DOXEPIN HYDROCHLORIDE
Generic: DOXEPIN HYDROCHLORIDE
Basic Information
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
89ed6385-cf6a-458e-81ea-c7f3fead41c5
Indications & Usage
1 INDICATIONS AND USAGE Doxepin hydrochloride capsules is indicated for the treatment of major depressive disorder (MDD) in adults.
• Doxepin hydrochloride capsules are tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.
• Doxepin hydrochloride capsules are 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)] • Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.
(6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG(3784) 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 capsules -treated patients) in 1,635 doxepin hydrochloride capsules -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 capsules 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 capsules.
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 capsules [see Drug Abuse and Dependence (9.3)].
The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.
(6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG(3784) 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 capsules -treated patients) in 1,635 doxepin hydrochloride capsules -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 capsules 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 capsules.
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 capsules [see Drug Abuse and Dependence (9.3)].
The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.