Tavin L (Tenofovir Disoproxil Fumarate, Lamivudine)

DESCRIPTION

Tavin L     tablets are containing anti-viral agents known as tenofovir disoproxil Fumarate and Lamivudine Tavin L     is pharmacologically categorized as adenine analogue reverse transcriptase inhibitor containing anti-viral activity against HIV-1 & hepatitis B.

Lamivudine: reverse transcriptase inhibitor, Zalcitabine analogue, nucleoside analogue Tavin L     is also classified as nucleoside reverse transcriptase prohibitor of adenosine. Tavin L     is used for both HIV-1 & HBV infectious condition.

INDICATION

The primary indications of Tavin L     are; HIV-1 infection

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

MECHANISM OF ACTION

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. Tenofovir is used to halt the viral DNA synthesis which is a process of chain elimination. Lamivudine: Lamivudine after absorption, undergoes phosphorylation intracellularly leads to form an active moiety known as lamivudine 5’ triphosphate (nucleoside analogue). This metabolite gets inserted into DNA of HIV virus which is aided by HIV RT & HBV polymerase.

ADME PROPERTIES

ABSORPTION

After absorption of Tenofovir tablets, the mean oral bioavailability is reaches by almost 25% and Lamivudine is 86% plus or minus 16% by very quick absorption. The Tenofovir peak serum concentration time occurs in 1 hour plus or minus 0.4 hours. Tavin L     administered with food, causes elevation of oral bioavailability by almost 40%.

DISTRIBUTION

Tenofovir get bounds to human plasma protein or serum proteins by less than 0.7 & 7.2% respectively. Lamivudine get binds to human plasma protein by <36%

METABOLISM

No cytochrome isoenzymes are involved in the metabolism of Tenofovir. Lamivudine get metabolized by undergoing biotransformation.

EXCRETION

The elimination of Tenofovir occurs via glomerular filteration & active tubular secretion. After oral administration of single dose of Tenofovir, reaches half life period at almost 17 hours. Nearly 70 to 80% of dose gets eliminated via urine & feces. Lamivudine eliminated by urine and half life of Lamivudine: 5 to 7 hours

DOSAGE MANAGEMENT

DOSAGE & ADMINISTRATION OF TENVIR L

The Tavin L     recommended dose for adult suffering from HIV infection The administrated one tablet orally given onace a day with combination of other antiretroviral agents. In pediatric patients dose: The patients should weighing atleast 35kg administrated one tablet given once a day via orally with combination of other antiretroviral agents.

OVERDOSAGE

There are no known specific treatment for 3TC overdose, If occurs patients should monitored and provide supportive treatment because negligible 3TC amount was removed through 4 hours hemodialysis and Tenofovir clinical experience of overdose is limited

SIDE EFFECTS

THE MOST COMMON ADVERSE EFFECTS ARE
Serious acute aggravation of hepatitis New commencement of worsening bone pain Muscle weakness Arms, hands ,leg or feet pains Swelling around your midsection Kidney problem such as no urination, feet and ankles swelling Signs of liver and pancreas problem Appetite decreased, upper stomach painclay-stools. Signs of new infection : fever, sweaing at night, swollen glands,weight loss

COMMON SIDE EFFECTS
Headache Pain Diarrhea Rash depression

PRECAUTION

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 Tavin L     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 Tavin L     and produced adverse effects. In some condition, over dosage or duplication of therapy should be occurred. Avoid the combination of Tavin L     with Trustiva, Viraday or Atripla.

HIV-1 & HBV CO INFECTION

Before initiating Tavin L     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 tenofovir DF 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.

VIROLOGIC FAILURE

Increased resistance condition leads to loss of virological responses. Caution should be taken during receiving the triple dose regimen. Monitor the patient’s resistance capacity frequently during the therapy.

DRUG INTERACTION

Tavin L     can harm your kidneys, specifically if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, or pain or arthritis (including aspirin, Tylenol, Advil, and Aleve).

Interaction with HIV-1 protease inhibitors may decrease Tenofovir AUC. Hence avoid CIMDUO should be discontinued Interaction with hepatitis C drugs may shown to increase Tenofovir exposure Other drugs may affect Tavin L     , involving prescription and over-the-counter medicines, vitamins, and herbal products.

Tell your doctor about all your current medicines and any medicine you start or stop using.

CONTRAINDICATIONS

No possible contraindication occurs Some hypersensitivity reactions are produced, if patients are contraindicated to ingredients of Tavin L     .

PREGNANCY & LACTATION

Pregnancy category of Tenofovir is B and Lamivudine is C Tavin L     should be used in pregnancy period only after knowing the risk benefits related to Tenvir L. 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.

STORAGE

The storage of Tavin L     is kept at temperature 25°C; allowed between 20°C to 25°C Protect the container from light Keep away from moisture & heat

MISSED DOSE

Tavin L     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