Aspen Dolutegravir 50 mg FC tablets
PDF Leaflet Revision Date: 17 January 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of HIV infection in adults.
Dosage (summary)
50 mg once daily for treatment-nau00efve and integrase inhibitor-nau00efve patients; 50 mg twice daily for integrase inhibitor resistant patients.
Special Populations
- Elderly
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy during the first trimester; not recommended during breastfeeding.
Key Drug Interactions
- Rifampicin decreases dolutegravir levels
- Metformin contraindicated
- Antacids decrease absorption
Contraindications
- Hypersensitivity to dolutegravir
- Moderate/severe hepatic impairment
- Pregnancy in first trimester
Common side effects
- Nausea
- Diarrhoea
- Headache
- Rash
Counselling Points
- Avoid pregnancy; use effective contraception
- Do not breastfeed
- Monitor for hypersensitivity reactions
Serious warnings
- Hypersensitivity reactions
- Immune reconstitution syndrome
- Osteonecrosis risk
Important Disclaimer
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