immediately Oligospermia and infertility reported; however, withdrawal of drug appears to reverse these effects Hepatic, renal, and hematologic toxicity Only after critical appraisal should therapy be administered to patients with hepatic or renal damage or blood dyscrasias; deaths associated with administration of sulfasalazine reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity; complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving therapy; discontinue treatment with sulfasalazine while awaiting results of blood tests Discontinue therapy if renal function deteriorates Infections Blood dyscrasias; serious infections reported, including fatal sepsis and pneumonia Some infections were associated with agranulocytosis, neutropenia, or myelosuppression; discontinue therapy if patient develops a serious infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment Frequently perform complete blood counts, as well as urinalysis with careful microscopic examination; discontinue treatment while awaiting results of blood tests; Pregnancy category: B; D if used for prolonged periods or near term; increased potential for kernicterus in the newborn Oral sulfasalazine inhibits the absorption and metabolism of folic acid which may interfere with folic acid supplementation and protection from neural tube defects Lactation: Excreted into human breast milk; caution with breastfeeding, some reports of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazinePregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Sulfasalazine is a prodrug that is metabolized to its active components, sulfapyridine and 5-aminosalicylic acid (5-ASA; mesalamine); beneficial effects are predominantly from the anti-inflammatory properties of 5-ASA, which inhibits leukotriene synthesis and lipoxygenase Absorption Bioavailability: <15% of parent drug; 60% (sulfapyridine); 10-30% (5-ASA) Peak plasma time: 6 hr; 10 hr (sulfapyridine and 5-ASA) Peak plasma concentration: 6 mcg/mL Distribution Protein bound: >99% to albumin; 70% (sulfapyridine) Vd: 7.5 L Metabolism Approximately 90% of sulfasalazine is converted by colon bacteria into its active components, sulfapyridine and mesalamine Elimination Half-life: 10.4-14.8 hr (sulfapyridine) Renal clearance: 37% Excretion: Urine (systematically absorbed sulfapyridine and 5-ASA); feces (majority of 5-ASA) BRAND FORM. UNIT PRICE PILL IMAGE Azulfidine oral- 500 mg tabletAzulfidine EN-tabs oral- 500 mg tabletsulfasalazine oral- 500 mg tabletsulfasalazine oral- 500 mg tabletsulfasalazine oral- 500 mg tabletsulfasalazine oral- 500 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationsulfasalazine oral SULFASALAZINE - ORAL (sull-fuh-SAL-uh-zeen) COMMON BRAND NAME(S): Azulfidine USES: Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines.In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs). HOW TO USE: Take this medication by mouth after meals with a full glass of water (8 ounces or 240 milliliters) as directed by your doctor. To prevent stomach upset, your doctor may recommend a slow increase in your dosage when starting treatment. The dosage is based on your medical condition and response to treatment. In children, dosage is also based on weight.If you are taking the delayed-release tablets, swallow them whole. Do not crush, chew, or break the tablets. Doing so may increase the chance of stomach upset.Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition does not improve or if it worsens. For the treatment of rheumatoid arthritis, it may take 1 to 3 months before you notice any improvement in your symptoms. SIDE EFFECTS: Stomach upset, nausea, vomiting, loss of appetite, headache, dizziness, or unusual tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.This medication may cause your skin and urine to turn orange-yellow. This effect is harmless and will disappear when the medication is stopped.Rarely, delayed-release tablets of sulfasalazine may appear whole or only partly dissolved in your stool. If this occurs, tell your doctor right away so your treatment can be changed.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: hearing changes (such as ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine, painful urination, blood in the urine), new lump/growth in the neck (goiter), numbness/tingling of the hands/feet, signs of low blood sugar (such as hunger, cold sweat, blurred vision, weakness, fast heartbeat).This medication may rarely cause very serious allergic reactions (such as Stevens-Johnson syndrome), blood disorders (such as agranulocytosis, aplastic anemia), liver damage, nerve/muscle problems and infections. Get medical help right away if you have any very serious side effects, including: headache that is severe or doesn't go away, skin rash/blisters/peeling, mouth sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, signs of infection (such as sore throat that doesn't go away, fever, chills, cough), swollen lymph nodes, easy bruising/bleeding, severe tiredness, muscle pain/weakness (especially with fever and unusual tiredness), pale or blue skin/lips/nails, new/worsening joint pain, confusion, unexplained neck stiffness, seizures, signs of liver problems (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking sulfasalazine, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or to aspirin and related drugs (salicylates, NSAIDs such as ibuprofen); or to mesalamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal blockage, urinary blockage, kidney disease, liver disease, blood disorders (such as aplastic anemia, porphyria), a certain genetic condition (G6PD deficiency), asthma, severe allergies, current/recent/returning infections.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.This medication is similar to aspirin. Children and teenagers younger than 18 years should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.This medication can temporarily affect fertility in males. Ask your doctor for more details.During pregnancy, this medication should be used only when clearly needed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. Discuss the risks and benefits with your doctor. If you become pregnant while taking this drug, contact your doctor right away. This medication may lower your folic acid levels, increasing the risk of spinal cord defects. Check with your doctor to make sure you are taking enough folic acid. Prenatal care should include tests for spinal cord defects.This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: digoxin, folic acid, methenamine, PABA taken by mouth.Sulfasalazine is very similar to mesalamine. Do not use mesalamine medications taken by mouth while using sulfasalazine.This medication may interfere with certain lab tests (such as urine normetanephrine levels, liver function tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting that doesn't stop, severe stomach/abdominal pain, extreme drowsiness, seizures. NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised May 2023. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is