Valdoxan Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Agomelatine

Indications/Uses

Major depressive episodes in adults. Generalised anxiety disorder (GAD).

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Dosage/Direction for Use

25 mg once daily at bedtime for at least 6 mth, may be increased to 50 mg once daily after: Major depressive episodes 2 wk if there is no improvement, GAD 4 wk if there is no improvement. Elderly <75 yr 25-50 mg daily.

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Overdosage

View Valdoxan overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Concomitant use of potent CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin. Hepatic impairment (ie, cirrhosis or active liver disease) or transaminases >3 times ULN.

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Special Precautions

Not to be initiated in patients w/ baseline values of ALT &/or AST >3 times ULN. Patients w/ pretreatment elevated transaminases (>ULN ranges & ≤3 times ULN range); hepatic injury risk factors eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, alcohol use disorder, substantial alcohol intake or concomitant use w/ drugs associated w/ risk of hepatic injury. History of bipolar disorder, mania or hypomania; history of suicide-related events; suicidal ideation. Perform LFTs prior to treatment & periodically thereafter. Concomitant use w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. May affect ability to drive & use machines. Severe or moderate renal impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <18 yr. Not to be used in elderly w/ dementia & elderly ≥75 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache. Anxiety, abnormal dreams; dizziness, somnolence, insomnia; nausea, diarrhoea, constipation, abdominal pain, vomiting; increased ALT &/or AST; back pain; fatigue; increased wt.

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Drug Interactions

Increased or decreased bioavailability w/ potent CYP1A2 (eg, fluvoxamine, ciprofloxacin), moderate CYP2C9 (eg, fluvoxamine), moderate CYP1A2 (eg, propranolol, enoxacin) inhibitors; oestrogens. Decreased bioavailability w/ rifampicin, smoking. Avoid use w/ alcohol.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Valdoxan detailed prescribing information

Storage

View Valdoxan storage conditions for details to ensure optimal shelf-life.

Description

View Valdoxan description for details of the chemical structure and excipients (inactive components).

Action

View Valdoxan mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antidepressants

ATC Classification

N06AX22 - agomelatine ; Belongs to the class of other antidepressants.

Regulatory Classification

Presentation/Packing

Form

Valdoxan FC tab 25 mg

Packing/Price

28's

Valdoxan

agomelatine

Manufacturer:

Servier

Distributor:

Zuellig Pharma