EFV600mg+FTC200mg+TDF300mg tab/PAC-30 gb

General Description
Efavirenz 600mg + Emtricitabine 200mg + Tenofovir Disoproxil Fumarate 300 mg, equivalent to 245 mg Tenofovir Disoproxil, film coated tablet, pack of 30 tablets
(gb = generic / bottle pack)

Technical Specifications
Each film coated tablet contains Efavirenz 600mg and Emtricitabine 200mg and Tenofovir Disoproxil Fumarate 300 mg, equivalent to 245 mg Tenofovir Disoproxil as fixed dose combination.

Therapeutic class
Efavirenz is a Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
Emtricitabine is a Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Tenofovir is a Nucleotide Reverse Transcriptase Inhibitor (NtRTI)

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.

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

Indications
Management of HIV-1 infection in adults as a complete regimen or in combination with other anti retroviral drugs. By mouth (oral) PO.

Storage
Store below 30ºC (86ºF), in a tightly closed container.
Pack should come with desiccant
Keep out of reach and sight of children.

Dispensing instructions
Dispense in original container. Do not repack.
To be taken on an empty stomach.
Advise patient to take the medicine at bedtime especially in the first 2-4 weeks to reduce CNS side effects.

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/