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Name:Asacol Hd
Manufacturer:Warner Chilcott (us), Llc
Category:Prescription Marketed Drugs


These highlights do not include all the information needed to use Asacol HD safely and effectively. See full prescribing information for Asacol HD. Asacol® HD (mesalamine) delayed-release tablet for oral administrationInitial U.S. Approval: 1987

ASACOL HD - mesalamine tablet, delayed release 
Warner Chilcott (US), LLC

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Asacol HD safely and effectively. See full prescribing information for Asacol HD.

Asacol® HD (mesalamine) delayed-release tablet for oral administration
Initial U.S. Approval: 1987


INDICATIONS AND USAGE

  • Asacol HD is a locally acting aminosalicylate indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established. (1)

DOSAGE AND ADMINISTRATION

  • Two 800 mg tablets three times daily for 6 weeks (2)
  • Asacol HD should be swallowed whole without cutting, breaking, or chewing (2)
  • One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol® (mesalamine) delayed-release 400 mg tablets (2)

DOSAGE FORMS AND STRENGTHS

  • 800 mg delayed-release tablet (3)
  • 800 mg tablet ID change from “PG 800” to “WC 800” (3)

CONTRAINDICATIONS

  • History of hypersensitivity to salicylates or aminosalicylates or to any component of the Asacol HD tablet (4)

WARNINGS AND PRECAUTIONS

  • Renal impairment may occur. Monitor renal function at the beginning of treatment and periodically during therapy (5.1)
  • Acute exacerbation of colitis symptoms can occur (5.2)
  • Patients with pyloric stenosis may have prolonged gastric retention of Asacol HD tablets (5.4)
  • Use caution with pre-existing liver disease (5.5)

ADVERSE REACTIONS

  • The most common adverse reactions (observed in >2% of patients) were headache, nausea, nasopharyngitis, abdominal pain, and worsening of ulcerative colitis (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC POPULATIONS

  • Use with caution in patients with renal disease (5.1)
  • Pregnancy: May cause fetal harm, based on animal data for dibutyl phthalate (inactive ingredient in Asacol HD enteric coating) (8.1)
  • Nursing Mothers: Caution should be excercised when administered to a nursing woman (8.3)
  • Monitor blood cell counts in geriatric patients (8.5)


See 17 for PATIENT COUNSELING INFORMATION

Revised: 10/2010

FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Renal Impairment

5.2 Exacerbation of Ulcerative Colitis Symptoms

5.3 Hypersensitivity

5.4 Pyloric Stenosis

5.5 Use in Hepatic Impairment

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Adverse Reaction Information from Other Sources

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Moderately Active Ulcerative Colitis

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL


FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Asacol® HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established.

2 DOSAGE AND ADMINISTRATION

For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD 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 use beyond 6 weeks has not been evaluated. Asacol HD should be swallowed whole without cutting, breaking, or chewing. One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

Asacol HD is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of Asacol HD tablets.

5 WARNINGS AND PRECAUTIONS

5.1 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 and periodically while on therapy. Exercise caution when using Asacol HD 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 (13.2)].

5.2 Exacerbation of Ulcerative Colitis Symptoms

Exacerbation of the symptoms of colitis has been reported in 2.3% of Asacol HD-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 tablets are discontinued.

5.3 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.

5.4 Pyloric Stenosis

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

5.5 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 to patients with liver disease.

6 ADVERSE REACTIONS

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

6.1 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  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 tablet and 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].)

The most common reactions reported in the Asacol HD 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 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 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 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 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 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)

N = number of patients within specified treatment group

% = percentage of patients in category and treatment group

*
One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].
Asacol*
2.4 g/day
Asacol HD*
4.8 g/day
(400 mg Tablet) (800 mg Tablet)
MedDRA Preferred Term (N = 732) (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 %

6.2 Adverse Reaction Information from Other Sources

In addition to the adverse reactions reported above in clinical trials involving the Asacol HD  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 (5.1)], 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.

7 DRUG INTERACTIONS

No formal drug interaction studies have been performed using Asacol HD with other drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C: There are no adequate well controlled studies of Asacol HD use in pregnant women. 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. Animal reproduction studies of mesalamine found no evidence of fetal harm. However, dibutyl phthalate (DBP) is an inactive ingredient in Asacol HD’s enteric coating, and in animal studies at doses >80 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 HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 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.

Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm to the fetus. These mesalamine doses were about 1.6 times (rat) and 3.2 times (rabbit) the recommended human dose, based on body surface area.

Dibutyl phthalate (DBP) is an inactive ingredient in Asacol HD’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol HD tablets is about 48 mg. Published reports in rats show that male rat offspring exposed in utero to DBP (≥100 mg/kg/day, approximately 17 times the human dose based on body surface area), display reproductive system aberrations compatible with disruption of androgenic dependent development. The clinical significance of this finding in rats is unknown. At higher dosages (≥500 mg/kg/day, approximately 84 times the human dose based on body surface area), additional effects, including cryptorchidism, hypospadias, atrophy or agenesis of sex accessory organs, testicular injury, reduced daily sperm production, permanent retention of nipples, and decreased anogenital distance are noted. Female offspring are unaffected. High doses of DBP, administered to pregnant rats was associated with increased incidences of developmental abnormalities, such as cleft palate (≥630 mg/kg/day, about 106 times the human dose, based on body surface area) and skeletal abnormalities (≥750 mg/kg/day, about 127 times the human dose based on body surface area) in the offspring.

8.3 Nursing Mothers

Mesalamine and its N-acetyl metabolite are excreted into human milk. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L. The concentration of the N-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/L. Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 - 0.017 mg/kg/day of mesalamine and 0.75-2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. Caution should be exercised when Asacol HD is administered to a nursing woman.

Dibutyl phthalate (DBP), an inactive ingredient in the enteric coating of Asacol HD tablets, and its primary metabolite mono-butyl phthalate (MBP) are excreted into human milk. In pregnant rats, DBP causes fetal reproductive system aberrations in male offspring [see Pregnancy (8.1)]. The clinical significance of this has not been determined.

8.4 Pediatric Use

Safety and effectiveness of Asacol HD in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Asacol HD 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. 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 therapy [see Warnings and Precautions (5.1)].

10 OVERDOSAGE

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 maintaining 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.

11 DESCRIPTION

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an anti-inflammatory 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:

Mesalamine structural formula

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.

12 CLINICAL PHARMACOLOGY

12.1 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.

12.3 Pharmacokinetics

Plasma concentrations of mesalamine (5-aminosalicylic acid; 5-ASA) and its metabolite, N-acetyl-5-aminosalicylic 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)
*
n = 11
n = 6
Mesalamine N-Ac-5-ASA
AUCtau (mcg h/mL) 20 ± 14 25 ± 11
Cmax (mcg/mL) 5.0 ± 4.0 4.6 ± 2.5
t1/2 (h) 12.6 ± 10.9* 23.6 ± 11.2

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 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 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.

13 NONCLINICAL TOXICOLOGY

13.1 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.

13.2 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).

14 CLINICAL STUDIES

14.1 Moderately Active Ulcerative Colitis

The efficacy of Asacol HD 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 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].)

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 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

 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.

 N 0430-0783-27 Bottle of 180 tablets

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

17 PATIENT COUNSELING INFORMATION

  • Instruct patients to swallow the Asacol HD tablets whole, taking care not to break, cut, or chew the tablets, because the 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. Inform patients that they should not substitute one Asacol HD tablet with two Asacol 400 mg tablets [see Dosage Forms and Strengths (3) and Clinical Pharmacology (12.3)].
  • 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 tablets from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the tablets.
  • Advise women who are pregnant, breastfeeding, or of childbearing potential that Asacol HD contains dibutyl phthalate, which caused malformations and adverse effects on the male reproductive system in animal studies. Dibutyl phthalate is excreted in human milk.

Manufactured by:
Warner Chilcott Deutschland GmbH
D-64331 Weiterstadt, Germany

Marketed by:
Warner Chilcott (US), LLC
Rockaway, NJ 07866
1-800-521-8813

Under license from Medeva Pharma Suisse AG (registered trademark owner).

U.S. Patent Nos. 5,541,170; 5,541,171; and 6,893,662. Other patents pending.

0783G010

Warner Chilcott logo

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0430-0783-27
New NDC Number
New Tablet ID
Asacol® HD
(mesalamine)
delayed-release tablets
800 mg per tablet
Not Bioequivalent to Asacol
Rx Only
180 Tablets
asacolHD.com

800 mg Tablet bottle label

ASACOL HD 
mesalamine tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0430-0783
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MESALAMINE (MESALAMINE) MESALAMINE 800 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
POLYETHYLENE GLYCOL  
POVIDONE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
Product Characteristics
Color BROWN (red-brown) Score no score
Shape CAPSULE (capsule-shaped) Size 19mm
Flavor Imprint Code WC;800
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0430-0783-95 24 CARTON ( CARTON) in 1 CASE contains a CARTON
1 1 BOTTLE ( BOTTLE) in 1 CARTON This package is contained within the CASE (0430-0783-95) and contains a BOTTLE
1 12 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE This package is contained within a CARTON and a CASE (0430-0783-95)
2 NDC:0430-0783-27 12 BOTTLE ( BOTTLE) in 1 CASE contains a BOTTLE
2 180 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE This package is contained within the CASE (0430-0783-27)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021830 05/28/2008

Labeler - Warner Chilcott (US), LLC (957203177)

Revised: 10/2010 Warner Chilcott (US), LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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