Tenof

Tenofovir Disoproxil Fumarate

Tenof is a hetero product which is FDA authorized product, containing anti-viral activity against both HIV infection and HBV infection. . Tenof is a most dominant, first line therapy used by the patients only under the guidance of medical practitioner who are well trained

Tenof tablets used for;

Tenof tablets are primarily indicated in the conditions like; .

HIV infection:

In HIV infection, Tenof tablet is not used alone it may combined with other anti-retroviral medicines (like NNRTI or PI)

Chronic hepatitis B infection:

Tenof is used in the treatment of severe hepatitis B viral infection mainly in adults

tenof-tablet

Tenof tablets warning signs:

Tenof tablets used patients have chance to get; Lactic acidosis & severe hepatomegaly with steatosis After therapy, there is a chance of getting severe worsening of HBV viral infection .

Tenof works as:

Tenof comprises of tenofovir disoproxil fumarate (TDF), acyclic nucleoside phosphonate diester analogue of adenosine monophosphate .

TDF desires initial diester hydrolysis for alteration of TDF into tenofovir Tenofovir is a parent compound, which is further phosphorylated into tenofovir diphosphate with the support of cellular enzymes. This active metabolite tenofovir diphosphate acts as chain dominator

Tenof exhibits its activity by insertion of tenofovir diphosphate into viral DNA and prohibits the effect of HIV-1 & HBV reverse transcriptase against the natural substrate deoxyadenosine 5’-triphosphate after insertion

Tenof dosage:

Tenof is used as a single dose regimen

Tenof tablets should be taken with or without food

Tenof tablets recommended dosage in the conditions like HIV-1 & HBV infections; In adults & pediatric around the age of 12 years or weight of 35kg or more in hepatitis B infection and 2 years of age in HIV condition;

One Tenof tablet 300mg should be administered orally as a single dose with or without food The dosage of Tenof should be calculated on the basis of creatinine clearance value and body weight of the patients

In renal impairment patients, hemodialysis occurs weekly three sessions around 4 hours. Tenof tablets should be taken only after conclusion of dialysis

Depending on body weight of pediatrics:

  • 17 to <22kg: 150mg
  • 22 to <28kg: 200mg
  • 28 to <35: 250mg
  • ≥35kg: 300mg

In adults:

Depending on creatine clearance:

≥50ml/min: 300mg of Tenof should be given every 24 hours

30 to 49ml/min: 300mg should be recommended for every 48 hours

10 to 29 ml/min: 300mg recommended dosage for every 72 to 96 hours

In hemodialysis patients: Tenof tablets should be taken every 7 days or after 12 hours of dialysis

Tenof contraindicated to:

Tenof tablet have no contraindication But some hypersensitivity reaction may occur if patients are contraindicated to the component of Tenof tablet

Tenof tablet produce some side effects;

Some undesirable effects occur during or after the therapy;

Immune restructuring syndrome

Serious acute aggravation of hepatitis B infection

New outbreak of renal impairment

Depletion of bone mineral density

Lactic acidosis or serious hepatomegaly with steatosis

Some common effects;

  • Headache
  • pain
  • Fever
  • Abdominal pain
  • Back pain
  • Asthenia
  • Diarrhea
  • Nausea
  • Dyspepsia
  • Vomiting
  • Arthralgia
  • Myalgia
  • Depression
  • Insomnia
  • Dizziness
  • Anxiety
  • Lipodystrophy
  • Pneumonia
  • Rashes

Body works for Tenof tablets as:

Tenofovir disoproxil fumarate is a prodrug which is converted into an active form tenofovir in-vivo.

The oral bioavailability of Tenof tablet is reaches relatively at 25%

The peak serum concentration occurs within 1.0 hours ± 0.4 hours Binding of tenofovir with human plasma protein or serum proteins is occurred in-vitro as less than 0.7% & 7.2% respectively

The volume of distribution occurs at steady state 1.3±0.6L/kg The metabolism of Tenof tablet occurs hepatically to form active tenofovir diphosphate which is pharmacologically active form with the help of cellular enzymes

The terminal half life period of Tenof occurs nearly 17 hours The effect of food with Tenof tablet on oral administration, with high fat meals increase the oral bioavailability at 40 to 50%

Tenof precautions:

In lactic acidosis or serious hepatomegaly with steatosis: To avoid this problem, patient must discontinue the therapy or postpone Severity of hepatitis B infection after conclusion of therapy:

Patients who are discontinue the therapy, should be monitored frequently

Continue the therapy if required Aggravation of renal impairment

Mostly tenofovir is eliminated renally; creatinine clearance must be monitored periodically before starting the treatment

Serum phosphorus, renal protein, creatine clearance, urine glucose values should be monitored before begin the therapy Avoid concurrent use of Tenof with drugs which reduce the renal function or nephrotoxic agents Care should be taken while using in patients who are co infected with HIV-1 & HBV

Major adverse effect is bone mineral density depletion, may leads to osteoporosis to avoid this condition calcium and vitamin D supplements should be provided Mineralization defects occurs

Tenof drug interaction:

Tenof containing active component tenofovir disoproxil fumarate interacts with some drugs and produce adverse effects

Tenof tablet concomitant with Didanosine, while receiving these drug at same time may produce some adverse effects related to Didanosine to avoid this problem stop the Didanosine tablet immediately

While concurrent use of Tenof with HIV 1 protease inhibitor, increases the concentration of tenofovir Tenof is a substrate of P-gp & BCRP transporters, whereas co administration of Tenof with P-gp inhibitors may increase the absorption

Tenof with Lopinavir/ritonavir, ritonavir boosted atazanavir or ritonavir boosted darunavir should increase the tenofovir associated adverse effects

Tenof co administered with hepatitis C anti-viral agents may have a chance to increase the tenofovir exposure, Tenof is excreted through renal, if Tenof tablet concomitant with drugs which decrease the renal function may elevates the serum concentration of tenofovir disoproxil fumarate. Some examples like acyclovir, cidofovir, valganciclovir, valaciclovir, amino glycosides

Tenof storage:

Tenof tablet container should be stored at room temperature at below 30oC

Tenof should be kept in dry and cool place

Container should be keep away from moisture, heat and light

Pregnancy and lactation:

Tenof tablets should be safe to use But in some patients placental transformation occurs, in that condition Tenof should not be recommended

Generally HIV infected women not breast feed the child, to avoid spreading of infection to babies through human milk

Missed dose:

Tenof tablet should be used only under the guidance of medical practitioner, if patient fail to take the dose of Tenof tablet, must consult the physician and take the dose as soon as possible

Otherwise the missed dose should be discontinued and follow the regular dosing schedule Do not take over dose

Product description:

Brand

Tenof

ingredients

Tenofovir Disoproxil Fumarate

Strength

300mg

Mfg

Hetero labs

Pack

30 tablets in a container

Category

Anti-hepaciviral & Anti-retro viral agent