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viropil Emcure Tablets : Uses, Side effects, MRP Cost india

VIROPIL

PRESCRIBING INFORMATION

Viropil is used adults patients weighing more than 40kg who suffering from human immunodeficiency virus (HIV) infection.

MECHANISM

Dolutegravir: The drug belongs to class of HIV-1 antiviral agent. It prevents HIV integrase  while bounding to the integrase active site and stops the strand transfer step of DNA synthesis  Viropil which is specific for HIV replication cycle. Strand which transfers biochemical assays  using rectified HIV-1 integrase and pre-processed substrate DNA resulted in IC values of 2.7nM and 12.6nM.
Tenofovir DF: Tenofovir DF is performs a nasty to viral action by threatening the turn around transcriptase aggregate by battling with regular substrate deoxyadenosine 5' triphosphate and after addition into DNA,Viropil tablet by viral DNA chain eliminator.
Viropil is used to stoppage the viral DNA synthesis which is a require for the process of chain elimination.
Lamivudine, Viropil tablet belongs to the class of  nucleoside synthetic analogue.
Lamivudine which is phosphorylated intracellularly into active 5’ triphosphate metabolite (lamivudine triphosphate 3TC-TP.
This active metabolite involves in prevention of reverse transcriptase Viropil  via chain termination after infusion of nucleotide analogue

ABSORPTION

The maximum plasma concentration Viropil of Dolutegravir is 2 to 3 hrs.
Tenofovir DF : 1hr plus/minus 0.4hrs and bioavailability is 25%
Lamivudine : 1.5± 0.5mcg/ml.
Bioavailability of Lamivudine is 80-87%

DISTRIBUTION

Protein binding for Dolutegravir ,Tenofovir, Lamivudine Viropil tablet is 98.9%, <0.7-7.2% and 36%.

METABOLISM

Dolutegravir is primarilyViropil metabolized through UGT1A1 with some contribution from CYP3A
Tenofovir Viropil tablet occurs metabolized at cytochrome P450 enzyme
where as Lamivudine is metabolized has trans sulfoxide and the biotransformation is catalyzed by sulfotrnsferases.

 EXCRETION

Dolutegravir unchanged form is excreted via feces is 53% and urine 31%, Lamivudine excreted by urine 5.2% ± 1.4% via trans-sulfoxide metabolite
Terminal half life of Dolutegravir is 14 hrs, Tenofovir DF is 17 hours and Viropil  is 5 to 7 hours.
VIROPIL
Viropil 

PRODUCT DETAILS:

Brand Name : Viropil
Composition : Dolutegravir 50mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg
Manufactured by : Emcure Pharmaceuticals Ltd.
Form : Tablet
Packing : Pack of 30
Price: Viropil price in india

WHEN TO TAKE THE DRUG

Piror to start the treatment with Viropil tablet Patient should be monitored for presence of HBV infection or not.
kidney function & hepatic function test should be performed.
The usual dose of Viropil  is one tablet of Dolutegravir 50mg, Tenofovir DF 300mg, Lamivudine 300mg should be administered as once daily.
The drug is administered on an empty stomach.
Due  to reducing the neurological problems. this Viropil tablet tablet should be take at bed time.

DOSAGE REGIMENS

The Viropil tablet prescribed  dose is one tablet of dolutegravir 50mg+ lamivudine 300mg + tenofovir DF 300mg administrated for once in a day.

Renal impairment:

Dosage adjustment is needed for patients with baseline Viropil tablet creatinine clearance <50-mL/min.

Hepatic impairment:

while patients with mild to moderate Viropil  liver impairment has no dosage adjustment is required.
Pediatric Use: use in that patients is not indicated by FDC
Geriatric use: for the elderly patients should be used with cautions.

DRUG CAUSED SIDE EFFECTS

Lactic acidosis
Aggravation of HBV
Renal damage
Psychiatric problems
Nervous problems
Skin related problems
Liver toxicity
Hepatic decompensated cirrhosis
Pancreatitis
Bone defects
Immune reconstitution syndrome
Redistribution of fat
The most common side effects;
Headache, pain, fever, abdominal pain, back pain, asthenia, diarrhea, nausea, dyspepsia, vomiting, lipodystrophy, arthralgia, insomnia
Lab abnormalities;
Increased cholesterol, elevation of creatine kinase, increased AST & ALT, Hematuria, neutropenia, increased serum amylase

DRUG- DRUG INTERACTION

  1. Viropil tabletl with CYP3A inducers causes increased clearance of Viropil & leads to reduce the plasma concentration.
  2. Viropil with warfarin causes fluctuation in prothrombin time & INR values.
  3. Viropil tabletl with anti-convulsants causes reduced effect of concentration of these drugs.
  4. Viropil with anti-fungals, anti-depressants, or anti-infective causes reduced effect of concentration of these drugs.
  5. Viropil tablet with anti-malarial, anti-mycobacterials, calcium channel blockers, or lipid lowering drugs causes decreased effect of concentration of these drugs.
  6. When interaction with metformin or dofetilide will cause the plasma concentration of these drugs are increased.

FOOD DRUG INTERACTION

Concomitant use of Dolutegravir Viropil with mineral or vitamin containing substances, it may cause to increase the ion content, and this alteration intercedes with absorption of Dolutegravir and depletes the effectiveness.
A minor food drug interaction occurs.
Diet should be maintained only after getting advice from the medical adviser.
Common foods;
Grape fruit or juice
Seville orange
Vitamin E, C containing foods
 Garlic
Calcium supplements

CONTRAINDICATIONS

Hypersensitivity reaction occurs in patients
Concomitant use with Dofetilide

SAFETY MEASURES

Severe hepatomegaly with staetosis / Lactic acidosis : While use of nucleoside analogues involves Viropil tablet alone or in combination will causes harm to fetal. Use Viropil  with caution in patients having liver disease with known factor
New-onset or worsening Renal impairment:  which including cases like acute renal failure and fanconi syndrome has reported with Tenofovir DF. While using Viropil tablet has no safety and efficacy data in patients. Routine monitoring of calculated creatinine clearanceand serum phosphorus should be performed.
Patients with HIV-1 and HBV Co-infection: post therapy exacerbations of hepatitis may occur In patients infected Viropil  with both HIV-1 and HBV when changing of treatment Lamivudine containing HIV-1 regimen to Lamivudine containing regimens .

PREGNANCY AND LACTATION

Pregnancy category of lamivudine: C
Pregnancy category of Tenofovir and Dolutegravir : B
The drug Viropil tablet is highly passes via placenta, no birth defects has observed at first trimester
Ths drug must be used with Viropil  probably benefits justifies the probably risk.
Breast feeding should not be allowed.

STORAGE AND HANDLING

Store at temperature below 30oC
Protect the drug  from heat, moisture & light

MISSED DOSE

If missed occurs, while you remember take Viropil  it soon otherwise leave the missed dose  Maintain the regular dosing schedule
Avoid the missed dose if possible. Please consult the doctor.
Do not self medicate the Viropil tablet.

OVER DOSAGE

The drug  overdosage Viropil  has no specific antidote. If occurs with patients then they should be monitored and provide standard supportive treatment but Viropil tablet higher dose removed by hemodialysis wih an extraction co efficient of approx 54%


CONTACT DETAILS:

PHONE NO: +919940472902

E-MAIL: millionhealthpharmaceuticals@gmail.com








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