"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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(olsalazine sodium) Capsules
The active ingredient in DIPENTUM Capsules (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to 5-aminosalicylic acid (5-ASA), which has anti-inflammatory activity in ulcerative colitis. Its empirical formula is C14H8N2N2O6 with a molecular weight of 346.21.
The structural formula is:
Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions.
DIPENTUM (olsalazine sodium capsules) is supplied in hard gelatin capsules for oral administration. The inert ingredient in each 250 mg capsule of olsalazine sodium is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.
What are the possible side effects of olsalazine (Dipentum)?
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 using olsalazine and call your doctor at once if you have any of these serious side effects:
- worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);
- chest pain, shortness of breath, fast or pounding heartbeats; or
- nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects...
What are the precautions when taking olsalazine sodium capsules (Dipentum)?
Before taking olsalazine, tell your doctor or pharmacist if you are allergic to it; or to aspirin or related drugs (salicylates such as mesalamine, NSAIDs such as ibuprofen, balsalazide, sulfasalazine); 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: asthma, growths in the nose (nasal polyps), kidney problems, liver problems, radiation treatment in the pelvic area.
This medicine may cause stomach bleeding. Daily use of alcohol may increase your risk for stomach bleeding, especially when combined with this medicine. Check with your doctor or...
Last reviewed on RxList: 8/19/2009
This monograph has been modified to include the generic and brand name in many instances.
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