Emtricitabine + Tenofovir disoproxil

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Generic Name of Emtricitabine + Tenofovir disoproxil - Learn More

Emtricitabine + Tenofovir disoproxil

Emtricitabine + Tenofovir disoproxil Precaution - What You Need to Know

Before starting treatment with Emtricitabine + Tenofovir disoproxil, patients must consult with their healthcare provider. The following precautions should be considered:

- Renal Function: Both Emtricitabine and Tenofovir disoproxil can cause kidney toxicity. Renal function should be assessed before starting the treatment and monitored regularly throughout therapy, especially in patients with pre-existing kidney disease.
- Liver Disease: Caution is required in patients with hepatic impairment, including those with chronic hepatitis B or C. Tenofovir can cause liver toxicity, and discontinuation can lead to acute exacerbations of hepatitis in some cases.
- Bone Health: Tenofovir disoproxil has been associated with bone mineral density loss, leading to an increased risk of fractures. Patients should be monitored for bone health, and calcium or vitamin D supplementation may be considered.
- Pregnancy and Breastfeeding: Emtricitabine + Tenofovir disoproxil are categorized as pregnancy category B, meaning they are generally considered safe during pregnancy but should be used only if clearly needed. The drugs pass into breast milk, so it is important to discuss with a doctor whether to breastfeed while taking these medications.
- Lactic Acidosis and Hepatomegaly: Lactic acidosis and hepatic steatosis (fatty liver) are rare but serious side effects that can occur, particularly in patients with liver disease or those receiving other antiretroviral medications. Monitoring for these complications is important during treatment.

Emtricitabine + Tenofovir disoproxil Indication - Uses and Benefits

Emtricitabine + Tenofovir disoproxil are commonly prescribed for the following conditions:

- HIV-1 Infection: They are used as part of combination antiretroviral therapy (ART) for the treatment of HIV-1 in adults and children. The combination helps to lower viral load and maintain immune system function by inhibiting the replication of the virus.
- Pre-exposure Prophylaxis (PrEP): When taken as part of a PrEP regimen, this combination helps prevent the transmission of HIV in high-risk individuals, such as those with an HIV-positive partner or those involved in high-risk behaviors.
- Chronic Hepatitis B: Emtricitabine and Tenofovir disoproxil may also be used in the treatment of chronic hepatitis B infection to reduce viral replication.

Emtricitabine + Tenofovir disoproxil Contraindications - Important Warnings

This combination should not be used in the following situations:

- Hypersensitivity: Contraindicated in patients with a known allergy to either Emtricitabine or Tenofovir disoproxil, or any other components of the formulation.
- Renal Impairment: Not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) as the drugs are primarily cleared by the kidneys and may accumulate, increasing the risk of adverse effects.
- Liver Disease: Contraindicated in patients with active hepatitis B or C without proper monitoring, especially if hepatic function is unstable.
- Pregnancy and Breastfeeding: Though considered safe during pregnancy, Emtricitabine + Tenofovir disoproxil should be avoided in pregnant women unless absolutely necessary, and a careful benefit-risk assessment should be conducted.

Emtricitabine + Tenofovir disoproxil Side Effects - What to Expect

Common and severe side effects of Emtricitabine + Tenofovir disoproxil include:

- Common Side Effects:
- Gastrointestinal issues: These may include nausea, vomiting, diarrhea, or abdominal pain.
- Fatigue: Some patients report feelings of tiredness or weakness.
- Headache: Mild headaches are commonly reported.
- Rash: A mild rash can occur in some individuals.

- Severe Side Effects:
- Liver Issues: Liver toxicity and hepatitis flare-ups (especially in those with chronic hepatitis B) are potential risks. Liver function should be monitored regularly.
- Renal Impairment: Acute renal failure or kidney toxicity may occur, particularly in patients with pre-existing kidney conditions or those on other nephrotoxic medications.
- Bone Mineral Density Loss: Long-term use of Tenofovir disoproxil can cause a reduction in bone mineral density, increasing the risk of fractures.
- Lactic Acidosis: A rare but life-threatening condition that can cause muscle pain, weakness, breathing difficulties, and liver problems.
- Pancreatitis: This is a risk with the use of didanosine alongside this combination.

Patients should contact their healthcare provider if they experience any of these symptoms.

Emtricitabine + Tenofovir disoproxil Pregnancy Category ID - Safety Information

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Emtricitabine + Tenofovir disoproxil Mode of Action - How It Works

Emtricitabine and Tenofovir disoproxil are nucleoside reverse transcriptase inhibitors (NRTIs), which work by interfering with the replication of the HIV virus.

- Emtricitabine: It is a nucleoside analogue that inhibits the reverse transcriptase enzyme, a critical step in the replication of HIV. By incorporating itself into the growing viral DNA chain, it prevents further elongation, halting viral replication.
- Tenofovir Disoproxil: Tenofovir is a nucleotide analogue that similarly inhibits reverse transcriptase. Once inside the cell, Tenofovir is converted into its active form and interferes with HIV's ability to replicate by terminating the viral DNA chain elongation.

Together, they work synergistically to prevent HIV from replicating, reducing the viral load, and improving the immune system's ability to fight off infections.

Emtricitabine + Tenofovir disoproxil Drug Interactions - What to Avoid

Emtricitabine + Tenofovir disoproxil may interact with other medications, including:

- Renal Toxic Drugs: Concomitant use with other nephrotoxic drugs (e.g., aminoglycosides, non-steroidal anti-inflammatory drugs (NSAIDs), and diuretics) may increase the risk of renal toxicity. Renal function should be monitored regularly.
- Didanosine: Didanosine and Tenofovir disoproxil when used together can increase the risk of lactic acidosis and pancreatitis. This combination should generally be avoided.
- Rifampin: Rifampin, a drug used in the treatment of tuberculosis, can decrease the effectiveness of both Emtricitabine and Tenofovir by inducing liver enzymes that increase their metabolism.
- Atazanavir and Other Protease Inhibitors: Protease inhibitors (such as Atazanavir) may interact with Emtricitabine + Tenofovir disoproxil and reduce their plasma concentration. This may lead to reduced efficacy.
- Tenofovir Disoproxil and Other Antiviral Drugs: Care should be taken when combining this drug with other antiretrovirals, such as lamivudine, as there may be an additive risk of toxic effects on the kidneys or bones.

Patients should inform their healthcare provider about all other medications, supplements, or herbal products they are taking.

Emtricitabine + Tenofovir disoproxil Adult Dose - Recommended Dosage

For adults, the recommended dose of Emtricitabine + Tenofovir disoproxil is:

- One tablet (containing 200 mg Emtricitabine and 300 mg Tenofovir disoproxil) taken orally once daily, with or without food.

For patients with renal impairment, the dosage may need adjustment based on kidney function.

Emtricitabine + Tenofovir disoproxil Child Dose - Dosage for Children

The safety and efficacy of Emtricitabine + Tenofovir disoproxil have been established for children aged 12 years and older:

- The recommended dose for children (12 years or older and weighing at least 35 kg) is one tablet (containing 200 mg Emtricitabine and 300 mg Tenofovir disoproxil) taken once daily.

For children under 12 years, specific dosage recommendations should be guided by a healthcare provider based on individual needs and weight.

Emtricitabine + Tenofovir disoproxil Renal Dose - Dosage for Kidney Conditions

For patients with renal impairment, the dosage of Emtricitabine + Tenofovir disoproxil may require modification:

- Creatinine Clearance ≥ 50 mL/min: The standard dose of one tablet daily is appropriate.
- Creatinine Clearance 30-49 mL/min: A dose adjustment is required. It is recommended to reduce the dosing interval to one tablet every 48 hours.
- Creatinine Clearance < 30 mL/min: The use of this combination is contraindicated in patients with severe renal impairment.

Frequent monitoring of renal function is essential for patients with kidney issues.