- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Pharmacokinetic parameters in children 12 years of age and older are similar to those in adults.
| Bio availability | 80–85% (lamivudine), Unknown (dolutegravir). |
| Vd | 0,24–0,29 l/kg (dolutegravir), ca. 1,3 l/kg (lamivudine). |
| T½ | approx. 14 hour (dolutegravir), approx. 18–19 hour (lamivudine). |
| Tmax | under fasting conditions: about 2.5 hours (dolutegravir), about 1 hour (lamivudine). |
| Cl/F | 1 L/hr (dolutegravir); 0,32 L/h/kg (lamivudine) |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Treatment HIV infection |
|---|
|
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Renal impaiment in children > 3 months
creatinine clearance l< 30 ml/min: avoid use of the fixed combination.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Based on the limited amount of available data regarding dolutegravir as a single agent or lamivudine as a single agent used with other antiretroviral agents for the treatment of adolescents (12-17 years of age), there were no additional types of adverse events beyond those observed in adult populations
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB12 | ||
| J05AB06 | ||
| J05AB16 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Phosphonic acid derivatives | ||
|---|---|---|
| J05AD01 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE08 | ||
| J05AE10 | ||
| J05AE07 | ||
| J05AE02 | ||
| J05AE04 | ||
| J05AE03 | ||
| J05AE01 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF06 | ||
| J05AF02 | ||
| J05AF09 | ||
| J05AF10 | ||
| J05AF05 | ||
| J05AF04 | ||
| J05AF07 | ||
| J05AF13 | ||
| J05AF13 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG06 | ||
| J05AG03 | ||
| J05AG04 | ||
| J05AG01 | ||
| J05AG05 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| J05AH01 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX28 | ||
| J05AX12 | ||
| J05AX07 | ||
| J05AX09 | ||
| J05AX08 | ||
| J05AX24 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Integrase inhibitors | ||
|---|---|---|
| J05AJ04 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP54 | ||
| J05AP57 | ||
| J05AP51 | ||
| J05AP08 | ||
| J05AP55 | ||
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Reference
- ViiV Healthcare B.V., SmPC Dovato (EU/1/19/1370) Rev 11; 08-11-22, www.ema.europa.eu
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Changes
Changes
