Amitriptyline (As Hydrochloride)
- Amitriptyline (As Hydrochloride)
- No Brand Name
- Tablet
- 25mg
- Blister
- 100 Tablets
-
• Depression
Mechanism of Action
Neurotransmitter (especially norepinephrine and serotonin) reuptake inhibitor, anticholinergic
Pharmacokinetics
Peak serum time: 4 hr
Excretion: Urine (18%), small amounts in feces
Contraindications
• Hypersensitivity
• Acute recovery phase following MI
• Concurrent use with Cisapride
• Contraindicated within 14 days of MAOIs
Adverse Reactions
Agitation, Agranulocytosis, Alopecia, Anxiety, Anorexia, Ataxia, Arrhythmia, Blurred vision, Coma, Confusion, Constipation, Diarrhea, Dizziness, Dry mouth, ECG changes, Eosinophilia, Extrapyramidal symptoms (EPS), Fatigue, Hallucination, Headache, Hypertension, Increased LFTs, Insomnia, Lethargy, Leukopenia, MI, Nausea, Ocular pressure increased, Orthostatic hypotension, Palpitation, Paresthesia, Photosensitivity, Rash, Restlessness, Sedation, Seizure, Sexual dysfunction, SIADH, Stroke, Stomatitis, Syncope, Sweating, Tachycardia, Thrombocytopenia, Tinnitus, Urinary retention, Urticaria, Vomiting, Xerostomia, Weakness, Weight gain
Major Drug Interactions
Disopyramide - Dronedarone - Ibutilide - Indapamide - Iobenguane I 123 - Isocarboxazid - Mavorixafor - Pentamidine - Phenelzine - Pimozide - Procainamide - Procarbazine - Quinidine - Safinamide - Selegiline - Sotalol - Tranylcypromine
Warnings
• This drug is not approved for use in pediatric patients <12 years
• Not FDA approved for treatment of bipolar depression
Recommendations for Patient
-
Pregnancy Considerations
Category: C
Breastfeeding Considerations
Milk levels of Amitriptyline and its metabolites are low. Amitriptyline use during breastfeeding would usually not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.
Other agents with fewer active metabolites may be preferred when large doses are required or while nursing a newborn or preterm infant.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe 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.
Neurotransmitter (especially norepinephrine and serotonin) reuptake inhibitor, anticholinergic
Pharmacokinetics
Peak serum time: 4 hr
Excretion: Urine (18%), small amounts in feces
Contraindications
• Hypersensitivity
• Acute recovery phase following MI
• Concurrent use with Cisapride
• Contraindicated within 14 days of MAOIs
Adverse Reactions
Agitation, Agranulocytosis, Alopecia, Anxiety, Anorexia, Ataxia, Arrhythmia, Blurred vision, Coma, Confusion, Constipation, Diarrhea, Dizziness, Dry mouth, ECG changes, Eosinophilia, Extrapyramidal symptoms (EPS), Fatigue, Hallucination, Headache, Hypertension, Increased LFTs, Insomnia, Lethargy, Leukopenia, MI, Nausea, Ocular pressure increased, Orthostatic hypotension, Palpitation, Paresthesia, Photosensitivity, Rash, Restlessness, Sedation, Seizure, Sexual dysfunction, SIADH, Stroke, Stomatitis, Syncope, Sweating, Tachycardia, Thrombocytopenia, Tinnitus, Urinary retention, Urticaria, Vomiting, Xerostomia, Weakness, Weight gain
Major Drug Interactions
Disopyramide - Dronedarone - Ibutilide - Indapamide - Iobenguane I 123 - Isocarboxazid - Mavorixafor - Pentamidine - Phenelzine - Pimozide - Procainamide - Procarbazine - Quinidine - Safinamide - Selegiline - Sotalol - Tranylcypromine
Warnings
• This drug is not approved for use in pediatric patients <12 years
• Not FDA approved for treatment of bipolar depression
Recommendations for Patient
-
Pregnancy Considerations
Category: C
Breastfeeding Considerations
Milk levels of Amitriptyline and its metabolites are low. Amitriptyline use during breastfeeding would usually not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.
Other agents with fewer active metabolites may be preferred when large doses are required or while nursing a newborn or preterm infant.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe 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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