Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride

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Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride Recall

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Side Effects & Adverse Reactions

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FDA Labeling Changes

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Uses

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

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History

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Other Information

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

Dicyclomine hydrochloride capsules for oral use contain 10 mg dicyclomine hydrochloride USP. Dicyclomine hydrochloride 10 mg capsules also contain inactive ingredients: sodium lauryl sulfate, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, pregelatinized starch, silicon dioxide.
Dicyclomine hydrochloride tablets for oral use contain 20 mg dicyclomine hydrochloride USP. Dicyclomine hydrochloride 20 mg tablets also contain inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue #1, hypromellose, lactose monohydrate, sodium starch glycolate, and stearic acid.

Dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula:

Dicyclomine Hydrochloride structural formula

Molecular weight: 345.95

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 Hydrochloride Capsule Dicyclomine Hydrochloride Manufacturers

A-s Medication Solutions Llc

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | 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.

No Recall
State Of Florida Doh Central Pharmacy

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | State Of Florida Doh Central Pharmacy

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

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.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

No Recall
Mylan Pharmaceuticals Inc.

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | Mylan 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 4 times a day.

After one week treatment with the initial dose, the dose may be increased to 40 mg 4 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.

No Recall
Mylan Institutional Inc.

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | Mylan Institutional Inc.

Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg 4 times a day.

After one week treatment with the initial dose, the dose may be increased to 40 mg 4 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.

No Recall
Actavis Pharma, Inc.

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | Actavis Pharma, 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.

No Recall
Cardinal Health

Dicyclomine Hydrochloride Capsule Dicyclomine Hydrochloride | Cardinal Health

Dosage must be adjusted to individual patient needs.
2.1 Oral Dosage and Administration in Adults
The recommended initial dose is 20 mg 4 times a day.

After one week treatment with the initial dose, the dose may be increased to 40 mg 4 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.

No Recall