Instgra and Tafero EM 3 Months

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BRAND :  INSTGRA - TAFERO-EM - 3MONTH COURSE PRICE :  425$ STRENGTH : 200MG, 25MG & 50MG ACTIVE :  INSTGRA-50MG-TABLET-TAFERO-EM-3-MONTH-COURSE COMPANY NAME :  HETERO... read more

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Drug profile of Instgra Tafero EM 3months Tablets

Instgra Tafero EM tablets are used for treatment involved in HIV-1 infections.

Instgra tablets are containing Dolutegravir as an active component; whereas Tafero EM tablets are containing Tenofovir Alafenamide & Emtricitabine as active ingredients.

Instgra is pharmacologically classified as an integrase inhibitor.

Tafero EM is pharmacologically classified as nucleoside reverse transcriptase inhibitor.

This Instgra Tafero EM combination is approved by FDA, which may provide better activity against HIV-1 infections.

Instgra Tafero EM should not have capability of curing the HIV infection, but it can able to reduce the development of HIV-1 further to AIDS.

This is a fixed dose combination of one Integrase inhibitor with two nucleoside reverse transcriptase inhibitors.

Brand name: Instgra Tafero EM 3months Tablets

Active components: Dolutegravir + Tenofovir Alafenamide & Emtricitabine

Strength: 50mg + 25mg & 200mg respectively

Pack: 30 tablets in a container of both products

Mfg: Instgra – Emcure; Tafero EM - Hetero

Category: Anti-retroviral drugs

 

Prescribing information of Instgra Tafero EM 3months Tablets

The prescribing information of Instgra Tafero EM is used for treating the HIV 1 infection for both adults and pediatric weighing of at least 30kg.

Tafero EM should not be combined with protease inhibitors.

Tafero EM indicated in pediatric patient with weight of at least 25kg & below 35kg.

Drawback occurs in Tafero EM uses;

Tafero EM should not be used in pre exposure prophylaxis therapy to diminish the danger of sexually obtained HIV-1 in grown-ups at high hazard.

Mechanism of Instgra Tafero EM

Instgra- Dolutegravir is a competitive to virus associated to HIV infection.

Dolutegravir is an Integrase strand transferase inhibitor, which is active against HIV type 1 infection. Dolutegravir binds to the active site of integrase enzyme, HIV enzyme that helps to transmit viral genetic material into human chromosomes.

This binding inhibition prevents integrase binding to retro virus DNA and causes blockade of strand transfer step which is required for cell proliferation process.

Instgra helps to prevent the HIV type 1 cell production.

TAF is manufactured as prodrug, which is conversed into active form inside the body known as tenofovir. TAF containing cell permeability activities, through this effect it get penetrate into the infected cells and changed over as tenofovir.

Inside the cells, tenofovir is phosphorylated into tenofovir diphosphate by hydrolysis.

Tenofovir diphosphate shown anti-retroviral activity by intercedes into viral DNA and causes inhibition of chain formation leads to stopping the viral production.

Emtricitabine into Emtricitabine 5’ triphosphate, this conversion occurs inside the body and causes chain eliminator effect by struggling with deoxycytidine 5’triphosphate.

Absorption

After administration, the maximum plasma concentration of Tafero EM;

TAF within 60 minutes; Emtricitabine occurs within 3 hours

Dolutegravir reaches within 2 to 3 hours.

The steady state level of Dolutegravir occurs within 5 days

The blood plasma ratio of Tafero EM;

TAF: 1.0; Emtricitabine: 0.6

Distribution

Binding property of TAF to human plasma protein by 80%; Emtricitabine to <4%

Dolutegravir is broadly binds to proteins by 98.9%.

Metabolism

The metabolism of Dolutegravir is majorly occurs with the aid of UTG1A1 with lesser range of CYP3A

The metabolism of TAF is occurs through cathepsin A, carboxyl esterase 1

Emtricitabine undergoes biotransformation.

Excretion

The major metabolism of Tafero EM is occurs through kidneys.

70% of Emtricitabine dose occurs via urine; 13.7% via feces.

<1% of TAF dose eliminated via urine; 31.7% eliminated via feces.

The elimination route of Dolutegravir is majorly occurs in urine, feces.

The half life period of Instgra is 14 hours

The half life period of Tafero EM is;

TAF: 0.51 hour; Emtricitabine 10 hours

When to take the Instgra Tafero EM

Both Instgra Tafero EM tablets should be administered with or without food.

Before taking the Tafero EM tablet, patient must be examine for hepatitis B infection.

Renal function test should be followed.

Dosage regimens of Instgra Tafero EM

The prescribed dose of Tafero EM is one tablet should be administered as a single dose.

Tafero EM is applicable for adults, pediatric with body weight at least 25 kg or below 35kg, or creatinine clearance higher or equal to 30ml/min.

Tafero EM should not be used in patient with CrCl below 30ml/min.

The dosage of Instgra tablets;

For adults;

Therapy naïve or therapy experienced INSTI:

The dose of Instgra is 50mg should be administered orally as once a day.

Therapy naïve or therapy experienced by combining with UGT1A or CYP3A:

The dose of Instgra is 50mg should be administered orally as two times a day.

INSTI experienced with INSTI related resistance:

The dose of Instgra is 50mg should be administered orally as two times a day.

For pediatrics;

The potency of Instgra is applicable only for patient with weight of at least 30kg.

30 to less than 40kg: 35mg of Instgra tablet should be given as once a day

(One 25 mg tablet + one 10 mg tablet).

40kg or higher: 50mg Instgra is administered as once a day

Instgra Tafero EM caused side effects

Instgra associated side effects;

Hypersensitivity reactions

Liver toxicity

Immune reconstitution syndrome

Insomnia

Depression

Abnormal dreams

Dizziness

Headache

Diarrhea

Nausea

Rash

Fatigue

Vertigo

Elevation of;

AST, ALT

Bilirubin

Creatine kinase

Blood glucose

Lipase

Post marketing effects;

Acute liver damage, liver toxicity

Arthralgia

Myalgia

Anxiety

Tafero EM associated side effects;

Aggravation of hepatitis B

Immune reconstitution syndrome

Outbreak or severity of renal impairment

Lactic acidosis or hepatic steatosis

 Loss of bone mineral density

Laboratory abnormality

Virological response alteration

Drug- drug interaction

1. TAF is a component of Tafero EM which is considered as substrate of P-gp, BCRP, OATP1B1, & OATP1B3.

2. Tafero EM co administered with strong P-gp or BCRP inhibitors leads to cause variation in TAF absorption.

3. Tafero EM co administered with P-gp inducers leads to cause depleting the absorption of TAF concludes as decreasing in plasma concentration of TAF and loss of effectiveness of Tafero EM.

4. Co administration of Tafero EM with drugs that inhibits the P-gp or BCRP leads to cause elevates the absorption & plasma concentration of TAF.

5. Tafero EM is majorly eliminated via kidneys. Tafero EM combined with drugs which affect the kidney functions causes increasing the concentration of component in Tafero EM and causes increasing the risk effects of Tafero EM.

6. Tafero EM with protease inhibitors causes decreasing the effect of concentration of TAF.

Tafero EM combines with anti-convulsants agent, anti-mycobacterials, or st Johns wort leads to produce decreasing effect of concentration of TAF.

7. Instgra elevates the plasma concentration of drugs which excreted through OCT2 or MATE1.

8. Etravirine diminishes the plasma concentration of Dolutegravir.

9. Instgra combined with efavirenz causes decrease the effect of concentration of Dolutegravir.

10. Instgra combined with protease enzymes leads to cause decreasing the effect of concentration of Dolutegravir.

11. Co administration of Instgra with dofetilide causes increasing concentration of dofetilide.

Instgra combined with anti-convulsants causing depletion of effect of concentration of Dolutegravir.

11. Instgra combined with calcium or iron containing supplements causes decreasing the effect of concentration of Dolutegravir.

12. Instgra combined with metformin, causes elevation of metformin concentration.

13. Instgra with rifampin produces depletion of Dolutegravir concentration.

Food drug interaction

Minor food drug interaction is occur

Diet should be followed by the patients after getting advice from the physician.

Possible contraindications

Hypersensitivity reactions produces, if patients are contraindicate to the component present in both Instgra & Tafero EM.

Co administration of Instgra & dofetilide or metformin is contraindicated because this combination leads to cause increasing the concentration of dofetilide or metformin. This may concludes as life threatening conditions.

Safety measures

During the treatment with Instgra Tafero EM some life threatening conditions may produce. Some safety precautions should be taken during or after completion of treatment.

1. An anaphylactic reaction occurs like rashes, sometimes organ dysfunction also occurs.

In this condition, patient may provide with general supportive measures and monitoring the liver enzymes level periodically.

In severe condition therapy should be discontinued.

2. Liver toxicity: This condition occurs due to increased serum AST & ALT levels.

Hepatic function test should be performed regularly and maintained the levels of hepatic enzymes.

In severe condition, therapy should be stopped.

3. Exposure of adverse reactions due to drug interactions; some drugs may reduce the plasma concentration of both the products and leads to loss the activity.

Avoid this type of concomitant treatment.

4. Immune reconstitution syndrome, this condition only occurred in the patients who are receiving anti-retroviral therapy. In severe condition patient should be discontinued with the treatment.

5. Severe aggravation of hepatitis B infection occurred in the patient receiving Tafero EM. The potency of Tafero EM in chronic hepatitis B infection has not been evaluated.

To overcome the problem patient should be treated with anti-hepatitis B drugs.

6. Renal impairment should be in severe condition in case of combining Tafero EM with drugs affecting the kidney functions. To avoid the problem kidney function test should be performed.

Patients, who are having creatinine clearance level below 30ml/min, should not be taking anti-retroviral medicines.

7. Lactic acidosis or hepatic steatosis; the major risk factor occurs during this condition is obesity. In severe condition stop the treatment.

Pregnancy and lactation

Pregnancy category of Tafero EM is B; Instgra is B

Instgra Tafero EM uses in pregnancy condition as cautiously. Counsel the patients about the risk benefits before starting the treatment with Instgra Tafero EM.

Breast feeding should not be allowed.

Storage and handling

Instgra container should be stores at 25oC; Tafero EM should be stored below 30oC.

Protect from light

Keep away from moisture & heat

Missed dose

In case of missed dose, patient must be consult with physician and follow the regular dosing schedule.

Over dosage

In case of over dosage of Instgra Tafero EM, patient should be;

Provide with general supportive management

The manifestation of over dosage should be monitored.

Instgra is crucial to remove through dialysis, because it is largely bound to human plasma protein.

Tafero EM should be removed by undergoing hemodialysis.

30% of Emtricitabine dose should be eliminated after 3 hours of hemodialysis.

54% of tenofovir content should be removed over the period of 4 hours of dialysis session.

 

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