Dicyclomine label

Dicyclomine

Dicyclomine Recall

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Side Effects & Adverse Reactions

In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

Dicyclomine hydrochloride may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

There are reports that administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma. Death has been reported. No causal relationship between these effects observed in infants and dicyclomine administration has been established. DICYCLOMINE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See CONTRAINDICATIONS and PRECAUTIONS: Nursing Mothers and Pediatric Use).

Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.

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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

For the treatment of functional bowel/irritable bowel syndrome.

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History

There is currently no drug history available for this drug.

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Other Information

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:

Each capsule, for oral administration, contains 10 mg of dicyclomine hydrochloride. Each capsule also contains the following inactive ingredients: Corn Starch, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose. Capsule shells contain FD&C Blue No. 1, FD&C Red No. 4, and Gelatin. The imprinting ink contains Titanium Dioxide.

Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the structural formula:

Image from Drug Label Content

Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.

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Dicyclomine Manufacturers

  • West-ward Pharmaceuticals
    Dicyclomine | West-ward Pharmaceuticals
    No Recall

    Dicyclomine | West-ward Pharmaceuticals

    Dicyclomine | West-ward Pharmaceuticals

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

    Adults-Oral

    The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.  If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Rebel Distributors Corp.
    Dicyclomine | Rebel Distributors Corp.
    No Recall

    Dicyclomine | Rebel Distributors Corp.

    Dicyclomine | Rebel Distributors Corp.

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

    Adults-Oral

    The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.  If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Stat Rx Usa Llc
    Dicyclomine | Stat Rx Usa Llc
    No Recall

    Dicyclomine | Stat Rx Usa Llc

    Dicyclomine | Stat Rx Usa Llc

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

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

    Dicyclomine | State Of Florida Doh Central Pharmacy

    Dicyclomine | State Of Florida Doh Central Pharmacy

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

    Adults-Oral

    The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.  If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    No Recall

    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    DOSAGE AND ADMINISTRATION

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

  • Blenheim Pharmacal, Inc.
    Dicyclomine | Blenheim Pharmacal, Inc.
    No Recall

    Dicyclomine | Blenheim Pharmacal, Inc.

    Dicyclomine | Blenheim Pharmacal, Inc.
    DOSAGE AND ADMINISTRATION

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

  • Golden State Medical Supply, Inc.
    Dicyclomine | Golden State Medical Supply, Inc.
    No Recall

    Dicyclomine | Golden State Medical Supply, Inc.

    Dicyclomine | Golden State Medical Supply, Inc.
    DOSAGE AND ADMINISTRATION

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

  • H.j. Harkins Company, Inc.
    Dicyclomine | H.j. Harkins Company, Inc.
    No Recall

    Dicyclomine | H.j. Harkins Company, Inc.

    Dicyclomine | H.j. Harkins Company, Inc.

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    No Recall

    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

    Dicyclomine | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

    DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS. (See CLINICAL PHARMACOLOGY.)

    Adults-Oral

    The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation.  If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Major Pharmaceuticals
    Dicyclomine | Major Pharmaceuticals
    No Recall

    Dicyclomine | Major Pharmaceuticals

    Dicyclomine | Major Pharmaceuticals

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Remedyrepack Inc.
    Dicyclomine | Remedyrepack Inc.
    No Recall

    Dicyclomine | Remedyrepack Inc.

    Dicyclomine | Remedyrepack Inc.

    Dosage must be adjusted to individual patient needs.

     

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

     

  • A-s Medication Solutions Llc
    Dicyclomine | A-s Medication Solutions Llc
    No Recall

    Dicyclomine | A-s Medication Solutions Llc

    Dicyclomine | A-s Medication Solutions Llc

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Pd-rx Pharmaceuticals, Inc.
    Dicyclomine | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Dicyclomine | Pd-rx Pharmaceuticals, Inc.

    Dicyclomine | Pd-rx Pharmaceuticals, Inc.

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Liberty Pharmaceuticals, Inc.
    Dicyclomine | Liberty Pharmaceuticals, Inc.
    No Recall

    Dicyclomine | Liberty Pharmaceuticals, Inc.

    Dicyclomine | Liberty Pharmaceuticals, Inc.

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Preferred Pharmaceuticals, Inc
    Dicyclomine | Preferred Pharmaceuticals, Inc
    No Recall

    Dicyclomine | Preferred Pharmaceuticals, Inc

    Dicyclomine | Preferred Pharmaceuticals, Inc

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

  • Bryant Ranch Prepack
    Dicyclomine | Bryant Ranch Prepack
    No Recall

    Dicyclomine | Bryant Ranch Prepack

    Dicyclomine | Bryant Ranch Prepack

    Dosage must be adjusted to individual patient needs.

    2.1 Oral Dosage and Administration in Adults

    The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

    If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

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