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Last updated: October 2024
Therapeutic action
- Antiretroviral, inhibitor of HIV integrase
Indications
- HIV infection, in combination with other antiretrovirals
Forms and strengths
- 10 mg dispersible tablet
- 50 mg tablet
Dosage
The daily dose is administered once daily.
- Child 1 month and over and adult:
| Weight | Daily dose | Tablets |
|---|---|---|
|
3 to < 6 kg |
5 mg |
½ disp tab 10 mg |
|
6 to < 10 kg |
15 mg |
1 ½ disp tab 10 mg |
|
10 to < 14 kg |
20 mg |
2 disp tab 10 mg |
|
14 to < 20 kg |
25 mg |
2 ½ disp tab 10 mg |
| ≥ 20 kg |
30 mg or 50 mg |
3 disp tab 10 mg or 1 tab 50 mg |
Duration
- Depending on the efficacy and tolerance of dolutegravir.
Contra-indications, adverse effects, precautions
- Administer with caution to patients with severe hepatic impairment or coinfection with hepatitis B or hepatitis C virus.
- May cause:
- insomnia, depression, anxiety, dizziness, headache, skin rash, gastrointestinal disturbances (nausea, vomiting, diarrhoea, etc.);
- rarely: hepatotoxicity, hypersensitivity reactions.
- Do not administer simultaneously with antacids (aluminium or magnesium hydroxide, etc.), ferrous salts, calcium and zinc salts (effect of dolutegravir decreased). Take these drugs at least 6 hours before or 2 hours after dolutegravir.
- In patients taking:
- metformin: monitor closely blood glucose level and renal function and adjust dose as needed (effect of metformin increased). Do not exceed 1 g of metformin daily.
- enzyme-inducing drug (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine): double the daily dose of dolutegravir (effect of dolutegravir decreased), e.g. 30 mg 2 times daily rather than 30 mg once daily, and maintain the double dose for 2 weeks after enzyme-inducing drug treatment completion.
- In adolescents and women of childbearing age, offer hormonal contraception or an intrauterine device.
- Pregnancy: small increased risk of neural tube defects but the benefits outweigh the risks. The administration of folic acid during the first trimester may reduce this risk.
Remarks
- Three 10 mg dispersible tablets are equivalent to one 50 mg tablet.
- In children 20 kg and over, preferably use 50 mg tablet unless they cannot swallow tablets.
- Do not cut, crush or chew dispersible tablets. They can be swallowed or dispersed in a small amount of water.
- Dolutegravir is also used for HIV post-exposure prophylaxis in combination with other antiretrovirals.
- Also comes in fixed-dose combinations:
- 300 mg tenofovir /300 mg lamivudine /50 mg dolutegravir. Preferably use this formulation when available in adolescents 30 kg and over and adults. In patients taking enzyme-inducing drugs, administer the fixed-dose combination in the morning and dolutegravir 50 mg in the evening.
- 60 mg abacavir/30 mg lamivudine/5 mg dolutegravir dispersible tablet. Preferably use this formulation when available in children 3 months of age and over and weighing from 6 to under 25 kg.
Storage
–
– Below 25 °C