Doxepin Hydrochloride
Generic: DOXEPIN HYDROCHLORIDE
Basic Information
Manufacturer
NorthStar RxLLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
03cef3a6-a63d-4082-a491-451b24227d9d
Indications & Usage
1 INDICATIONS AND USAGE Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.
Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.
Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Angle-Closure Glaucoma [see Warnings and Precautions (5.3)] Sedation and Driving Risks [see Warnings and Precautions (5.4)] Activation of Mania or Hypomania [see Warnings and Precautions (5.5)] Risk of Seizures [see Warnings and Precautions (5.6)] Psychosis [see Warnings and Precautions (5.7)] To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.
To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions (≥ 2% of doxepin hydrochloride -treated patients) in 1,635 doxepin hydrochloride -treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%).
Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were: .
Ear and Labyrinth Disorders : Tinnitus.
Gastrointestinal Disorders : Diarrhea, dyspepsia, vomiting.
General Disorders and Administration Site Conditions : Asthenia, edema, chills.
Metabolism and Nutrition Disorders : Decreased appetite.
Nervous System Disorders : Ataxia, paresthesia, headache, extrapyramidal disorder.
Psychiatric Disorders : Agitation, confusional state, libido decreased.
Pulmonary Disorders : Asthma exacerbation.
Renal and Urinary Disorders : Urinary retention.
Reproductive System and Breast Disorders : Breast enlargement.
Skin & Subcutaneous Tissue Disorders : Rash, pruritus.
Vascular Disorders : Flushing.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders : Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.
Cardiac Disorders : Conduction disorder, arrhythmia.
Endocrine Disorders : Inappropriate antidiuretic hormone secretion.
Eye Disorders : Angle-closure glaucoma, mydriasis.
Gastrointestinal Disorders : Aphthous stomatitis, abdominal pain upper.
General Disorders and Administration Site Conditions : Facial edema, hyperpyrexia.
Hepatobiliary Disorders : Jaundice.
Investigations : Blood glucose increased.
Nervous System Disorders : Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome.
Psychiatric Disorders : Hallucination, disorientation.
Reproductive System and Breast Disorders : Testicular swelling, gynecomastia, galactorrhea.
Skin and Subcutaneous Tissue Disorders : Photosensitivity reaction, tongue edema, alopecia, urticaria.
Vascular Disorders : Hypertension.
Withdrawal syndrome occurred after stopping doxepin hydrochloride [see Drug Abuse and Dependence (9.3)].
The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.
Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.
To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions (≥ 2% of doxepin hydrochloride -treated patients) in 1,635 doxepin hydrochloride -treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%).
Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were: .
Ear and Labyrinth Disorders : Tinnitus.
Gastrointestinal Disorders : Diarrhea, dyspepsia, vomiting.
General Disorders and Administration Site Conditions : Asthenia, edema, chills.
Metabolism and Nutrition Disorders : Decreased appetite.
Nervous System Disorders : Ataxia, paresthesia, headache, extrapyramidal disorder.
Psychiatric Disorders : Agitation, confusional state, libido decreased.
Pulmonary Disorders : Asthma exacerbation.
Renal and Urinary Disorders : Urinary retention.
Reproductive System and Breast Disorders : Breast enlargement.
Skin & Subcutaneous Tissue Disorders : Rash, pruritus.
Vascular Disorders : Flushing.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders : Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.
Cardiac Disorders : Conduction disorder, arrhythmia.
Endocrine Disorders : Inappropriate antidiuretic hormone secretion.
Eye Disorders : Angle-closure glaucoma, mydriasis.
Gastrointestinal Disorders : Aphthous stomatitis, abdominal pain upper.
General Disorders and Administration Site Conditions : Facial edema, hyperpyrexia.
Hepatobiliary Disorders : Jaundice.
Investigations : Blood glucose increased.
Nervous System Disorders : Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome.
Psychiatric Disorders : Hallucination, disorientation.
Reproductive System and Breast Disorders : Testicular swelling, gynecomastia, galactorrhea.
Skin and Subcutaneous Tissue Disorders : Photosensitivity reaction, tongue edema, alopecia, urticaria.
Vascular Disorders : Hypertension.
Withdrawal syndrome occurred after stopping doxepin hydrochloride [see Drug Abuse and Dependence (9.3)].
The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.