Yes

5-Aminosalicylic Acid Derivative

Management of ulcerative colitis; enteric coated tablets are used for for rheumatoid arthritis in patients who inadequately respond to analgesics and NSAIDs

B/D (at term)

Hypersensitivity to sulfasalazine, sulfa drugs, or any component; porphyria, GI or GU obstruction; hypersensitivity to salicylates; children <2 years of age

Use with caution in patients with renal impairment; impaired hepatic function or urinary obstruction, blood dyscrasia, severe allergies or asthma, or G-6-PD deficiency; may cause folate deficiency (consider providing 1 mg/day folate supplement)

>10%:

Central nervous system: Dizziness, headache (33%)

Dermatologic: Photosensitivity

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea (33%)

Genitourinary: Reversible oligospermia (33%)

<3%:

Dermatologic: Urticaria/pruritus (<3%)

Hematologic: Hemolytic anemia (<3%), Heinz body anemia (<3%)

<0.1%: Lyell's syndrome, Stevens-Johnson syndrome, thyroid function disturbance, crystalluria, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, jaundice, interstitial nephritis, acute nephropathy, hematuria, serum sickness-like reactions

Symptoms of overdose include drowsiness, dizziness, anorexia, abdominal pain, nausea, vomiting, hemolytic anemia, acidosis, jaundice, fever, agranulocytosis; the aniline radical is responsible for hematologic toxicity

High volume diuresis may aid in elimination and prevention of renal failure

Decreased effect of iron, digoxin, folic acid, and, as with other sulfa drugs, PABA or PABA metabolites of drugs (ie, procaine, proparacaine, tetracaine)

Increased effect of oral anticoagulants, methotrexate, and oral hypoglycemic agents as with other sulfa drugs

Protect from light; shake suspension well

Acts locally in the colon to decrease the inflammatory response and systemically interferes with secretion by inhibiting prostaglandin synthesis

Absorption: 10% to 15% of dose is absorbed as unchanged drug from the small intestine

Distribution: Small amounts appear in feces and breast milk

Metabolism: Following absorption, both components are metabolized in the liver; split into sulfapyridine and 5-aminosalicylic acid (5-ASA) in the colon

Half-life: 5.7-10 hours

Elimination: Primary excretion in urine (as unchanged drug, components, and acetylated metabolites)

Oral:

Adults: Initial: 1 g 3-4 times/day, 2 g/day maintenance in divided doses; may initiate therapy with 0.5-1 g/day enteric-coated tablets

Dosing interval in renal impairment:

Cl_cr 10-30 mL/minute: Administer twice daily

Cl_cr <10 mL/minute: Administer once daily

Dosing adjustment in hepatic impairment: Avoid use

Since sulfasalazine impairs folate absorption, consider providing 1 mg/day folate supplement.

Dizziness is common; sulfonamides reported to cause restlessness, irritability, depression, euphoria, disorientation, panic, hallucinations, and delusions

Photosensitivity is common; use caution with concurrent psychotropics; may cause leukopenia; caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Do not crush, chew, or dissolve coated tablets. Shake suspension well before use. Do not take on an empty stomach or with antacids. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake) to prevent kidney damage. Increased dietary iron may be recommended. You may experience nervousness or dizziness (use caution when driving or engaging in hazardous activities until response to drug is known). You may experience photosensitivity (use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight). Orange-yellow color of urine, sweat, tears is normal and will stain contact lenses and clothing. Report rash, persistent nausea or anorexia, or lack of improvement in symptoms (after 1-2 months). Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber if breast-feeding.

Drug commonly imparts an orange-yellow discoloration to urine and skin

Tablet: 500 mg

Tablet, enteric coated: 500 mg

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