AGOMELATINE — 25 mg / 50 mg tablets
📦 Product Snapshot
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🧠 Overview
Agomelatine is an atypical antidepressant with a unique pharmacological profile. It acts as a potent agonist at melatonergic MT1 and MT2 receptors (resynchronizing circadian rhythms) and as a neutral antagonist at serotonergic 5‑HT₂C receptors (increasing dopamine and norepinephrine release in the prefrontal cortex). This dual mechanism is distinct from SSRIs/SNRIs, which primarily block monoamine reuptake.
Clinical efficacy: Agomelatine is indicated for the treatment of Major Depressive Disorder (MDD) in adults, including prevention of relapse, and for Generalised Anxiety Disorder (GAD). It has demonstrated efficacy in improving depressive symptoms and has a favourable profile on sleep quality — patients often report better sleep continuity and less daytime drowsiness compared to SSRIs. Importantly, it does not cause sexual dysfunction, weight gain, or discontinuation syndrome, which are common reasons for poor adherence to other antidepressants.
Regulatory context: Agomelatine is approved in Europe, Australia, and India, but its development was not pursued in the United States due to concerns about hepatotoxicity and mixed efficacy data. The drug carries a requirement for regular liver function monitoring, which has limited its first‑line use in some regions despite its tolerability advantages.
🏷️ Strengths & Brand Examples
- 25 mg film‑coated tablets (standard dose)
- 50 mg dose achieved by taking two 25 mg tablets
- Agoprex® 25 mg (Sun Pharmaceutical Industries Ltd)
- Noveltin® 25 mg (Intas Pharmaceuticals Ltd)
- Agopose® 25 mg (Mankind Pharma Ltd)
- Agoviz® 25 mg (Abbott) [citation:2]
- Simelatin® 25 mg (Alkem Laboratories Ltd)
- Agotine® 25 mg (Torrent Pharmaceuticals Ltd)
- Circaltin® 25 mg (Zydus Cadila)
- Agodep® 25 mg (Sun Pharma)
- Lupibliss® 25 mg (Lupin Ltd)
- Agosan® 25 mg (Eisai Pharmaceuticals India)
- Valdoxan® (Servier — Europe, Australia, Taiwan)
- Thymanax® (Servier — UK, Europe)
- Agomelatine‑WGR® (Wagner Pharmaceuticals — Australia)
⚠️ Safety, Side Effects & Monitoring
- Headache, nausea, dizziness
- Somnolence or insomnia
- Anxiety, fatigue
- Back pain, abdominal pain, constipation, diarrhea
- Hyperhidrosis (excessive sweating)
- Elevated liver enzymes (dose‑dependent — see monitoring schedule)
• Contraindications: Hepatic impairment (cirrhosis, active liver disease), baseline transaminases >3x ULN, concomitant potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin).
• Suicidality: As with all antidepressants, monitor for worsening depression or suicidal thoughts, especially in young adults (18–24) during initial treatment.
• Bipolar switching: May precipitate manic episodes in patients with unrecognised bipolar disorder. Discontinue if signs of mania appear.
• Elderly: Not recommended for GAD in >65 years; limited data in MDD ≥75 years — avoid.
• Renal impairment: Caution in moderate/severe impairment (limited data).
• Pregnancy/lactation: Avoid use — safety not established.
• Driving: May cause dizziness or somnolence — caution when operating machinery.
Before initiation: Check baseline ALT/AST. Do not start if >3x ULN.
During treatment (25 mg): Monitor at approximately:
- 3 weeks
- 6 weeks (end of acute phase)
- 12 weeks
- 24 weeks (end of maintenance phase)
- Then when clinically indicated [citation:1]
If dose increased to 50 mg: Repeat the entire monitoring schedule (baseline for new dose, then 3, 6, 12, 24 weeks).
Discontinue immediately if:
- ALT/AST exceed 3x ULN
- Signs/symptoms of liver injury: dark urine, pale stools, yellow skin/eyes, right upper quadrant pain, unexplained fatigue
- Contraindicated: Potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) — increase agomelatine exposure.
- Caution with: Moderate CYP1A2 inhibitors (estrogens, propranolol, enoxacin) — may increase levels.
- Smoking (CYP1A2 inducer): Reduces agomelatine exposure. Dose adjustment may be needed.
- Alcohol: Avoid — increases dizziness and sedation.