Dicyclomine Hydrochloride

DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride capsule
DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride tablet
Mylan Institutional Inc.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP.

  • The 10 mg capsules are a hard-shell gelatin capsule with a light turquoise blue opaque cap and light turquoise blue opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 1610 in black ink on both the cap and the body.

Dicyclomine Hydrochloride Tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP.

  • The 20 mg tablets are blue, round, unscored tablets debossed with M over D6 on one side of the tablet and blank on the other side.

4 CONTRAINDICATIONS

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)] , nursing mothers [see Use in Specific Populations (8.3)] and in patients with:

5 WARNINGS AND PRECAUTIONS

5.2 Cardiovascular Conditions

Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3)] .

5.3 Peripheral and Central Nervous System

The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6)] .

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms and inappropriate affect.

Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

Dicyclomine may produce drowsiness, dizziness 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 dicyclomine.

5.4 Myasthenia Gravis

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [see Contraindications (4)].

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