Chlordiazepoxide and Amitriptyline (Chlordiazepoxide / Amitriptyline Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Chlordiazepoxide and amitriptyline hydrochloride is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone.

Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.

DOSAGE AND ADMINISTRATION

Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients.

Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP 10 mg/25 mg are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily.

Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP 5 mg/12.5 mg in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses.

HOW SUPPLIED

Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP are available containing 5 mg of chlordiazepoxide, and 12.5 mg of amitriptyline (as the hydrochloride salt) or 10 mg of chlordiazepoxide, and 25 mg of amitriptyline (as the hydrochloride salt).

The 5 mg/12.5 mg tablets are green film-coated, round tablets debossed with MYLAN on one side of the tablet and 211 on the other side. They are available as follows:

NDC 0378-0211-01
bottles of 100 tablets

NDC 0378-0211-05
bottles of 500 tablets

The 10 mg/25 mg tablets are white film-coated, round tablets debossed with MYLAN on one side of the tablet and 277 on the other side. They are available as follows:

NDC 0378-0277-01
bottles of 100 tablets

NDC 0378-0277-05
bottles of 500 tablets

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Dispense a Medication Guide with each prescription.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED AUGUST 2007
CDAM:R12mc