CHLORDIAZEPOXIDE HYDROCHLORIDE and CLIDINIUM BROMIDE

Golden State Medical Supply, Inc.

Chlordiazepoxide HCI and Clidinium Br Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• Rx Only
• 1  CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE INDICATIONS AND USAGE:
• 2  CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE DOSAGE AND ADMINISTRATION:
• 4  CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CONTRAINDICATIONS:
• 5 WARNINGS AND PRECAUTIONS:
• 6 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE ADVERSE REACTIONS:
• 8  USE IN SPECIFIC POPULATIONS:
• 8.1  Pregnancy:
• 8.2  Nursing Mothers:
• 8.3  Pediatric Use:
• 8.4 Geriatric Use:
• 10  OVERDOSAGE:
• 10.1 Signs and symptoms
• 10.2 Treatment
• 11  CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE DESCRIPTION:
• 12  CLINICAL PHARMACOLOGY:
• 16  HOW SUPPLIED:
• 17  INFORMATION FOR PATIENTS:
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Rx Only

CONTENTS AND FULL PRESCRIBING INFORMATION (FPI)

• BOXED WARNING
• 1 INDICATIONS and USAGE
• 2 DOSAGE and ADMINISTRATION
• 3 DOSAGE FORMS and STRENGTHS
• 4 CONTRAINDICATIONS
• 5 WARNINGS and PRECAUTIONS
• 6 ADVERSE REACTIONS
• 7 DRUG INTERACTIONS
• 8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Nursing mothers

8.3 Pediatric use

8.4 Geriatric use

• 9 DRUG ABUSE and DEPENDENCE
• 10 OVERDOSAGE

10.1 Signs and symptoms

10.2 Treatment

• 11 DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
• 14 CLINICAL STUDIES
• 15 REFERENCES
• 16 HOW SUPPLIED/STORAGE and HANDLING
• 17 PATIENT COUNSELING INFORMATION
  

1  INDICATIONS AND USAGE:

The FDA has classified this drug as "possibly" effective for the following indications: For use as adjunctive therapy in the treatment of Irritable bowel syndrome (Irritable colon, spastic colon, mucous colitis) and acute enterocolitis .
Final classification of the less-than-effective indications requires further investigation.

2  DOSAGE AND ADMINISTRATION:

An individualized dosage of Chlordiazepoxide HCI and Clidinium Br Capsules should be made to achieve the most beneficial results. The usual maintenance dose is one (1) or two (20 capsules, three (3) or four (4) times a day, administered before meals and at bedtime.
Geriatric Dosing: Dosage should be limited to the smallest effective amount to minimize CNS effect and to preclude the development of ataxia, excessive sedation or confusion. The initial dose should not exceed two (2) Chlordiazepoxide HCI and Clidinium Br Capsules per day, to be increased gradually as needed and/or tolerated.

4  CONTRAINDICATIONS:

Chlordiazepoxide HCI and Clidinium Br Capsules are contraindicated in patients with glaucoma, prostatic hypertrophy and/or benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.

5 WARNINGS AND PRECAUTIONS:

Chlordiazepoxide HCI and Clidinium Br Capsules may produce drowsiness and blurred vision. The patient should be warned about in engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery.

Use caution when prescribing Chlordiazepoxide HCI and Clidinium Br Capsules concurrently with psychotropic agents, especially those that include MAD inhibitors and phenothiazines. Patients with impaired renal or hepatic function should be observed, along with patients being treated for anxiety or depression. Paradoxical reactions to chlordiazepoxide hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be considered during Chlordiazepoxide HCI and Clidinium Br Capsules therapy.

6 ADVERSE REACTIONS:

When chlordiazepoxide hydrochloride has been used alone, drowsiness, ataxia and confusion have been reported in some patients, particularly the elderly and debilitated. These effects can be avoided in almost all instances by adjusting the dosage, and have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported. Also reported are isolated instances of skin eruptions, edema, nausea and constipation, extrapyramidal symptoms, minor menstrual irregularities, 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 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.

Typical of anticholinergic agents, adverse effects reported with use of Chlordiazepoxide HCI and Clidinium Br Capsules may include dry mouth, blurred vision, urinary hesitancy and constipation. Constipation occurred most often when combined with other spasmolytic agents and/or a restrictive, low residue diet.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

8  USE IN SPECIFIC POPULATIONS:

8.1  Pregnancy:

Several studies suggest an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy. Use during the first trimester should almost always be avoided unless indicataed by their prescribing physician. Patients should be advised to communicate with their physicians if they are pregnant, become pregnant during therapy or intend to become pregnant.

8.2  Nursing Mothers:

Lactation may be inhibited, as with all anticholinergic drugs. Patients should be advised to consider the importance of the drug against the known benefits of breastfeeding.

8.3  Pediatric Use:

Safety and effectiveness in pediatric patients have not been established

8.4 Geriatric Use:

Elderly subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide HCI and Clidinium Br Capsules. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. (See DOSAGE AND ADMINISTRATION).

10  OVERDOSAGE:

10.1 Signs and symptoms

The symptoms of overdosage of clidinium bromide are excessive dry mouth, blurred vision, urinary hesitancy and constipation, which are caused by by the anticholinergic actions.

10.2 Treatment

Chlordiazepoxide hydrochloride overdosage symptoms include: drowsiness, confusion, coma and diminshed reflexes.  Call your doctor or local Poison Control Center if overdosage is suspected.

11  DESCRIPTION:

Chlordiazepoxide HCI and Clidinium Br Capsules is a single capsule formulation that includes the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide.

Chlordiazepoxide HCI and Clidinium Br Capsules contain 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide, along with lactose, starch, talc, titanium dioxide, FD&C yellow #5 and FD&C yellow #6.

12  CLINICAL PHARMACOLOGY:

Chlordiazepoxide hydrochloride is prescribed for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile.

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.

Clidinium bromide is a synthetic anticholinergic agent that has antispasmodic and antisecretory effect on the gastrointestinal tract.

16  HOW SUPPLIED:

Chlordiazepoxide HCI and Clidinium Br Capsules, NDC# 60429-189-01, are available as light green capsules in bottles of 100. Each light green capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide and is imprinted with ASC 186.

17  INFORMATION FOR PATIENTS:

To assure the safe and effective use of benzodiazepines, patients should be informed that because 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.

Manufactured by: ASCEND Laboratories, LLC, Montvale, NJ 07645

Marketed/Packaged by: GSMS Inc., Camarillo, CA 93012

PL409

PRINCIPAL DISPLAY PANEL

NDC 60429-189-01
100 Capsules

Chlordiazepoxide HC and Clidinium Br Capsules

Each capsule contains:

Chlordiazepoxide Hydrochloride ...................... 5 mg

Clidinium Bromide ..............2.5 mg

Rx ONLY