Xophanu 10 mg & 15 mg Orodispersible tablets

Xophanu 10 mg & 15 mg Orodispersible tablets

S5
PDF Leaflet Revision Date: 27 January 2026


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of schizophrenia and acute manic episodes in Bipolar I Disorder.

Dosage (summary)

Starting dose: 10-15 mg/day; Maintenance: 15 mg/day; Max: 30 mg/day.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Safety not established; monitor neonates for withdrawal symptoms if exposed in third trimester.

Key Drug Interactions

  • CYP3A4 inhibitors
  • CYP2D6 inhibitors
  • CYP3A4 inducers

Contraindications

  • Hypersensitivity to aripiprazole
  • Paediatric use under 18 years

Common side effects

  • Sedation
  • Dizziness
  • Weight gain
  • Akathisia
  • Hyperglycaemia

Counselling Points

  • Monitor for suicidal thoughts
  • Avoid alcohol
  • Caution with driving and machinery

Serious warnings

  • Suicidal behavior risk
  • Neuroleptic Malignant Syndrome
  • Tardive Dyskinesia
Important Disclaimer

The Xophanu 10 mg & 15 mg Orodispersible tablets professional information leaflet below is the property of Dr Reddy’S Laboratories and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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