Agotin 25 mg (Tablet)

Title

• Agomelatine Tablets

Categories

• Medicine
• Health & Wellness
• Pharmaceuticals

Description

• Indicated for major depressive disorder, generalized anxiety disorder, bipolar depression, sleep disturbances, seasonal affective disorder, migraine, and cluster headaches
• Binds to melatoninergic and serotoninergic receptors to normalize circadian rhythms and sleep-wake cycles
• Effective dose is 25 mg per day, can be increased to 50 mg per day
• Orally administered with or without food, recommended for night time dosing
• Metabolized by cytochrome P450 1A2 and CYP2C9, potential interactions with inhibitors of these isoenzymes
• Contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or excipients
• Commonly reported adverse effects include headache, nausea, and diarrhea
• For caution in pregnant and lactating women, potential effects on breastfeeding infant not established
• Increases liver enzyme levels, monitoring recommended before and during therapy
• Limited clinical data on use in children, caution in elderly patients
• Limited experience with overdose, no specific antidotes known

Dimensions and Weight

• Standard tablet size and weight

Color Options

• White tablets

Functions

• Treats major depressive disorder, anxiety disorders, bipolar depression, sleep disturbances, and headaches

Materials

• Active ingredient: Agomelatine
• Excipients: to be specified based on product label

Technical Specifications

• Binds to melatoninergic receptors MT1 and MT2, serotoninergic 5-HT2c receptor
• Metabolized mainly by cytochrome P450 1A2 (CYP1A2) and by CYP2C9

Design Elements

• Tablet form

Usability Features

• Oral administration with or without food
• Night time dosing recommended
• Potential interactions with inhibitors of cytochrome P450 1A2 and CYP2C9 isoenzymes

Dosage

• 25 mg per day initially, can be increased to 50 mg per day for inadequate response

Administration

• Oral administration with or without food
• Most adult patients should take a dosage of 25 mg daily, usually prior to bed time

Interaction

• Metabolized mainly by cytochrome P450 1A2 (CYP1A2) and by CYP2C9, potential interactions with inhibitors of these isoenzymes

Contraindications

• Hepatic impairment
• Hypersensitivity to the active substances or excipients

Side Effects

• Headache
• Nausea
• Diarrhea

Pregnancy & Lactation

• Caution in pregnant women, potential excretion into human milk, caution in breastfeeding mothers

Precautions & Warnings

• Increases liver enzyme levels, monitoring recommended before and during therapy

Use in Special Populations

• Not recommended in the treatment of depression in patients under 18 years
• Limited clinical data on use in elderly patients

Overdose Effects

• Limited experience with overdose
• No specific antidotes known

Therapeutic Class

• Atypical anti-depressant drugs

Storage Conditions

• Store in a cool and dry place away from light
• Keep out of the reach of children

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