Quviviq 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

Concise Prescribing Info

Contents

Daridorexant

Indications/Uses

Adult patients w/ insomnia characterised by symptoms present for at least 3 mth & considerable impact on daytime functioning.

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Dosage/Direction for Use

50 mg once per night, in the evening w/in 30 min before going to bed. Based on clinical judgement, some patients may be treated w/ 25 mg once per night. Max daily dose: 50 mg. Assess continued treatment appropriateness w/in 3 mth & periodically thereafter Moderate hepatic impairment 25 mg once per night. Co-administration w/ moderate CYP3A4 inhibitors 25 mg once per night.

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Overdosage

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Administration

May be taken with or without food: Taking soon after a large meal may reduce the effect on sleep onset.

Contraindications

Hypersensitivity. Narcolepsy. Concomitant use w/ strong CYP3A4 inhibitors.

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Special Precautions

Concomitant use w/ CNS-depressants & alcohol. Consider discontinuation when sleep paralysis (mainly during 1st wk of treatment) or when symptoms similar to mild cataplexy occurs. Reports of worsening of depression & suicidal thoughts in primarily depressed patients treated w/ hypnotics. Exercise caution in patients w/ psychiatric co-morbidities, severe obstructive sleep apnoea (apnoea-hypopnoea index ≥30 events/hr) or severe COPD (FEV₁ <40% of predicted). Increased risk for abuse in individuals w/ abuse or addiction history to alcohol or other substances. Avoid grapefruit or grapefruit juice consumption in the evening. Major influence on ability to drive & use machines. Not recommended w/ severe hepatic impairment. Use during pregnancy only if clinical condition requires treatment. Risk of excessive somnolence to breastfed infant cannot be excluded. Limited efficacy & safety data in paed & elderly >75 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, somnolence, dizziness; nausea; fatigue.

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Drug Interactions

Increased AUC & C_max w/ diltiazem, erythromycin, ciprofloxacin & cyclosporine. Decreased AUC & C_max w/ efavirenz. Decreased C_max w/ famotidine. Caution in simultaneous administration of 50 mg Quviviq w/ sensitive CYP3A4 substrates w/ narrow therapeutic index (eg, high-dose simvastatin, tacrolimus) & P-gp substrates w/ narrow therapeutic index (eg, digoxin). Prolonged absorption w/ alcohol.

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Caution For Usage

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

Storage

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Description

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Action

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MIMS Class

Hypnotics & Sedatives

ATC Classification

N05CJ03 - daridorexant ; Belongs to the class of orexin receptor antagonists. Used as hypnotics.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Quviviq FC tab 25 mg

Packing/Price

30's

Form

Quviviq FC tab 50 mg

Packing/Price

30's

Quviviq

Manufacturer:

Farmea

Distributor:

DCH Auriga - Healthcare