Asacol HD (Mesalamine Delayed-Release Tablets, Oral)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Asacol HD (Mesalamine Delayed-Release Tablets, Oral)

Asacol® HD
(mesalamine) Delayed-Release Tablet for Oral Administration

DRUG DESCRIPTION

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an antiinflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, 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:

Asacol® HD (mesalamine)  Structural Formula Illustration

Molecular Weight : 153.1
Molecular Formula : C7H7NO3

Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc.

What are the possible side effects of mesalamine oral (Apriso, Asacol, Asacol HD, Lialda, Pentasa)?

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 taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • constipation;
  • headache or...

Read All Potential Side Effects and See Pictures of Asacol HD »

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Asacol HD (mesalamine delayed-release tablets, oral) is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD (mesalamine delayed-release tablets, oral) beyond 6 weeks has not been established.

DOSAGE AND ADMINISTRATION

For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD (mesalamine delayed-release tablets, oral) in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 g, for a duration of 6 weeks. Asacol HD (mesalamine delayed-release tablets, oral) use beyond 6 weeks has not been evaluated. Asacol HD (mesalamine delayed-release tablets, oral) should be swallowed whole without cutting, breaking, or chewing. One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Asacol HD (mesalamine delayed-release tablets, oral) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.

Storage And Handling

Asacol HD tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.

NDC 0149-0783-01 Bottle of 180

Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].

Procter & Gamble Pharmaceuticals, Inc., Cincinnati, OH 45202, under license from Medeva Pharma Suisse AG. Made in Germany, D-64331 Weiterstadt.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

  • Renal impairment, including renal failure (rare) [see WARNINGS AND PRECAUTIONS]
  • Acute exacerbation of colitis [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Asacol HD (mesalamine delayed-release tablets, oral) has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 g/day with Asacol (mesalamine) 2.4 g/day as control in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with the Asacol HD (mesalamine delayed-release tablets, oral) tablet and 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].)

The most common reactions reported in the Asacol HD (mesalamine delayed-release tablets, oral) group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), exacerbation of ulcerative colitis (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse drug reactions that occurred in the three studies. The most common reactions in the primary efficacy population of patients with moderately active ulcerative colitis (602 patients dosed with Asacol HD (mesalamine delayed-release tablets, oral) and 618 patients dosed with the Asacol 400 mg tablet) were the same as all treated patients. The majority of adverse reactions with Asacol HD (mesalamine delayed-release tablets, oral) in the double-blind, active-controlled trials were mild or moderate in severity and were reversible.

Discontinuations due to adverse reactions occurred in 3.9% of patients in the Asacol HD (mesalamine delayed-release tablets, oral) group and in 4.2% of patients in the Asacol 400 mg tablet comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.

Severe adverse reactions occurred in 7.6% of patients in the Asacol HD (mesalamine delayed-release tablets, oral) group and in 7.6% of patients in the Asacol 400 mg tablet comparator group. Most of these reactions were gastrointestinal symptoms related to ulcerative colitis. Serious adverse reactions occurred in 0.8% of patients in the Asacol HD (mesalamine delayed-release tablets, oral) group and in 1.8% of patients in the Asacol 400 mg tablet comparator group. The majority involved the gastrointestinal system.

Table 1 : Adverse Reactions Occurring in 1% or More of All Treated Patients (Three studies combined; Intent-to-treat population)

MedDRA Preferred Term Asacol*
2.4 g/day
(400 mg Tablet)
(N=732)
Asacol HD (mesalamine delayed-release tablets, oral) *
4.8 g/day
(800 mg Tablet)
(N=727)
Headache 4.9 % 4.7 %
Nausea 2.9 % 2.8 %
Nasopharyngitis 1.4 % 2.5 %
Abdominal pain 2.3 % 2.3 %
Ulcerative Colitis 2.7 % 2.3 %
Diarrhea 1.9 % 1.7 %
Dyspepsia 0.8 % 1.7 %
Vomiting 1.6 % 1.4 %
Flatulence 0.7 % 1.2 %
Influenza 1.2 % 1.0 %
Pyrexia 1.2 % 0.7 %
Cough 1.4 % 0.3 %
N = number of patients within specified treatment group
% =percentage of patients in category and treatment group
*One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].

Adverse Reaction Information from Other Sources

In addition to the adverse reactions reported above in clinical trials involving the Asacol HD (mesalamine delayed-release tablets, oral) tablet, the adverse events listed below have been reported in controlled clinical trials, open label studies, literature reports, or foreign and domestic marketing experience with Asacol 400 mg tablets or other products that contain or are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Facial edema, edema, peripheral edema, asthenia, chills, infection, malaise, pain, neck pain, chest pain, back pain, abdominal enlargement, lupus-like syndrome, drug fever (rare).

Cardiovascular: Pericarditis (rare), pericardial effusion, myocarditis (rare), vasodilation, migraine.

Gastrointestinal: Dry mouth, stomatitis, oral ulcers, anorexia, increased appetite, eructation, pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer (rare), constipation, hemorrhoids, rectal hemorrhage, bloody diarrhea, tenesmus, stool abnormality.

Hepatic: There have been rare reports of hepatotoxicity, including jaundice, cholestatic jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which usually resolve during continued use or with discontinuation of the drug have also been reported. One case of Kawasaki-like syndrome, that included changes in liver enzymes, was also reported.

Hematologic: Agranulocytosis (rare), aplastic anemia (rare), anemia, thrombocytopenia, leukopenia, eosinophilia, lymphadenopathy.

Musculoskeletal: Gout, rheumatoid arthritis, arthritis, arthralgia, joint disorder, myalgia, hypertonia.

Neurological/Psychiatric: Anxiety, depression, somnolence, insomnia, nervousness, confusion, emotional lability, dizziness, vertigo, tremor, paresthesia, hyperesthesia, peripheral neuropathy (rare), Guillain-Barré syndrome (rare), and transverse myelitis (rare).

Respiratory/Pulmonary: Sinusitis, rhinitis, pharyngitis, asthma exacerbation, pleuritis, bronchitis, eosinophilic pneumonia, interstitial pneumonitis.

Skin: Alopecia, psoriasis (rare), pyoderma gangrenosum (rare), erythema nodosum, acne, dry skin, sweating, pruritus, urticaria, rash.

Special Senses: Ear pain, tinnitus, ear congestion, ear disorder, conjunctivitis, eye pain, blurred vision, vision abnormality, taste perversion.

Renal/Urogenital: Renal failure (rare), interstitial nephritis, minimal change nephropathy [see WARNINGS AND PRECAUTIONS], dysuria, urinary frequency and urgency, hematuria, epididymitis, decreased libido, dysmenorrhea, menorrhagia.

Laboratory Abnormalities

Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.

Read the Asacol HD (mesalamine delayed-release tablets, oral) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No formal drug interaction studies have been performed using Asacol HD (mesalamine delayed-release tablets, oral) with other drugs.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Renal Impairment

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.

It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol HD (mesalamine delayed-release tablets, oral) and periodically while on therapy. Exercise caution when using Asacol HD (mesalamine delayed-release tablets, oral) in patients with known renal dysfunction or history of renal disease.

In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity [see Nonclinical Toxicology].

Exacerbation of Ulcerative Colitis Symptoms

Exacerbation of the symptoms of colitis has been reported in 2.3% of Asacol HD (mesalamine delayed-release tablets, oral) -treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of Asacol HD tablets as well as other mesalamine products. Symptoms usually abate when Asacol HD (mesalamine delayed-release tablets, oral) tablets are discontinued.

Hypersensitivity

Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Asacol HD tablets or to other compounds that contain or are converted to mesalamine.

Pyloric Stenosis

Patients with pyloric stenosis may have prolonged gastric retention of Asacol HD tablets, which could delay release of mesalamine in the colon.

Use in Hepatic Impairment

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 HD (mesalamine delayed-release tablets, oral) to patients with liver disease.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are approximately 0.8 and 1.7 times the 4.8 g/day Asacol HD dose (based on body surface area). Mesalamine was not genotoxic in the Ames test, the Chinese hamster ovary cell chromosomal aberration assay, and the mouse micronucleus test. Mesalamine, at oral doses up to 480 mg/kg/day (about 0.8 times the recommended human treatment dose based on body surface area), was found to have no effect on fertility or reproductive performance of male and female rats.

Use In Specific Populations

Pregnancy

Pregnancy Category B: Reproduction studies have been performed in rats at oral doses up to 480 mg/kg/day (about 0.8 times the recommended human treatment dose of 4.8 g/day based on body surface area) and rabbits at oral doses up to 480 mg/kg/day (about 1.6 times the recommended human treatment dose of 4.8 g/day based on body surface area) 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, this drug should be used during pregnancy only if clearly needed.

Mesalamine is known to cross the placental barrier.

Nursing Mothers

Mesalamine and its N-acetyl metabolite have been detected in human breast milk. The clinical significance of this has not been determined. Caution should be exercised when Asacol HD (mesalamine delayed-release tablets, oral) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Asacol HD (mesalamine delayed-release tablets, oral) in pediatric patients have not been established.

Geriatric Use

Clinical studies of Asacol HD (mesalamine delayed-release tablets, oral) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Asacol HD (mesalamine delayed-release tablets, oral) . Reports from uncontrolled clinical studies and postmarketing reporting systems for Asacol (mesalamine) suggested a higher incidence of blood dyscrasias, i.e., agranulocytosis, neutropenia, pancytopenia, in patients who were 65 years or older. Caution should be taken to closely monitor blood cell counts during mesalamine therapy.

Mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol HD therapy and periodically while on Asacol HD (mesalamine delayed-release tablets, oral) therapy [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with Asacol HD (mesalamine delayed-release tablets, oral) should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintaining adequate renal function. Asacol HD (mesalamine delayed-release tablets, oral) 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 (mesalamine delayed-release tablets, oral) based on body surface area), 4595 mg/kg in rats (approximately 7.8 times the recommended human dose of Asacol HD (mesalamine delayed-release tablets, oral) 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.

CONTRAINDICATIONS

Asacol HD (mesalamine delayed-release tablets, oral) is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of Asacol HD (mesalamine delayed-release tablets, oral) tablets.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacokinetics

Plasma concentrations of mesalamine (5-aminosalicylic acid; 5-ASA) and its metabolite, N-acetyl-5aminosalicylic acid (N-Ac-5-ASA) are highly variable following administration of Asacol HD tablets. The time to peak plasma concentration (tmax) is prolonged for mesalamine and N-Ac-5-ASA with the median values from various studies ranging from 10 to 16 hours, reflecting the delayed-release characteristics. Based on cumulative urinary recovery of mesalamine and N-Ac-5-ASA from single dose studies in healthy volunteers, approximately 20% of the orally administered mesalamine in Asacol HD tablets is systemically absorbed. The absorbed mesalamine is rapidly acetylated in the gut mucosal wall and by the liver to N-Ac-5-ASA which is excreted mainly by the kidney. The PK parameters following administration of 1600 mg three times daily in healthy subjects are shown in Table 2.

Table 2 : Mean (± S.D.) PK parameters in healthy subjects following administration of two 800 mg tablets three times daily for 6 days (n=16)

  Mesalamine N-Ac-5-ASA
AUCtau (mcg h/mL) 20 ± 14 25 ± 11
Cmax (mcg/mL) 5.0 ± 4.0 4.6 ± 2.5
t½ (h) 12.6 ± 10.9* 23.6 ± 11.2#
* n=11, #n=6

A high fat meal does not affect the extent of systemic exposure to mesalamine after single-dose administration of Asacol HD, but mesalamine Cmax decreases by 47% and tmax is delayed by 14 hours under fed conditions.

One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets. In a single dose, cross-over pharmacokinetic study in 20 healthy volunteers, the mean mesalamine Cmax was 36% lower and the mean mesalamine AUC was 25% lower with administration of one Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet relative to two Asacol 400 mg tablets. Because the mechanism of action of mesalamine appears to be topical, the impact of these differences in measures of systemic exposure on clinical efficacy is not known.

Animal Toxicology and/or Pharmacology

In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity. (In the following, comparisons of animal dosing to recommended human dosing are based on body surface area and a 4.8 g/day dose for a 50 kg person.)

Mesalamine causes renal papillary necrosis in rats at single doses of approximately 750 mg/kg to 1000 mg/kg (1.3 to 1.7 times the recommended human dose). Doses of 170 and 360 mg/kg/day (about 0.3 and 0.6 times the recommended human dose) given to rats for six months produced papillary necrosis, papillary edema, tubular degeneration, tubular mineralization, and urothelial hyperplasia.

In mice, oral doses of 4000 mg/kg/day (approximately 3.4 times the recommended human dose) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis.

In dogs, single doses of 6000 mg (approximately 6.25 times the recommended human dose) of delayed-release mesalamine tablets resulted in renal papillary necrosis but were not fatal. Renal changes have occurred in dogs given chronic administration of mesalamine at doses of 80 mg/kg/day (0.5 times the recommended human dose).

Clinical Studies

Moderately Active Ulcerative Colitis

The efficacy of Asacol HD (mesalamine delayed-release tablets, oral) at 4.8 g/day was studied in a six-week, randomized, double-blind, active-controlled study in 772 patients with moderately active ulcerative colitis (UC). Moderately active UC was defined as a Physician's Global Assessment (PGA) score of 2; the PGA is a four-point scale (0-3) that encompasses the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings.

Patients were randomized 1:1 to the Asacol HD 4.8 g/day group (two Asacol HD tablets three times a day) or the Asacol (mesalamine) 2.4 g/day group (two Asacol 400 mg tablets three times a day). (One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets).

Patients characteristically had a history of previous use of oral 5-ASAs (86%), steroids (41%), and rectal therapies (49%), and demonstrated clinical symptoms of three or more stools over normal per day (87%) and obvious blood in the stool most or all of the time (70%). The study population was primarily Caucasian (97%), had a mean age of 43 years (8% aged 65 years or older), and included slightly more males (56%) than females (44%).

The primary endpoint was treatment success defined as improvement from baseline to Week 6 based on the PGA. Treatment success rates were similar in the two groups: 70% in the Asacol HD (mesalamine delayed-release tablets, oral) group and 66% in the Asacol group (difference: 5%; 95% CI: [-1.9%, 11.2%]).

A second controlled study supported the efficacy of Asacol HD at 4.8 g/day. Treatment success was 72% in patients with moderately active UC treated with Asacol HD (mesalamine delayed-release tablets, oral) .

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

  • Instruct patients to swallow the Asacol HD (mesalamine delayed-release tablets, oral) tablets whole, taking care not to break, cut, or chew the tablets, because the outer coating is an important part of the delayed-release formulation.
  • Inform patients that if they are switching from a previous oral mesalamine therapy to Asacol HD they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol HD (mesalamine delayed-release tablets, oral) . Inform patients that they should not substitute one Asacol HD tablet with two Asacol 400 mg tablets [see Dosage Forms and Strengths and CLINICAL PHARMACOLOGY].
  • Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly.
  • Instruct patients to protect Asacol HD (mesalamine delayed-release tablets, oral) tablets from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the tablets.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

  • Instruct patients to swallow the Asacol HD (mesalamine delayed-release tablets, oral) tablets whole, taking care not to break, cut, or chew the tablets, because the outer coating is an important part of the delayed-release formulation.
  • Inform patients that if they are switching from a previous oral mesalamine therapy to Asacol HD they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol HD (mesalamine delayed-release tablets, oral) . Inform patients that they should not substitute one Asacol HD tablet with two Asacol 400 mg tablets [see Dosage Forms and Strengths and CLINICAL PHARMACOLOGY].
  • Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly.
  • Instruct patients to protect Asacol HD (mesalamine delayed-release tablets, oral) tablets from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the tablets.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

Asacol® HD
(mesalamine) Delayed-Release Tablet for Oral Administration

DRUG DESCRIPTION

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an antiinflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, 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:

Asacol® HD (mesalamine)  Structural Formula Illustration

Molecular Weight : 153.1
Molecular Formula : C7H7NO3

Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

Asacol® HD
(mesalamine) Delayed-Release Tablet for Oral Administration

DRUG DESCRIPTION

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an antiinflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, 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:

Asacol® HD (mesalamine)  Structural Formula Illustration

Molecular Weight : 153.1
Molecular Formula : C7H7NO3

Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

Asacol® HD
(mesalamine) Delayed-Release Tablet for Oral Administration

DRUG DESCRIPTION

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an antiinflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, 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:

Asacol® HD (mesalamine)  Structural Formula Illustration

Molecular Weight : 153.1
Molecular Formula : C7H7NO3

Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

Asacol HD Patient Information Including Side Effects

Brand Names: Apriso, Asacol, Asacol HD, Lialda, Pentasa

Generic Name: mesalamine (oral) (Pronunciation: me SAL a meen)

What is mesalamine oral (Asacol HD)?

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for purposes not listed in this medication guide.

Asacol 400 mg

oblong, red, imprinted with ASACOLNE

Pentasa 500 mg

blue, imprinted with PENTASA 500 mg, LOGO

What are the possible side effects of mesalamine oral (Asacol HD)?

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 taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Asacol HD (mesalamine delayed-release tablets, oral) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about mesalamine oral (Asacol HD)?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine).

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Side Effects Centers

Asacol HD Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking mesalamine oral (Asacol HD)?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

To make sure you can safely take mesalamine, tell your doctor if you have any of these other conditions:

  • a stomach condition called pyloric stenosis;
  • a history of allergy to sulfasalazine (Azulfidine);
  • a heart condition such as congestive heart failure;
  • kidney disease; or
  • liver disease.

FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Mesalamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take mesalamine oral (Asacol HD)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take mesalamine with a full glass of water.

Mesalamine can usually be taken with or without food. Follow your doctor's instructions.

Mesalamine extended-release capsules (Lialda) should be taken with a meal.

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

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.

Store at room temperature away from moisture and heat.

Side Effects Centers

Asacol HD Patient Information including If I Miss a Dose

What happens if I miss a dose (Asacol HD)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Asacol HD)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, dizziness, headache, confusion, drowsiness, sweating, shortness of breath, vomiting, and diarrhea.

What should I avoid while taking mesalamine oral (Asacol HD)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect mesalamine oral (Asacol HD)?

Tell your doctor about all other medicines you use, especially:

  • azathioprine (Imuran) or mercaptopurine (Purinethol);
  • pentamidine (Nebupent, Pentam);
  • tacrolimus (Prograf);
  • amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
  • antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), diclofenac (Voltaren), etodolac (Lodine), indomethacin, nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with mesalamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about mesalamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision date: 7/20/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com