Amitriptyline Hydrochloride is indicated for:

• Depressive disorders, particularly when sedation is beneficial
• Nocturnal enuresis (bedwetting) in children
• Prevention of migraine
• Tension-type headaches
• Chronic pain conditions

Amitriptyline is a tricyclic antidepressant with strong anticholinergic and sedative properties. It works by inhibiting the reuptake of neurotransmitters such as norepinephrine and serotonin at nerve endings. After oral administration, it is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 2 to 12 hours. It is mainly excreted in the urine as metabolites.

The exact mechanism of action of amitriptyline is not fully understood. It is believed to inhibit the reuptake of neurotransmitters such as norepinephrine and serotonin, thereby increasing their availability in the synaptic cleft of the brain. These neurotransmitters play a key role in mood regulation. According to the monoamine hypothesis, depression is associated with reduced levels of serotonin and/or norepinephrine in the brain. Amitriptyline helps counteract this imbalance, thereby improving depressive symptoms. Its analgesic effects may be related to its antidepressant activity or may involve additional pharmacological mechanisms that are not fully defined.

Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.

Nocturnal Enuresis: Child 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before the further course.

Prophylaxis of Migraine: 100 mg daily.

Tension Headache: 10-25 mg three times daily.

Tricyclic antidepressants (TCAs) can enhance the sedative effects of alcohol and opioid analgesics. Concurrent use with drugs such as moxifloxacin or terfenadine may increase the risk of ventricular arrhythmias. Metabolism of amitriptyline may be inhibited by drugs like disulfiram and cimetidine, leading to increased plasma levels. When used together with diuretics, there is an increased risk of postural hypotension.

Amitriptyline is contraindicated in patients with recent myocardial infarction, cardiac arrhythmias (especially any degree of heart block), mania, and severe hepatic impairment. Initial sedation may impair the ability to drive or operate machinery.

• Anticholinergic effects: Excessive sweating, dry mouth, blurred vision, fever, urinary retention, and urinary tract dilation.
• Cardiovascular effects: Hypotension, syncope, postural hypotension, hypertension, tachycardia, palpitations, and myocardial infarction.
• CNS and neuromuscular effects: Confusion, poor concentration, disorientation, delusions, etc.
• Allergic reactions: Skin rash, urticaria, photosensitivity.
• Hematological effects: Bone marrow suppression.
• Gastrointestinal effects: Nausea, epigastric discomfort, vomiting, loss of appetite, stomatitis, unpleasant taste, weight loss, diarrhea, and constipation.
• Endocrine effects: Testicular swelling, gynecomastia, breast enlargement, galactorrhea.

Pregnancy Category C. Amitriptyline crosses the placenta. It should be used during pregnancy only if the expected benefit outweighs the potential risk to the fetus. Amitriptyline is excreted into breast milk. A decision should be made whether to discontinue breastfeeding or the drug, considering its importance to the mother.

Use with caution in patients with epilepsy, glaucoma, urinary retention, cardiovascular disease, diabetes, hepatic impairment, thyroid disorders, increased intraocular pressure, and psychotic conditions (may worsen mania).

Tricyclic Antidepressant

Store below 30°C in a cool and dry place. Protect from light and moisture.