Asacol label

Asacol

Asacol Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

History

There is currently no drug history available for this drug.

Other Information

Each Asacol delayed-release tablet for oral administration contains 400 mg of mesalamine, an anti-inflammatory drug. The Asacol delayed-release tablets are coated with acrylic based resin, Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is:

Chemical Structure

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

Asacol Manufacturers

  • State Of Florida Doh Central Pharmacy
    Asacol | State Of Florida Doh Central Pharmacy
    No Recall

    Asacol | State Of Florida Doh Central Pharmacy

    Asacol | State Of Florida Doh Central Pharmacy

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol HD 800 mg tablet.

  • Remedyrepack Inc.
    Asacol | Remedyrepack Inc.
    No Recall

    Asacol | Remedyrepack Inc.

    Asacol | Remedyrepack Inc.
    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.
    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol HD 800 mg tablet.

  • Remedyrepack Inc.
    Asacol | Remedyrepack Inc.
    No Recall

    Asacol | Remedyrepack Inc.

    Asacol | Remedyrepack Inc.
    For the treatment of mildly to moderately active ulcerative colitis:The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis:The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.
    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol HD 800 mg tablet.

  • Asacol | Cardinal Health
    No Recall

    Asacol | Cardinal Health

    Asacol | Cardinal Health

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

  • Asacol | American Health Packaging
    No Recall

    Asacol | American Health Packaging

    Asacol | American Health Packaging

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

  • Asacol | Kaiser Foundation Hospitals
    No Recall

    Asacol | Kaiser Foundation Hospitals

    Asacol | Kaiser Foundation Hospitals

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

  • Remedyrepack Inc.
    Asacol | Remedyrepack Inc.
    No Recall

    Asacol | Remedyrepack Inc.

    Asacol | Remedyrepack Inc.
    For the treatment of mildly to moderately active ulcerative colitis:The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.
    For the maintenance of remission of ulcerative colitis:The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.
    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one AsacolHD (mesalamine) delayed-release 800 mg tablet.

  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Asacol | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    No Recall

    Asacol | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    Asacol | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

  • Asacol | Cardinal Health
    No Recall

    Asacol | Cardinal Health

    Asacol | Cardinal Health

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

  • Remedyrepack Inc.
    Asacol | Remedyrepack Inc.
    No Recall

    Asacol | Remedyrepack Inc.

    Asacol | Remedyrepack Inc.

    For the treatment of mildly to moderately active ulcerative colitis:

    The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis:

    The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one AsacolHD (mesalamine) delayed-release 800 mg tablet.

     

  • Asacol | Janssen Pharmaceuticals, Inc.
    No Recall

    Asacol | Janssen Pharmaceuticals, Inc.

    Asacol | Janssen Pharmaceuticals, Inc.

    There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.

    To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less HALDOL (haloperidol). The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.

    Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory. The maximum dose is 20 mg/day.

    Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    Switchover Procedure

    An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12–24 hours following the last parenteral dose.

    INSTRUCTIONS FOR OPENING AMPULE
    1. Medication often rests in the top part of the ampule. Before breaking the ampule, lightly tap the top of the ampule with your finger until all fluid moves to the bottom portion of the ampule. The ampule has a colored ring(s) and colored point which aids in the placement of fingers while breaking the ampule. Step 1



    2. Hold the ampule between thumb and index finger with the colored point facing you. Step 2



    3. Position the index finger of the other hand to support the neck of the ampule. Position the thumb so that it covers the colored point and is parallel to the colored ring(s). Step 3



    4. Keeping the thumb on the colored point and with the index fingers close together, apply firm pressure on the colored point in the direction of the arrow to snap the ampule open. Step 4


  • State Of Florida Doh Central Pharmacy
    Asacol | State Of Florida Doh Central Pharmacy
    No Recall

    Asacol | State Of Florida Doh Central Pharmacy

    Asacol | State Of Florida Doh Central Pharmacy

    For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

    For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

    Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.