Drug Catalog - Product Detail
DOXEPIN HCL CAP 75 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0220-01 | PAR PHARMACEUTICAL | 100 | 75MG | CAPSULE |
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Description
DESCRIPTION Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO•HCl having a molecular weight of 315.84. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. Its structural formula is: C 19 H 21 NO●HCl MW: 315.84 Chemically,Doxepin HCl is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6 H )ylidene- N,N -dimethyl-hydrochloride. Each doxepin hydrochloride capsule is equivalent to 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin for oral administration. Each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, magnesium stearate, pharmaceutical glaze, sodium lauryl sulfate, synthetic black iron oxide, titanium dioxide and other ingredients. In addition, the 10 mg capsule contains FD&C Yellow #6; the 25 mg and 50 mg capsules contain FD&C Yellow #6 and propylene glycol; the 75 mg capsule contains FD&C Green #3 and propylene glycol, and the 100 mg capsule contains FD&C Green #3. This is the chemical structure
How Supplied
HOW SUPPLIED Doxepin HCl capsules USP, equivalent to 10 mg of doxepin are hard gelatin capsules with buff opaque body and buff opaque cap, imprinted “Par 217” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-217-01). Doxepin HCl capsules USP, equivalent to 25 mg of doxepin are hard gelatin capsules with white opaque body and ivory opaque cap, imprinted “Par 218” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-218-01). Doxepin HCl capsules USP, equivalent to 50 mg of doxepin are hard gelatin capsules with ivory opaque body and ivory opaque cap, imprinted “Par 219” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-219-01). Doxepin HCl capsules USP, equivalent to 75 mg of doxepin are hard gelatin capsules with bright light green opaque body and bright light green opaque cap, imprinted “Par 220” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-220-01). Doxepin HCl capsules USP, equivalent to 100 mg of doxepin are hard gelatin capsules with white opaque body and bright light green opaque cap, imprinted “Par 221” on both body and cap. They are supplied in bottles of 100 (NDC # 49884-221-01). Doxepin HCl capsules USP, equivalent to 150 mg of doxepin are buff opaque/buff opaque capsules, imprinted “Par 222” on both body and cap. They are supplied in bottles of 50 (NDC # 49884-222-03), 100 (NDC # 49884-222-01), and 500 (NDC # 49884-222-05). All sizes of 100’s or less are packaged with a child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]
Indications & Usage
INDICATIONS AND USAGE Doxepin HCl is recommended for the treatment of: •Psychoneurotic patients with depression and/or anxiety. •Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). •Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). •Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin HCl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin HCl is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin HCl is not recommended for use in children under 12 years of age.
Dosage and Administration
DOSAGE AND ADMINISTRATION For most patients with illness of mild to moderate severity, a starting daily dose of 75 mg is recommended. Dosage may subsequently be increased or decreased at appropriate intervals and according to individual response. The usual optimum dose range is 75 mg/day to 150 mg/day. In more severely ill patients higher doses may be required with subsequent gradual increase to 300 mg/day if necessary. Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg/day. In patients with very mild symptomatology or emotional symptoms accompanying organic disease, lower doses may suffice. Some of these patients have been controlled on doses as low as 25 to 50 mg/day. The total daily dosage of doxepin HCl may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment. Anti-anxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for two to three weeks.