Dicyclomine Hydrochloride

DICYCLOMINE HYDROCHLORIDE- dicyclomine hydrochloride tablet
RedPharm Drug, Inc.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP.
Dicyclomine hydrochloride capsules USP, for oral use
Dicyclomine hydrochloride tablets USP, for oral use
Initial U.S. Approval: 1950

RECENT MAJOR CHANGES

Warnings and Precautions, Peripheral and Central Nervous System (5.3) 07/2012

INDICATIONS AND USAGE

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)

DOSAGE AND ADMINISTRATION

Dosage for dicyclomine hydrochloride must be adjusted to individual patient needs (2).

If a dose is missed, patients should continue the normal dosing schedule (2).

Oral in adults (2.1):

Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation
Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment

DOSAGE FORMS AND STRENGTHS

Dicyclomine Hydrochloride Capsules USP, 10 mg (3)
Dicyclomine Hydrochloride Tablets USP, 20 mg (3)

CONTRAINDICATIONS

Infants less than 6 months of age (4)
Nursing mothers (4)
Unstable cardiovascular status in acute hemorrhage (4)
Myasthenia gravis (4)
Glaucoma (4)
Obstructive uropathy (4)
Obstructive disease of the gastrointestinal tract (4)
Severe ulcerative colitis (4)
Reflux esophagitis (4)

WARNINGS AND PRECAUTIONS

Cardiovascular conditions: worsening of conditions (5.2)
Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted (5.3)
Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride (5.3)
Myasthenia Gravis: overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase (5.4)
Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal (5.5)
Salmonella dysenteric patients: due to risk of toxic megacolon (5.6)
Ulcerative colitis: Dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon (5.7)
Prostatic hypertrophy: Dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention (5.8)
Hepatic and renal disease: should be used with caution (5.9)
Geriatric: use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events (5.10)

ADVERSE REACTIONS

The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness (6)

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-800-325-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Antiglaucoma agents: anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure (7)
Anticholinergic agents: may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs (7)
Antacids: interfere with the absorption of anticholinergic agents (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: use only if clearly needed (8.1)
Pediatric Use: Safety and effectiveness not established (8.4)
Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

RECENT MAJOR CHANGES
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Oral Dosage and Administration in Adults
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.2 Cardiovascular Conditions
5.3 Peripheral and Central Nervous System
5.4 Myasthenia Gravis
5.5 Intestinal Obstruction
5.6 Toxic Dilatation of Intestinemegacolon
5.7 Ulcerative Colitis
5.8 Prostatic Hypertrophy
5.9 Hepatic and Renal Disease
5.10 Geriatric Population
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
6.3 Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
7 DRUG INTERACTIONS
7.1 Antiglaucoma Agents
7.2 Other Drugs with Anticholinergic Activity
7.3 Other Gastrointestinal Motility Drugs
7.4 Effect of Antacids
7.5 Effect on Absorption of Other Drugs
7.6 Effect on Gastric Acid Secretion
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.2 Use in Infants
17.3 Use in Nursing Mothers
17.4 Peripheral and Central Nervous System

*
Sections or subsections omitted from the full prescribing information are not listed.

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 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.

3 DOSAGE FORMS AND STRENGTHS

Dicyclomine Hydrochloride Capsules USP, 10 mg: blue capsules with a white powder fill, imprinted logo LANNETT on the cap and 0586 on the body
Dicyclomine Hydrochloride Tablets USP, 20 mg: blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282

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:

unstable cardiovascular status in acute hemorrhage
myasthenia gravis [see Warnings and Precautions (5.4)]
glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]
obstructive uropathy [see Warnings and Precautions (5.8)]
obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)]
severe ulcerative colitis [see Warnings and Precautions (5.7)]
reflux esophagitis

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 hydrochloride 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 hydrochloride.

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)].

5.5 Intestinal Obstruction

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 [see Contraindications (4)].

Rarely development of Ogilvie’s syndrome (colonic pseudo-obstruction) has been reported. Ogilvie’s syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.

5.6 Toxic Dilatation of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

5.7 Ulcerative Colitis

Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [see Adverse Reactions (6.3)]. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [see Contraindications (4)].

5.8 Prostatic Hypertrophy

Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [see Adverse Reactions (6.3)].

5.9 Hepatic and Renal Disease

Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.

5.10 Geriatric Population

Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.