Provigil 100mg Tablet

Provigil 100mg Tablet

S5
PDF Leaflet Revision Date: 5 October 2007

API: Modafinil | Company: Litha Pharma

Clinical Summary

Quick overview from the medicine insert

Indication

Improves wakefulness in excessive daytime sleepiness associated with narcolepsy.

Dosage (summary)

200 mg/day as a single morning dose; reduce in elderly and hepatic impairment.

Onset of Action / Duration

Onset: 2-4 hours, Duration: ~15 hours

Special Populations

  • Elderly
  • Hepatic impairment
  • Renal impairment

Pregnancy & Breastfeeding

Safety not established; caution advised during pregnancy and lactation.

Key Drug Interactions

  • CYP2C19 substrates (e.g., diazepam, phenytoin)
  • CYP3A4 substrates (e.g., hormonal contraceptives)
  • Tricyclic antidepressants

Contraindications

  • Hypersensitivity to modafinil
  • Major anxiety
  • Children under 16
  • Severe renal impairment

Common side effects

  • Headache
  • Nausea
  • Anxiety
  • Insomnia

Counselling Points

  • Avoid alcohol while taking PROVIGIL
  • Notify doctor if pregnant or breastfeeding
  • Discuss all medications with doctor due to interaction potential

Serious warnings

  • Monitor blood pressure in hypertensive patients
  • Risk of psychosis in predisposed individuals
Important Disclaimer

The Provigil 100mg Tablet professional information leaflet below is the property of Litha Pharma 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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