Avonza 300mg/300mg/400mg Mylan treats HIV virus infection (30 tablets)
Dosage form Box of 30 tablets
Specifications Efavirenz, Lamivudin, Tenofovir
Ingredient Mylan Laboratories Limited
Ingredient
| Composition information | Content |
| Efavirenz | 400mg |
| Lamivudin | 300mg |
| Tenofovir | 300mg |
Uses
indications
Avonza drugs are indicated for treatment of HIV infection in adults and teenagers over 12 years old.
Pharmacology
Group of pharmacological treatment: antiviral drugs to treat HIV infection, combination form, ATC code: josar11.
Pharmacological classification: 7.13 antiviral drugs.
Mechanism of action
Efavirenz is a non-nucleoside drug inhibiting the reverse transcriptase of HIV-1.
Efavirenz directly attaches to the enzyme and selects the activities of DNA polymerase depends on DNA and depends on RNA by indulging the change of space configuration that causes interrupting at the catalyst position of the enzyme.
The activity of Efavirenz is not competing with nucleoside triphosphates or similar substances Nucleoside Triphosphates.
Enzyme transcription HIV-2 and DNA polymerases in eukaryote (such as DNA polymerase A, B, 7 or 5) are not inhibited by Efavirenz.
lamivudine is a transmission co -delusion of 2 -Deoxy -3 - - --Actidine, has the same structure as a dideoxoxucleoside tenofovir disoproxil fumarate is converted in vivo into tenofovir, a nucleoside monophosphate (nucleotide) similar to Adenosine monophosphate.
lamivudine and tenofovir are phosphorylation by intracellular enzymes to form lamivudine triphosphate and tenofovir diphosphate. Lamivudine Triphosphate and Tenofovir Diphosphate inhibit competition with HIV-1 backward enzyme, leading to the end of the DNA string. Both of these substances have the activity of HIV-1 and HIV-2 resistance as well as resistance to hepatitis B viruses.
resistance:
Most patients have failed viruses while using Efavirenz will be resistant to Efavirenz.
The mutations that appear mainly are K103N, G190Sae and Y188L, just one of these mutations is enough to cause high levels. The cross resistance between Efavirenz and Nevirapine or Delavirline is very spacious, so the patient has ever failed viruses with one of these drugs that almost contains Virus that is not sensitive to Efavirenz and vice versa.
With the accumulation of NNRTI mutations, Etravirine sensitivity will also be affected.
Due to Efavirenz's long selling time, after stopping an effective Retrovirus anti -Retrovirus containing Efavirenz, there may be a period like using Efavirenz. This can cause significant resistance and reduce the effectiveness of Efavirenz, Nevirapine or Delavirline in the future.
In many cases when a treatment regimen containing lamivudine fails, the M184V mutation will be selected at an early stage. M184V causes high level Lamivudine resistance (reducing sensitivity> 300 times). The virus has a less effective reprinting M184V than the wild virus strains.
In vitro data suggests that continuing to use lamivudine in the Retrovirus resistance regimen, although the M184V mutant development may give the remaining Retrovirus resistant activity (almost through reduced viral compatibility). The clinical matching of these findings has not been established.
Cross resistance caused by m184V mutations is limited in the group of antiviral drugs inhibiting nucleoside or nucleotide. M184V causes adequate cross resistance to Emtricitabine.
Zidovudine and Stavudine maintain retrovirus anti-Retrovirus activity for Lamivudine resistance.
Abacavir maintains the retrovirus resistance for HIV-1, Lamivudine resistance contains only M184V mutation. M184V mutations show that reduced sensitivity to the Didanosine
The K65R mutation is selected in vitro when HIV-1 is cultured in Tenofovir environment with increasing concentration. It also appears on Vivo when the virus fails with the treatment regimen containing Tenofovir.
K65R reduces tenofovir sensitivity on In vitro about twice and is associated with the lack of response to Tenofovir containing regimen.
Clinical studies assessing Tenofovir's HIV-resistant activity against HIV-1 strains have similar mutations of Thymidine (TAMS) that is not selected by Tenofovir in patients who have been treated.
Patients with HIV shows that at least 3 tams mutations contain or M41L or L210W show a decrease in response to tenofovir.
Clinical effectiveness
When using Tenofovir Disoproxil Fumarate and Lamivudine in collaboration with Efavirenz in HIV-1-infected patients who have never been treated, the proportion of original random allocation patients (ITT) has HIV-RNA There is no specific study using a combination of Tenofovir Disoproxil Fumarate, Lamivudine and Efavirenz on adolescents.
pharmacokinetics
efavirenz
absorption and bioavailability:
Birth reaches 40% to 45% without food. Food increases significant absorption.
Time to achieve peak concentration in plasma (3-5 hours) does not change after many doses and plasma concentrations reach a stable state in 6-7 days.
After taking a single dose of 1 tablet in healthy volunteers, the average CMAX value (ESD) of Efavirenz is 2,689 (#785) ng/ml and the AUC value of 0-72H is equivalent to 64,850 (+21.728) ng.H now/ml.
The average TMAX value of Efavirenz is 4.28 (+ 1,61) hours.
Distribution:
Efavirenz is strongly attached (more than 99%) to human plasma proteins, mainly albumin.
HIV-1-infected patients who have received Efavirenz 200 to 600 mg 1 time/day for at least 1 month, the average concentration in cerebrospinal fluid is 0.69% compared to the corresponding concentration in plasma.
This ratio is about 3 times higher than the non -binding part of the protein (free form) of Efavirenz in plasma.
Metabolism
Efavirenz is converted mainly by cytochrome P450 into hydroxylate metabolic.
These metabolites do not have HIV-1.
In vitro studies are supported by the records on the vivo suggesting that CYP3A4 and CYP2B6 are the main enhancers responsible for Efavirenz metabolism.
Efavirenz induces cytochrome enzymes P450, resulting in its own transformation.
Elimination:
Efavirenz has a relatively long -lasting waste time from 17 to 154 hours after single dose and 40-55 hours after many doses. In patients with mutant CYP2B6 genotypes (such as the T/T genotype in G516T), the end -phase selling time can be significantly extended and exposed to higher drugs.
These genotypes are especially popular among African and African Americans. In patients with liver failure, Efavirenz clearance is reduced and exposed to higher drugs.
About 14 -34% of Efavirenz doses marked radioactive found in urine and less than 1% of the doses were eliminated in urine in the form of unchanged efavirenz.
lamivudine
absorption and bioavailability:
lamivudine is quickly absorbed after drinking. Bioions reach from 80 to 85%.
After taking the single dose of 1 Avonza 300mg: 300mg: 400mg in healthy volunteers, the average CMAX (+ SD) of Lamivudine is 2,483 (4706) ng/ml and the corresponding AUC value is 13.457 (4 3,717) ng.He/ml. The average TMAX value (ESD) of Lamivudine is 1.92 (20.93) hours.
Simultaneous use of lamivudine with food delayed TMAX and reducing CMAX (down about 47%). However, the lamivudine absorption level (based on AUC) is not affected.
Distribution:
Studies using lamivudine intravenously show that the average app integral integral is 1.3 1/kg.
lamivudine represents linear pharmacokinetics during the treatment dose and shows the cohesion of the albumin protein in plasma (
Metabolism:
Metabolism is only auxiliary path in the elimination of lamivudine. Lamivudine is mainly eliminated in a constant form through the excretion in the kidney.
The ability to interact with drugs in metabolism with lamivudine is very low due to low liver metabolism (5 - 10%) and binding to low plasma proteins.
Elimination:
LAMIVUDINE's waste time is recorded as 5 - 7 hours.
The sale time of lamivudine triphosphate is determined about 22 hours.
The average body clearance of lamivudine is about 0.32 1/hour/kg, mainly eliminated in the kidneys (> 70%), including the excretion of the renal tubules through the organic cation transport system.
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate is a water -soluble ester precursor, which is rapidly transformed in Vivo into Tenofovir and Formaldehyde. Tenofovir is converted intracellular into tenofovir monophosphate and the component of the Tenofovir Diphosphate activity.
absorption:
After taking Tenofovir Disoproxil Fumarate by HIV -infected patients, Tenofovir Disoproxil Fumarate is quickly absorbed and transformed into Tenofovir.
Tenofovir's oral bioavailability from Tenofovir Disoproxil Fumarate in patients at hunger is about 25%.
Take Tenofovir Disoproxil Fumarate along with a fat -rich meal that increases oral bioavailability, increases the AUC of Tenofovir about 40% and CMAX about 14%.
After taking single dose 1 tablet Tenofovir disoproxil fumarate/lamivudine/efavirenz 300 mg/300mg/400 mg in healthy volunteers, the average cmax of tenofovir ( ± sd) is 277 ( ± 79) ( ± 627)
TMAX of the average tenofovir ( ± sd) is 1.17 ( ± 0.57) hours.
Distribution:
After intravenous intravenous injection, tenofovir's distribution volume in a stable state is determined about 800 ml/kg. In vitro, the protein cohesion of tenofovir with plasma proteins and serum corresponding to less than 0.7 and 7.2% with tenofovir concentration between 0.01 to 25 ng/ml.
Elimination:
Tenofovir is mainly eliminated by the kidneys through filtration and active transportation system in the renal tubules, about 70-80% of the dose is eliminated in the form of unchanged urine after intravenous injection.
The total clearance is determined about 230 ml/hour/kg (about 300 ml/min).Renal clearance is determined by about 160 ml/hour/kg (about 210 ml/min) exceeding the ratio of glomerular filtration. This shows the active excretion in the renal tubules that play an important role in the excretion of Tenofovir.
After drinking Tenofovir's waste time is about 12 to 18 hours.
Studies show that the active excretion path in the renal tubules of Tenofovir is pumped into the close tube cell by the organic anion in humans (media) 1 and 3 and pushed into the urine by multi -drug protein 4 (MRP 4).
In vitro studies have identified both Tenofovir Disoproxil Fumarate and Tenofovir are not the substrate of the enzyme CYP450.
Before taking Avonza 300mg/300mg/400mg Mylan treats HIV virus infection (30 tablets)
How to use
should take Avonza 300mg: 300mg: 400mg at hunger (1 hour before eating or 2 hours after eating). Take the whole Avonza 300mg: 300mg: 400mg with water.
Taking Avonza 300mg: 300mg: 400mg before going to bed can be helpful. That helps avoid problems caused by some adverse effects (such as dizziness, drowsiness).
Dosage
always use Avonza 300mg: 300mg: 400mg in accordance with the dose prescribed by a doctor. This helps ensure that the drug will fully promote the effect and reduce the risk of developing drug resistance.
You should check with a doctor, pharmacist or medical staff if you feel uncertain. Do not change the dose unless the doctor's prescribed.
The usual dose is 1 tablet daily.
Do not use this drug for children (under 12 years old or weighs less than 40 kg).
If your doctor decides to stop one of the ingredients of Avonza 300mg: 300mg: 400mg or change the dose of any ingredients of the drug, you may be prescribed Efavirenz, Lamivudine and/or Tenofovir preparations instead of the drug in combination or other drugs to treat HIV infection.
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 using overdose? Bring the vial you used to be able to describe what happened.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? If you forget a dose, use the next dose as soon as possible. However, when taking the next dose time will come within 12 hours, take the next dose when you take normal medication.
If you vomit immediately after taking the medication, you should take another tablet. Do not wait until the next dose.
Side Effects
Like all other drugs, Avonza 300mg: 300mg: 400mg can cause unwanted effects but not everyone encountered.
Notify your doctor if you experience any of the unwanted effects below:
Do not want to be very common: can affect more than 1 of 10 people.
Anemia (reduced red blood cells can make you tired and short of breath), leukocytes (can make you susceptible to infections), thrombocytopenic reduction (can make you susceptible to bleeding).
Attitude, affecting the mood, abnormal thoughts, restlessness, excitement state, crazy status characterized by excessive stages of operation, excitement or irritability), hallucinations (paranoia), forgetful, encounter problems of coordination, confusion, suicide thoughts and plans, seeing or hearing things that are not really there.
Excess lactic acid in the blood (lactic acidic acidosis - unwanted effects that can be fatal). The following unwanted effects may be a sign of lactic acidic acidosis:
Unwanted effects are very rare: can affect 1 of 10,000 people.
Sad breath: Neurological damage causes weakness and pain, stinging or numbness, especially in the feet and arms (peripheral neuropathy).
New bone marrow failure produces new red blood cells (bone marrow failure one line of red blood cells): damage to the mythical body of the body of the body).
Other undesirable effects:
Please inform your doctor if you have any unwanted effects become serious, or you notice any unwanted effects not listed in this user manual.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
AVONZA drugs contraindicated in the following cases:
Be cautious when using
notify your doctor if you have kidney disease or test results show that you have kidney problems. If so, it may be necessary to reduce the dose of tenofovir and lamivudine. At that time, other preparations should be used containing Efavirenz, Lamivudine and Tenofovir instead of Avonza 300mg: 300mg: 400mg combined form.
Avonza 300mg: 300mg: 400mg can affect your kidneys.
Before using this drug, you may need to test blood to check if your kidneys work well. It may also be necessary to test blood during treatment to monitor kidney function.
Do not use Avonza 300mg: 300mg: 400mg with drugs that can cause kidney damage. If it is unavoidable to use simultaneously, it is necessary to periodically check the kidney function.
Do not use Avonza 300mg: 300mg: 400mg for children under 12 years old or weighs under 40 kg.
Before using this medication, you should notify doctors on current or a history of allergies, convulsions, neuropathy, alcohol abuse or other substances.
Mild -to -medium light to the first 2 weeks of using Avonza 300mg: 300mg: 400mg and always recover within 4 weeks after the beginning of treatment.
In case of heavy rash, you need to notify the doctor immediately and may need to stop Avonza 300mg: 300mg: 400mg.
After starting to use Avonza 300mg: 300mg: 400mg, unwanted effects are common on the central nervous system including dizziness, confusion, difficulty sleeping, drowsiness, distraction and abnormal dreams and always appear in the first week of treatment. Other unwanted effects include memory loss, hallucinations, excitement, depression, suicide ideas or mental disorders. These unwanted effects always recover within 4 weeks of treatment.
Notify the doctor and medical staff if you have a history of liver disease, including hepatitis.
HIV -infected patients with liver disease include chronic hepatitis B or C, who have been treated with antiviral drugs Retrovirus, are at risk of serious and fatal liver complications.
If you have HIV infection and hepatitis B virus, your doctor will consider carefully about the best treatment regimen for you. If you have a history of liver disease or chronic hepatitis B virus, your doctor may perform blood tests to monitor your liver function.
Be vigilant with signs of lactic acidic acidosis (excess lactic acid in the blood) once you start taking Avonza 300mg: 300mg: 400mg. The signs of lactic acidic acidosis are:
Fast, deep breathing.
Drinking, nausea and stomach pain.
This unwanted effect is rare but serious, can make the liver enlargement and sometimes death.
Lactic acidic acidosis appears more often in women and overweight patients. If you have liver disease, your risk of lactic acidic acidosis will be higher.
While treating with Avonza 300mg: 300mg: 400mg, your doctor will closely monitor any signs of lactic acidic acidosis. If you think you may have lactic acidic acidosis, contact your doctor immediately.
Be careful to avoid infecting others. Avonza 300mg: 300mg: 400mg does not eliminate the risk of HIV transmission to others through sex or blood sugar. You should continue to avoid infection.
If you have progressed HIV infection (AIDS) and opportunistic infections, you may have symptoms of infections and inflammation or worsen the symptoms of infection when starting with Avonza 300mg: 300mg: 400mg.
These symptoms may show that the immune system is fighting against infections. Be wary of signs of inflammation or infection immediately after you start using Avonza 300mg: 300mg: 400mg.
If you pay attention to signs of inflammation or infection, notify your doctor or medical staff.
Some patients who use antiviral drugs in combination may develop a bone disease called bone necrosis (bone tissue death caused by loss of blood supply for bones). Retrovirus treatment time, using a corticosteroids such as dexamethasone or prednisolone, alcohol consumption, severe immunodeficiency and overweight may be some risks in many risk factors for developing this disease.
Signs of bone necrosis are stiffness, aches and joint pain (especially in the hips, knees and shoulders) and difficult to exercise. If you see these signs, notify your doctor.
Bone problems (sometimes fracture) may appear due to kidney cell damage.
Bone growth may be affected when adequate adolescents use Avonza 300mg: 300mg: 400mg. Therefore, if you or the person treated as teenagers, the doctor will consider carefully the benefits and risks when using Avonza 300mg: 300mg: 400mg.
You will need to use Avonza 300mg: 300mg: 400mg per day.
This drug helps control your condition but is not a cure for HIV infection.
You may continue other infections and other HIV -related diseases. You should have a regular health check. Do not stop the medicine without notifying the doctor.
Women during pregnancy and lactation
should not use drugs for pregnant women in the first 3 months of pregnancy.
The ability to drive and operate machinery
dizziness, concentration, drowsiness has been reported during the drug treatment process. If you have these symptoms, you should avoid activities that can be dangerous such as driving or operating machinery.
Drug interaction
Notice to doctors, pharmacists or medical staff if you are using or recently used any medication, including non -prescribing drugs.
Do not use Avonza 300mg: 300mg: 400mg with pharmaceutical products containing St. John's Wort (Hypericum Perforatum - used to treat anxiety and depression) or Voriconazole (antifungal drug).
In addition, should not use Avonza 300mg: 300mg: 400mg with the following drugs:
Do not use Avonza 300mg: 300mg: 400mg If you have used other drugs containing emtricitabine, lamivudine or tenofovir disoproxil fumarate. Do not use Avonza 300mg: 300mg: 400mg and Adefovir Dipivoxil at the same time.
Need to notify the doctor if you use other drugs that can cause kidney damage including:
Other drugs containing Didanosine (HIV -treated drugs):
Use Avonza 300mg: 300mg: 400mg with drugs containing didanosine can increase blood leftine concentration. Rarely, pancreatitis and lactic acidic acidosis (excess lactic acid in the blood) are sometimes reported to be reported when using drugs containing tenofovir disoproxil fumarate and didanosine simultaneously. Tenofovir combination with Didanosine can reduce the effect of antiviral drugs.
Avonza 300mg: 300mg: 400mg can interact with the following drugs and can do unwanted effects or can affect the effectiveness of the drug:
Storage
Store in a cool dry place, no more than 30 ° C. Store in the original packaging. Avoid light.
Do not use the drug after expiry on the packaging.
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