Aripen 10 Tablet

Generic Name: Aripiprazole

Manufacturer: Opsonin Pharma Ltd.

Strength: Available in 10 mg tablets.

Indications:

Aripen is indicated for the treatment of:

• Schizophrenia in adults and adolescents (13-17 years).
• Acute manic and mixed episodes associated with Bipolar I Disorder in adults and pediatric patients (10-17 years) as monotherapy or as an adjunct to lithium or valproate.
• Adjunctive treatment of Major Depressive Disorder (MDD) in adults.
• Irritability associated with Autistic Disorder in pediatric patients (6-17 years).
• Agitation associated with Schizophrenia or Bipolar Mania.

Dosage and Administration:

• Schizophrenia:
  • Adults: Initial and recommended dose is 10-15 mg once daily. Maximum dose is 30 mg/day.
  • Adolescents (13-17 years): Initial dose is 2 mg/day, increased to 5 mg/day after 2 days, with a target dose of 10 mg/day. Maximum dose is 30 mg/day.
• Bipolar Mania:
  • Adults: Initial and recommended dose is 15 mg once daily as monotherapy or adjunct therapy. Maximum dose is 30 mg/day.
  • Pediatric patients (10-17 years): Initial dose is 2 mg/day, with a target dose of 10 mg/day. Maximum dose is 30 mg/day.
• Adjunctive treatment of Major Depressive Disorder:
  • Adults: Initial dose is 2-5 mg/day. Recommended dose is 5-10 mg/day. Maximum dose is 15 mg/day.
• Irritability associated with Autistic Disorder:
  • Pediatric patients (6-17 years): Initial dose is 2 mg/day. Recommended dose is 5-10 mg/day. Maximum dose is 15 mg/day.
• Aripen tablets can be taken once daily without regard to meals.
• Dosage adjustments should not be made before 2 weeks, the time needed to achieve steady state.

Contraindications:

• Known hypersensitivity to aripiprazole or any component of the product.

Side Effects:

• Common: Nausea, vomiting, constipation, headache, dizziness, akathisia (restlessness), anxiety, insomnia, somnolence, extrapyramidal disorder, tremor, fatigue, blurred vision, increased saliva production.

Precautions:

• Elderly Patients with Dementia-Related Psychosis: Increased risk of cerebrovascular adverse events (e.g., stroke). Aripen is not approved for this use.
• Suicidality and Antidepressants: Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults with MDD.
• Tardive Dyskinesia: Discontinue if signs and symptoms occur.
• Metabolic Changes: May cause hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. Monitor for these changes.
• Orthostatic Hypotension: Use with caution in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension.
• Seizures/Convulsions: Use cautiously in patients with a history of seizures.
• May impair the ability to operate machinery or drive.
• Use with caution with other centrally acting drugs and alcohol.
• Inform your doctor about all other medications you are taking, as interactions may occur (e.g., with carbamazepine, ketoconazole, fluoxetine, paroxetine, quinidine).

Use in Pregnancy & Lactation:

• Pregnancy: Pregnancy Category C. Should be avoided during pregnancy unless the potential benefit outweighs the risk.
• Lactation: It is recommended that women receiving Aripen should not breast-feed.

Storage:

• Store below 30°C, away from light and moisture.
• Keep out of reach of children.

Packaging:

• Available in strips. Please refer to the specific packaging details on the product.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.