Doxepin (As Hydrochloride)
- Doxepin (As Hydrochloride)
- Doxipen®
- Capsules and Oral Powder
- 25mg
- Blister
- 100 Capsule
-
• Depression/Anxiety
Mechanism of Action
Mechanism of action for depression is unknown, may increase CNS synaptic concentrations of serotonin and norepinephrine by inhibiting reuptake
Pharmacokinetics
Peak plasma time: 2 hr
Onset: >2 weeks
Excretion: Urine
Contraindications
• Hypersensitivity
• Untreated narrow-angle glaucoma
• Severe urinary retention
• Within 14 days of MAO inhibitors
Adverse Reactions
Sedation, Fatigue, Weakness, Lethargy, Dry mouth, Constipation, Blurred vision, Headache, Agitation, Insomnia, Anxiety, Nausea, Vomiting, Sweating, Confusion, Extrapyramidal Symptoms (EPS), Dizziness, Paresthesia, Orthostatic hypotension, ECG changes, Tachycardia, Increased LFTs, Tinnitus, Sexual dysfunction, Rash, Seizure, Agranulocytosis, Thrombocytopenia, Eosinophilia, Leukopenia, SIADH
Major Drug Interactions
Disopyramide - Ibutilide - Indapamide - Iobenguane I 123 - Isocarboxazid - Lefamulin - Mavorixafor - Pentamidine - Phenelzine - Pimozide - Procainamide - Procarbazine - Quinidine - Safinamide - Selegiline - Sotalol - Thioridazine - Tranylcypromine
Warnings
• This drug is not approved for use in pediatric patients
Recommendations for Patient
-
Pregnancy Considerations
Available data from published epidemiologic studies and post marketing reports have not established increased risk of major birth defects or miscarriage, there are risks of poor neonatal adaptation with exposure to drug during pregnancy
Breastfeeding Considerations
Because of its sedating potential, active metabolite, presence in infant serum, two reports of adverse effects in breastfed infants, and only one report of use without apparent adverse reactions, doxepin is a poor choice and other agents are preferred, especially while nursing a newborn or preterm infant.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Mechanism of action for depression is unknown, may increase CNS synaptic concentrations of serotonin and norepinephrine by inhibiting reuptake
Pharmacokinetics
Peak plasma time: 2 hr
Onset: >2 weeks
Excretion: Urine
Contraindications
• Hypersensitivity
• Untreated narrow-angle glaucoma
• Severe urinary retention
• Within 14 days of MAO inhibitors
Adverse Reactions
Sedation, Fatigue, Weakness, Lethargy, Dry mouth, Constipation, Blurred vision, Headache, Agitation, Insomnia, Anxiety, Nausea, Vomiting, Sweating, Confusion, Extrapyramidal Symptoms (EPS), Dizziness, Paresthesia, Orthostatic hypotension, ECG changes, Tachycardia, Increased LFTs, Tinnitus, Sexual dysfunction, Rash, Seizure, Agranulocytosis, Thrombocytopenia, Eosinophilia, Leukopenia, SIADH
Major Drug Interactions
Disopyramide - Ibutilide - Indapamide - Iobenguane I 123 - Isocarboxazid - Lefamulin - Mavorixafor - Pentamidine - Phenelzine - Pimozide - Procainamide - Procarbazine - Quinidine - Safinamide - Selegiline - Sotalol - Thioridazine - Tranylcypromine
Warnings
• This drug is not approved for use in pediatric patients
Recommendations for Patient
-
Pregnancy Considerations
Available data from published epidemiologic studies and post marketing reports have not established increased risk of major birth defects or miscarriage, there are risks of poor neonatal adaptation with exposure to drug during pregnancy
Breastfeeding Considerations
Because of its sedating potential, active metabolite, presence in infant serum, two reports of adverse effects in breastfed infants, and only one report of use without apparent adverse reactions, doxepin is a poor choice and other agents are preferred, especially while nursing a newborn or preterm infant.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
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