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dicyclomine hydrochloride capsule
----------Dicyclomine Hydrochloride Capsule
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form: Each capsule, for oral administration, contains 10mg of dicyclomine hydrochloride. Each capsule also contains the following inactive ingredients: Corn Starch, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose. Capsule shells contain FD and C Blue No. 1, FD and 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:
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.
Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: (1) a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and (2) a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl2. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.
1. Obstructive uropathy
2. Obstructive disease of the gastrointestinal tract
3. Severe ulcerative colitis (See PRECAUTIONS)
4. Reflux esophagitis
5. Unstable cardiovascular status in acute hemorrhage
7. Myasthenia gravis
8. Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations
9. Infants less than 6 months of age (See WARNINGS and PRECAUTIONS: Information for Patients.)
10. Nursing Mothers (See WARNINGS and PRECAUTIONS: Information for Patients.)
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.
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.
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.
Use with caution in patients with:
Information for Patients:
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 to perform hazardous work while taking this drug.
The following agents may increase certain actions or side effects of anticholinergic drugs: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
There are no known human data on long-term potential for carcinogenicity or mutagenicity. Long-term studies in animals to determine carcinogenic potential are not known to have been conducted. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine hydrochloride produced no deleterious effects on breeding, conception, or parturition.
Teratogenic Effects:Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of impaired fertility or harm to the fetus due to dicyclomine. Epidemiologic studies in pregnant women with products containing dicyclomine hydrochloride (at doses up to 40 mg/day) have not shown that dicyclomine increases the risk of fetal abnormalities if administered during the first trimester of pregnancy. There are, however, no adequate and well-controlled studies in pregnant women at the recommended doses (80-160 mg/day). Because animal reproduction studies are not always predictive of human response, dicyclomine hydrochloride as indicated for functional bowel/irritable bowel syndrome should be used during pregnancy only if clearly needed.
Since dicyclomine hydrochloride has been reported to be excreted in human milk, DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN NURSING MOTHERS. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: Pediatric Use and ADVERSE REACTIONS.)
(See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Nursing Mothers.) DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE. Safety and effectiveness in pediatric patients have not been established.
Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Not all of the following adverse reactions have been reported with dicyclomine hydrochloride. Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.
Central Nervous System: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia
Ophthalmologic: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension
Dermatologic/Allergic: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis
Genitourinary: urinary hesitancy, urinary retention
Cardiovascular: tachycardia, palpitations
Respiratory: Dyspnea, apnea, asphyxia (see WARNINGS)
Other: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation (see PRECAUTIONS: Nursing Mothers)
DRUG ABUSE AND DEPENDENCE
Abuse and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.
Signs and Symptoms:
The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
Minimum Human Lethal Dose/Maximum Human Dose Recorded:
The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride (see WARNINGS), the blood concentrations of drug were 200, 220, and 505 ng/mL, respectively.
DOSAGE AND ADMINISTRATION
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.
Dicyclomine Hydrochloride Capsules USP, 10 mg are supplied as dark blue capsules printed "West-ward 3126" and are available in:
NDC 51138-022-30 - Bottles of 30 capsules.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised September 2008
Med-Health Pharma, LLC
North Las Vegas, NV 89032
MHP LB-60007 rev00
Revised: 01/2011 Med Health Pharma, LLC
Reproduced with permission of U.S. National Library of Medicine
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