Hetemcit is a medicine used to treat HIV. It contains two main ingredients, emtricitabine and tenofovir disoproxil fumarate, which help stop the virus from multiplying in the body. It belongs to the pharmacological class 20.2.8 Antimicrobial (chemotherapeutic) agents – Antiviral agents and is widely used for treating HIV-1 infections in adults.
Composition
HETEMCIT contains the following active and inactive ingredients:
| Component | Quantity per Tablet |
|---|---|
| Emtricitabine | 200 mg |
| Tenofovir Disoproxil Fumarate | 300 mg |
| Excipients | Croscarmellose sodium, Magnesium stearate, Microcrystalline cellulose, Pregelatinized starch, Opadry II Blue |
| Sugar Content | Lactose monohydrate 80 mg |
Pharmacological Action
HETEMCIT is a combination of two nucleoside reverse transcriptase inhibitors (NRTIs):
- Emtricitabine: A cytosine analogue that inhibits reverse transcriptase, thereby preventing HIV replication.
- Tenofovir Disoproxil Fumarate: A derivative of adenosine monophosphate that inhibits viral reverse transcriptase and terminates viral DNA synthesis.
Indications
HETEMCIT is prescribed for:
- Treatment of HIV-1 infection in adults (in combination with other antiretroviral drugs).
- Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in high-risk individuals.
Contraindications
HETEMCIT should not be used in:
- Patients allergic to Emtricitabine, Tenofovir, or any excipients.
- Pregnant or breastfeeding women.
- Patients with moderate to severe renal impairment.
Warnings & Precautions
1. Lactic Acidosis & Hepatomegaly
- Cases of fatal lactic acidosis and severe hepatomegaly with steatosis have been reported.
- Treatment should be discontinued if severe liver toxicity is detected.
2. Renal Impairment
- HETEMCIT is eliminated through the kidneys, so patients with renal dysfunction require careful monitoring.
- Not recommended for patients with creatinine clearance < 30 ml/min.
3. Bone Effects
- Long-term use may lead to bone density reduction, requiring monitoring in high-risk patients.
4. Immune Reconstitution Syndrome
- Patients with severe immune deficiency may develop an inflammatory response during initial treatment.
5. HIV & Hepatitis B Co-infection
- HETEMCIT is not approved for treating chronic Hepatitis B Virus (HBV).
- Patients discontinuing HETEMCIT should be monitored for severe HBV exacerbations.
Pharmacokinetics(The study of how our genes affect the way we respond to medications)
| Property | Emtricitabine | Tenofovir Disoproxil Fumarate |
|---|---|---|
| Absorption | 93% bioavailability | 25% bioavailability (39% with high-fat meal) |
| Protein Binding | Low | Low |
| Elimination Half-life | 8-10 hours | 14-17 hours (Intracellular: 11-49 hours) |
| Excretion | Primarily in urine | 70-80% eliminated unchanged in urine |
Hetemcit Drug Interactions
| Interacting Drug | Effect |
|---|---|
| Didanosine | Increases didanosine toxicity, requiring dose adjustments. |
| Nephrotoxic agents (e.g., Acyclovir, Ganciclovir) | Increased risk of renal toxicity. |
| Atazanavir + Ritonavir | Increases tenofovir concentration; requires dose monitoring. |
| Lamivudine | Should not be co-administered due to similarity with Emtricitabine. |
Hetemcit Tablet Side Effects
Common side effects include:
- Gastrointestinal: Nausea, vomiting, diarrhea
- Neurological: Dizziness, headache, fatigue
- Renal: Increased creatinine levels, kidney dysfunction
- Musculoskeletal: Bone mineral density reduction
- Metabolic: Lactic acidosis, lipodystrophy
Dosage & Administration
- For HIV treatment: One tablet once daily, combined with other antiretrovirals.
- For PrEP: One tablet once daily in high-risk individuals.
- Renal Impairment: Dose adjustments required for creatinine clearance 30-49 ml/min.
Special Populations
- Paediatrics: Not recommended for patients under 18 years.
- Elderly: Use with caution due to potential renal and hepatic impairment.
- Pregnancy & Lactation: Contraindicated.
Storage & Handling
- Store below 25°C.
- Protect from moisture and direct sunlight.
- Keep out of reach of children.
Availability of Hetemcit in South Africa
Hetemcit is classified as a Schedule 4 medication under South African pharmaceutical regulations. This classification means that it is a prescription-only drug, requiring authorization from a licensed healthcare professional before it can be dispensed.
The medication is not available for over-the-counter (OTC) purchase and must be obtained through registered pharmacies, hospitals, or healthcare providers. Patients prescribed Hetemcit must follow their doctor’s instructions regarding dosage and administration to ensure optimal effectiveness and minimize potential risks.
Each bottle of Hetemcit contains 30 film-coated tablets, which typically provide a one-month supply when taken as directed (one tablet daily). The packaging is designed to maintain the stability and efficacy of the medication by protecting it from moisture, light, and contamination.
Since Hetemcit is used for the treatment and prevention of HIV infection, access to the medication may also be supported by government health programs, medical aid schemes, and nonprofit organizations that focus on HIV/AIDS treatment and prevention in South Africa.
Patients who require Hetemcit should consult their doctor or pharmacist for guidance on availability, pricing, and potential medical aid coverage to ensure continued access to their prescribed treatment.
Conclusion
HETEMCIT is an effective HIV-1 treatment and PrEP option, combining Emtricitabine and Tenofovir Disoproxil Fumarate. Proper monitoring for renal function, hepatic effects, and potential drug interactions is essential for safe use. Consultation with a healthcare provider is necessary before initiation.
2 thoughts on “Hetemcit Tablet: Uses, Side Effects, Precautions, and More”