Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Injection, USP, 20 mg/2 mL (10 mg/mL) is supplied as follows: NDC 0517-1980-05 2 mL single-dose vials 5 vial carton NDC 0517-1980-10 2 mL single-dose vials 10 vial carton Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label - 20 mg/2 mL NDC 0517-1980-01 Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) FOR INTRAMUSCULAR USE ONLY 2 mL Single Dose Vial Rx Only AMERICAN REGENT, INC. Shirley, NY 11967 Carton Labeling - 5 Pack NDC 0517-1980-05 Rx Only Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) For Intramuscular Use Only 5 x 2 mL Single-Dose Vials AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton Labeling - 10 Pack NDC 0517-1980-10 Rx Only Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) For Intramuscular Use Only 10 x 2 mL Single-Dose Vials AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label Carton - 5 pack Carton - 10 pack; Serialization Label (5 pack) Serialization Label; Serialization Label (10 pack) Serialization Label (10 pack)
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Injection, USP, 20 mg/2 mL (10 mg/mL) is supplied as follows: NDC 0517-1980-05 2 mL single-dose vials 5 vial carton NDC 0517-1980-10 2 mL single-dose vials 10 vial carton Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label - 20 mg/2 mL NDC 0517-1980-01 Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) FOR INTRAMUSCULAR USE ONLY 2 mL Single Dose Vial Rx Only AMERICAN REGENT, INC. Shirley, NY 11967 Carton Labeling - 5 Pack NDC 0517-1980-05 Rx Only Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) For Intramuscular Use Only 5 x 2 mL Single-Dose Vials AMERICAN REGENT, INC. SHIRLEY, NY 11967 Carton Labeling - 10 Pack NDC 0517-1980-10 Rx Only Dicyclomine Hydrochloride Injection, USP 20 mg/2 mL (10 mg/mL) For Intramuscular Use Only 10 x 2 mL Single-Dose Vials AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label Carton - 5 pack Carton - 10 pack
- Serialization Label (5 pack) Serialization Label
- Serialization Label (10 pack) Serialization Label (10 pack)
Overview
Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: Dicyclomine Hydrochloride Injection, USP is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as a vial containing 20 mg/2 mL (10 mg/mL). Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride. Dicyclomine Hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: BENTYL Structure Molecular weight: 345.95 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. BENTYL Structure
Indications & Usage
Dicyclomine hydrochloride injection is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine Hydrochloride Injection, USP is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
Dosage & Administration
Dosage must be adjusted to individual patients needs. 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 ). Intramuscular in adults ( 2.2 ): Intramuscular administration recommended no longer than 1 or 2 days when patients cannot take oral administration Recommended dose: 10 mg to 20 mg four times a day 2.2 Intramuscular Dosage and Administration in Adults Dicyclomine Hydrochloride Intramuscular Injection must be administered via intramuscular route only. Do not administer by any other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day [ see CLINICAL PHARMACOLOGY (12) ]. The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms. 2.3 Preparation for Intramuscular Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.
Warnings & Precautions
For Intramuscular injection only; should not be administered by any other route. Intravenous injection may result in thrombosis or thrombophlebitis and injection site reactions ( 5.1 ) 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 ) 5.1 Inadvertent Intravenous Administration Dicyclomine hydrochloride solution is for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis and injection site reactions such as pain, edema, skin color change, and reflex sympathetic dystrophy syndrome [see ADVERSE REACTIONS (6.2)] . 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 confusion, 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.
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 SPECIFICPOPULATIONS (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 PRECATIONS (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) 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)
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 American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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. 6.2 Postmarketing 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 Cases of thrombosis, thrombophlebitis and injection site reactions such as local pain, edema, skin color change and even reflex sympathetic dystrophy syndrome have been reported following inadvertent IV injection of dicyclomine hydrochloride. 6.3 Adverse 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.
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) 7.1 Antiglaucoma 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)] . 7.2 Other 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. 7.3 Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. 7.4 Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided. 7.5 Effect 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. 7.6 Effect 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.
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