Mesacol OD Tablets (Generic Mesalamine Prolonged Release Tablets 1.2 g) – Product Information
Mesacol OD tablets (Generic Mesalamine prolonged release tablets) are locally acting 5-aminosalicylic acid (5-ASA) used for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Mesacol-OD Prolonged Release tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strength of 1200 mg.
We also stock Motilium Tablets (Domperidone 10 mg) which is a medicine that increases the movements or contractions of the stomach and bowel.
Name of Drug
Mesacol OD tablets
Manufacturer of Mesacol OD Tablets (Mesalamine Prolonged Release Tablets 1.2 g)
Sun Pharmaceutical Industries Limited, India
Website: sunpharma.com
Active Pharmaceutical Ingredient
The active pharmaceutical ingredients contained in Mesacol-OD tablets is Mesalamine. Each tablet of Mesacol OD contains 1200 mg of Mesalamine.
Mechanism of Action
Although the mechanism of action of Mesalamine (Mesacol OD Tablets) is not fully understood, it is thought to possess a topical anti-inflammatory effect on colonic epithelial cells Label. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon
Uses of Generic Mesalamine Prolonged Release Tablets (Mesacol-OD Prolonged Release Tablets)
Mesacol OD prolonged release tablets(Generic Mesalamine Prolonged Release Tablets) is an aminosalicylate anti-inflammatory medicine and is used to treat flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring. It works inside the bowels to reduce inflammation and other symptoms of the disease.
Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed.
Mesacol OD Tablets – Dosage
For induction of remission of active, mild to moderate ulcerative colitis, two to four 1.2 g tablets taken once daily with food.
For maintenance of remission of ulcerative colitis, two 1.2 g tablets taken once daily with food.
Missed Dosage Instructions
If a dose of this medication has been missed, it should be skipped and taken as usual the next day
Mesacol-OD Prolonged Release Tablets Contraindications
Mesacol-OD prolonged release tablets are contraindicated in persons with a hypersensitivity (allergy) to Mesalamine, salicylates or aminosalicylates or any of the other ingredients of this medicine.
Storage Instructions for Mesacol-OD Prolonged Release Tablets
Mesacol-OD Prolonged Release Tablets (Generic Mesalamine Prolonged release tablets) should be stored at 25 degrees Celsius or room temperature. Excursions are permitted to (59°F to 86°F, 15°C to 30°C). Protect from light. Mesacol-OD tablets should be kept out of the reach of children.
Warnings and Precautions to be taken when using Mesalamine Prolonged Release Tablets (Mesacol-OD Prolonged Release Tablets)
Before using Mesalamine prolonged release tablets please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function.
Mesalamine-Induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected.
Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected.
Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment.
Photosensitivity: Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
Nephrolithiasis: Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment.
Risks in Patients with Phenylketonuria: Contains phenylalanine. Before prescribing Mesacol-OD prolonged release tablets to a patient with Phenylketonuria (PKU), consider the combined daily amount of phenylalanine from all sources, including Mesacol-OD.
Interference with Laboratory Tests: Use of Mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection.
Side Effects of Mesalamine Prolonged Release Tablets (Mesacol-OD)
Side effects of Mesalamine prolonged release tablets (Mesacol-OD prolonged release tablets) that Occurred in 1% or more of of all treated patients during clinical trials include Headache, Nausea, Nasopharyngitis, Abdominal pain, Diarrhea, Dyspepsia, Vomiting, Flatulence, Influenza, Pyrexia and Cough. Other possible side effects reported infrequently (less than 1%) by Mesalamine prolonged Release Tablets -treated ulcerative colitis patients in the two controlled trials include:
- Cardiac Disorder: tachycardia
- Vascular Disorders: hypertension, hypotension
- Skin and Subcutaneous Tissue Disorders: acne, prurigo, rash, urticaria
- Gastrointestinal Disorders: abdominal distention, colitis, diarrhea, pancreatitis, rectal polyp, vomiting
- Investigations: decreased platelet count
- Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain
- Nervous System Disorders: somnolence, tremor
- Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain
- General Disorders and Administrative Site Disorders: asthenia, face edema, fatigue, pyrexia
- Ear and Labyrinth Disorders: ear pain
The most serious side effects seen in Mesalamine prolonged release tablets clinical trials or with other products that contain or are metabolized to Mesalamine are:
- Renal impairment, including renal failure
- Mesalamine-induced acute intolerance syndrome
- Hypersensitivity reactions
- Hepatic impairment, including hepatic failure
Mesalamine Prolonged Release Tablets (Mesacol-OD Tablets) – Drug Interactions
The drug Interactions of Mesalamine prolonged release tablets (Mesacol-OD prolonged release tablets) are given below:
The concurrent use of Mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic medications for changes in renal function and Mesalamine-related adverse reactions.
The concurrent use of Mesalamine with Azathioprine or 6-Mercaptopurine and/or other medicines known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications.
Mesalamine Prolonged Release Tablets (Mesacol-OD Tablets) and Alcohol
There are no known interactions between alcohol and Mesacol-OD prolonged release tablets. However, if you get headaches or feel nauseated while taking Mesalamine prolonged release tablets, drinking alcohol could make this worse.
Some people also find that drinking alcohol can cause a flare-up of ulcerative colitis. In some people, alcohol may also trigger symptoms like diarrhea, cramping, or bloating.
Mesalamine Prolonged Release Tablets (Mesacol-OD Tablets) Overdosage
Mesalamine prolonged-release tablets (Mesacol-OD prolonged release tablets) is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures).
Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement.
There is no specific antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent of further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.
Mesalamine (Mesacol-OD Prolonged Release Tablets) During Pregnancy
Mesalamine (Mesacol-OD prolonged release tablets) is classified by the US FDA as Pregnancy Category B.
Reproduction studies with mesalamine have been performed in rats at doses up to 1000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of impaired fertility or harm to the fetus due to Mesalamine.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Mesacol-OD prolonged release tablets should be used during pregnancy only if clearly needed. Mesalamine is known to cross the placental barrier.
Low concentrations of Mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. While there is limited experience of lactating women using Mesalamine, caution should be exercised if Mesacol-OD prolonged release tablets is administered to a nursing mother, and used only if the benefits outweigh the risks.
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