Indications
Agomelatine is indicated for:
- Major depressive disorder especially in non-responders and intolerant to SSRIs
- Generalized anxiety disorder
- Bipolar depression
- Sleep disturbances
- Seasonal affective disorder
- Migraine and cluster headaches
Dosage
The effective dose of agomelatine is 25 mg per day given once at bed time for two weeks and can be increased to 50 mg per day in patients with inadequate response. Night time dosing is recommended because agomelatine improves the quality of sleep without day time sedation.
Administration
For oral administration with or without food. Most adult patients should take a dosage of 25 mg (one tablet) daily. It is usually taking prior to bed time. If no improvement is noticed after two weeks, the dosage can be increased to 50 mg (two tablets) daily.
Interaction
Potential interactions affecting agomelatine:Â Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of agomelatine with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Contraindications
It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.
Side Effects
The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.
Pregnancy & Lactation
Use in pregnancy: For agomelatine, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing to pregnant women.
Use in lactation: It is not known whether Agomelatine is excreted into human milk. agomelatine or its metabolites are excreted in the milk of lactating rats. Potential effects of agomelatine on the breastfeeding infant have not been established. If treatment with agomelatine is considered necessary, breastfeeding should be discontinued.
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