Country: United States
Language: English
Source: NLM (National Library of Medicine)
CHLORDIAZEPOXIDE HYDROCHLORIDE (UNII: MFM6K1XWDK) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR), CLIDINIUM BROMIDE (UNII: 91ZQW5JF1Z) (CLIDINIUM - UNII:BO76JF850N)
ECI Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide.
Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg are available in green opaque hard gelatin capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 51293-696-01), and 1000 (NDC 51293-696-10) with imprinted "696" on the cap and body of the capsule in black ink. Store 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].
Abbreviated New Drug Application
CHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE ECI Pharmaceuticals LLC ---------- MEDICATION GUIDE Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules (klor dye az e pox' ide) (kli di' nee um) What is the most important information I should know about chlordiazepoxide hydrochloride and clidinium bromide capsules? • Do not stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. Stopping chlordiazepoxide hydrochloride and clidinium bromide capsules suddenly can cause serious side effects. • Taking chlordiazepoxide hydrochloride and clidinium bromide capsules with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. • Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide hydrochloride and clidinium bromide capsules affects you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide hydrochloride and clidinium bromide capsules may make your sleepiness or dizziness much worse. • chlordiazepoxide hydrochloride and clidinium bromide capsules can cause abuse and dependence. • Do not stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules all of a sudden. Stopping chlordiazepoxide hydrochloride and clidinium bromide capsules suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating. • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. What are chlordiazepoxide hydrochloride and clidinium bromid Read the complete document
CHLORDIAZEPOXIDE HYDROCHLORIDE/CLIDINIUM BROMIDE- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE ECI PHARMACEUTICALS LLC ---------- CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES USP, 5 MG/2.5 MG WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH (SEE WARNINGS AND PRECAUTIONS). RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. DESCRIPTION Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin. The imprinting ink contains ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide hydrochloride is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4- benzodiazepine 2-oxide monohydrochloride. A white to slightly yellow, crystalline powder, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.2. The structural formula of chlordiazepoxide Read the complete document