ACriptega 50mg/300mg/300mg Mylan treats viral infections causing immunodeficiency in HIV-1 people (30 tablets)

Dosage form Box of 30 tablets
Specifications Dolutegravir, lamivudine, tenofovir disoproxil
Ingredient Mylan Laboratories Limited

Ingredient

Composition information	Content
Dolutegravir	50mg
Lamivudine	300mg
Tenofovir disoproxil	300mg

Uses

indications

ACriptega 50mg/300mg/300mg Mylan 30V is indicated in the following cases:

Treatment of virus infection causing immunodeficiency in HIV-1 people in adults and adolescents (from 12 years old and weight ≥ 40 kg) capable of inhibiting viruses to HIV-1 RNA concentration Dolutegravir inhibits HIV Integrase by linking to the position of Integrase and preventing the movement of the integration of Deoxyribonucleic Acid Retrovirus (DNA). This is essential for the HIV copy cycle.

pharmacokinetics

lamivudine

fast absorption after drinking, bioavailability from 80-85%. The distribution volume is 1.3 l/kg. Lamivudine is excreted mainly in the form of unchanged due to the excretion through the kidneys. The sale time is from 5 to 7 hours.

tenofovir disoproxil fumarate

The drug is quickly absorbed and switched to Tenofovir. Born in patients with hunger is 25%. The use of Tenofovir Disoproxil Fumarate with a high fat meal increases oral bioavailability. The volume of distribution is in the stable state of tenofovir approximately 800 ml/kg.

Tenofovir is excreted mainly by the kidneys, both by filter and renal tubular transportation system with about 70-80% of the dosage is eliminated without changing in urine. The end of the sale time is from 12 to 18 hours.

dolutegravir

Be absorbed quickly after drinking with average TMAX after 2-3 hours. Foods increase the level and slow down the absorption rate of dolutegravir. Therefore, the drug is recommended to be used with the food of patients with HIV -infected with Integrase. Absolute bioavailability has not been set. Dolutegravir has a high link rate (> 99%) for plasma proteins based on in vitro data. The distribution volume is 17-20L.

The drug is metabolized through glucuronids with a small part of CYP3A4. Eliminating the form of the kidney is low (

Before taking ACriptega 50mg/300mg/300mg Mylan treats viral infections causing immunodeficiency in HIV-1 people (30 tablets)

How to use

Treatment should be due to an experienced doctor in HIV-1 infection treatment.

Swallow all the tablets with water.

Dosage

Adults and adolescents (from 12 years old and weighing ≥ 40 kg):

Recommendations of dolutegravir/lamivudine/tenofovir disoproxil fumarate tablets 50mg/300mg/300mg in adults and adolescents are a tablet once a day.

Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg should not be used in adults or adolescents with a weight of less than 40kg because this is a fixed dose combination.

Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg is a fixed dose combination and should not be prescribed for patients to request dose adjustments. The separate preparations of Lamivudine, Tenofovir Disoproxil Fumarate and Dolutegravir are available in the case of appointing or adjusting the dose of one of the active ingredients.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Only a significant amount of lamivudine has been removed by separating (4 hours).

Currently there is very little experience with the overdose of Dolutegravir. There is no specific treatment for dolutegravir overdose. If an overdose occurs, patients need to be supported with appropriate monitoring.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using ACriptega 50mg/300mg/300mg Mylan 30V, you may experience unwanted effects (ADR).

Very common, common ADR> 1/100:

Hematology: Neutral leukemia, anemia (sometimes severe), platelets.

Disorders of metabolism and nutrition: Hypermath of blood phosphate.

nerve: dizziness, headache and insomnia.

Respiratory: cough, nose symptoms.

digestive: diarrhea, nausea, vomiting, abdominal pain/cramps, flatulence.

Skin and subcutaneous tissue: rash, hair loss.

musculoskeletal: joint pain, muscle disorders.

Systemic: fatigue, discomfort, fever.

Rare, very rare, ADR

Hematology: Soldier red blood cells.

Metabolism: Lactic acidosis. nerve: peripheral neuropathy.

Respiratory: Difficulty breathing.

digestive: pancreatitis, increased serum amylase, hepatitis.

Digital kidney: Acute renal failure, renal failure, near renal tubular disease (including fanconi syndrome), increased serum creatinine, acute renal necrosis.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

ACriptega 50mg/300mg/300mg Mylan 30V contraindicated in the following cases:

Patients with hypersensitivity to tenofovir, lamivudine, dolutegravir or any excipients in the formula.

Use in combination with dofetilide.

Be cautious when using

ACriptega tablets should not be used simultaneously with other drugs containing any ingredients and active ingredients such as dolutegravir, lamivudine or tenofovir disoproxil fumarate, similar substances Cytidine such as Emtricitabine and Adefovir Dipivoxil.

HIV infection:

Treatment with ACriptega tablets does not show the exclusion of the risk of HIV transmission through sex or blood sugar, although the risk may decrease. Patients should continue to use appropriate preventive measures to prevent HIV transmission.

Liver disease:

Dolutegravir's safety and pharmacokinetics were not investigated in patients with severe liver disease. Therefore, ACriptega tablets should only be used in patients if the benefits are greater than the risk and closely monitor.

Patients with HIV and co -infection with hepatitis B (HBV) or hepatitis C (HCV):

Patients with chronic hepatitis B or C and treated with a Retrovirus resistance regimen are at risk of increasing serious adverse effects on the liver or may cause death.

Hypersensitivity reactions:

Hypersensitivity reactions have been reported to Dolutegravir, characterized by rash, physical symptoms, and sometimes, organs disorders, including severe liver reactions. Dolutegravir should be stopped immediately and other suspected drugs if there are signs or symptoms of hypersensitivity reactions (including, but not limited, severe rash or rash along with increased liver enzymes, fever, discomfort, fatigue, muscle or joint pain, blistering, mouth damage, conjunctivitis, facial inflammation, eosinophilia, angioedema).

Kidney function:

Tenofovir is excreted mainly by the kidneys through a combination of glomerular filtration and excretion activity in the renal tubules. Therefore, the clearance in patients with impaired renal function.

Lactic acidosis:

Lactic acidosis is a rare but very dangerous complication related to the use of nucleoside enzyme inhibitors (NRTI).

Pancreatitis:

ACRIPTEGA treatment should be stopped immediately if there are clinical signs, symptoms or abnormalities in the laboratory that suggests pancreatitis.

An opportunity infection:

Patients with Retrovirus resistance can continue to develop opportunistic infections and other HIV infections.

The ability to drive and operate machinery

There is no research to investigate the action of dolutegravir on driving capacity or machine performance. However, patients need to be notified that dizziness has been reported during treatment with Dolutegravir. The patient's clinical condition and the adverse reaction of Dolutegravir should be remembered when considering the ability to drive or operate the patient's machines.

Pregnancy

Animal studies not only indicate the direct or indirect effects of Tenofovir Disoproxil Fumarate for the development of pregnant women, fetal development, childbirth or postpartum development. In humans, the safety of Tenofovir during pregnancy has not been fully established.

There is no increased risk of birth defects that have been reported to Lamivudine. However, it is not possible to rule out the risk for the fetus.

There are very few data from using Dolutegravir in pregnant women. The effect of dolutegravir on pregnancy in humans is not known. Dolutegravir should be used during pregnancy only if the benefits are higher than the potential risk to the fetus.

The period of breastfeeding

In animal studies, it has been shown that Tenofovir is secreted milk. It is not known whether Tenofovir will excrete in human milk. Lamivudine is excreted into breast milk. The current recommendations for HIV and breastfeeding (such as WHO) should be consulted before advising patients on this issue. Priority options may vary depending on local circumstances.

Do not know if Dolutegravir has excreted in breast milk. Animal toxic data has shown the excretion of dolutegravir in milk. It is recommended that HIV -infected women do not breastfeed in any case to avoid HIV transmission.

Drug interaction

Interactions related to lamivudine:

Simultaneously used with trimethoprim/sulfamethoxazole increases 40% of the area under the curve of Lamivudine. It is not necessary to adjust the dose of ACriptega. Lamivudine does not affect the pharmacokinetics of trimethoprim or sulfamethoxazole.

Interactions related to tenofovir:

DIDANOSINE: Do not share tenofovir disoproxil fumarate and didanosine.

The drugs are eliminated through the kidneys: Because Tenofovir is mainly eliminated by the kidneys, it is common to use Tenofovir Disoproxil Fumarate with products that reduce the kidney function or compete excreted through the renal tubules through activated, activated 3 or MRP 4 (for example, Cidofovir) can increase the concentration of serum tenofovir and/or simultaneous drug products.

Tenofovir disoproxil fumarate should avoid using a kidney poison product simultaneously, such as aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidin, vancomycin, cidofovir or interleukin-2. Using Tacrolimus can affect kidney function, should closely monitor when used simultaneously with Tenofovir Disoproxil Fumarate.

Tenofovir disoproxil fumarate must be used with food because food increases the bioavailability of Tenofovir.

Interactions related to dolutegravir:

All factors that reduce the concentration of dolutegravir should avoid when there is integrase resistance. Dolutegravir is removed mainly through the metabolism of UGT1A1. Dolutegravir is also the substrate of UGT1A3, UGT1A9, CYP3A4, PGP, and BCRP; Therefore, these enzymes can reduce the plasma concentrations of dolutegravir and reduce the effectiveness of dolutegravir.

Storage

Storage below 30 ° C.

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