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mesalamine

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Overview

What is Asacol HD?

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an aminosalicylate. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid and methyl methacrylate copolymer (1:2), NF) and Eudragit L (methacrylic acid and methyl methacrylate copolymer (1:1), NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti- inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is:

Inactive Ingredients:



What does Asacol HD look like?



What are the available doses of Asacol HD?

Delayed-release tablets: 800 mg ()

What should I talk to my health care provider before I take Asacol HD?

Geriatric Patients

8.5

How should I use Asacol HD?

Asacol® HD is indicated for the treatment of moderately active ulcerative colitis in adults.

Limitations of Use

Do not substitute one Asacol HD 800 tablet for two mesalamine delayed-release 400 mg oral products  ()

Evaluate renal function prior to initiation of Asacol HD (, )

Take on an empty stomach, at least 1 hour before and 2 hours after a meal

Swallow whole; do not cut, break or chew the tablets.


What interacts with Asacol HD?

Sorry No Records found


What are the warnings of Asacol HD?

Sorry No Records found


What are the precautions of Asacol HD?

Sorry No Records found


What are the side effects of Asacol HD?

Sorry No records found


What should I look out for while using Asacol HD?

Asacol HD is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD  .


What might happen if I take too much Asacol HD?

There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with Asacol HD should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. Asacol HD is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.

Single oral doses of 5000 mg/kg mesalamine suspension in mice (approximately 4.2 times the recommended human dose of Asacol HD based on body surface area), 4595 mg/kg in rats (approximately 7.8 times the recommended human dose of Asacol HD based on body surface area) and 3000 mg/kg in cynomolgus monkeys (approximately 10 times the recommended human dose of Asacol HD based on body surface area) were lethal.


How should I store and handle Asacol HD?

Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]Asacol HD (mesalamine) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “WC 800” in black.NDC  Store and dispense in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant pouch (silica gel) from bottle.Store at controlled room temperature, 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Non-Clinical Toxicology
Asacol HD is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD  .

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients taking products such as Asacol HD that contain or are converted to mesalamine  .

Evaluate renal function prior to initiation of Asacol HD and periodically while on therapy. Evaluate the risks and benefits of using Asacol HD in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs  .

The most serious adverse reactions seen in Asacol HD clinical trials or with other products that contain mesalamine or are metabolized to mesalamine were:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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