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Agotin 25mg Tablet 1 Strip
Agotin is prescribed for the treatment of major depressive disorder (MDD) in adults, particularly for patients who do not respond well to, or cannot tolerate, selective serotonin reuptake inhibitors (SSRIs). It is also used to prevent relapse of depression.
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✅ Description:
✔️ Dosage & Administration
Standard Dose: Adults typically take 25 mg once daily, preferably at bedtime, for at least two weeks.
- If there is no noticeable improvement, the dose may be increased to 50 mg daily (two tablets).
- It can be taken with or without food.
Children under 18 years: Not recommended, unless prescribed by a physician.
- Agomelatine is generally avoided for children and adolescents due to the lack of safety data and the risk of adverse effects like suicidal behavior and aggression, which were observed in trials of other antidepressants.
Elderly patients (<75 years): The efficacy and safety of the medication are established for patients under 75 years old.
- Agomelatine is not recommended for elderly patients over 75 years as its efficacy has not been conclusively demonstrated.
✔️ Overdose Effects
- Overdose experiences with Agotin are limited. Cases reported during clinical trials involved doses of up to 450 mg alone or 525 mg combined with other psychotropic drugs.
- Symptoms included drowsiness and epigastric pain, with no severe adverse reactions.
- There is no specific antidote; treatment focuses on symptom management and regular monitoring.
✔️ Common side effects observed during clinical trials include:
- Headache, nausea, diarrhea, and an increase in liver enzyme levels.
- Regular monitoring of liver enzyme levels is essential, particularly before starting treatment and periodically during therapy.
Unlike many antidepressants, Agotin does not show significant treatment-emergent sexual dysfunction compared to placebo.
✔️ Drug Interactions
Agotin is metabolized primarily by CYP1A2 enzymes (90%) and to a lesser extent by CYP2C9/19 (10%). As such:
- CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) significantly reduce Agotin metabolism, leading to a substantial increase in drug levels in the blood (up to 60-fold).
- Co-administration of these drugs is contraindicated.
✔️ Agotin is contraindicated in patients with:
- Hypersensitivity to Agomelatine or any of its components.
- Hepatic impairment, such as active liver disease or liver enzymes (ALT/AST) levels exceeding three times the upper limit of normal.
- Concomitant use of potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin).
✔️ Use During Pregnancy & Lactation
- Pregnancy: There is no clinical data on the use of Agotin during pregnancy. Animal studies suggest no harmful effects on fetal development, but caution should still be exercised.
- Breastfeeding: It is unclear whether Agotin is excreted into human milk. Animal studies indicate its excretion in lactating rats. If necessary, breastfeeding should be discontinued during treatment.
✔️ Precautions & Warnings
- Baseline liver enzyme tests are mandatory before initiating therapy.
- Treatment should not be started if ALT or AST levels exceed three times the normal limit.
- Patients at risk of hepatic injury or on medications with known hepatic toxicity should be closely monitored.
- Use Agotin cautiously in patients aged ≥75 years due to limited efficacy and safety data.
- It is not recommended for elderly patients with dementia.
- Agotin is not advised for individuals under 18 years due to insufficient data on safety and efficacy.
- Other antidepressants in children have been linked to suicidal thoughts, hostility, and aggression, which raises concerns.
- Exercise caution when prescribing to patients with a history of bipolar disorder, mania, or hypomania.
✔️ Storage Instructions
- Store below 30°C in a cool, dry place, away from direct light.
- Keep out of reach of children.
(To be dispensed only with a valid prescription from a registered physician.)
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