Austell Diclofenac Sodium 25 mg/mL Solution for injection

Austell Diclofenac Sodium 25 mg/mL Solution for injection

S3
PDF Leaflet Revision Date: 18 March 2022


Clinical Summary

Quick overview from the medicine insert

Indication

Initial therapy for inflammatory and degenerative rheumatic diseases and mild to moderate pain.

Dosage (summary)

75 mg IM once daily, may increase to twice daily in severe cases; max 150 mg/day.

Onset of Action / Duration

Onset: 10-20 mins, Duration: Not specified

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Contraindicated in late pregnancy; avoid during breastfeeding.

Key Drug Interactions

  • Increased plasma concentrations of lithium/digoxin
  • Increased risk of GI bleeding with corticosteroids/NSAIDs
  • Enhanced anticoagulant effects

Contraindications

  • Hypersensitivity to diclofenac
  • Active GI ulcers
  • History of GI bleeding
  • Severe renal/hepatic impairment
  • Pregnancy after 20 weeks

Common side effects

  • Nausea
  • Headache
  • Dizziness
  • Gastrointestinal bleeding
  • Skin rash

Counselling Points

  • Use the lowest effective dose for the shortest duration
  • Monitor for signs of GI bleeding
  • Avoid use in late pregnancy

Serious warnings

  • Risk of serious GI events
  • Potential for renal and hepatic toxicity
  • Serious skin reactions
Important Disclaimer

The Austell Diclofenac Sodium 25 mg/mL Solution for injection professional information leaflet below is the property of Austell 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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