Description

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.

Potential interactions affecting agomelatine: 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.

It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.

The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.

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. 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.

It is found to increase the level of liver enzymes and so monitoring of enzyme level is warranted before starting therapy and therefore every 6 weeks.

Children under 18 years: Should be given only on medical advice. Children and adolescents: Agomelatine is not recommended in the treatment of depression in patients . Use in the elderly: Efficacy has not been clearly demonstrated in the elderly (65 years). Only limited clinical data is available on the use of Agomelatine in elderly patients 65 years with major depressive episodes. Therefore, caution should be exercised when prescribing Agomelatine to these patients.