Abacavir 300mg tabs/PAC-60 gb

General Description
Abacavir 300mg film coated tablets, bottle pack of 60, each film coated tablet containing Abacavir Sulphate equivalent to 300mg Abacavir. (gb = generic / bottle pack).


Tablets are scored with at least one break line to allow for division of tablets into two parts, each containing the same amount of active ingredients.

Therapeutic class
Abacavir (ABC) is a Nucleoside Reverse Transcriptase Inhibitor (NRTI).

Standard shelf life
36 Months

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

Guidelines for use
For more details, please see WHO treatment guidelines www.who.int/hiv/pub/guidelines/en/index.html and WHO Essential Medicines Library www.who.int/emlib/ or your regional/national guidelines.

Details about paediatric dosage schemes can be found at http://www.who.int/hiv/topics/paediatric/en/index.html

WHO generic tool for assessing paediatric ARV dosing
http://www.who.int/hiv/paediatric/generictool/en/

Indications
Management of HIV-1 infection in children and adults in combination with at least one other antiretroviral drugs. By mouth (oral) PO.
Can be taken without regard to food

Storage
Do not store above 30ºC
Store in tightly closed original container
Keep out of reach and sight of children

Dispensing instructions
Dispense in original container. Do not repack
Pack comes with Warning Card
Can be taken without regard to food

Note: Patients should be told the importance of regular dosing (intermittent therapy may increase sensitization), how to recognize signs of hypersensitivity, and advised to seek immediate medical attention if symptoms develop or before re-starting treatment.

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

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