Trustiva medicine 600mg/200mg/300mg heterero treatment HIV-1 infection (30 tablets)

Dosage form Box
Specifications Efavirenzum, Emtricitabin, Tenofovir Disoproxil

Ingredient

Composition information	Content
Efavirenzum	600mg
Emtricitabin	200mg
Tenofovir disoproxil	300mg

Uses

Indications

used separately in a regimen or when used in combination with other anti-virus drugs to treat HIV-1 infection in adults and children at least 12 years of age.

Pharmacokology

Mechanism of operation:

efavirenz:

Efavirenz is an anti-copy inhibitor in the Non-Nucleosid (RT) of HIV-1. Efavirenz's activity is carried out mainly through intermediaries by inhibiting non-competitive reverse copying activities (RT) of HIV-1. Efavirenz does not inhibit HIV-2 RT and cell polymerases in humans α, β, γ and Δ.

emtricitabin:

Emtricitabin, a synthetic substance similar to nucleosid nucleosides of cytidin are phosphorus by subtle enzymes that turn into emtricitabin 5'-triphosphate. Emtricitabin 5'-Triphosphate inhibits the operation of HIV-1 RT by competing with natural substrates Deoxyctidin 5'-triphosphate and by ending the DNA chain after integrating into the virus new DNA chain. Emtricitabin 5'-Triphosphate is a weak inhibitor of DNA polymerase cells in mammals α, β, ε, and DNA polymerase cells γ.

tenofovir disoproxil fumarat:

Tenofovir DF is similar to nucleosid nucleosid phosphonate nucleosides of adenosine monophosphate. Tenofovir DF initially needed hydrolyzed to convert into tenofovir and then phosphorus by cell enzymes to form Tenofovir Diphosphate. Tenofovir diphosphate inhibits the operation of HIV-1 RT by competing with natural substrates Deoxyadenosin 5-triphosphate and by ending the DNA chain after integrating into the DNA chain. Tenofovir Diphosphate is a weak inhibitor of polymerase cell DNA in mammals α, β and DNA polymerase cells γ.

Dynamic pharmacokinetics

emtricitabin: After using Emtricitabin, there is no change in pharmacokinetics due to skin color.

Tenofovir Disoproxil Fumarat: In addition to white people, there is not enough quantity from skin and ethnic groups that are easy to identify the differences of pharmacokinetics after using Tenofovir DF among specific objects.

Sex: Efavirenz's pharmacokinetics, Emtricitabin and Tenofovir are similar among male and female research subjects.

Patients with children: Only Trustiva is used for children from 12 years old with a weight larger than or equal to 40kg.

Elderly patients: There is no full assessment of Trustiva's pharmacokinetics in people aged 65 and over.

Patients with renal failure:

Efavirenz: There is no study of Efavirenz pharmacokinetics on kidney failure subjects; However, only less than 1% is excreted intact in the urine, so the impact of kidney failure on Efavirenz's elimination is at a minimum.

Emtricitabin and Tenofovir Disoproxil Fumarat: The pharmacokinetics of Emtricitabin and Tenofovir DF have changed in renal failure researchers. In research objects with creatinine clearance below 50 ml/min, CMAX and AUC0-∞ Emtricitabin and Tenofovir have increased.

Patients with liver failure:

Efavirenz: A non-significant multi-dose trial has any significant impact on Efavirenz pharmacokinetics on mild liver failure studies (type A child-pgh points) when compared to verified research subjects. There is no enough data to determine whether the liver failure is moderate or heavy (the Child-Pugh point B or C) has an impact on the pharmacokinetics of Efaviren.

Emtricitabin: There is no study of the pharmacokinetics of Emtricitabin on subjects studying liver failure, however, liver enzymes do not metabolize Emtricitabin so the impact of liver failure is limited.

Tenofovir disoproxil fumarat: Tenofovir's pharmacokinetics after using Tenofovir DF 300 mg has been studied on non -HIV -contaminated studies with medium and severe liver failure. There is no significant change in Tenofovir's kinetic dynamics on liver failure subjects compared to non -hepatic research subjects.

Before taking Trustiva medicine 600mg/200mg/300mg heterero treatment HIV-1 infection (30 tablets)

How to use

oral medication.

Dosage

Adult patients and children aged 12 and older with at least 40 kg:

Dosage Trustiva a single tablet once a day when hungry.

Dosage before bed can improve the tolerance of central nervous system symptoms.

kidney failure:

Because Trustiva is a combination of fixed dose, the drug is not prescribed for patients who need to adjust the dose such as renal failure in a moderate or severe level (creatinine clearance below 50 ml/min).

Concomitant use with rifampin: When using Trustiva drugs simultaneously with rifampin in patients weighing at least 50 kg, using Efavirenz 200 mg/day is recommended.

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?

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Efavirenz:

Unknown frequency

Mental: depression, anxiety, restlessness.

Metabolism: Increase total cholesterol.

emtricitabin:

Unknown frequency

musculoskeletal joints: joint pain, muscle pain, back pain.

Neurological: Perception, peripheral neuropathy (including peripheral nerve and neurological disease).
Respiratory: cough, pneumonia, rhinitis.
digestive: digestive disorders, abdominal pain.
Other: Fever, rash (including rash, rash rash, urticaria, pustules and allergic reactions).
tenofovir disoproxil fumarate:
Unknown frequency

Metabolism: Lactic acid infection.

Liver: Liver enlargement of fatty, acute severe hepatitis clinically progresses. kidney - urinary: New kidney failure or further renal failure.
musculoskeletal joints: Reduce the concentration of minerals in bone.
immunity: immunosuppressive syndrome.
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

Contraindicated

Patients with clinical history of hypersensitivity (for example, Stevens-Johnson syndrome, diverse erythematosus or skin poisoning) with Efavirenz, a component of Trustiva.

Simultaneously used with drugs that affect CYP3A enzymes such as Voriconazole antifungal drugs, Ergot derivatives (dihydroergotamine, ergonovin, ergotamin, methylergovin), Benzodiazepine (Midazolam, triazolam), calcium channel blockers (Bepridil) (Cisaprid), sedative (Pimozid), St. John's Wort (Hypericum Perforatum).

Be cautious when using

Lactic acid infection/heavy liver fatty:

Most female patients are susceptible to lactic acid/ liver enlargement of severe fatty fatty, including deaths, when using nucleosid nucleus, including Tenofovir DF, a compound of Trustiva when combined with other antiviral agents. Obesity and prolonged nucleosid nucleus are risk factors.

Particularly cautious when using nucleosid nucleus for any patient with risk factors that have been identified to cause liver disease; However, there are also cases where patients do not have risk factors. It is necessary to stop Efavirenz, Emtricitabin and Tenofovir DF in any patient developing clinical detections or tests that suspects lactic acid infection or liver toxicity (which may include severe liver fatty liver even without significant liver enamel increased).

Patients infected with HIV-1 and HBV:

Recommended that all HIV-1-infected patients should check for the presence of chronic HBV before using antiviral therapy. Trustiva has not been approved to treat chronic HBV infection, and it is unclear the safety and effectiveness of Trustiva for patients infected with both HBV and HIV-1 types. Patients with bacterial infections of both HBV and HIV-1 and have stopped Emtricitabin or Tenofovir DF, two compounds of Trustiva have developed into acute severe hepatitis B.

In some HBV infected patients and have been treated with Emtricitabin, the progressive patient with hepatitis B is accompanied by liver and liver failure. Patients infected with both HBV and HIV-1 types need to be closely monitored in terms of clinical and monitoring test indicators for a few months before stopping treatment with Efavirenz, Emtricitabin, Tenofovir Disoproxil Fumarate. If necessary, start using hepatitis b.

Trustiva is not used simultaneously with Hepsera® (Adefovir Divivoxil).

Drug interaction:

The concentration of the plasma Efavirenz may be changed by the substrates, inhibitors, and derivatives of CYP3A. Also, Efavirenz can change the plasma concentration of drugs caused by CYP3A or CYP2B6.

Relevant products are not used simultaneously with Trustiva including: Comlera (Emtricitabin/ Rilpivirin/ Tenofovir DF), Emtriva (Emtricitabin), Sustiva (Efavirenz), unless the dose adjustment is needed (such as Rifampin). Due to the similarity between Emtricitabin and Lamivudin, Trustiva is not used simultaneously with lamivudin-containing drugs, including Combivir (Lamivudin/ Zidovudin), Epivir, or Epivir-HBV (Lamivudin), Epzicom (Abacavir Sulfat/ Lamivudin) or TrizIVIR) lamivudin/ zidovudin).

Mental symptoms:

Serious mental adultery reactions such as severe depression, suicide thoughts, suicide intentions that do not cause death, aggressive behavior, cognitive disorder reaction, and mixed sad and happy reaction have been reported in patients treated with Efavirenz. Other factors accompanied by increasing frequency of these mental symptoms including drug injections, mental history and mental medication when starting with drug treatment.

It is necessary to medical examination for patients with serious mental adultery reactions to determine whether these symptoms are related to the use of Efavirenz and if any, to determine whether the risk of continuing the use of therapy will bring more benefits.

Nervous symptoms:

Symptoms reported include excitement, confusion, agitation, dementia, bewilderment, abnormal thoughts and forgetting themselves. Patients should be notified that when continuing to use therapy, common symptoms are likely to be improved and are currently unpredictable when the next attacks of mental symptoms are less often. Dosage before bed can improve the tolerance of nervous system symptoms.

Patients using Trustiva should be noted about the ability to affect the central nervous system when using Trustiva simultaneously with alcohol and psychotropic medicine.

Patients who have experienced symptoms of central nervous systems such as decreased concentration, dizziness and/ or sleeping chicken should avoid doing dangerous jobs such as driving or operating machinery.

New kidney failure or progressive renal failure:

Emtricitabin and Tenofovir are mainly eliminated through the kidneys; However, Efavirenz does not excrete through the kidneys. Because Trustiva is a combined product and the dose of the compounds in the drug cannot be replaced, patients with creatinine clearance below 50 ml/minute should not be used Trustiva. Renal failure, including cases of acute renal failure and fanconi syndrome (renal tubular lesions with severe hypoglycemia), have been reported with the use of Tenofovir DF.

It is recommended to calculate creatinine clearance in all patients before starting to see if it is clinically suitable when using Trustiva. Monitoring the regular regime of creatinine and serum phosphorus in patients at risk of renal failure, including patients with a history of kidney disease when used with Hepsera. Trustiva should be avoided with simultaneous medications or recent kidney poisoning drugs.

Floating:

Stop Trustiva in patients detecting severe symptoms that accompanied by swollen skin, flaking, uncomfortable mucosa or fever. Reasonable use of antihistamine and/ or corticosteroid drugs can improve tolerance with accelerating the rash.

Liver poisoning:

Recommendations to monitor enzymes in the liver before and in treatment in patients with patients with hidden liver disease including hepatitis B and C virus infections; patients increasing transaminase clearly; and patients treated with other drugs related to liver poisoning.

It is also necessary to consider monitoring the liver in patients without a history of liver function impairment or other risk factors. It is necessary to calculate the benefits of continuing treatment with Trustiva when compared to the unknown risks of liver poisoning in patients with persistent increased serum transaminase greater than 5 times on a normal limit.

Reduce the concentration of minerals in bones:

It is necessary to evaluate the concentration of minerals in the bone (BMD) in patients with a history of pathological fractures or other risk factors that cause osteoporosis or loss of bone substance. Although the impact of adding calcium and vitamin D has not been studied, this supplement may benefit all patients.

Consult your doctor if there are abnormal doubts about bone. When used for treatment with Tenofovir DF, the impact of BMD changes and biochemical signs on the long -term health of bones and the risk of future fractures are still unknown. Cases of bone puree (related to renal disease in the near -coal tube and it contributes to the fracture) has been reported when using Tenofovir DF.

convulsions:

Be cautious in any patient with a history of convulsions. Periodic monitoring of plasma concentrations in patients using simultaneously anti -convulsive drugs that these drugs are metabolized mainly through the liver such as phenytoin and phenobarbital.

immunosuppressive syndrome:

In the first phase of combined antiviral drug treatment, it is necessary to evaluate and treat more patients that the immune system responds can develop to respond to inflammation of opportunistic infections that do not cause pain and other bacterial infections [such as Mycobacterium virus infection, cell virus, pneumucystis jirovecii pneumonia (PCP), or tuberculosis].

Fat distribution:

The redistribution/ accumulation of fat in the body including abdominal obesity, widespread obesity in the neck and back (humpback buffalo), excess in the peripheral, excess on the face, chest development and "Cushing syndrome" recorded in patients using other antiviral drugs. The mechanism and long -term effects of these phenomena are still unknown. The involvement of these causes is still unknown.

The ability to drive and operate machinery

Patients using Trustiva should be noted the possibility of affecting the central nervous system when using Trustiva simultaneously with alcohol and psychotropic medicine. Patients who have experienced symptoms of central nervous systems such as decreased concentration, dizziness and/ or sleeping chickens should avoid doing dangerous jobs such as driving or operating machinery.

Pregnancy

Efavirenz may be harmful to the fetus when used in the first three months of pregnancy. Pregnant women should avoid using Trustiva. Always use various contraceptive measures (such as oral contraception and hormonal contraception). Due to the prolonged semi -destructive time of Efavirenz, the use of proper contraception within 12 weeks after the trustiva stop is recommended.

Pregnant women need to check pregnant tests before using Trustiva, if using this drug for three months of pregnancy, or if pregnant patients use this drug, the patient should be notified of the harmful effects on the drug's pregnancy.

There is no full test of Trustiva in pregnant women. Trustiva is only used during pregnancy if the benefits bring more risks to the fetus.

The period of breastfeeding

It is unclear whether Efavirenz, Emtricitabin, or Tenofovir is excreted through human milk. Due to the risk of HIV-1 transmission to babies and serious adverse reactions when breastfeeding, mothers need to be instructed not to breastfeed if used Trustiva.

Drug interaction

Efavirenz has an influence on CYP3A and CYP2B6 liver enzymes. The substrates of CYP3A or CYP2B6 can reduce plasma concentrations when used simultaneously with Efavirenz. In vitro studies have shown that Efavirenz inhibits the CYP2C9, 2C19, and 3A4 iszyme in the recording of plasma concentrations. The simultaneous use of Efavirenz with drugs caused by these iszyme can lead to changes in plasma concentrations of medications used simultaneously. Therefore, the appropriate dose adjustment may be necessary for these drugs.

CYP3A activity stimulants (such as Phenobarbital, Rifampin, Rifabutin) are predicted to increase Efavirenz clearance, leading to reduced plasma concentrations.

emtricitabin and tenofovir disoproxil fumarate:

Do Emtricitabin and Tenofovir mainly excreted the kidneys to simultaneously use Efavirenz, Emtricitabin and Tenofovir disoproxil Fumarate with drugs that reduce kidney function or compete with active excretion via renal tubules that can increase the concentration of cetricitabin, tenofovir and/ or other types of diarrhea. A few examples include the following drugs but not limited only in these drugs are Acyclovir, Adefovir Dipivoxil, Cidofovir, Ganciclovir, Valacyclovir, and Valganciclovir.

Concomitant use with Tenofovir DF and Didanosin must be cautious and patients using combined drugs need to be closely monitored on the pervasive reactions caused by Didanosin. Didanosin should be discontinued in patients developing adverse reactions. CD4+ cell inhibition has been recorded in patients using Tenofovir DF with didanosin 400 mg/day.

Storage

Store at 300C, avoid moisture. Leave the medicine out of the reach of children.

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