Viread-Generic (tenofovir disoproxil fumarate) 300mg x30 tabs, Tenvir
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Price: $155.00
Product ID : tenvir_300
Manufacturer: CIPLA
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Description
Tenofovir Disoproxil Fumarate
Pronunciation: (ten-OH-foe-vir DYE-soe-PROX-il fue-MAR-ate)
Class: Nucleotide analog reverse transcriptase inhibitor Trade Names: Viread
- Tablets 300 mg (equivalent to tenofovir disoproxil 245 mg)
Manufacturer/Pricing: Manufacturer: Gilead Sciences DEA/FDA:
Approximate Retail Pricerom www.drugstore.com
- 300 mg (30 ea): $723.55 (this is the normal pharmacy price in the states)
Patient Education - English
- Generic Name: tenofovir
- Pronounced: ten OF oh vir
- Brand Name: Viread
What is the most important information I should know about tenofovir?
Do not take other medicines that also contain tenofovir (such as Truvada).
Some people have developed a life-threatening condition called lactic acidosis while taking tenofovir. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.
Tenofovir can also cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.
If you have hepatitis B you may develop liver symptoms after you stop taking tenofovir, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.
HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.
What is tenofovir?
Tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.
Tenofovir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Tenofovir is not a cure for HIV or AIDS. Tenofovir is also used to treat chronic hepatitis B.
Tenofovir may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking tenofovir?
Do not use this medication if you have ever had an allergic reaction to a medicine containing tenofovir, including Truvada.
You should not take tenofovir if you are also taking Truvada (emtricitabine/tenofovir) or adefovir (Hepsera).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking tenofovir, tell your doctor if you are allergic to any drugs, or if you have:
- liver disease (including hepatitis B);
- kidney disease; or
- bone problems (such as osteopenia).
Some people have developed a life-threatening condition called lactic acidosis while taking tenofovir. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.
Tenofovir can also cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.
Your name may need to be listed on an antiviral pregnancy registry when you start using tenofovir. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether tenofovir had any effect on the baby.
You should not breast-feed while you are using tenofovir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.
Tenofovir should not be given to a child unless your doctor has told you otherwise.
How should I take tenofovir?
Take tenofovir exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take tenofovir with a full glass of water.
Tenofovir can be taken with or without food.
It is important to take tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.
To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using tenofovir. Do not miss any scheduled visits.
Store tenofovir at room temperature away from moisture, heat, and direct light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an tenofovir overdose are not known.
What should I avoid while taking tenofovir?
Avoid drinking alcohol while taking tenofovir. Alcohol may increase the risk of damage to the liver.
Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
What are the possible side effects of tenofovir?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, dizziness, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired;
- kidney problems - increased thirst and urination, loss of appetite, weakness, constipation, urinating less than usual or not at all;
- fever, chills, body aches, flu symptoms; or
- any other signs of new infection.
Less serious side effects may include:
- sleep problems (insomnia), strange dreams;
- depression, headache, dizziness;
- diarrhea, bloating, gas;
- muscle or joint pain;
- skin rash; or
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Y
What other drugs will affect tenofovir?
Before taking tenofovir, tell your doctor if you are using any of the following drugs:
- amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
- pentamidine (Nebupent, Pentam);
- tacrolimus (Prograf);
- antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
- antiviral medicines such as acyclovir (Zovirax), cidofovir (Vistide), foscarnet (Foscavir), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);
- aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others;
- cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
- other HIV or AIDS medications such as atazanavir (Reyataz), didanosine (Videx), lopinavir and ritonavir (Kaletra).
This list is not complete and there are many other medicines that can interact with tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about tenofovir.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Pill Pictures
 Viread (tenofovir) 300 mg
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Indications and Usage
Treatment of HIV-1 infection in combination with other antiretroviral agents; treatment of chronic hepatitis B infection in adults.
Contraindications
Standard considerations.
Dosage and Administration
Adults
PO 300 mg/day without regard to food. The optimal duration of therapy for chronic hepatitis B is not known.
Renal Function Impairment
Adults
PO CrCl at least 50 mL/min, give 300 mg every 24 h; CrCl 30 to 49 mL/min, give 300 mg every 48 h; CrCl 10 to 29 mL/min, give 300 mg every 72 to 96 h.
Hemodialysis
Give 300 mg every 7 days or after a total of about 12 h of dialysis.
Storage/Stability
Store tablets at controlled room temperature (59° to 86°F).
Drug Interactions
Atazanavir
May increase tenofovir plasma levels. Tenofovir may decrease AUC and C min of atazanavir, decreasing the therapeutic effect. Do not administer atazanavir without ritonavir in patients receiving tenofovir.
Didanosine
Plasma concentrations of didanosine may be increased, increasing the risk of adverse reactions.
Drugs that reduce renal function or compete for active tubular secretion (eg, acyclovir, adefovir, dipivoxil, ganciclovir)
May increase serum levels of tenofovir and/or increase the levels of other renally eliminated drugs.
Lopinavir/Ritonavir
May increase tenofovir plasma levels.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Asthenia (11%); depression, headache (8%); peripheral neuropathy (5%); insomnia (4%); dizziness (3%).
Dermatologic
Rash including maculopapular rash, pruritus, pustular rash, urticaria, and vesiculobullous rash (7%); sweating (3%).
GI
Diarrhea (16%); nausea (11%); abdominal pain, vomiting (7%); anorexia, dyspepsia, flatulence (4%); hepatitis, increased liver enzymes, pancreatitis (postmarketing).
Genitourinary
Acute renal failure, acute tubular necrosis, Fanconi syndrome, interstitial nephritis, nephrogenic diabetes insipidus, polyuria, proteinuria, proximal tubulopathy, renal failure, renal insufficiency (postmarketing).
Lab Tests
Increased creatine kinase (12%); increased triglycerides (11%); increased ALT (10%); increased serum amylase (7%); increased AST (4%); glycosuria, increased serum glucose (3%); decreased neutrophils (2%).
Metabolic-Nutritional
Weight loss (4%); hypophosphatemia, lactic acidosis (postmarketing).
Musculoskeletal
Back pain, myalgia (4%); myopathy, osteomalacia (postmarketing).
Respiratory
Pneumonia (3%), dyspnea (postmarketing).
Miscellaneous
Pain (12%); fever (4%); chest pain (3%); allergic reaction (postmarketing).
Precautions
WarningsLactic acidosis and severe hepatomegaly with steatosis (including fatal cases) were reported with the use of nucleoside analogs alone or in combination with other antiretrovirals. Severe acute exacerbations of HBV have been reported in HBV-infected patients who have discontinued anti–hepatitis B therapy, including tenofovir. Monitor hepatic function closely with clinical and laboratory follow-up for at least several months in patients who discontinue tenofovir. If appropriate, resumption of anti–hepatitis B therapy may be warranted. |
MonitorMonitor renal function and serum phosphorous in patients at risk for, or with history of, renal dysfunction and patients receiving nephrotoxic agents. Monitor bone density in HIV-infected patients with history of pathologic bone fracture or who are at risk for osteopenia. Ensure that liver enzymes are evaluated before starting therapy and periodically thereafter during prolonged treatment. Monitor patient for signs and symptoms of lactic acidosis. If patient develops any of the following, withhold drug: profound weakness or tiredness; unexpected stomach discomfort; fatty diarrhea; feelings of coldness, dizziness, or light-headedness; slow or irregular heartbeat. |
Pregnancy
Category B .
Lactation
Undetermined. HIV-infected mothers should not breast-feed infants.
Children
Safety and efficacy not established.
Elderly
Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity.
Renal Function
See Route/Dosage section for recommended adjustments. Renal function impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia) has been reported. If possible, avoid using tenofovir in patients with concurrent or recent use of nephrotoxic agent.
Bone effects
Reduction in bone mineral density and fractures have been reported. Ensure that supplementation with calcium and vitamin D has been considered in patient with HIV-associated osteopenia or osteoporosis.
Fat redistribution
Accumulation and redistribution of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, may occur.
Hepatitis B
Discontinuation of anti–hepatitis B therapy may cause severe acute exacerbations of hepatitis. Test HIV patients for chronic HBV before starting antiretroviral therapy.
HIV-1
Test HBV patients for HIV-1 before starting therapy.
Immune reconstitution syndrome
During initial phase of therapy, patients whose immune system responds may develop an inflammatory response to indolent of residual opportunistic infections.
Lactic acidosis/severe hepatomegaly with stenosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Use with caution in patients with risk factors for liver disease.
Patient Information
- Advise patient or caregiver to review the patient information leaflet before starting therapy and with each refill.
- Advise patient to take tenofovir once daily without regard to meals but to take with food if stomach upset occurs.
- Instruct patient that if a dose is missed, to take it as soon as possible and take the next dose at the regularly scheduled time. If it is almost time for the next dose, advise patient to not take the missed dose and to take the next dose as scheduled. Caution patient not to double the next dose to catch up.
- Warn patient that this drug is not to be used by itself for HIV, but is combined with other antiviral agents.
- Instruct patient to report these symptoms immediately to health care provider: abdominal swelling or enlargement; fatty diarrhea; profound weakness or tiredness; unexpected stomach discomfort; feeling cold, dizzy, or light-headed; or slow or irregular heartbeat.
- Inform patient that drug does not completely eliminate HIV virus and therefore does not reduce risk of transmitting HIV to others. Appropriate precautions must still be followed.
- Advise patient that drug is not a cure for HIV infection and that illnesses associated with HIV infection, including opportunistic infections, may continue to be acquired. Patients should remain under a health care provider's care.
- Advise patient with HIV-associated osteopenia or osteoporosis to discuss need for supplementation with calcium and vitamin D with health care provider
- Advise HIV-infected mothers not to breast-feed to prevent infecting infants with HIV.
All Wholesale Prices are marked as F.O.B.-Panama / F.O.B.-Mexico; We ship via Commercial Air Cargo, DHL, Fedex, UPS or other private carriers. All our generic medicines are produced in W.H.O-Geneva or FDA Inspected and Approved Laboratories. This is a Generic drug and not a brand name medicine; because of it's generic form a compulsary licence(s) were issued in numerous countries allowing their fabrication, importation and distribution where they are legally permitted; and not in violation of any accords in regards to trademarks and patents. Be sure you are able to import these generic pharmaceuticals into your country prior to ordering; as some countries will not allow their importation.
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