to prevent neural tube defects.

Sulfasalazine and its metabolites (sulfapyridine and 5-ASA) are excreted into breast milk. While generally considered compatible with breastfeeding, caution is advised. Monitor the infant for signs of adverse effects such as diarrhea, bloody stools, or rash. There is a theoretical risk of kernicterus in jaundiced or premature infants due to sulfapyridine, but this is rare.

Approved for use in children for ulcerative colitis and juvenile idiopathic arthritis. Dosing is weight-based. Close monitoring for adverse effects, especially blood dyscrasias and hypersensitivity reactions, is crucial. Risk of kernicterus in neonates (contraindicated).

Use with caution in elderly patients due to increased susceptibility to adverse effects, particularly blood dyscrasias, renal impairment, and hepatotoxicity. Start with lower doses and titrate slowly. Monitor renal and hepatic function more frequently.

• Sulfasalazine is a prodrug; its efficacy depends on bacterial cleavage in the colon. Therefore, it's crucial for patients to adhere to the prescribed dosage and not crush or chew enteric-coated tablets.
• Patients should be advised to drink plenty of fluids to prevent crystalluria and kidney stone formation.
• Folic acid supplementation is essential for all patients on sulfasalazine, especially women of childbearing potential and pregnant women, due to its antifolate effects.
• Slow acetylators (a genetic polymorphism) may have higher sulfapyridine levels and thus an increased risk of dose-related adverse effects, particularly systemic ones like rash, fever, and blood dyscrasias.
• The onset of action for rheumatoid arthritis is slow (weeks to months), so patients should be counseled on this to manage expectations and ensure adherence.
• Discoloration of urine or skin (orange-yellow) may occur and is usually harmless, but patients should be informed to avoid alarm.

• Other 5-aminosalicylates (e.g., mesalamine, olsalazine, balsalazide for UC)
• Corticosteroids (e.g., prednisone, budesonide for UC/RA flares)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate for UC/RA)
• Biologic agents (e.g., TNF inhibitors, anti-integrins for UC/RA)
• JAK inhibitors (for UC/RA)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.