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

INDICATIONS AND USAGE

Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate.

Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.

DOSAGE AND ADMINISTRATION

Since dosage for children has not been established, this product is not recommended for use in children.

The total daily dose of perphenazine and amitriptyline hydrochloride tablets should not exceed 16 mg of perphenazine and 200 mg of amitriptyline hydrochloride.

Initial Dosage

In psychoneurotic patients when anxiety and depression are of such a degree as to warrant combined therapy, one tablet of the 2 mg/25 mg or 4 mg/25 mg three or four times a day or one tablet of the 4 mg/50 mg combination twice a day is recommended.

In more severely ill patients with schizophrenia, the 4 mg/25 mg combination is recommended in an initial dose of two tablets three times a day. If necessary, a fourth dose may be given at bedtime.

In elderly patients and adolescents, and some other patients in whom anxiety tends to predominate, perphenazine and amitriptyline hydrochloride tablet 4 mg/10 mg combination may be administered three or four times a day initially, then adjusted as required for subsequent adequate therapy.

Maintenance Dosage

Depending on the condition being treated, therapeutic response may take from a few days to a few weeks or even longer. After a satisfactory response is noted, dosage should be reduced to the smallest amount necessary to obtain relief from the symptoms for which this product is being administered. A useful maintenance dosage is one tablet of the 2 mg/25 mg or 4 mg/25 mg combination two to four times a day or one tablet of the 4 mg/50 mg combination twice a day. Perphenazine and amitriptyline hydrochloride tablets, 2 mg/10 mg and 4 mg/10 mg can be used to increase flexibility in adjusting maintenance dosage to the lowest amount consistent with relief of symptoms. In some patients, maintenance dosage is required for many months.

HOW SUPPLIED

Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:

DOSAGE FORM

ACTIVE INGREDIENT
	2 mg/10 mg
Perphenazine, USP	2
Amitriptyline hydrochloride, USP	10
	2 mg/ 25 mg
Perphenazine, USP	2
Amitriptyline hydrochloride, USP	25
	4 mg/10 mg
Perphenazine, USP	4
Amitriptyline hydrochloride, USP	10
	4 mg/25 mg
Perphenazine, USP	4
Amitriptyline hydrochloride, USP	25
	4 mg/50 mg
Perphenazine, USP	4
Amitriptyline hydrochloride, USP	50

The 2 mg/10 mg combination tablets are white film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 330 on the other side. They are available as follows:

NDC 0378-0330-01
bottles of 100 tablets

NDC 0378-0330-05
bottles of 500 tablets

The 2 mg/25 mg combination tablets are purple film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 442 on the other side. They are available as follows:

NDC 0378-0442-01
bottles of 100 tablets

NDC 0378-0442-05
bottles of 500 tablets

The 4 mg/10 mg combination tablets are blue film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 727 on the other side. They are available as follows:

NDC 0378-0042-01
bottles of 100 tablets

The 4 mg/25 mg combination tablets are orange film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 574 on the other side. They are available as follows:

NDC 0378-0574-01
bottles of 100 tablets

NDC 0378-0574-05
bottles of 500 tablets

The 4 mg/50 mg combination tablets are purple film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 73 on the other side. They are available as follows:

NDC 0378-0073-01
bottles of 100 tablets

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

Protect from light.

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.

* Poisindex Toxicologic Management. Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED JULY 2014
PRAT:R17mc