Agomelatine

Antidepressant · Melatonin receptor agonist and selective serotonin receptor antagonist

Indications

Major depressive episodes.

Dosage

Adults: 25 mg once daily at bedtime. If no improvement after 2 wk, increase to 50 mg once daily. Children: Not recommended.

Adverse Effects

Headache, dizziness, somnolence, insomnia, migraine, GI upset, hyperhidrosis, back pain, fatigue, anxiety, raised ALT/AST.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Contraindicated or not recommended. Contraindications: Hepatic impairment. Precautions: Moderate to severe renal impairment. Monitor liver function at initiation and when increasing dose, at weeks 3, 6, 12 and 24 and periodically thereafter; repeat within 48 hours, if ALT or AST raised, discontinue if >3 x ULN. Advise patients to report symptoms of liver injury; discontinue immediately if occurs. Obesity, overweight, non-alcoholic fatty liver disease, diabetes. History of bipolar disorders, mania or hypomania; discontinue if manic symptoms develops. Monitor for suicidal ideation. Elderly.

Interactions

Fluvoxamine, ciprofloxacin, other CYP1A2 inhibitors. Alcohol, smoking, hepatotoxic drugs.

Advice to Patient

Take with or without meals immediately before bedtime. Contact prescriber if there is difficulty in sleeping, anxiousness, increased sweating and back pain, dark urine, pale stools, jaundice (yellowing of skin or the whites of eyes), upper abdominal pain, unusual tiredness. Avoid alcohol during therapy. To prevent constipation and abdominal pain, take a well-balanced diet containing fresh fruit and vegetables. Drink plenty of water.

Pharmacokinetics

Absorption: Rapidly and well absorbed. Bioavailability: <5%. Metabolism: Hepatic. Half-life elimination: 1-2 hrs. Time to peak, plasma: 1-2 hrs. Excretion: Mainly via urine (80%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

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