国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DICYCLOMINE HYDROCHLORIDE (UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)
Fresenius Kabi USA, LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
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)]
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.
Abbreviated New Drug Application
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- 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 完全なドキュメントを読む