What is asacol generic

Do not crush, break, or chew the tablet. Swallow the tablet whole. The enteric-coated tablet has a special coating to protect your stomach.

Breaking the pill could damage this coating. Call your doctor if you find undissolved tablets in your stool. Take a missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.

Do not take an extra Mesalamine tablet to make up for the missed dose. Mesalamine Tablets - Contraindications Mesalamine tablets are contraindicated in the following cases: If the patient is hypersensitive allergic to salicylates. If the patient is hypersensitive allergic to mesalazine or any of the other ingredient present in Mesacol tablets.

If the patient has severe kidney problems. If the patient has severe liver problems. Mesalamine tablets should not be administered to children under 2 years of age. Get emergency medical help if you have any of these signs of an allergic reaction to Mesacol tablets by Sun Pharma Generic Asacol: Less serious side effects of Mesacol tablets may include: Call your doctor for medical advice about side effects. Mesalamine Overdose Overdose symptoms of Mesalamine tablets may include ringing in your ears, dizziness, headache, confusion, drowsiness, sweating, and shortness of breath, vomiting, and diarrhea.

There is little data on overdose which do not indicate renal or hepatic toxicity. Tell your doctor if you are breast-feeding a baby. Do not give this medicine to a child without medical advice. How should I take Asacol HD? Take Asacol HD exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take the tablets with a full glass of water. Take Asacol HD delayed-release mg tablets on an empty stomach, at least 1 hour before and 2 hours after a meal.

Follow your doctor's instructions or the directions on your medicine label. Do not crush, break, or chew a delayed-release tablet. Swallow the tablet whole. The enteric-coated tablet has a special coating to protect your stomach. Breaking the tablet could damage this coating. Tell your doctor if you find undissolved tablets in your stool.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse. Asacol HD can cause unusual results with certain medical tests. Symptoms include cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment.

If acute intolerance syndrome is suspected, promptly discontinue treatment with Asacol. Hypersensitivity Reactions Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Asacol or to other compounds that contain or are converted to mesalamine.

Mesalamine-induced cardiac hypersensitivity reactions myocarditis and pericarditis have been reported with Asacol and other mesalamine medications. Caution should be taken in prescribing this medicine to patients with conditions predisposing them to the development of myocarditis or pericarditis.

Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering Asacol to patients with liver disease. Prolonged Gastric Retention In Patients With Upper Gastrointestinal Obstruction Organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of Asacol which would delay release of mesalamine in the colon.

Mutagenesis Mesalamine was negative in the Ames assay for mutagenesis , negative for induction of sister chromatid exchanges SCE and chromosomal aberrations in Chinese hamster ovary cells in vitro, and negative for induction of micronuclei MN in mouse bone marrow polychromatic erythrocytes. Limited published human data on mesalamine show no increase in the overall rate of congenital malformations.

Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. Furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2 to 4 percent for major malformations, and 15 to 20 percent for pregnancy loss. No evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.

However, dibutyl phthalate DBP is an inactive ingredient in Asacol's enteric coating, and in animal studies in rats at doses greater than times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system.

Asacol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Human Data Mesalamine crosses the placenta. In prospective and retrospective studies of over women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population.

Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes. There was no evidence of impaired fertility or harm to the fetus.

These mesalamine doses were about 1. Dibutyl phthalate DBP is an inactive ingredient in Asacol's enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol tablets is about 21 mg. The clinical significance of this finding in rats is unknown.

Female offspring are unaffected. Nursing Mothers Mesalamine and its N-acetyl metabolite are present in human milk. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from mg to 3 g daily. The concentration of mesalamine in milk ranged from non-detectable to 0.

The concentration of the N-acetylaminosalicylic acid metabolite ranged from 5 to Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 to 0. Dibutyl phthalate DBP , an inactive ingredient in the enteric coating of Asacol tablets, and its primary metabolite mono-butyl phthalate MBP are excreted into human milk.

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