Arsenor 10 mg (Tablet)

Indications

• Treatment of adult patients with active psoriatic arthritis
• Treatment of moderate to severe plaque psoriasis
• Candidates for phototherapy or systemic therapy

Pharmacology

• Apremilast is a small molecule inhibitor of PDE-4
• Increases intracellular levels of cAMP
• Inhibits production of proinflammatory mediators
• Restores homeostatic balance between pro- and anti-inflammatory signalling

Dosage & Administration

• Recommended initial dosage titration from Day 1 to Day 5
• Recommended maintenance dosage of 30 mg twice daily from Day 6
• Can be administered without regard to meals
• Dosage adjustment in patients with severe renal impairment

Interaction

• Co-administration of strong cytochrome P450 enzyme inducer Rifampin resulted in reduction of systemic exposure
• Avoid co-administration with cytochrome P450 enzyme inducers

Contraindications

• Known hypersensitivity to Apremilast or any of the excipients

Side Effects

• Frequently occurring side effects: nausea, diarrhea, headache
• Less frequent side effects: upper respiratory tract infection, vomiting, nasopharyngitis, abdominal pain, hypersensitivity, and more

Pregnancy & Lactation

• Pregnancy Category C
• Caution when administered to nursing women

Precautions & Warnings

• Associated with increased adverse reactions of depression
• Weight decrease between 5-10% of body weight reported in 10% of subjects treated with Arsenor

Use in Special Populations

• Safety and effectiveness in paediatric patients less than 18 years not established

Therapeutic Class

• Disease-modifying antirheumatic drugs (DMARDs)

Storage Conditions

• Store at cool & dry place
• Protented from light & moisture
• Keep out of the reach of children

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