LPV/r 40+10mg pellets in caps/PAC-120

General Description
Lopinavir 40mg + Ritonavir 10mg oral pellets contained in capsules, bottle pack of 120

Technical specifications
Each capsule contains oral pellets of a fixed boosted protease inhibitor combination of Lopinavir 40mg + Ritonavir 10mg in a heat stable form.

Therapeutic class
Protease Inhibitors (PI)

Standard shelf life
2 years (24 months)

Other available formulations
The product may also be available in other formulations, pack sizes, or in combinations with other ARVs.

Indications
Management of HIV-1 infection in infected adults and children above 14 days of age in combination with at least two other antiretroviral drugs.

Route of Administration
By mouth (PO)
Carefully open the number of capsules for the required dose and sprinkle the entire contents on sweetened porridge at room temperature. The entire mixture should be swallowed immediately without chewing or crushing. After the child swallows the dose, a drink of water may be administered. This will ensure that the entire dose is swallowed and no pellets are left behind in the child's mouth.
The capsules should not be swallowed whole.

Storage
Do not store above 30°C
Store in tightly closed original container, protect from moisture.
Keep out of reach and sight of children

Dispensing instructions
Dispense in original container. Do not repack.
Use twice daily in paediatric patients.
Dispense medication guide with product.

Regulatory Status
For latest updates check the list of ‘Prequalified Medicines’ on the WHO website ‘Prequalification Programme’.
http://apps.who.int/prequal/

For latest updates check the list of ‘USFDA approved and tentatively approved’ items on the USFDA website.
http://www.fda.gov/default.htm
http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/

Guidelines for use
For more details, please see WHO treatment guidelines and

WHO Essential Medicines Library or your regional/national guidelines.

Details about paediatric dosage schemes

WHO generic tool tool for assessing paediatric ARV dosing