Drug Catalog - Product Detail
Doxepin HCl Conc 10 MG/ML 120 ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 54838-0512-40 | LANNETT | 120 | 10MG/ML | LIQUID |
PACKAGE FILES
Generic Name
DOXEPIN HYDROCHLORIDE
Substance Name
DOXEPIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA074721
Description
11 DESCRIPTION Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C 19 H 21 NO·HCl with a molecular weight of 315.84. It is a white crystalline solid soluble in water, lower alcohols and chloroform. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride. The structural formula of doxepin is shown below. doxepin hydrochloride Doxepin Hydrochloride Oral Solution USP is available as a concentrate for oral administration containing doxepin hydrochloride equivalent to 10 mg of doxepin per mL. It also contains the following inactive ingredients: glycerin; methylparaben; peppermint flavor; propylparaben; water. May contain hydrochloric acid and/or sodium hydroxide. doxepin hydrochloride
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxepin Hydrochloride Oral Solution USP (Concentrate). Each mL of oral solution contains 10 mg of doxepin as a clear, colorless solution and is supplied in 120 mL bottles (NDC 54838-512-40) with an accompanying dropper calibrated at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Store Doxepin Hydrochloride Oral Solution USP at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Doxepin hydrochloride is indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with doxepin hydrochloride, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 ) Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. ( 2.2 ) Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). ( 2.2 ) Maximum recommended dosage is 100 mg three times daily. ( 2.2 ) Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride. ( 2.3 ) See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers. ( 2.4 , 2.5 , 2.6 ) When discontinuing doxepin hydrochloride, gradually reduce the dosage until discontinued. ( 2.7 ) See Full Prescribing Information for recommended preparation instructions for the oral solution. ( 2.8 ) 2.1 Screen for Bipolar Disorder Prior to Starting Doxepin Hydrochloride Prior to initiating treatment with doxepin hydrochloride, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] . 2.2 Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride is 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). The maximum recommended oral dosage for doxepin hydrochloride is 100 mg three times daily. 2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7 )] . Wait at least 14 days after discontinuation of doxepin hydrochloride before initiating therapy with an MAOI [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7 )] . 2.4 Dosage Modifications Intended to Reduce the Risk of Anticholinergic Effects If anticholinergic effects (e.g., dry mouth, blurred vision, constipation) develop, reduce the doxepin hydrochloride dosage [see Adverse Reactions ( 6.1 )] . 2.5 Dosage Modifications for Strong CYP2D6 Inhibitors Reduce the doxepin hydrochloride dosage based on doxepin plasma concentrations when used concomitantly with strong CYP2D6 inhibitors [see Drug Interactions ( 7 )] . 2.6 Dosage Modifications in Known CYP2D6 and CYP2C19 Poor Metabolizers Reduce the doxepin hydrochloride dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poor metabolizers [see Use in Specific Populations ( 8.7 )] . 2.7 Discontinuation of Doxepin Hydrochloride Treatment When discontinuing doxepin hydrochloride, gradually reduce the dosage until discontinued [see Adverse Reactions ( 6 )] . 2.8 Preparation of Doxepin Hydrochloride Oral Solution Recommended preparation instructions for the Doxepin Hydrochloride Oral Solution are as follows: Use the supplied calibrated dropper to measure the amount of Doxepin Hydrochloride Oral Solution needed. The calibrated dropper has markings at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Just prior to administration, mix doxepin hydrochloride with 120 mL of water, whole or skimmed milk, or orange, grapefruit, tomato, prune, or pineapple juice. Do not mix with other liquids. Administer the dose immediately after mixing.