Etrafon (Perphenazine and Amitriptyline)

ETRAFONĀ® Preparations

Schering

Amitriptyline HCl – Perphenazine

Antidepressant – Antipsychotic

Indications And Clinical Uses: The treatment of patients with anxious or agitated depression. Particularly indicated in patients with depression associated with marked psychomotor unrest and anxiety. Etrafon has also been used in some schizophrenic patients who have associated symptoms of depression and in depressed patients suffering from marked agitation, anxiety and tension, which may respond to a phenothiazine agent.

Contraindications, Precautions and Adverse Effects: See Trilafon and amitriptyline. Known hypersensitivity to any of its components. Discontinue therapy several days before elective surgery if possible.

Dosage And Administration: In prescribing Etrafon, the recommended indications, management considerations, dosage schedules and attention to tolerance and response that are normal practice in using each of the combined drugs, perphenazine and amitriptyline, should be borne in mind.

Initial Dosage: In ambulatory depressed patients, when anxiety and/or agitation are of such degree as to warrant combined therapy, 1 tablet of Etrafon-D (2-25) or Etrafon-F (4-25) 3 or 4 times daily, depending on the severity of the agitation and anxiety. In the more severely ill patients with schizophrenia and associated symptoms of depression that may benefit from amitriptyline, Etrafon-F (4-25) may be administered in an initial dose of 2 tablets 3 times a day. If necessary, a fourth dose may be given at bedtime. The total daily dose should not exceed 9 tablets.

In elderly patients and adolescents, and other patients as indicated, 1 tablet of Etrafon-A (4-10) or Etrafon 2-10 may be administered 3 or 4 times daily for the initial dosage and then adjusted if required to produce an adequate response.

Maintenance Dosage: Depending on the condition being treated, the onset of therapeutic response may vary 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 Etrafon is being administered.

A useful maintenance dosage is 1 tablet of Etrafon-D (2-25) or Etrafon-F (4-25) 2 to 4 times daily. In some patients, maintenance dosage is required for many months.

Etrafon 2-10 and Etrafon-A (4-10) can be used to increase flexibility in adjusting maintenance dosage to the lowest amount consistent with relief of symptoms.

Availability And Storage: Etrafon (2-10): Each yellow coated tablet imprinted with a black Schering trade mark on one side and the designation 2-10 on the other side contains: perphenazine USP 2 mg and amitriptyline HCl USP 10 mg. Nonmedicinal ingredients: cornstarch; dye, FD & C Yellow No. 6; lactose; magnesium stearate and povidone; coating: carnauba wax; dye, Opalux Yellow; gelatin; sucrose; talc; terra alba; titanium dioxide and white wax. Tartrazine-free. Bottles of 100.

Etrafon-A (4-10): Each orange coated tablet imprinted with a black Schering trade mark on one side and a black letter A on the other side contains: perphenazine USP 4 mg and amitriptyline HCl USP 10 mg. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate and povidone; coating: acacia, calcium phosphate, carnauba wax; FD & C Yellow No. 6; gelatin; sucrose; terra alba; titanium dioxide and white wax. Tartrazine-free. Bottles of 100.

Etrafon-D (2-25): Each pink coated tablet imprinted with a black Schering trade mark on one side and a black letter D on the other side contains: perphenazine USP 2 mg and amitriptyline HCl USP 25 mg. Nonmedicinal ingredients: cornstarch; dye, D & C Yellow No. 10; lactose; magnesium stearate and povidone; coating: calcium sulfate, carnauba wax; dye, Opalux Pink; gelatin; sucrose; talc; titanium dioxide and white wax. Tartrazine-free. Bottles of 100 and 500.

Etrafon-F (4-25): Each red coated tablet imprinted with a black Schering trade mark on one side and a black letter F on the other side contains: perphenazine USP 4 mg and amitriptyline HCl USP 25 mg. Nonmedicinal ingredients: calcium sulfate, charcoal, cornstarch, lactose, magnesium stearate and povidone; coating: carnauba wax; dye, Opalux Red; gelatin; sucrose; talc; titanium dioxide and white wax. Tartrazine-free. Bottles of 100.

ETRAFONĀ® Preparations Schering Amitriptyline HCl – Perphenazine Antidepressant – Antipsychotic

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