Chlordiazepoxide Hydrochloride And Clidinium Bromide

Acella Pharmaceuticals, LLC

Chlordiazepoxide Hydrochloride And Clidinium Bromide

FULL PRESCRIBING INFORMATION: CONTENTS*

• 1. CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE INDICATIONS AND USAGE
• 2. CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE DOSAGE AND ADMINISTRATION
• 3. CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CONTRAINDICATIONS
• 4. WARNINGS AND PRECAUTIONS
• 5. CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE ADVERSE REACTIONS
• 6. USE IN SPECIFIC POPULATIONS 6.1 Pregnancy
• 6.2 Nursing Mothers
• 6.3 Pediatric Use
• 6.4 Geriatric Use
• 7. OVERDOSAGE 7.1 Signs and symptoms 7.2 Treatment
• 8. CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE DESCRIPTION
• 9. CLINICAL PHARMACOLOGY
• 10. HOW SUPPLIED
• 11. INFORMATION FOR PATIENTS

FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

The FDA has classified this drug as 'possibly' effective for the following indications: For use as adjunctive bowel syndrome (irritable colon, spestic colon, mucous colitish) and acute enterocolltis. Final classification of the less-than-effective indications requires further investigation.

2. DOSAGE AND ADMINISTRATION

An individualized dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules should be made to achieve the most beneficial results. The usual maintenence dose in one (1) or two (2) capsules, three (3) or four (4) times a day, administered before meals and at bedtime.   Geriatric Dosing: Dosage should be irrited to the smallest effective amount to minimize CNS effect and to preclude the develpoment of ataxia, excessive seciation or confusion. The intial dose should not exceed two (2)  Chlordiazpoxide Hydrochloride and Clidinium Bromide Capsules per day, to be increased gradually as needed and/or tolerated.

3. CONTRAINDICATIONS

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is contraindicated in patients with glaucoma, prostatic hypertrophy and/or benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Chloriazepoxide hydrochloride and/or Clidnium bromide.

4. WARNINGS AND PRECAUTIONS

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery.  Use caution when prescribing Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules concurrently with psychotropic agents, especially those that include MAQ exhibitors 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 Hydrochloride and clidinium Bromide Capsule therapy.

5. 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 adjsuting 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 agranulocytosia, 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 Hydrochloride and Clidinium Bromide Capsules may include dry mouth, blurred vision, urinary hesitancy and constipation. Constipation has occured 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 suspected side effects to the FDA at 1-800-FDA-1088.

6. USE IN SPECIFIC POPULATIONS 6.1 Pregnancy

Several studies suggest an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazeparn and meprobamate) during the first trimester of pregnancy. Use during the first trimerster should almost always be avoided unless indicated by their prescribing physician. The possibility that a women of childbearing potential may be pregnant at the time of institution of therapy should be consideded. Patients should communicate with their physicians if they are pregant, become pregnant during therapy or intend to become pregnant.

6.2 Nursing Mothers

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

6.3 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.4 Geriatric Use

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

7. OVERDOSAGE 7.1 Signs and symptoms 7.2 Treatment

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

Treatment:  Chlordiazepoxide hydrochloride overdosage symptoms include drowsiness, confusion, coma and diminished reflexes. Call your doctor or local poison control center if oversdosage is suspected.

8. DESCRIPTION

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is a single capsule formulation that includes the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide.  Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule contains 5 mg Chlordiazepoxide Hydrochloride and 2.5 mg clidinium bromide, along with lactose, pre-gelatinized starch, talc, titanium dioxide, and Black Ink SB-9041 (Shellac, Propylene Glycol, FDandC Blue #1 Aluminum Lake, FDandC Yellow #6 Aluminum Lake, FDandC Red #40 Aluminum Lake).

9. 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.

10. HOW SUPPLIED

Chlordiazepoxide Hydrochloride And Clidinium Bromide Capsules, NDC# 42192-336-01, is available as white capsules in bottles of 100. Each white capsule contains 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide.  Manufactured by:  Winder Laboratories, LLC  Winder, GA 30680 USA   Rev. 0411V1  Manufactured for: Acella Pharmaceuticals, LLC  Alpharetta, GA 30004 USA.

11. INFORMATION FOR PATIENTS

To ensure the safe and effective use of benzodlazeplnes, 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.  All prescription substitutions and/or recommedations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients excipients, inactive ingredients and chemical information provided herein.

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules  Rx Only  NDC# 42192-336-01

NDC 42192-336-01  Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules  Each capsule contains:  Chlordiazepoxide Hydrochloride, USP.....................................5 mg
                Clidinium Bromide, USP........................................................2.5 mg

Rx Only                                                                                                           100 Capsules

                                         Acella PHARMACEUTICALS, LLC

SEE LABEL FOLDOUT FOR FULL PRESCRIBING INFORMATION.  Tamper-evident seal under cap. Do not use if there is evidence of tampering.  Store at 25 degree C (77 degree F); excursion permitted to 15 degree - 30 degree C (59 degree - 86 degree F).  KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.  PHARMACIST: Preserve and dispense in a tight light-resistant container as defined in the USP/NF.   Manufactured by:  Winder Laboratories, LLC  Winder, GA 30680 USA   Manufactured for: Acella Pharmaceuticals, LLC  Alpharetta, GA 30004 USA.  3 42192  33601  8   NDC 42192-336-01  Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules  Each capsule contains:  Chlordiazepoxide Hydrochloride, USP.....................................5 mg   Clidinium Bromide, USP........................................................2.5 mg  Rx Only  100 Capsules  Acella PHARMACEUTICALS, LLC