DICYCLOMINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICYCLOMINE HYDROCHLORIDE (UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. 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)]

Product summary:

  Dicyclomine Hydrochloride Injection, USP is supplied as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DICYCLOMINE HYDROCHLORIDE INJECTION.
DICYCLOMINE HYDROCHLORIDE INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1950
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)
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
DOSAGE FORMS AND STRENGTHS
Dicyclomine Hydrochloride Injection, USP 20 mg per 2 mL (10 mg per mL)
( 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
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): sign