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Tafero-EM-200m-25mg

PRODUCT DETAILS

Trade name : Tafero EM
Active ingredient : Tenofovir Alafenamide & Emtricitabine
Strength availability : 25mg & 200mg
Manufactured by : Hetero
Package : 30 tablets

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Tafero-EM is a anti-retroviral medication containing two eminent ingredients known as; Tenofovir Alafenamide fumarate Emtricitabine Tenofovir Alafenamide is a nucleotide reverse transcriptase inhibitor Emtricitabine is a nucleoside reverse transcriptase inhibitor. Both are most effective & potent compounds against HIV-1 infections, but it does not cure the infection condition it is only used for preventing & suppressing the progression of HIV-1 infection into AIDS. In Tafero-EM tablets, TAF is present as a prodrug form. Emtricitabine is synthetic fluoro derivative of thiacytidine.

INDICATION

Tafero EM, a combination tablet contains tenofovir Alafenamide fumarate and Emtricitabine is mainly indicated for the treatment of HIV-1 infection in adult’s patients.

DOSAGE

The prescribed dose of Tafero-EM is one table should be given orally as once a day. Important points; Before starting the treatment, patient should be examining for presence of hepatitis B infection or not. Patient’s renal values should be investigated like creatinine clearance, urine glucose & urine protein. Tafero-EM should be used in adolescents, pediatric patient with weighing at least 25kg & creatinine clearance of patients should be larger or equal to 30ml/min. Tafero-EM should not be applicable for patients with creatinine clearance below 30ml/min. Tafero-EM tablets should be administered with food or without food.

PHARMACOLOGY

Tafero-EM contains Tenofovir Alafenamide fumarate and Emtricitabine TAF is pharmacologically nucleotide simple of invert transcriptase inhibitors, which is available as prodrug shape. It gets changed over as a functioning structure in-vivo, known as tenofovir. Tenofovir experiences diminishing the building squares of typical DNA happens. The water atom is basic for the phosphodiester bond linkage. Tenofovir is battling with typical nucleotides for addition into proviral DNA and interference of generation of 5' to 3' phosphodiester linkage which is essential for DNA prolongation. Tenofovir engaged with; Chain disposal DNA stretching end Stops the proviral DNA interpretation Emtricitabine; Emtricitabine is in charge of deterring the viral reverse transcriptase chemical which is essential for viral creation. Emtricitabine includes; Chain disposal Stops the HIV RNA duplicates augmentation Serves to emulates the viral load

What the body does to Tafero-EM after administration

After oral administration : The absorption of Tafero-EM should be occurs very quickly and tenofovir peak plasma concentration time is 1 hour. The mean absolute bioavailability of Emtricitabine is occurs by 93%. Food doses not affect the absorption of Tafero-EM. The human plasma protein binding nature of Tafero-EM is; TAF: 80%; Emtricitabine: below 4% Metabolism of Tafero-EM; TAF get hydrolyzed to active form called as Tenofovir by using cathepsin A or carboxylesterase 1. Emtricitabine metabolism is mediated by biotransformation. The terminal half life period of Tafero-EM is; TAF: 0.51 hour Emtricitabine: 10 hours The elimination process of Tafero-EM is occurs via active tubular secretion & renal lomerular filteration process.

SAFETY MEASURES

Aggravation of hepatitis B infection: Patients should be examine earlier for occurrence of hepatitis B infection or not. The effectiveness of Tafero-EM tablets for advanced hepatitis B infection has not been evaluated. This condition mostly occurred in patients who are HIV-1/HBV co infected. Immune reconstitution syndrome: To overcome the problem by discontinuing the treatment with Tafero-EM. Renal impairment worsening: Stop using Tafero-EM with drugs affecting the renal functions. Monitor the creatinine clearance value frequently. In severe conditions CrCl below 30ml/min use of Tafero-EM should be avoid. Lactic acidosis & hepatic steatosis: Discontinue the therapy using Tafero-EM

DRUG INTERACTION

Tafero-EM + P-gp or BCRP potent inhibitors: affect the absorption of TAF. Tafero-EM + potent P-gp or BCRP inducers: reduce the absorption of TAF causes reducing=g the plasma concentration of TAF and finally results as loss of effectiveness of Tafero-EM. Tafero-EM elimination process occurs through kidneys, combination of Tafero-EM with drugs affecting the renal activity causes increasing the effect of concentration of ingredients of Tafero-EM & concludes as elevation of adverse effects associated to these components. Tafero-EM combines with drugs like tipranavir/ritonavir causes diminishing the effect of concentration of TAF. Tafero-EM concurrently used with anti-convulsants causes decreasing the effect of concentration of TAF. Tafero-EM concurrently used with anti-mycobacterials or st Johns wort causes decreasing the effect of concentration of TAF.

CONTRAINDICATION

Tafero-EM is contraindicated to patients with CrCl below 30ml/min Anaphylactic reactions are produced due to patients are contraindicated to the components of Tafero-EM.

OVER DOSAGE

The over dosage of Tafero-EM should be treated with hemodialysis. Emtricitabine should be removed by 30% range after completing 3 hours of dialysis process. TAF should be eliminated by 54% of range after 4 hours dialysis session.

PEDIATRIC

The potency & effectiveness of Tafero-EM should not be evaluated in pediatric patients with weighing below 25kg.

GERIATRIC

The potency of Tafero-EM should not be evaluated in clinical trials for geriatric patients with age of above 65 years.

RENAL DAMAGE

The uses of Tafero-EM should be avoided in patients with CrCl below 30ml/min.

SIDE EFFECTS

Lactic acidosis, Hepatic steatosis, Serious exacerbation of hepatitis B, Immune reconstitution syndrome, New outbreak or aggravation of renal impairment.
Some side effects are :
Increased cholesterol levels, Serum creatinine level get increased, Bone mineral density effects, CD+ cells counts varies.

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