Concise Prescribing Info
Dosage/Direction for Use
Adult 25 mg once daily at bedtime, may be increased to 50 mg once daily after 2 wk if there is no improvement of symptoms. Treatment duration: At least 6 mth. Switching therapy from SSRI/serotonin-norepinephrine reuptake inhibitors (SNRI) to agomelatine: Immediately start agomelatine while tapering the dosage of a SSRI/SNRI to avoid potential discontinuation symptoms.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ potent CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin). Hepatic impairment (ie, cirrhosis or active liver disease) or transaminases >3 x upper limit of normal (ULN).
Special Precautions
Perform liver function tests (LFT) before starting treatment & then after around 3 wk, 6 wk (end of acute phase), 12 wk & 24 wk (end of maintenance phase) & thereafter when clinically indicated; do not initiate in patients w/ transaminases >3 x ULN. Perform LFT w/ the same frequency as in initiating treatment when increasing the dosage. Cases of liver injury, including hepatic failure (few cases were exceptionally reported w/ fatal outcome or liver transplantation in patients w/ hepatic risk factors), elevations of liver enzymes >10 x ULN, hepatitis & jaundice. Patients w/ hepatic injury risk factors (eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, substantial alcohol intake); concomitantly receiving medicines associated w/ risk of hepatic injury; w/ pretreatment elevated transaminases (> & ≤3 x ULN). Discontinue immediately if patient develops signs or symptoms of potential liver injury (eg, dark urine, light coloured stools, yellow skin/eyes, pain in the upper right abdomen, sustained new-onset & unexplained fatigue) & increased serum transaminases >3 x ULN. Discontinue if manic symptoms develop in patients w/ history of bipolar disorder, mania or hypomania. Depression associated w/ increased risk of suicidal thoughts, self harm & suicide (suicide-related events); closely monitor until improvement occurs; increased risk of suicide in the early stages of recovery; carefully monitor patients w/ history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement due to greater risk of suicidal thoughts or attempts; monitor for any clinical worsening, suicidal behaviour or thoughts, & unusual behavioural changes. Increased exposure w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Contains lactose; not for patients w/ rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Renal impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <18 yr. Not for major depressive episodes in the elderly w/ dementia.
Adverse Reactions
Headache. Anxiety; dizziness, somnolence, insomnia; nausea, diarrhoea, constipation, abdominal pain, vomiting; increased ALAT &/or ASAT; back pain; fatigue; increased wt.
Drug Interactions
Bioavailability may be increased or decreased w/ isoenzymes CYP450, CYP1A2 (90%) & by CYP2C9/19 (10%). 60-fold increased exposure w/ fluvoxamine; several-fold increased exposure w/ oestrogens (moderate CYP1A2 inhibitors). Bioavailability may be decreased by rifampicin; decreased bioavailability w/ smoking, especially in heavy smokers (>15 cigarettes/day). Not advisable w/ alcohol.
MIMS Class
ATC Classification
N06AX22 - agomelatine ; Belongs to the class of other antidepressants.
Valdoxan FC tab 25 mg
2 × 14's
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