"The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
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(mesalamine) Delayed-Release Tablets
Each Asacol delayed-release tablet for oral administration contains 400 mg of mesalamine, an anti-inflammatory drug. The Asacol (mesalamine delayed-release tablets) delayed-release tablets are coated with acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is:
Molecular Weight: 153.1
Molecular Formula: C7H7NO3
Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, and talc.
What are the possible side effects of mesalamine oral (Apriso, Asacol, Asacol HD, Lialda, Pentasa)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking mesalamine and call your doctor at once if you have a serious side effect such as:
- severe stomach pain, cramping, fever, headache, and bloody diarrhea.
Less serious side effects may include:
- mild nausea, vomiting, stomach cramps, diarrhea, gas;
- fever, sore throat, or other flu symptoms;
- headache or...
Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Asacol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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