Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: 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. Final classification of the less-than-effective indications requires further investigation.

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Advisory information

contraindications
CONTRAINDICATIONS Chlordiazepoxide HCl 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.
Special warnings and precautions
PRECAUTIONS In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide HCl and Clidinium Bromide Capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed – particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used. The usual precautions in treating patients with impaired renal or hepatic function should be observed. Paradoxical reactions to Chlordiazepoxide Hydrochloride, eg, excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide HCl and Clidinium Bromide therapy. The usual precautions are indicated when Chlordiazepoxide Hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary. Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and Chlordiazepoxide Hydrochloride. Information for Patients To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. Pediatric Use Safety and effectiveness in pediatric patients has not been established. Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide HCl and Clidinium Bromide Capsules. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see DOSAGE AND ADMINISTRATION). Chlordiazepoxide HCl and Clidinium Bromide Capsules are contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS).
Adverse reactions
ADVERSE REACTIONS No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide HCl and Clidinium Bromide Capsules. However, since Chlordiazepoxide HCl and Clidinium Bromide Capsules contain Chlordiazepoxide Hydrochloride and Clidinium Bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When Chlordiazepoxide Hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients – particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported. Other adverse reactions reported during therapy with Chlordiazepoxide Hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Chlordiazepoxide Hydrochloride treatment. Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with Chlordiazepoxide Hydrochloride. When Chlordiazepoxide Hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable. Adverse effects reported with use of Chlordiazepoxide HCl and Clidinium Bromide Capsules are those typical of anticholinergic agents, ie, dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Chlordiazepoxide HCl and Clidinium Bromide Capsules therapy has been combined with other spasmolytic agents and/or a low residue diet.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide HCl and Clidinium Bromide Capsules varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules orally, 3 or 4 times a day administered before meals and at bedtime. Geriatric Dosing Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Chlordiazepoxide HCl and Clidinium Bromide Capsules per day, to be increased gradually as needed and tolerated.

More information

Category Value
Agency product number 91ZQW5JF1Z
Orphan designation No
Product NDC 51293-607
Date Last Revised 29-12-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 889614
Storage and handling 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]. Dispense in a tight, light-resistant container as defined in the USP/NF. Keep this and all medication out of the reach of children.
Marketing authorisation holder ECI Pharmaceuticals, LLC
Warnings INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows: "Possibly" effective: 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. Final classification of the less-than-effective indications requires further investigation.