Get your patient on Chlordiazepoxide Hydrochloride And Clidinium Bromide - Chlordiazepoxide Hydrochloride And Clidinium Bromide capsule (Chlordiazepoxide Hydrochloride And Clidinium Bromide)

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.

Recommended Dosage

Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules vary 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, 3 or 4 times a day administered before meals and at bedtime.

Recommended Geriatric Dosage

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 Hydrochloride and Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (see PRECAUTIONS ).

Discontinuation or Dosage Reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS and DRUG ABUSE AND DEPENDENCE ).

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.

No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. However, since Chlordiazepoxide Hydrochloride 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 Hydrochloride and Clidinium Bromide Capsules are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation. Constipation has occurred most often when Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules therapy has been combined with other spasmolytic agents and/or a low residue diet.

To report SUSPECTED ADVERSE REACTIONS, contact Sunrise Pharmaceutical, Inc. at 732-382-6085 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Opioids

The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.

Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules and opioids, and follow patients closely for respiratory depression and sedation.

Oral Anticoagulants

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, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules.

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic.

Each Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule 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, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin.

Chlordiazepoxide hydrochloride is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A colorless, crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows:

Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is:

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are available in light green opaque cap and light green opaque body containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, in bottle of 100 (NDC 11534-197-01), with black imprint “N36” on both the cap and body.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Keep out of reach of children.
Dispense in a tight, light-resistant container as defined in USP/NF.

Manufactured by:
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065

5355/00

Rev. 07/2021