Daxas 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

Roflumilast

Indications/Uses

Maintenance treatment of severe COPD associated w/ chronic bronchitis in adults w/ history of frequent exacerbations as add-on to bronchodilator treatment.

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Dosage/Direction for Use

500 mcg once daily.

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Overdosage

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Administration

May be taken with or without food: Swallow w/ water. Take at the same time each day.

Contraindications

Hypersensitivity. Moderate or severe hepatic impairment (Child-Pugh B or C).

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Special Precautions

Not as emergency treatment for relief of acute bronchospasm. Monitor body wt regularly. Severe immunological disease & acute infections, cancers (except basal cell carcinoma). Latent infections eg, TB, viral hepatits, herpes viral infection & herpes zoster. Not recommended in patients w/ CHF (NYHA grades III & IV) & history of depression associated w/ suicidal ideation or behavior. Black, non-smoking females. Concomitant use w/ CYP1A2/2C19/3A4 inhibitors, immunosuppressants; theophylline. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Mild hepatic impairment. Not recommended in women of childbearing potential not using contraception. Not recommended during pregnancy. Not to be used during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased wt & appetite; insomnia; headache; diarrhea, nausea, abdominal pain.

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Drug Interactions

Increased exposure & persistent intolerability w/ enoxacin, cimetidine, fluvoxamine. Reduced therapeutic efficacy w/ phenobarb, carbamazepine, phenytoin. Increased total PDE4 inhibitory activity w/ erythromycin, ketoconazole, theophylline, OCs.

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Caution For Usage

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

Storage

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Description

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Action

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MIMS Class

Antiasthmatic & COPD Preparations

ATC Classification

R03DX07 - roflumilast ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.

Regulatory Classification

Presentation/Packing

Form

Daxas FC tab 500 mcg

Packing/Price

30's

Daxas

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma