Conditions Treated

Abdominal Pain or Discomfort

• • By Mouth (Adults): Initially 5–10 mg daily at night, increased in steps of 10 mg at least every 2 weeks as required; maximum 30 mg per day.

Major Depressive Disorder

• • By Mouth (Adults): Initially 50 mg daily in 2 divided doses, then increased in steps of 25 mg on alternate days if required; maximum 150 mg daily.
  • By Mouth (Elderly): Initially 10–25 mg daily, increased if necessary up to 100–150 mg daily in 2 divided doses; use doses above 100 mg with caution.

Obsessive-Compulsive Disorder, Neuropathic Pain, Migraine Prophylaxis, Chronic Tension-Type Headache Prophylaxis

• • By Mouth (Adults): Initially 10–25 mg daily in the evening, then increased if tolerated, in steps of 10–25 mg every 3–7 days in 1–2 divided doses; usual dose 25–75 mg daily, maximum per dose 75 mg.

Emotional Lability in Multiple Sclerosis

• • By Mouth (Adults): Initially 10–25 mg daily; increased, if tolerated, in steps of 10–25 mg every 1–7 days; maximum 75 mg per day.

Unlicensed Use

• Not licensed for use in abdominal pain or emotional lability in multiple sclerosis.

Cautions and Further Information

• Arrhythmias and Cardiovascular Disease: Caution advised due to potential for heart block and arrhythmias.
• Chronic Constipation, Diabetes, Epilepsy, History of Bipolar Disorder: Use with caution.
• Hyperthyroidism and Phaeochromocytoma: Risk of arrhythmias.
• Prostatic Hypertrophy, Pyloric Stenosis, Glaucoma, Urinary Retention: Use with caution due to anticholinergic effects.

Interactions

• Refer to Appendix 1 for interactions specific to tricyclic antidepressants.

Side Effects

• Common/Very Common: Anticholinergic syndrome, drowsiness, QT interval prolongation.
• Rare or Very Rare: Acute glaucoma, leucopenia, neutropenia, oesophageal pain, pharyngitis, respiratory disorders, speech disorder, vasculitis.
• Frequency Not Known: Bone fracture, agranulocytosis, alopecia, arrhythmias, asthenia, and more.

Special Considerations

• Pregnancy: Use only if potential benefit outweighs risk.
• Breastfeeding: The amount secreted into breast milk is considered too small to be harmful.
• Hepatic Impairment: Use with caution; avoid in severe impairment.
• Withdrawal: Preferably reduce dose gradually over about 4 weeks to prevent withdrawal symptoms.

Patient and Carer Advice

• Driving and Skilled Tasks: Drowsiness may affect the performance of skilled tasks.
• Alcohol Interaction: Effects of alcohol are enhanced.

Medicinal Forms

Oral Solution

• Amitriptyline Hydrochloride (Non-proprietary):

• • Strengths Available:

• • • 2 mg per 1 ml (10 mg/5 ml oral solution, sugar-free)
    • 5 mg per 1 ml (25 mg/5 ml oral solution, sugar-free)
    • 10 mg per 1 ml (50 mg/5 ml oral solution, sugar-free)

Tablets

• Amitriptyline Hydrochloride (Non-proprietary):

• • Strengths Available:

• • • 10 mg
    • 25 mg
    • 50 mg