Concise Prescribing Info
Major depressive episodes in adults.
Dosage/Direction for Use
Adult 1 tab once daily; may be increased after 2 wk to 2 tab once daily if there is no improvement of symptoms. All doses to be taken at bedtime. Any dose increase to 50 mg should be made on individual patient benefit/risk basis & w/ strict respect of LFT monitoring. Patients should be treated for at least 6 mth.
May be taken with or without food.
Hypersensitivity. Hepatic impairment or transaminases exceeding 3x ULN. Concomitant use of potent CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin.
Special Precautions
Cases of liver injury, including hepatic failure, liver enzymes elevations >10x ULN, hepatitis & jaundice. Monitor liver function before starting treatment. Patients w/ hepatic injury risk factors eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, alcohol use disorder &/or substantial alcohol intake & receiving concomitant drugs associated w/ risk of hepatic injury. Baseline liver function test should be taken in all patients, & treatment should not be initiated in patients w/ baseline values of ALT &/or AST >3x ULN. Pretreatment elevated transaminases (> ULN ranges & ≤3x ULN range). Perform liver function test in all patients; patient should have liver function test repeated w/in 48 hr if increased serum transaminases develops. Monitor transaminases periodically after 3 wk, 6 wk, 12 wk & 24 wk, & thereafter when clinically indicated. Repeat liver function tests at the same frequency as when initiating treatment when increasing dosage. Immediately discontinue if patient develops signs or symptoms of potential liver injury, & the increase in serum transaminases >3 x ULN; repeat liver function test until serum transaminases return to normal in discontinuation of therapy. Bipolar disorder/mania/hypomania (caution); discontinued if maniac symptoms appear. Closely monitor patients for suicidal thoughts. Concomitant use w/ potent CYP1A2 inhibitors is contraindicated. Possible occurrence of dizziness & somnolence. Pregnancy (not recommended) & lactation (caution). Patients <18 yr (not recommended). Elderly ≥75 yr & w/ dementia (should not be used).
Adverse Reactions
Nausea & dizziness. Anxiety; headache, somnolence, insomnia, migraine; diarrhoea, constipation, abdominal pain, vomiting; increased ALAT &/or ASAT; hyperhidrosis; back pain; fatigue, suicidal thoughts or behavior, agitation, irritability, restlessness, aggression, nightmares, abnormal dreams, confusional state, paraesthesia, restless leg syndrome, blurred vision, tinnitus, eczema, pruritus, urticaria, mania/hypomania, hallucinations, akathisia, hepatitis, increased γ-glutamyltransferase, increased alkaline phosphatase, hepatic failure, jaundice, erythematous rash, face oedema & angioedema, increased/decreased wt, urinary retention.
Drug Interactions
CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin, propranolol, enoxacin, oestrogens), rifampicin, alcohol.
MIMS Class
ATC Classification
N06AX22 - agomelatine ; Belongs to the class of other antidepressants.
Valdoxan FC tab 25 mg
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