FDA

Dicyclomine Hydrochloride

Approved 4 Aug 2023OralTablet

The FDA lists this product in 42 strengths and forms.

Indications

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

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 Infants less than 6 months of age ( 4 ).

Glaucoma ( 4 ). Nursing mothers ( 4 ). Obstructive uropathy ( 4 ). Unstable cardiovascular status in acute hemorrhage ( 4 ). Obstructive disease of the gastrointestinal tract ( 4 ). Myasthenia gravis ( 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 hours 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 ).

At a glance

Brand name: Dicyclomine Hydrochloride
Route: Oral
Dosage form: Tablet
Applicant: Bionpharma
Status: Prescription
FDA approval: 4 Aug 2023
Application: ANDA217916-001

Contraindications

Warnings and precautions

Interactions

Antiglaucoma agents : Anticholinergics antagonize antiglaucoma agents and may increase intraocular 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 ).

7.1Antiglaucoma Agents

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. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications (4) ].

7.2Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: 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.

7.3Other Gastrointestinal Motility Drugs Interaction

with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

7.4Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.

7.5Effect on Absorption of Other Drugs

Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

7.6Effect on Gastric Acid Secretion

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.

Adverse reactions

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12) ] . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued. The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2 , 5.3 )].

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 Bionpharma Inc., at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day) In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients.

Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) % Placebo % Dry Mouth 33 5 Dizziness 40 5 Vision blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride 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.

6.2Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: palpitations, tachyarrhythmias Eye disorders: cycloplegia, mydriasis, vision blurred Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting General disorders and administration site conditions: fatigue, malaise Immune System Disorders : drug hypersensitivity including face edema, angioedema, anaphylactic shock Nervous system disorders: dizziness, headache, somnolence, syncope Psychiatric disorders : As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Dicyclomine.

Nervousness and insomnia have also been reported. Reproductive system and breast disorders: suppressed lactation Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

6.3Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Gastrointestinal: anorexia Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis) Ophthalmologic: diplopia, increased ocular tension Dermatologic/Allergic: urticaria, itching, and other dermal manifestations Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy Cardiovascular: hypertension Respiratory: apnea Other: decreased sweating, sneezing, throat congestion, impotence.

With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of dicyclomine hydrochloride.

Dicyclomine Hydrochloride

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Dicyclomine Hydrochloride

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.2Cardiovascular Conditions

5.3Peripheral and Central Nervous System

5.4Myasthenia Gravis

5.5Intestinal Obstruction

5.7Ulcerative Colitis

5.8Prostatic Hypertrophy

5.9Hepatic and Renal Disease

5.10Geriatric Population

Interactions

7.1Antiglaucoma Agents

7.2Other Drugs with Anticholinergic Activity

7.3Other Gastrointestinal Motility Drugs Interaction

7.4Effect of Antacids

7.5Effect on Absorption of Other Drugs

7.6Effect on Gastric Acid Secretion

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category B Adequate

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

6.3Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Composition

Strengths and forms

Official product information