Tigan label

Tigan

Tigan Recall

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Side Effects & Adverse Reactions

Tigan® may produce drowsiness. Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined.

Usage in Pregnancy

Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.

Usage with Alcohol

Concomitant use of alcohol with Tigan® may result in an adverse drug interaction.

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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Uses

Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

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History

There is currently no drug history available for this drug.

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Other Information

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Chemical Structure

Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

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Tigan Manufacturers

  • Jhp Pharmaceuticals Llc
    Tigan | H E B
    No Recall

    Tigan | H E B

    Tigan | H E B
    • take only as directed – see overdose warning • do not exceed 4 doses per 24 hours

    adults & children 12 yrs & over

    2 softgels with water every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    Other information • store at 20-25 °C (68-77 °F)
  • General Injectables & Vaccines, Inc
    Tigan | General Injectables & Vaccines, Inc
    No Recall

    Tigan | General Injectables & Vaccines, Inc

    Tigan | General Injectables & Vaccines, Inc

    (See WARNINGS and PRECAUTIONS.)
    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients
    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered
    in elderly patients with renal impairment (creatinine clearance £ 70 mL/min/1.73m2). Final dose adjustment should be based upon
    integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment
    In subjects with renal impairment (creatinine clearance £ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose
    administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and
    DOSAGE AND ADMINISTRATION).
    INJECTABLE, 100 mg/mL (Not for use in pediatric patients)
        Usual Adult Dosage
        2 mL (200 mg) t.i.d. or q.i.d. intramuscularly.
    NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use.
    Intramuscular administration may cause pain, stinging, burning, redness and swelling at the site of injection. Such effects may be
    minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.

  • Rebel Distributors Corp
    Tigan | Rebel Distributors Corp
    No Recall

    Tigan | Rebel Distributors Corp

    Tigan | Rebel Distributors Corp

    (See WARNINGS and PRECAUTIONS.)

    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients

    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment

    In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

    INJECTABLE, 100 mg/mL (Not for use in pediatric patients)
                Usual Adult Dosage
                2 mL (200 mg) t.i.d. or q.i.d. intramuscularly.

    NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use.

    Intramuscular administration may cause pain, stinging, burning, redness and swelling at the site of injection. Such effects may be minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.

  • Remedyrepack Inc.
    Tigan | Remedyrepack Inc.
    No Recall

    Tigan | Remedyrepack Inc.

    Tigan | Remedyrepack Inc.

    (See WARNINGS and PRECAUTIONS.)

    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients

    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment

    In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    CAPSULES, 300 mg

    Usual Adult Dosage

    One 300 mg capsule t.i.d. or q.i.d.

     

  • Remedyrepack Inc.
    Tigan | Remedyrepack Inc.
    No Recall

    Tigan | Remedyrepack Inc.

    Tigan | Remedyrepack Inc.

    (See WARNINGS and PRECAUTIONS.)

    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients

    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment

    In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    CAPSULES, 300 mg

    Usual Adult Dosage

    One 300 mg capsule t.i.d. or q.i.d.

     

  • Remedyrepack Inc.
    Tigan | Remedyrepack Inc.
    No Recall

    Tigan | Remedyrepack Inc.

    Tigan | Remedyrepack Inc.

    (See WARNINGS and PRECAUTIONS.)

    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients

    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment

    In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    CAPSULES, 300 mg

    Usual Adult Dosage

    One 300 mg capsule t.i.d. or q.i.d.

     

  • Pfizer Laboratories Div Pfizer Inc
    Tigan | Pfizer Laboratories Div Pfizer Inc
    No Recall

    Tigan | Pfizer Laboratories Div Pfizer Inc

    Tigan | Pfizer Laboratories Div Pfizer Inc

    (See WARNINGS and PRECAUTIONS.)

    Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

    Geriatric Patients

    Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    Patients with Renal Impairment

    In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

    CAPSULES, 300 mg

    Usual Adult Dosage

    One 300 mg capsule t.i.d. or q.i.d.

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