Product Details
EMTRICITABINE-TENOFOVIR 200-300MG TAB 30
Manufacturer: Amneal
MFG#: 69238-2095-03
NDC: 69238-2095-03
PID: 281982
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Product Properties:
| Description | - |
|---|---|
| Description | N |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | AB |
| Drug Category | - |
| Drug Category | USES: This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details. |
| Drug Type Code | N |
| Drug Type Code | COMMON BRAND NAME(S): Truvada |
| FDA Approval Date | 03/31/2021 |
| FDA Therap Equiv | TAB |
| HCPCS | - |
| HCPCS | 1 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (EM-trye-SYE-ta-been/ten-OF-oh-vir) |
| Termination Date | 1 |
| Unit | 30 |
| Units Per Pkg | 08/22/2018 |
| Active Ingredients | 1321 emtricitabine 143491570; 9358 tenofovir disoproxil fumarate 202138509 |
| Active Ingredients | 1321 emtricitabine 143491570; 9358 tenofovir disoproxil fumarate 202138509 |
| AHFS Class | 8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS |
| AHFS Class | 8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 57883 emtricitabine/tenofovir (TDF) ORAL TABLET 200-300 MG |
| Gen Code and Des | 57883 emtricitabine/tenofovir (TDF) ORAL TABLET 200-300 MG |
| Inactive Ingredients | - |
| Inactive Ingredients | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 200-300 MG |
| Strength | 200-300 MG |
| Common Brand Name | COMMON BRAND NAME(S): Truvada |
| Common Brand Name | - |
| Drug Interaction | - |
| Drug Interaction | DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: adefovir, orlistat, other drugs that may harm the kidneys (including aminoglycosides such as amikacin/gentamicin). Tenofovir can decrease the effectiveness of another medication, atazanavir (by decreasing blood levels). If you are taking atazanavir with this product, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details. Check the labels on all your medicines for HIV infection because they may contain the same or similar ingredients as those in this product (such as tenofovir, emtricitabine, lamivudine). Do not take medications that contain the same or similar ingredients as this product. |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 24 |
| Case Quantity | 24 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily with or without food. The dosage is based on your kidney function, medical condition, and response to treatment. For children, the dosage is also based on weight. When used to treat HIV infection, this product is taken with other medicines that treat HIV. If you are also taking didanosine enteric-coated tablets, take both products either on an empty stomach or with a light meal. If you are taking the didanosine buffered tablets, take both drug products on an empty stomach. It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day. Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. |
| How to Use | - |
| Missed Dose | 30 |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as kidney tests, urine glucose/protein, liver tests, viral load, T-cell counts, blood mineral levels, bone density tests, test for hepatitis B virus) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. |
| Notes | TAB |
| Overdose | AB |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Phonetic Pronunciation | (EM-trye-SYE-ta-been/ten-OF-oh-vir) |
| Phonetic Pronunciation | - |
| Precautions | PRECAUTIONS: Before taking emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to either of the medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), kidney disease. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you have HIV infection, treatment can lower the risk of passing HIV infection to your baby, and this medication may be part of that treatment. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Also, if you have HIV infection, do not breast-feed because breast milk can transmit HIV. |
| Precautions | - |
| Side Effects | - |
| Side Effects | SIDE EFFECTS: Diarrhea, headache, dizziness, trouble sleeping, back pain, or change in the color of skin on your palms or soles of your feet may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. As your immune system gets stronger with HIV treatment, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), signs of kidney problems (such as change in the amount of urine, pink/bloody urine). Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness). Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Storage | STORAGE: Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Storage | 08/22/2018 |
| Uses | - |
| Uses | USES: This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: emtricitabine and tenofovir. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir is called a nucleotide reverse transcriptase inhibitor. They are often called NRTIs. This product should not be used by itself to help control HIV infection. Doing so can make your treatment less effective. Combination treatment with at least one other HIV medication should be used. This product is also used to help prevent HIV infection in people who have a high risk for infection. Some things that increase risk include having a partner infected with HIV, having unprotected sex, having multiple sex partners, infection with a sexually transmitted disease-STD, or use/abuse of drugs or alcohol. Emtricitabine/tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details. |
Frequently Asked Questions (FAQs)
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EMTRICITABINE-TENOFOVIR 200-300MG TAB 30 is manufactured by Amneal.
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