Tenolam

Tenolam tablets are containing anti-viral agents known as tenofovir disoproxil fumarate and lamivudine. Tenolam is pharmacologically categorized as adenine analogue reverse transcriptase inhibitor containing anti-viral activity against
HIV-1. Tenolam is used by combining with other anti-viral agents for better activity. Tenolam is present as prodrug form, which get converted into an active moiety in-vivo. Tenolam is also classified as nucleoside reverse transcriptase prohibitor of adenosine.

Tenofovir disoproxil fumarate + lamivudine

Tenolam

300mg + 300mg

Mylan





Indication of Tenolam

The primary indications of Tenolam are; HIV-1 infection

For HIV-1 infection

Tenolam is used by combining with other anti-retroviral agents during this condition. Tenolam is applicable for adults & pediatrics with age of 2 years & older. Before beginning the treatment with Tenolam , caution should be taken; Avoid combination of Tenolam with Atripla.

Mechanism of Tenolam

Tenofovir DF

Tenolam containing an active component like Tenofovir disoproxil fumarate is a prodrug which gets altered into Tenofovir by undergoing intracellular mechanism. Tenofovir is show a hostile to viral action by forbidding the turnaround transcriptase compound by battling with regular substrate deoxyadenosine 5' triphosphate and after addition into DNA, by viral DNA chain eliminator. Tenolam is used to halt the viral DNA synthesis which is a process of chain elimination.

Lamivudine

Lamivudine undergoes phosphorylation intracellularly, to form active moiety known as 5’ triphosphate metabolite, lamivudine triphosphate which exhibits anti-retro viral action. The most important action of this metabolite is prohibition of reverse transcriptasethrough DNA chain elimination which is occurring after insertion of nucleoside analogues




PHARMACOKINETIC

After absorption of Tenolam tablets, the mean oral bioavailability is reaches by almost 25% is Tenofovir DF and Lamivudine: 86 ± 16%; The high serum concentration time occurs in 1 hour plus or minus 0.4 hours is Tenofovir DF. Tenolam administered with food.

Tenofovir DF get bounds to human plasma protein or serum proteins by less than 0.7 & 7.2% respectively and <36% for lamivudine.

No cytochrome isoenzymes are involved in the metabolism of Tenofovir DF. The known metabolite of lamivudine is trans-sulfoxide metabolite. Biotransformation is occurred by using sulfotransferases.

The elimination of Tenofovir DF occurs via glomerular filtration & active tubular secretion. After oral administration of single dose of Tenofovir DF, reaches half-life period at almost 17 hours. Nearly 70 to 80% of dose gets eliminated via urine & feces. The major route of elimination of lamivudine occurs via urine as an unchanged form. It also excreted in human milk. The terminal half-life period of lamivudine is 5 to 7 hours.





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Tenolam
Brand Tenolam
Ingredients Tenofovir disoproxil fumarate + lamivudine
Strength 300mg + 300mg
Manufactured Mylan
Rating


In HIV-1 infection; (adults & pediatric patients 2 years to less than 12 years of age

Before beginning the therapy with Tenolam , patient should be examined for presence of HBV infection or not. Follow Renal function & liver function test before the treatment. The Tenolam recommended dose for adult suffering from HIV infection The administrated one tablet orally given once a day with combination of other antiretroviral agents. Tenolam is a three-drug fixed dose combination; it should be administered on an empty stomach. This tablet should be consumed at bed time due to reducing the neurological problems.

Tenolam should not be prescribed for

Patients who have creatinine clearance less than 50ml/min With severe renal impairment Hemodialysis patient Tenolam should not be used for; Moderate & severe liver impairment patients In pediatric patient’s dose: The patients should be weighing at least 35kg administrated one tablet given once a day via orally with combination of other antiretroviral agents.

The most common adverse effects are

Serious acute aggravation of hepatitis New commencement of worsening renal damage, Lactic acidosis, Hepatic steatosis, Bone defects, Immune reconstitution syndrome

The most common side effects

Headache, Pain, Fever, Abdominal pain, Back pain, Asthenia, Diarrhea, Nausea, Dyspepsia, Vomiting, Muscular skeletal disorders, Arthralgia, Myalgia, Depression, Dizziness, Insomnia, Peripheral neuropathy, Anxiety, Respiratory , Pneumonia, Skin rashes, Anemia

Aggravation of hepatitis infection

After conclusion of treatment, patients may suspect with worsening of HBV infection condition. Patient infected with HBV condition should be monitored frequently after discontinuing the HBV anti-viral therapy. In this condition, patient should be resuming the anti-HBV treatment.

New outbreak or worsening of renal damage

Avoid combination of Tenolam with drugs affecting the renal function. Monitor the renal function by measuring the creatinine clearance, serum protein, serum glucose levels.

Lactic acidosis & hepatic steatosis

This condition should be takes place due to imbalance level of hepatic enzymes. To overcome the problem by monitoring the hepatic function test In severe condition, therapy should be discontinued.

Drug interactions

Some drugs may interact with activity of Tenolam and produced adverse effects. In some condition, over dosage or duplication of therapy should be occurred. Avoid the combination of Tenolam with Trustiva, Viraday or Atripla.

HIV-1 & HBV co infection

Before initiating Tenolam treatment in co infected patients, HIV-1 antibody testing should be undergone. Examine the HIV-1 infected patients thoroughly whether they are co infected with HBV infection or not.

Bone defects

During Tenolam receiving condition, patients bone mineral density will be drops and causes bone related defects like osteomalacia. To overcome the problem by maintain the calcium levels in the body by supplying vitamin D supplements.

Immune reconstitution syndrome

During anti-retroviral treatment, patients must acquire this fatal case. In this condition, discontinue the treatment.


DRUG INTERACTION



  • Interaction with HIV-1 protease inhibitors may decrease Tenofovir AUC. Hence avoid CIMDUO should be discontinued
  • Interaction with hepatitis C drugs may show to increase Tenofovir exposure
  • Tenolam with drugs affecting the renal functions causes increased concentration of tenofovir and leads to increase the adverse effects.
  • Tenolam should not be combined with cannabinoids receptors
  • Tenolam with CYP3A inducers causes increased clearance of Tenolam & leads to reduce the plasma concentration.
  • Interaction of Tenolam with warfarin causes fluctuation in prothrombin time & INR values.
  • Tenolam combination with anti-fungal, anti-depressants, or anti-infective causes reduced effect of concentration of these drugs.
  • Interaction of Tenolam with anti-malarial, anti-mycobacterial, calcium channel blockers, or lipid lowering drugs causes decreased effect of concentration of these drugs.
  • Tenolam should not be combined with other anti-retroviral drugs. Tenolam should not be combined with QT prolonged drugs




Contraindications of Tenolam


Some hypersensitivity reactions are produced, if patients are contraindicated to ingredients of Tenolam .



Pregnancy category of Tenolam is tenofovir DF is B Lamivudine is C Tenolam should be used in pregnancy period only after knowing the risk benefits related to Tenolam . Counsel the patients about the risk before initiating the treatment.

Breast feeding should not be allowed for preventing the spreadness of infection from mother to baby. Breastfeeding should have avoided during treatment

The storage of Tenolam is kept at temperature 20-25°C; allowed between 15°C to 30°C (59 – 86°F) Protect the container from light Keep away from moisture & heat

Tenolam is a single dose regimen. In case of missed dose, patient must be get advice from medical practitioner & follow the instructions. Maintain the regular dosing schedule. Skip the missed dose if possible

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