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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Emtricitabine And Tenofovir Disoproxil Fumarate
Brand Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Generic Name
Emtricitabine And Tenofovir Disoproxil Fumarate
Active Ingredient
EmtricitabineCategory
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Variants
42
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 100 mg/1 | TABLET, FILM COATED | ORAL | 69238-2092 |
| 100 mg/1 | TABLET, FILM COATED | ORAL | 70710-1364 |
| 167 mg/1 | TABLET, FILM COATED | ORAL |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Emtricitabine And Tenofovir Disoproxil Fumarate, you must consult a qualified healthcare professional.
| 200 mg/1 | TABLET, FILM COATED | ORAL | 60219-2095 |
| 133 mg/1 | TABLET, FILM COATED | ORAL | 69238-2093 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 70710-1367 |
| 133 mg/1 | TABLET, FILM COATED | ORAL | 70771-1621 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 68071-3695 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 76282-677 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 16714-534 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 42291-980 |
| 100 mg/1 | TABLET, FILM COATED | ORAL | 59651-165 |
+ 30 more variants
Detailed information about Emtricitabine And Tenofovir Disoproxil Fumarate
Emtricitabine is a potent nucleoside reverse transcriptase inhibitor (NRTI) used in the treatment and prevention of HIV-1 infection, often as part of combination antiretroviral therapy.
For the treatment of HIV-1 infection or for use in Pre-Exposure Prophylaxis (PrEP), the standard adult dosage of Emtricitabine is 200 mg taken orally once daily. In the context of PrEP, it is vital that the medication is taken every single day to maintain protective levels in the body tissues. Clinical trials have shown that the efficacy of PrEP is highly dependent on adherence; missing doses significantly increases the risk of HIV acquisition. When used for HIV treatment, Emtricitabine must be used as part of a multi-drug antiretroviral regimen. Your healthcare provider will select the specific combination based on your medical history and viral resistance testing.
Emtricitabine is approved for use in pediatric patients, including neonates. The dosage for children is typically calculated based on body weight to ensure safety and efficacy.
Healthcare providers must carefully monitor pediatric growth and development while the child is on this medication.
Because Emtricitabine is primarily cleared by the kidneys, patients with decreased kidney function require dosage interval adjustments to prevent drug accumulation and toxicity. According to the FDA-approved labeling, the following adjustments are recommended based on Creatinine Clearance (CrCl):
For patients on hemodialysis, the dose should be administered after the dialysis session if the dose falls on a dialysis day.
No dosage adjustment is typically required for patients with hepatic (liver) impairment. However, since many patients taking Emtricitabine may also have chronic Hepatitis B or C, liver function must be monitored closely.
Clinical studies did not include enough subjects aged 65 and over to determine if they respond differently than younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Emtricitabine should be taken at the same time every day to maintain a consistent level of the drug in your system.
If you miss a dose of Emtricitabine, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up. Consistency is the most important factor in preventing viral resistance and ensuring the effectiveness of PrEP.
There is no specific antidote for Emtricitabine overdose. If an overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment should be applied as necessary. Hemodialysis can remove approximately 30% of an Emtricitabine dose over a 3-hour period. If you suspect an overdose, contact your local poison control center or seek emergency medical attention immediately. Symptoms of overdose may include severe nausea, vomiting, or an intensification of common side effects.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as this can lead to viral resistance or a 'flare-up' of underlying conditions like Hepatitis B.
In clinical trials, Emtricitabine was generally well-tolerated, but some patients experienced side effects, particularly during the first few weeks of treatment. Common side effects (occurring in more than 10% of patients) include:
Emtricitabine is a potent medication that requires careful medical supervision. It is not a cure for HIV-1 infection or AIDS. Patients must remain under the care of a physician experienced in treating infectious diseases. It is also important to understand that while taking Emtricitabine for PrEP reduces the risk of getting HIV, it does not protect against other sexually transmitted infections (STIs) such as syphilis, chlamydia, or gonorrhea. Consistent condom use and regular STI testing remain essential components of a comprehensive sexual health strategy.
All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy or PrEP. Emtricitabine is not approved for the treatment of chronic HBV infection. In patients co-infected with HIV-1 and HBV, severe acute exacerbations of Hepatitis B have been reported after the discontinuation of Emtricitabine. Liver function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV-1 and HBV and discontinue Emtricitabine. If appropriate, initiation of anti-Hepatitis B therapy may be warranted.
Emtricitabine should not be administered concurrently with other medications that contain Emtricitabine or its close chemical relative, Lamivudine (3TC). Because Lamivudine and Emtricitabine are both cytidine analogs and work via the same mechanism, taking them together provides no additional benefit and significantly increases the risk of toxicity. Common brand names containing these ingredients include Epivir, Combivir, Trizivir, and Epzicom.
While Emtricitabine does not interact with the Cytochrome P450 enzyme system, it is primarily excreted by the kidneys via glomerular filtration and active tubular secretion. Therefore, drugs that reduce renal function or compete for active tubular secretion may increase the concentration of Emtricitabine in the blood.
Emtricitabine is absolutely contraindicated in patients with a known hypersensitivity (severe allergy) to Emtricitabine or any of the inactive ingredients in the formulation. An allergic reaction may manifest as a severe skin rash, hives, swelling of the face or throat, or difficulty breathing. If a hypersensitivity reaction occurs, the drug must be discontinued immediately and never restarted.
Another absolute contraindication is the use of Emtricitabine as monotherapy for the treatment of HIV-1 infection. Using only one drug to treat HIV allows the virus to quickly develop mutations that make it resistant to the medication. Once resistance develops, the drug will no longer work for that patient, and they may pass a resistant strain of the virus to others. For treatment, Emtricitabine must always be part of a complete antiretroviral regimen.
Relative contraindications require a careful risk-benefit analysis by a healthcare professional:
Emtricitabine is generally considered one of the safer antiretroviral drugs to use during pregnancy. It is classified as Pregnancy Category B (under the old FDA system). Extensive data from the Antiretroviral Pregnancy Registry (APR) has shown no increase in the risk of major birth defects when Emtricitabine is used during the first, second, or third trimesters compared to the background rate in the general population.
For pregnant individuals living with HIV, maintaining an undetectable viral load is the most effective way to prevent mother-to-child transmission of the virus. Therefore, healthcare providers often recommend continuing Emtricitabine-based therapy throughout pregnancy. There is no evidence of teratogenicity (harm to the fetus) in animal studies at doses much higher than human therapeutic levels.
In the United States and other regions where safe infant formula and clean water are available, the CDC and many medical associations recommend that individuals with HIV avoid breastfeeding to eliminate the risk of postnatal HIV transmission. Emtricitabine is known to pass into human breast milk. While the effects on the nursing infant are generally considered low-risk, the primary concern remains the potential for the infant to acquire HIV through breast milk or to develop drug-resistant HIV if they are infected. If you are taking Emtricitabine for PrEP and are HIV-negative, discuss the risks and benefits of breastfeeding with your doctor.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI). Its molecular structure is 5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. The addition of the fluorine atom at the 5-position of the cytidine ring increases its potency and extends its intracellular half-life compared to older analogs like Lamivudine.
Once inside the host cell, Emtricitabine is phosphorylated by cellular kinases (deoxycytidine kinase, cytidylate kinase, and nucleoside diphosphate kinase) into its active form: emtricitabine 5'-triphosphate. This active metabolite inhibits the HIV-1 reverse transcriptase enzyme by competing with the natural deoxycytidine 5'-triphosphate. Once the enzyme incorporates emtricitabine 5'-triphosphate into the viral DNA, the lack of a 3'-OH group prevents the formation of a 5' to 3' phosphodiester bond. This causes obligate chain termination, effectively stopping the synthesis of viral DNA and preventing the virus from integrating into the host genome.
Emtricitabine shows high antiviral activity against HIV-1, with IC50 values (the concentration needed to inhibit 50% of viral replication) in the low micromolar range. It is also active against the Hepatitis B virus (HBV). The relationship between the concentration of the drug in the blood and its effect is well-established; however, the intracellular concentration of the triphosphate form is the most accurate predictor of antiviral efficacy. Because of its high potency and long intracellular half-life, the drug provides sustained suppression of viral replication throughout a 24-hour dosing interval.
Common questions about Emtricitabine And Tenofovir Disoproxil Fumarate
Emtricitabine is primarily used for the treatment of HIV-1 infection in adults and children, always in combination with other antiretroviral medications. It is also a key component of Pre-Exposure Prophylaxis (PrEP), which is a strategy used by HIV-negative individuals at high risk of exposure to prevent acquiring the virus. By inhibiting the reverse transcriptase enzyme, it stops the virus from replicating and spreading within the body. While it is highly effective at managing HIV, it is not a cure for HIV or AIDS. Your doctor will determine the best way to use this medication based on your specific health needs and viral profile.
The most frequently reported side effects of Emtricitabine include headache, diarrhea, nausea, and fatigue. Some patients also experience dizziness, insomnia, or vivid dreams, particularly when starting the medication. A unique but generally harmless side effect is hyperpigmentation, which is the darkening of the skin on the palms of the hands or soles of the feet. Most of these symptoms are mild and tend to improve as the body adjusts to the medication over several weeks. However, if you experience severe abdominal pain, yellowing of the skin, or extreme tiredness, you should contact your healthcare provider immediately as these could be signs of rare but serious complications.
There is no known direct chemical interaction between Emtricitabine and alcohol that would make it unsafe to consume in moderation. However, both alcohol and certain HIV medications can put stress on the liver, so excessive drinking is generally discouraged. Furthermore, heavy alcohol use can lead to missed doses, which is dangerous because consistency is vital for the drug's effectiveness. Maintaining a regular dosing schedule is the most important factor in preventing viral resistance. If you have underlying liver disease, such as Hepatitis B or C, you should discuss your alcohol consumption with your doctor to ensure it does not worsen your condition.
Yes, Emtricitabine is considered one of the preferred medications for treating HIV during pregnancy. Extensive data from the Antiretroviral Pregnancy Registry has shown no increased risk of birth defects in babies whose mothers took the drug. For pregnant individuals living with HIV, taking antiretroviral therapy is essential to reduce the risk of passing the virus to the baby. Healthcare providers generally recommend continuing the medication throughout the pregnancy to maintain an undetectable viral load. Always inform your doctor if you are pregnant or planning to become pregnant so they can provide the most up-to-date guidance for your specific situation.
Emtricitabine begins working to inhibit viral replication shortly after the first dose is taken and absorbed into the cells. However, it may take several weeks or even months of consistent daily use to reach an 'undetectable' viral load in the blood. For those taking it as part of PrEP, it typically takes about 7 to 20 days of daily dosing to reach maximum protective levels in various body tissues. It is crucial to take the medication exactly as prescribed every day, even if you do not 'feel' it working. Your doctor will perform regular blood tests to monitor your viral load and ensure the treatment is effective.
You should never stop taking Emtricitabine without first consulting your healthcare provider. Stopping the medication suddenly can cause the amount of HIV in your blood to increase rapidly, which can lead to illness and make the virus harder to treat in the future. For patients who also have chronic Hepatitis B, stopping Emtricitabine can cause a severe and dangerous 'flare-up' of the hepatitis virus, potentially leading to liver failure. If you need to stop the medication for any reason, your doctor will need to monitor your health very closely for several months. Always ensure you have an adequate supply of your medication so you do not run out.
If you miss a dose of Emtricitabine, take it as soon as you remember that same day. However, if it is nearly time for your next scheduled dose, you should skip the missed dose and simply take your next dose at the regular time. Never take two doses at once to make up for a missed one, as this can increase the risk of side effects. For the medication to be most effective, especially for PrEP, it needs to be taken at roughly the same time every day. If you find yourself frequently forgetting doses, talk to your doctor or pharmacist about tools like pillboxes or phone apps to help you stay on track.
Emtricitabine itself is not strongly associated with significant weight gain, but it is often taken in combination with other drugs that are. Recent clinical studies have suggested that some newer antiretroviral combinations, particularly those containing Integrase Inhibitors and Tenofovir Alafenamide (which is often paired with Emtricitabine), may lead to more weight gain than older regimens. This weight gain is often more pronounced in women and people of color. If you are concerned about changes in your weight while taking this medication, discuss it with your healthcare provider. They can help determine if the weight change is due to the medication, improved health, or other lifestyle factors.
Emtricitabine can be taken with many other medications, but there are important exceptions. It should never be taken with Lamivudine, as they are too similar and will increase toxicity without added benefit. It can also interact with other drugs that are cleared by the kidneys, such as certain antivirals (like cidofovir) or high doses of NSAIDs. Because Emtricitabine is usually part of a combination pill, you must also consider the interactions of the other ingredients in that pill. Always provide your doctor with a complete list of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements you are taking to avoid dangerous interactions.
Yes, Emtricitabine is available as a generic medication in many countries, including the United States. Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name version (Emtriva). Using generic Emtricitabine can significantly reduce the cost of treatment for patients and healthcare systems. Many of the combination pills that contain Emtricitabine, such as the generic version of Truvada (Emtricitabine/Tenofovir Disoproxil Fumarate), are also widely available. Check with your pharmacist or insurance provider to see if a generic version is a suitable and cost-effective option for you.
Other drugs with the same active ingredient (Emtricitabine)
> Warning: Stop taking Emtricitabine and call your doctor immediately if you experience any of the following serious symptoms:
Emtricitabine carries a FDA Black Box Warning regarding the post-treatment exacerbation of Hepatitis B. In patients co-infected with HIV-1 and HBV, stopping Emtricitabine has been associated with severe, acute exacerbations of Hepatitis B. These 'flare-ups' can lead to liver failure. If you have Hepatitis B and stop taking Emtricitabine, your doctor will need to monitor your liver function closely for several months through both clinical and laboratory follow-ups. If necessary, initiation of anti-hepatitis B therapy may be warranted.
Report any unusual symptoms or changes in your health to your healthcare provider immediately. Regular blood tests are necessary to monitor for these side effects.
To ensure the safe use of Emtricitabine, your healthcare provider will require regular laboratory monitoring, including:
Emtricitabine generally does not interfere with the ability to drive or operate machinery. However, some patients have reported dizziness or fatigue. If you experience these symptoms, avoid hazardous activities until you know how the medication affects you.
There are no known direct interactions between Emtricitabine and alcohol. However, excessive alcohol consumption can strain the liver and may interfere with your ability to adhere to a daily medication schedule. Discuss your alcohol intake with your doctor.
Never stop taking Emtricitabine without consulting your doctor. Sudden discontinuation can lead to a 'rebound' in viral load, increasing the risk of illness and transmission. For patients with Hepatitis B, stopping the drug can cause a life-threatening liver flare-up. If the drug must be stopped, your doctor will provide a specific plan for monitoring and potentially starting alternative medications.
> Important: Discuss all your medical conditions, especially kidney or liver disease, with your healthcare provider before starting Emtricitabine.
Emtricitabine has no significant interactions with specific foods. It can be taken with or without meals. Unlike some other HIV medications, it does not require a high-fat meal for absorption, nor is it affected by dairy or caffeine. However, maintaining a healthy, balanced diet is recommended to support overall immune health while managing HIV.
Emtricitabine does not typically interfere with standard laboratory tests, other than the intended effects on viral load and CD4 counts. However, it can cause asymptomatic increases in creatine kinase (CK), which is an enzyme released when muscle tissue is damaged. If your CK levels are elevated, your doctor will investigate whether it is due to the medication, intense exercise, or another underlying cause.
For each major interaction, the management strategy usually involves either avoiding the combination or increasing the frequency of kidney function monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers and vitamins.
There is a potential for cross-sensitivity between Emtricitabine and Lamivudine. Because these two drugs are chemically very similar, a patient who has had a severe allergic reaction to Lamivudine should not take Emtricitabine unless specifically directed by an allergist or infectious disease specialist under controlled conditions.
> Important: Your healthcare provider will evaluate your complete medical history, including any previous drug allergies and your current kidney and liver function, before prescribing Emtricitabine.
Emtricitabine is FDA-approved for use in pediatric patients from birth through adolescence. It is available in an oral solution specifically for infants and children who cannot swallow pills. Clinical trials have demonstrated that the safety and efficacy profile in children is similar to that in adults. The most common side effect reported in children is hyperpigmentation (skin darkening). Pediatric patients must have their doses adjusted as they grow and gain weight to ensure they continue to receive an effective amount of the medication.
There is limited data on the use of Emtricitabine specifically in patients over the age of 65. However, older adults are more likely to have decreased kidney function (reduced GFR). Since Emtricitabine is cleared by the kidneys, elderly patients are at a higher risk of drug accumulation and toxicity. Healthcare providers should assess renal function before starting the drug and monitor it frequently. Additionally, older patients may be taking multiple other medications (polypharmacy), increasing the potential for drug interactions involving the kidneys.
Renal impairment is a significant consideration for Emtricitabine. For patients with a Creatinine Clearance (CrCl) below 50 mL/min, the dosing interval must be extended (e.g., taking the pill every 48, 72, or 96 hours instead of every 24 hours). For patients on hemodialysis, the drug is partially removed during the procedure, so the dose should be administered after the dialysis session. Failure to adjust the dose in renal impairment can lead to high blood levels of the drug, increasing the risk of side effects like headache and gastrointestinal distress.
No dose adjustment is required for patients with liver impairment. However, as noted, patients with Hepatitis B must be monitored for liver 'flares' if the drug is stopped. The pharmacokinetics of Emtricitabine have not been specifically studied in patients with severe hepatic impairment (Child-Pugh Class C), so caution is still advised in this population.
> Important: Special populations require individualized medical assessment and frequent monitoring to ensure the safest possible treatment outcome.
| Parameter | Value |
|---|---|
| Bioavailability | ~93% |
| Protein Binding | < 4% |
| Half-life (Plasma) | ~10 hours |
| Half-life (Intracellular) | ~39 hours |
| Tmax | 1–2 hours |
| Metabolism | Minimal (not CYP dependent) |
| Excretion | Renal (86%), Fecal (14%) |
Emtricitabine is a Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]. It is closely related to Lamivudine (3TC) but is generally considered more potent. It is a core component of many 'single-tablet regimens' (STRs) used in modern HIV management. Within the NRTI class, it is often paired with a nucleotide analog like Tenofovir to provide a 'backbone' for antiretroviral therapy.