Registered Malawi · PMRA

EFAVIRENZ-EMTRICITABINE-TDF 600/200/300MG TABLETS

EFAVIRENZ-EMTRICITABINE-TDF

PMPB/PL272/33 TABLETS

What it does

Efavirenz-emtricitabine-tdf is a combination medicine used to treat HIV, which helps to manage the virus and improve quality of life.

Commonly used for: HIV infection, Human Immunodeficiency Virus (HIV)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL272/33
Registration date
23/07/2013
Expiry date
31/03/2023
Status
Registered
Active ingredient
EFAVIRENZ-EMTRICITABINE-TDF
Dosage form
TABLETS
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:39 · updated 2026-09-29 04:33:05

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Efavirenz-emtricitabine-tdf is a combination medicine used to treat HIV, which helps to manage the virus and improve quality of life.

What it treats

  • HIV infection
  • Human Immunodeficiency Virus (HIV)

How it works

This medicine works by preventing the virus from multiplying in the body, helping to control the infection.

Who it's for

It is for adults and children who are infected with HIV.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: efavirenzemtricitabinetdf

Efavirenz/emtricitabine/tenofovir disoproxil fumarate is a fixed-dose combination antiretroviral medication used for the treatment of HIV-1 infection. It combines three active ingredients: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir disoproxil fumarate, an nucleotide reverse transcriptase inhibitor. This combination therapy helps to suppress viral load, improve immune function, and reduce the risk of HIV transmission.

Indications

  • HIV-1 infection
  • Prevention of HIV transmission
  • HIV prophylaxis

Dosage

Adults: Refer to specific clinical guidelines and BNF for dosing recommendations.

Mechanism of action

Efavirenz binds to the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA, which is essential for viral replication. Emtricitabine and tenofovir disoproxil fumarate both inhibit the reverse transcriptase enzyme, interfering with the replication of HIV by incorporating into the viral DNA chain and causing chain termination. This multi-targeted approach enhances efficacy and reduces the likelihood of resistance development.

Pharmacodynamics

The pharmacodynamics of efavirenz/emtricitabine/tenofovir disoproxil fumarate involves the inhibition of HIV replication through multiple mechanisms of action. The combination of an NNRTI and two NRTIs results in a synergistic effect, leading to a significant decrease in viral load and an increase in CD4 cell counts. This therapy is particularly effective in treatment-naïve patients and has been shown to maintain virologic suppression over time.

Pharmacokinetics

Efavirenz is well-absorbed orally, with peak plasma concentrations occurring within 3 to 5 hours post-dose. It is highly protein-bound (about 99%) and is metabolized primarily by the hepatic cytochrome P450 system (CYP2B6). Emtricitabine and tenofovir disoproxil fumarate are also absorbed well, with their peak concentrations reached within 1 to 2 hours. Tenofovir is primarily cleared by the kidneys. The half-lives of the components facilitate once-daily dosing, enhancing adherence to therapy.

Contra-indications

  • Severe hepatic impairment
  • Concomitant use with certain medications that are strong CYP3A4 inducers or inhibitors

Adverse effects

  • Central nervous system effects (e.g., dizziness, insomnia, vivid dreams)
  • Rash
  • Nausea
  • Fatigue
  • Hepatotoxicity
  • Hyperlipidemia

Interactions

  • May interact with other drugs metabolized by CYP450 enzymes, especially CYP3A4
  • Can affect the effectiveness of hormonal contraceptives
  • Concomitant use with antituberculosis medications (e.g., rifampicin) may reduce efficacy

Precautions

  • Monitor for signs of hepatotoxicity
  • Caution in patients with a history of mental health disorders
  • Use with caution in patients with a history of seizures

Pregnancy

Use is not recommended during pregnancy due to potential risks to the fetus. If used, benefits must outweigh risks.

Breast-feeding

Not recommended, as efavirenz can be excreted in human milk and may affect the nursing infant.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Fixed-dose combination tablet containing efavirenz and emtricitabine
  • Single-agent formulations of efavirenz and emtricitabine

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.