Azulfidine 500mg En (delayed Rel)tb

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, mesalamine). 5-ASA is believed to exert its anti-inflammatory effects locally in the colon by modulating inflammatory mediators (e.g., leukotrienes, prostaglandins, cytokines) and scavenging free radicals. Sulfapyridine is thought to be responsible for the systemic effects, particularly in rheumatoid arthritis, through immunomodulatory and anti-inflammatory actions, though its precise mechanism is not fully elucidated.

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Feeling extremely tired or weak
Pale skin
Unexplained bruising or bleeding
Swollen glands
Shortness of breath
Sudden weight gain
Swelling in the arms or legs

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin conditions. These reactions can be life-threatening. Seek immediate medical attention if you experience:

Red, swollen, blistered, or peeling skin
Skin irritation (with or without fever)
Red or irritated eyes
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 notice any of the following side effects, or if they bother you or persist, contact your doctor:

Headache
Stomach pain or heartburn
Upset stomach or vomiting
* Decreased appetite

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 sulfa allergy.
Certain health conditions, including:
+ Bowel blockage
+ Porphyria
+ Urinary retention (trouble passing urine)

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

To ensure your safety, please disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so.

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, as they may be at a higher risk of developing anemia. This enzyme deficiency is more common in people of African, South Asian, Middle Eastern, and Mediterranean descent.

Regular blood tests and urine checks are crucial, as directed by your doctor. Be sure to follow their instructions and discuss any concerns with them. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.

You may notice a change in the color of your urine or skin to a yellow or orange hue, but this is a harmless side effect. However, it is crucial to be aware of the potential for severe and life-threatening reactions, including allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, and blood disorders. Some patients have also experienced persistent nerve or muscle problems. If you have any concerns, discuss them with your doctor.

Men taking this medication may experience sperm problems, which could affect their ability to father a child. Although this issue may resolve once the medication is stopped, it is essential to discuss any questions or concerns with your doctor.

If you notice what appears to be a tablet in your stool, contact your doctor to discuss this further. It is also vital to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to weigh the benefits and risks of this medication to both you and your baby.

• Digoxin (decreased absorption)
• Folic acid antagonists (e.g., methotrexate, trimethoprim-sulfamethoxazole) (increased risk of myelosuppression)
• Warfarin (potentiates anticoagulant effect)
• Azathioprine/Mercaptopurine (increased risk of myelosuppression)

• Iron supplements (decreased sulfasalazine absorption)
• Oral contraceptives (decreased efficacy of oral contraceptives)
• Antibiotics (e.g., ampicillin, rifamycin) (may alter gut flora, affecting sulfasalazine metabolism)
• Cyclosporine (decreased cyclosporine levels)

• Fever
• Sore throat
• Rash (especially severe, blistering, or widespread)
• Unusual bleeding or bruising
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Pale skin
• Fatigue
• Abdominal pain
• Nausea/vomiting
• Diarrhea
• Headache
• Dizziness
• Shortness of breath
• Swelling of face, lips, tongue, or throat

Generally considered low risk (Category B by older classification, but current labeling advises careful consideration). Sulfasalazine crosses the placenta. While not associated with major birth defects, it can interfere with folate metabolism, necessitating folic acid supplementation (at least 2 mg/day) for pregnant women taking sulfasalazine. Use only if clearly needed and benefits outweigh risks.

Sulfasalazine and its metabolites (sulfapyridine and 5-ASA) are excreted into breast milk. While generally considered compatible with breastfeeding for full-term, healthy infants, caution is advised. Monitor infants for signs of adverse effects.

Approved for use in children ≥6 years for ulcerative colitis and juvenile rheumatoid arthritis. Dosing is weight-based. Close monitoring for adverse effects, especially blood dyscrasias and hypersensitivity reactions, is crucial. Not recommended for systemic juvenile idiopathic arthritis (SJIA) due to risk of severe systemic reactions.

Use with caution in elderly patients due to increased likelihood of decreased renal or hepatic function and potential for increased sensitivity to adverse effects. Start at the lower end of the dosing range and monitor closely for toxicity, especially blood dyscrasias and renal impairment.

• Sulfasalazine is a prodrug; its efficacy depends on bacterial cleavage in the colon. Delayed-release formulation ensures delivery to the colon.
• Patients should be advised to drink plenty of fluids to prevent crystalluria and kidney stone formation.
• Folic acid supplementation (1-2 mg/day) is strongly recommended for all patients on sulfasalazine, especially women of childbearing potential and pregnant women, due to its antifolate effects.
• Monitor CBC, LFTs, and renal function regularly, especially during the initial months of therapy, due to the risk of serious hematologic and hepatic toxicities.
• Orange-yellow discoloration of urine, skin, or contact lenses may occur and is harmless.
• Slow acetylators of sulfapyridine may experience more adverse effects due to higher systemic levels of the metabolite.
• Discontinue immediately if signs of hypersensitivity (rash, fever, lymphadenopathy) or severe adverse reactions occur.

• For Ulcerative Colitis: Mesalamine (various formulations), Olsalazine, Balsalazide, Corticosteroids (e.g., prednisone, budesonide), Immunomodulators (e.g., azathioprine, mercaptopurine), Biologics (e.g., infliximab, adalimumab, vedolizumab, ustekinumab), JAK inhibitors (e.g., tofacitinib).
• For Rheumatoid Arthritis: Methotrexate, Hydroxychloroquine, Leflunomide, Biologics (e.g., TNF inhibitors, abatacept, rituximab, tocilizumab), JAK inhibitors (e.g., tofacitinib, baricitinib, upadacitinib).

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.