Sulfasalazine 500mg Tablets

Sulfasalazine is a prodrug that is poorly absorbed from the gastrointestinal tract. In the colon, it is cleaved by bacterial azoreductase into two components: sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA, mesalamine). 5-ASA is believed to be the therapeutically active moiety in inflammatory bowel disease, exerting local anti-inflammatory effects by inhibiting prostaglandin synthesis, leukotriene synthesis, and scavenging free radicals. SP is largely responsible for the systemic side effects and is thought to contribute to the therapeutic effect in rheumatoid arthritis, though its exact mechanism is less clear.

Urgent Side Effects: Seek Medical Help Immediately

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 medical attention right away:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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

In rare cases, this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions. These conditions can be life-threatening. Seek medical help immediately 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 may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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

Reporting 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 and its symptoms.
A known sulfa allergy.
Certain health conditions, including:
+ Bowel blockage
+ Porphyria
+ Urinary retention or difficulty 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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so, considering all your medications and health conditions.

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 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 discuss your test results with your doctor. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with 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 experience any unusual symptoms, consult 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 concerns with your doctor.

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

• Methotrexate (increased risk of myelosuppression)
• Azathioprine/Mercaptopurine (increased risk of myelosuppression, especially in patients with low TPMT activity)
• Digoxin (decreased absorption of digoxin)

• Folic acid (decreased absorption of folic acid, leading to deficiency)
• Warfarin (may enhance anticoagulant effect, monitor INR)
• Oral contraceptives (may reduce efficacy of oral contraceptives)
• Broad-spectrum antibiotics (may alter gut flora, affecting sulfasalazine metabolism and efficacy)
• Phenytoin (may increase phenytoin levels)

• Fever
• Sore throat
• Rash (especially severe, blistering, or widespread)
• Unusual bleeding or bruising
• Jaundice (yellowing of skin or eyes)
• Dark urine
• Pale stools
• Persistent nausea or vomiting
• Abdominal pain
• Shortness of breath
• Swelling of face, lips, tongue, or throat
• Signs of infection

Sulfasalazine is generally considered compatible with pregnancy (Pregnancy Category B). However, it can interfere with folic acid absorption, which is crucial for fetal development. Folic acid supplementation (e.g., 2 mg/day) is strongly recommended for pregnant women taking sulfasalazine to prevent neural tube defects.

Sulfasalazine and its metabolites (sulfapyridine and 5-aminosalicylic acid) are excreted into breast milk. While generally considered compatible with breastfeeding (L3), monitor the infant for potential adverse effects such as bloody stools, diarrhea, or rash. Use with caution, especially in premature infants or those with G6PD deficiency.

Approved for use in children 6 years and older for ulcerative colitis and juvenile rheumatoid arthritis. Dosing is weight-based. Close monitoring for adverse effects, especially blood dyscrasias and hypersensitivity reactions, is crucial.

Use with caution in elderly patients due to increased risk of adverse reactions, particularly blood dyscrasias and renal impairment. Start with lower doses and titrate slowly. Monitor renal function, liver function, and CBC more frequently.

• Sulfasalazine is a prodrug that requires bacterial activation in the colon; therefore, its efficacy can be affected by broad-spectrum antibiotics.
• Always advise patients to take folic acid supplementation due to the drug's interference with folate absorption, especially important for women of childbearing potential and pregnant women.
• Counsel patients about the potential for orange-yellow discoloration of urine and skin, which is harmless.
• Encourage adequate hydration to prevent crystalluria and kidney stone formation.
• Monitor patients closely for signs of hypersensitivity reactions (rash, fever, DRESS syndrome) and blood dyscrasias (sore throat, fever, unusual bleeding/bruising), especially during the initial months of therapy.
• Oligospermia (reversible) is a known side effect in males, which typically resolves within 2-3 months after discontinuation.

• Mesalamine (for ulcerative colitis)
• Olsalazine (for ulcerative colitis)
• Balsalazide (for ulcerative colitis)
• Corticosteroids (e.g., prednisone, budesonide)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate, cyclosporine)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• JAK inhibitors (e.g., tofacitinib)
• Other DMARDs (e.g., methotrexate, hydroxychloroquine, leflunomide for rheumatoid arthritis)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. 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 name of the medication, the amount taken, and the time it was taken.