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ADME process


After absorption of Tenof EM , reaches maximum plasma concentration time are; Emtricitabine: 1 to 2 hours; tenofovir DF: 1.0 plus or minus 0.4 hour. The oral bioavailability of tenofovir is occurs by 25%, by administering with food, bioavailability reaches by 40%.


Tenofovir has low binding capacity, <0.7% to human plasma proteins & <7.2% to serum proteins. Emtricitabine has low protein binding capacity by less than 4%.


The metabolism of Tenofovir DF not induced by cytochrome isoenzymes The metabolism of Emtricitabine is induced by undergoing biotransformation.


The elimination of Tenof EM is occurs through glomerular filteration & active tubular secretion. The half lives of Tenof EM is Tenofovir DF: 17 hours with range of 12.0 to 25.7 hours. Emtricitabine: 10 hours with range of 7.4 to 18.0 hours


Brand : Tenof EM
Ingredients : Tenofovir disoproxil fumarate & Emtricitabine
Strength : 300mg & 100mg
Manufactured : Hetero
Package : 30 Tablets

Dosage & Administration of Tenof EM

1. Before begin the treatment using with Tenof EM , patient should be examine thoroughly for presence of HBV infection or not. Hepatic function test & renal function test should be monitored. 2. Patients receiving Tenof EM for PrEP, screening the HIV-1 infection for once three months.

Dosage recommendation

The advised dose of Tenof EM for adults & pediatric with weight of at least 35kg is one tablet should be administered as once daily by taking with food or without food.

For PrEP condition

One Tenof EM tablet should be taken as once daily for both adults & pediatric with weight of at least 35kg.

Dosage adjustment for renal impaired patients

CrCl ≥50ml/min, one tablet should be taken for every 24 hours CrCl 30 to 49ml/min, one Tenof EM tablet should be taken for every 48 hours CrCl <30ml/min, Tenof EM tablet should not be recommended

Side effects of Tenof EM

Lactic acidosis & hepatic steatosis Serious exacerbation of HBV Renal damage Immune reconstitution syndrome Bone defects

Common effects

Headache Insomnia Nasopharyngitis Vomiting Fatigue Depression Nausea Diarrhea Respiratory tract infection Sinusitis Rash

Lab abnormalities

Increased alkaline phosphatase Increased AST & ALT Anemia Increased blood glucose Hematuria Glycosuria Increased cholesterol Elevation of serum lipase Increased creatine kinase Neutropenia

Post marketing effects

Renal & urinary disorders Hepatobiliary disorders Musculoskeletal disorders

Lactic acidosis & hepatic steatosis

This fatal condition is occurs due to increased hepatic enzymes. To prevent this condition by monitoring the hepatic functions & hepatic enzymes levels. In severe condition, Tenof EM should be stopped.

Due to drug interactions

Some combinational therapy leads to cause severe adverse effects. Tenof EM should not be combined with Trustiva, Atripla, or Viraday.

HIV-1 & HBV co infection

Due to exposure of advancement of HIV-1 resistance, Tenof EM should be used in patients who are co infected with HIV-1 HBV by combining with other anti-retroviral drugs. Before initiating the treatment, patient should examined by testing the HIV-1 antibody

Aggravation of HBV infection

This severe fatal case is occurs, after conclusion of anti-hepatitis B treatment. To prevent this effect by monitoring the patient’s hepatic functions before begin the therapy. In final condition, patient should be resuming with anti-HBV therapy.

Bone defects

The major risk of Tenof EM is loss of bone mineral density. To overcome the problem by providing the vitamin D supplements.

Newly commenced or aggravation of renal impaired patients

To prevent this worsening condition, patients renal function should be examine clearly by measuring the creatinine clearance, urine protein, urine glucose levels. Avoid the concomitant use of Tenof EM with drugs affecting the renal functions.

Immune reconstitution syndrome

This is most frequently occurred in anti-retroviral agents receiving patients. In this condition, Tenof EM should be discontinued and provide a supportive measures.

Loss of virological response

During the combination of triple dose regimens, resistance will produced and leads to loss of activity. Monitoring the patients thoroughly while using triple dose regimen, if resistance formed or not.


Warning and precaution

Tenof EM co administered with HIV-1 protease inhibitors, leads to decreasing the AUC & Cmin value of these protease inhibitors. Avoid the concomitant of Tenof EM with protease inhibitors. Tenof EM combines with hepatitis C viral agents, causes elevation of risk of tenofovir by increasing its concentration. Tenof EM combines with drugs affecting the renal functions causes increasing the concentration of component of Tenof EM and increase the risk associated with Tenof EM . Tenof EM combined with Didanosine causes increasing effect of concentration of Didanosine and leads to elevating the adverse effects related to Didanosine.


Tenof EM for PrEP is contraindicated to patients with unidentified or positive HIV-1 satus. Hypersensitivity reactions are formed if patients are contraindicated to component of Tenof EM .

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