Agotin Tablet
Agomelatine
25mg
Beacon Pharmaceuticals Ltd.
| Pack size | 10's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 50.00 AED |
Indications
Agotin Tablet is used for:
Major depressive disorder
Adult Dose
PO: 25-50 mg at bedtime.
Recommended Dose: 25 mg once daily taken orally at bedtime.
The decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of liver function test (LFT) monitoring.
After 2 weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily ie, two 25-mg tab, taken together at bedtime.
Child Dose
Renal Dose
Renal Impairment: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
Caution in moderate to severe impairment.
Administration
May be taken with or without food.
Contra Indications
Co-administration of potent CYP1A2 inhibitors (eg fluvoxamine or ciprofloxacin). Hepatic impairment.
Precautions
Suicidal thoughts & worsening of depression. Mania, dementia, lactose intolerance. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescent <18 yr. Alcoholism. bipolar disorder. diabetes. elderly with dementia (safety and efficacy not established)excessive alcohol consumption. hypomania. mania. nonalcoholic fatty liver disease. obesity. patients 75 years of age or older (safety and efficacy not established).
Monitoring Parameters
Test liver function before treatment and after 3, 6, 12 and 24 weeks of treatment, and then regularly thereafter when clinically indicated (restart monitoring schedule if dose increased); discontinue if serum transaminases exceed 3 times the upper limit of reference range or symptoms of liver disorder.
Pregnancy-Lactation
Interactions
Increased or decreased bioavailabity w/ CYP1A2 (eg, fluvoxamine, ciprofloxacin), oestrogens. CYP1A2 inhibitors (eg propanolol, enoxacin). Decreased bioavailabilty w/ rifampicin, smoking. Alcohol.
Adverse Effects
Side effects of Agomelatine :
Common or very common Abdominal pain. anxiety. back pain. constipation. diarrhoea. dizziness. drowsiness. fatigue. headaches. nausea. sleep disorders. vomiting. weight changes
Uncommon Aggression. confusion . hyperhidrosis . mood altered. movement disorders. paraesthesia. skin reactions. suicidal behaviors. tinnitus. vision blurred
Rare or very rare Angioedema. face edema. hallucination. hepatic disorders. urinary retention
Mechanism of Action
Agomelatine possesses both melatonin receptor (MT1 and MT2) agonist and 5-hydroxytryptamine receptor (5-HT2C) antagonist properties. These properties act in a complementary and perhaps synergistic manner to improve depressed states by resynchronization of circadian rhythms, enhancement of dopaminergic and adrenergic input to the frontal cortex, induction of neurogenesis, as well as through other mechanisms. Furthermore, melatonergic agonism and 5-HT2C receptor antagonism also act in harmony to favourably influence anxious symptoms, sleep and sexual function.
Note
Agotin 25mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Agomelatine. Agotin is availble in Bangladesh.
Farmaco BD drug index information on Agotin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.