Dicyclomine Hydrochloride

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Overview

What is Dicyclomine Hydrochloride?

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent.

Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular 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 hydrochloride tablets, for oral administration, contain 20 mg of dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No.1 Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate.

What does Dicyclomine Hydrochloride look like?

What are the available doses of Dicyclomine Hydrochloride?

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What should I talk to my health care provider before I take Dicyclomine Hydrochloride?

Sorry No records found

How should I use Dicyclomine Hydrochloride?

For the treatment of functional bowel/irritable bowel syndrome.

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

What interacts with Dicyclomine Hydrochloride?

Obstructive uropathy

Obstructive disease of the gastrointestinal tract

Severe ulcerative colitis (See .)

Reflux esophagitis

Unstable cardiovascular status in acute hemorrhage

Glaucoma

Myasthenia gravis

Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations

Infants less than 6 months of age (See and .)

Nursing mothers (See and .)

What are the warnings of Dicyclomine Hydrochloride?

Array

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 HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See and and .)

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

What are the precautions of Dicyclomine Hydrochloride?

General

Use with caution in patients with:

Investigate any tachycardia before administration of dicyclomine hydrochloride since it may increase the heart rate.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

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.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age and in nursing mothers. (See , , and and .)

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 a physician contacted.

Drug Interactions

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.

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. (See also .)

Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentrations may result. Anticholinergic drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. Because antacids may interfere with the absorption of anticholinergic agents, simultaneous use of these drugs should be avoided. The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

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.

Pregnancy

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 to 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.

Nursing Mothers

Since dicyclomine hydrochloride has been reported to be excreted in human milk, DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN NURSING MOTHERS. (See , , and .)

Pediatric Use

(See , , and .)

DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE.

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of dicyclomine 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See )

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

What are the side effects of Dicyclomine Hydrochloride?

Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. (See .)

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.

Gastrointestinal:

Central Nervous System:

Ophthalmologic:

Dermatologic/Allergic:

Genitourinary:

Cardiovascular:

Respiratory:

Other:

What should I look out for while using Dicyclomine Hydrochloride?

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 HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See and and .)

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

What might happen if I take too much Dicyclomine Hydrochloride?

How should I store and handle Dicyclomine Hydrochloride?

StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]Dicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central PharmacyDicyclomine Hydrochloride Tablets, USP are available containing dicyclomine hydrochloride, USP equivalent to 10 mg of dicyclomine.The 10 mg tablet is a blue, round, tablet debossed with over on one side of the tablet and blank on the other side. They are supplied by as follows:Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]To prevent fading, avoid exposure to direct sunlight.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505This Product was Repackaged By:State of Florida DOH Central Pharmacy

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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 (, 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. studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl. 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.

In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. The principal route of elimination is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg q.i.d.) demonstrated a favorable clinical response compared with 55% treated with placebo (P < 0.05). In these trials, most of the side effects were typically anticholinergic in nature (see table) and were reported by 61% of the patients.

Nine percent (9%) of patients were discontinued from the drug because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. (See .)

Non-Clinical Toxicology

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 HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See and and .)

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

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.

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. (See also .)

Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentrations may result. Anticholinergic drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. Because antacids may interfere with the absorption of anticholinergic agents, simultaneous use of these drugs should be avoided. The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

Use with caution in patients with:

Investigate any tachycardia before administration of dicyclomine hydrochloride since it may increase the heart rate.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. (See .)

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.

Gastrointestinal:

Central Nervous System:

Ophthalmologic:

Dermatologic/Allergic:

Genitourinary:

Cardiovascular:

Respiratory:

Other:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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