Mesacol 400 mg and 800 mg Tablets (Generic Mesalamine Delayed Release Tablets) – Product Information
Mesacol tablets (Generic Mesalamine delayed 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 delayed release tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strength of 400 mg and 800 mg. Generic Mesalamine is available in the US as Mesacol OD prolonged release tablets and Mesacol delayed release tablets, which you can purchase online.
We also stock Esomeprazole tablets which is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.
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 tablets
Manufacturer of Mesacol Tablets (Mesalamine Delayed Release Tablets 400 mg and 800 mg)
Sun Pharmaceutical Industries Limited, India
Website: sunpharma.com
Active Pharmaceutical Ingredient
The active pharmaceutical ingredients contained in Mesacol tablets is Mesalamine. Each tablet of Mesacol contains 400 mg or 800 mg of Mesalamine.
Mechanism of Action – How Does Mesalamine Work?
Although the mechanism of action of Mesalamine (Mesacol 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 Delayed Release Tablets (Mesacol Delayed Release Tablets)
Mesacol Delayed release tablets(Mesalamine Delayed 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 Delayed Release Tablets – Dosage
Two Mesacol 400 mg tablets have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.
Evaluate renal function prior to initiation of Mesacol. You may take this medicine with or without food.Drink extra fluids so you will urinate more often and help prevent kidney problems (eg, kidney stones).
Swallow the capsules whole; do not cut, break, crush or chew.
For patients who are unable to swallow the capsules, the capsules can be opened and the inner tablets swallowed. Drink an adequate amount of fluids.
Please consult your doctor for exact dosing instructions. Mesacol Delayed Release Tablets (Mesalamine Delayed Release Tablets) should be administered in the dose prescribed by the doctor and for the duration recommended by the doctor.Do not stop using this medicine without checking first with your doctor.
Treatment of Mildly to Moderately Active Ulcerative Colitis:
Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks
Maintenance of Remission of Ulcerative Colitis:
Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses
Missed Dosage Instructions for Mesacol Delayed Release Tablets
If a dose of this medication has been missed, it should be skipped and taken as usual the next day
Mesacol Delayed Release Tablets Contraindications
Mesacol delayed 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 Generic Mesalamine Delayed Release Tablets
Generic Mesalamine 400 mg and 800 mg Delayed Release Tablets (Generic Mesalamine Delayed 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 tablets should be kept out of the reach of children.
Warnings and Precautions to be taken when using Mesalamine Delayed Release Tablets (Mesacol Delayed Release Tablets)
Before using Mesalamine Delayed 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. Discontinue Mesacol Delayed Release if renal function deteriorates.
Mesalamine-induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation; monitor for worsening symptoms; discontinue if acute intolerance syndrome 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.
Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 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 hydration during treatment.
Iron Content of Mesacol tablets: Consider the iron content of Mesacol 400 mg and 800 mg in patients taking iron supplementation and those at risk of iron overload.
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 Delayed Release Tablets (Mesacol 400 mg and 800 mg)
Side effects of Mesalamine Delayed release tablets (Mesacol 400 mg and 800 mg 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 delayed 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 delayed 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
Mesacol 400 mg and 800 mg Tablets – Drug Interactions
The drug Interactions of Mesalamine delayed release tablets (Mesacol delayed release tablets) are given below:
Nephrotoxic Agents including NSAIDs: Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions.
Azathioprine or 6-Mercaptopurine: Increased risk of blood disorders; monitor complete blood cell counts and platelet counts
Mesalamine Delayed Release Tablets (Mesacol Tablets) and Alcohol
There are no known interactions between alcohol and Mesacol delayed release tablets. However, if you get headaches or feel nauseated while taking Mesalamine delayed 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.
Mesacol Tablets Overdosage
Mesalamine Delayed-release tablets (Mesacol Delayed 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 Delayed Release Tablets) During Pregnancy
Mesalamine (Mesacol delayed release tablets) is classified by the US FDA as Pregnancy Category B.
Limited published data on Mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Mesacol Delayed 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. There are limited reports of diarrhea in breastfed infants. There is no information on the effects of the drug on milk production. While there is limited experience of lactating women using Mesalamine, caution should be exercised if Mesacol Delayed release tablets is administered to a nursing mother, and used only if the benefits outweigh the risks.
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