Description of Tavin EM
* Brand Name : TAVIN - EM
* Active ingredient: Tenofovir Disoproxil Fumarate +
* Manufactured by: Emcure Ltd
* Strength : 300 mg + 200mg
* Dosage Form : Tablets
* Packing : Pack of 30 Tablets
Tavin-EM is a combination of three active ingredients ( Emtricitabine + Tenofovir) is used alone or with other antiviral drug for the treatment of HIV infection. Tavin-EM will not cure or prevent HIV/AIDS. Tavin-EM suppress the HIV replication of virus cell and despite the destruction of the immune system. Tavin-EM may help to delay the problems arises from AIDS/HIV diseases. The medicine allowed to purchase only with doctors prescription.
Pharmacology of Tavin EM
MECHANISM OF ACTION:
An acyclic nucleoside phosphonate di ester associate of adenosine monophosphate is Tenofovir Disoproxil Fumarate ( Tavin-EM), that hydrolysed to Tenofovir, finally cellular enzymes phosphorylated to form Tenofovir diphosphate, an restrict chain terminator. Tenofovir involves with DNA synthesis of HIV through aggressive inhibition of reverse transcriptase and fusion into viral DNA. Tenofovir also prevents hepatitis B virus polymerase, resulting in blockage of viral replication.
Emtricitabine ( Tavin-EM ) is a synthetic nucleoside coordinate of cytidine, which go through phosphorylation occurring inside a cell to emtricitabine 5'-triphosphate, then take part with deoxycytidine 5'-triphosphate and is incorporated into viral DNA which leads to chain termination. Emtricitabine activity against HIV-1, HIV-2 viruses and hepatitis B virus (HBV).
ABSORPTION: Tenofovir ( Tavin-EM ) absorbed immediately from the GI tract, bioavailability with high fat meal is approx 25% and duration of peak plasma concentration (PPC) is 1-2hr. In Emtricitabine ( Tavin-EM ) , bioavailability is 93%(capsulel) and solution 75%, PPC is 1-2 hrs.
DISTRIBUTION: Tenofovir( Tavin-EM ) volume of distribution is 1.2-1.3 L/kg and plasma protein binding is <1%, In Emtricitabine ( Tavin-EM ) independent of concentration and protein binding is <4%. METABOLISM: Tenofovir Disoproxil Fumarate ( Tavin-EM , that hydrolysed to Tenofovir, finally cellular enzymes phosphorylated to form Tenofovir diphosphate, an restrict chain terminator. In Emtricitabine ( Tavin-EM ) is limited metabolism.
ELIMINATION: Tenofovir ( Tavin-EM ) excreted through urine by active glomerular filtration and tubular secretion and half life is 18hr. Emtricitabine ( Tavin-EM eliminated highly unchanged in urine and low limit in faeces, half life is 10hr.
Indication of Tavin EM
Tavin-EM is used with combination of antiretroviral drug or alone medicine in adult and children 12yrs / >12yrs for the treatment of HIV-1 infection.
Dose & Dosage's of Tavin EM
In adult â‰¥18yrs, Tavin-EM medicine should administrated at once in a daily, one tablet orally in an empty stomach.
In children, safety and efficacy of drug is not recommended at age <18yrs.
Side Effects of Tavin EM
Major effects: Lactic acidosis, severe hepatomegaly with steatosis
Renal effects: Nephritis, Nephrogenic, diabetes insipidus, renal failure
GI events: Anorexia, abdominal distention, diarrhea, dyspepsia, flatulence
Common effects: vertigo, fatigue, raised liver enzyme, athralgia,rhabdomyolysis, osteomalacia.
Contraindication of Tavin EM
Tavin-EM contraindicated in patient with hypersensitivity to Efavirenz. When coadministration with voriconazole, Tavin-EM is contraindicated and lactation patient is also contraindicated with Viraday
Drug Interaction of Tavin EM
Concentration of atazanavir decreased with tenofovir unless also co-administered with ritonavir.
Increased serum concentration of both tenofovir and emtricitabine (Tavin-EM) if taken with drugs that are excreted by active tubular secretion.
Tavin-EM risk increased by renal impairment with continue use of nephrotoxic agents.
Tavin-EM interaction with didanosine levels become high and therefore increasing risk of pancreatitis and with a high therapy .
Avoid using emtricitabine with lamivudine due to same resistance profile causes high risk of lactic acidosis with Î±-interferon.
Precaution of Tavin EM
Before administration of Tavin Em, Patients should take care of these caution as follows:
* Patient with hepatomegaly or other serious factors for liver disease, Renal impairment, Pregnancy.
* Patient Counseling: This drug may cause dizziness, if affected, do not drive or operate machinery.
* Monitoring Parameters: Check the renal function and serum phosphate concentrations before start of the treatment, 4 weekly during the 1st week, and then 3 monthly.
* Hepatic function for several months following discontinuation. Determine HIV status in all hepatitis B virus (HBV) infected patients before the treatment.
Usage & Safety profile of Tavin EM Pregnancy & Lactation
Tenofovir and Emtricitabine ( Tavin-EM ) has category B: Animal studies have been developed adverse effect, but sufficient and well-tolerated studies in pregnant women which have failed to develop arisk to the fetus in all trimester in pregnancy.
Storage of Tavin EM
~ Tavin-EM store at temperature of 15-300C.
~ Tavin-EM store with caution and proper label.
~ Tavin-EM store in a cool and dry place.
~ Tavin-EM should kept in children resistance place.
~ Tavin-EM should used before expiry date.