Modton Tablets 25Mg (1 Box = 10 Tablets)

Requires Prescription (YES/NO)

Yes

Generics

Agomelatine

Used For

Depression

How it works

Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for a, ß adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors. Agomelatine resynchronizes circadian rhythms in circadian rhythm disruption. Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin .

Dosage

Agomelatine

Side Effects

Psychiatric disorders Common: Anxiety Uncommon: Agitation and related symptoms (such as irritability and restlessness), Aggression Nightmares, Abnormal dreams, confusional state Rare: Mania/hypomania, Hallucinations Frequency not known: Suicidal thoughts or behavior Nervous system disorders Common: Headache, Dizziness, Somnolence, Insomnia, Migraine Uncommon: Paraesthesia, Restless leg syndrome Rare: Akathisia Eyes disorders Uncommon: Blurred vision Ear and vestibular system disorders Uncommon: Tinnitus Gastrointestinal Disorders Common: Nausea, Diarrhoea, Constipation, Abdominal pain, vomiting Hepato- biliary disorders Common: Increased ALAT and/or ASAT Rare: Hepatitis, Increased gamma-glutamyltransferase (GGT) (>3 times the upper limit of the normal range), Increased alkaline phosphatase (>3 times the upper limit of the normal range), Hepatic failure Jaundice Skin and subcutaneous tissue disorders Common: Hyperhidrosis Uncommon: Eczema, Pruritus, Urticaria Rare: Erythematous rash, Face edema and angioedema Musculoskeletal and connective tissue disorders Common: Back pain General disorders and administration site conditions Common: Fatigue Renal and Urinary disorders Rare: Urinary retention

Drug Interactions

Potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin , moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin ) .

Indication

Treatment of major depressive disorder in adults including prevention of relapse.

When not to Use

• Hypersensitivity to Agomelatine • Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 times the upper limit of normal. • Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin)

Precaution

Caution should be exercised when prescribing Agomelatine with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.

Warning 1

Agomelatine should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Agomelatine have not been established in these patients.

Warning 2

Agomelatine should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms.

Warning 3

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery .

Pregnancy category

Always consult your physician before using any medicine.

Storage (YES/NO)

Store this medicine at room temperature, away from direct light and heat.