Savi Tenofovir 300 medicine for HIV-1 infection in adults (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Tenofovir disoproxil fumarat
Ingredient
| Composition information | Content |
| Tenofovir disoproxil fumarat | 300mg |
Uses
Indications
Treatment of infection HIV -1 in adults and children ≥ 12 years: Must be coordinated with other antacids.
Treatment chronic hepatitis B in adults.
Chronic hepatitis B in children ≥ 12 years old with liver function is still compensated, has active virus evidence, increases Alt (Alanine Amino Transferase), long -term, active hepatitis.
Preventive treatment for health workers must be exposed to the specimens (blood, body fluids ...) at risk of HIV-1 infection: must be coordinated with other antacids.
Pharmacokology
Mechanism of action
Tenofovir disoproxil fumarat is an oral antiviral drug, with acylic nucleosid phosphonat diester structure similar to adenosin monophosphate. The drug is hydrolyzed into tenofovir and subject to phosphorylation reactions by cell enzymes to convert into tenofovir diphosphate. Tenofovir Diphosphate prevents the activity of the HIV-1 copy enzyme (Human ImmunodeFicIency Virus 1) and HBV's polymerase enzyme (Hepatitis B Virus) by competition with substrates in Deoxyadenosin 5'-triphosphate virus and after attaching DNA will extend the ADN chain. Tenofovir diphosphate has the main activity that prevents the DNA-polymerase enzyme α, β of mammals and enzymes of the DNA-polymerase complex chain γ.
pharmacokinetics
absorption:
Tenofovir disoproxil fumarat is a water -soluble diester. Tenofovir's oral bioavailability is about 25%. Oral dose of 300 mg Tenofovir for patients with HIV-1 infected for the maximum serum concentration is within 1 ± 0.4 hours. Maximum concentration value CMAX (Maximum Concentration) and area below the curve (Area under the curve: AUC) is 0.30 ± 0.09 μg/ml and 2.29 ± 0.69 μg/ml, respectively.
The pharmacokinetics of Tenofovir is proportional to the dose in the dose range from 75 to 600 mg and is not affected by repeated dose.
Distribution:
In vitro testing for tenofovir cohesion with human plasma and protein for values lower than 0.7 and 7.2%, corresponding and tenofovir concentration is between 0.01 to 25 μg/ml. The distribution voltage in a stable state is 1.3 ± 0.6 l/kg and 1.2 ± 0.4 l/kg after taking a dose of Tenofovir 1.0 mg/kg and 3.0 mg/kg.
Metabolism:
In vitro studies show that Tenofovir Disoproxil or Tenofovir are not the substrate of CYP enzymes (Cytochrome P450 enzymes).
Era:
After intravenous injection, about 70-80% Tenofovir is excreted in the urine in the form of unchanged after 72 hours. After taking a dose of Tenofovir 300 mg (150 mg x 2 tablets), the elimination time of tenofovir is about 17 hours. After taking 300 mg continuous doses (150 mg x 2 capsules) daily, about 32 ± 10% of oral drinks are excreted in the urine after 24 hours.
Tenofovir is excreted by a mechanism of glomerular filtration and selective excretion through renal tubules. This can create a competitive excretion with other drugs that the drug is also excreted by the kidney.
Before taking Savi Tenofovir 300 medicine for HIV-1 infection in adults (3 blisters x 10 tablets)
How to use 2>Take medicine during meals or when snacks. The drug is best absorbed when full and when food is high in fat.
Dosage
HIV-1 infection treatment:
Adults: Combined with other Retrovirus anti -Retrovirus drugs.
Adults:
Children ≥ 12 years old and weight ≥ 35 kg:
Can stop treatment with tenofovir when losing serum hbsag. The current optimal drug stop time is unknown. Can stop:
Backup HIV-1 infection in adults:
Combined with other antiviral drugs, take 1 tablet/time, once a day. Use early, within a few hours after being exposed and continue to use for the next 4 weeks if the drug is well tolerated.
Special subjects:
Elderly: No recommended dose in people> 65 years old.
kidney failure:
Adjust the dose in people with kidney failure and hematurian jurors. For people with medium to severe kidney failure, the dose adjustment is based on basic creatinine clearance ≥ 50 30 - 49 10 - 29 Every 24 hours. Every 48 hours. Every 72 to 96 hours. Every 7 days or 12 hours after the examination. B normal every week is divided 3 times, about 4 hours each time. Savi Tenofovir 300 is used immediately after the appraisal. Hepatic failure No dose adjustments in the liver failure. 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? In a study with a dose of 600 mg of Tenofovir Disoproxil Fumarat for 8 patients taking for 28 days, there were no serious side effects that were reported. The consequences of higher doses are not known. If there is an overdose, the patient manifests the proof of poisoning, the symptom treatment should be conducted and the necessary supportive measures. Tenofovir is removed by hemolysis with an extract coefficient of nearly 54%. With the oral dosage of 300 mg Tenofovir disoproxil Fumarat, after 4 hours of hemorrhage, the dose has removed nearly 10% of the dose. If you forget to take medicine for more than 12 hours and near the next dose, skip the forgotten dose, take the next dose like the usual calendar. Do not take double the dose to compensate for the dose to forget to drink. What to do when you forget 1 dose?
Side Effects
When using Savi Tenofovir300 medicine , you may experience unwanted effects (ADR).
Common, ADR> 1/100
Instructions on how to handle ADR
Must stop the drug if there are manifestations of liver, kidney, acidic infection 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
Savi Tenofovir 300 drug is contraindicated in the following cases:
Be cautious when using
Patients with lactic acidosis and severe liver edema due to fatty fatty:
There was a report on death when the aforementioned patients used the active ingredients "similar to nucleosid" including tenofovir, drinking with other Retrovirus anti -Retrovirus drugs. Most of these cases occur for women, due to obesity and for long -term use of similar active ingredients nucleosid. Especially cautious when using this medication for patients with known factors that cause liver disease.
Before taking Tenofovir, patients need to be tested in advance about lactic acidosis and severe liver edema.
serious hepatitis after treatment:
Non -continuous treatment of hepatitis B (HBV), even with Tenofovir, can cause serious hepatitis clinically manifested and on the test occurs at least 7 months after stopping. Should re -perform the appropriate treatment.
Symptoms of renal functional impairment:
Tenofovir is mainly excreted in the kidney. Renal weakening, including acute renal failure and fanconi syndrome (renal tubular lesions, accompanied by a decrease in blood phosphate). Before taking the drug, it is necessary to check the clearance of creatinine and serum phosphorus regularly for patients at risk of renal function.
Tenofovir is used with kidney toxic drugs (such as amphotericin B, foscarnet, anti -inflammatory steroids ...) increases symptoms of kidney failure.
Dolgence combined with other anti -ARV (antiretroviral) drugs:
Do not share tenofovir with other drugs in the ingredient containing tenofovir disoproxil fumarat or adefovir dipivoxil.
Used for patients with HIV-1 and HBV co-infected:
Due to the risk of increased HIV-1 resistance, Tenofovir is only used for patients with HIV-1 and HBV co-infected patients as part of the appropriate ARV treatment regime. HIV-1 antibody tests should be performed for HBV infected patients before using Tenofovir.
The decrease in the mineral density of the bone (BMD: Bone Mineral Density):
It is necessary to check the monitoring of the mineral density of bone in patients with a history of fracture or osteoporosis (osteopenia, deficiency). However, although the addition of calcium and vitamin D has not been studied, taking calcium and vitamin D supplements is useful for patients.
There has been a report on bone softness (Osteomalacia) accompanied by edema in the nephrotic tube when used in combination with Efavirenz and Lamivudin with Tenofovir. Bone effects of Tenofovir have not been studied in chronic hepatitis B patients.
Fat distribution (fat):
In patients with HIV-1 infection, the rate of re-distribution/ fat accumulation in the body, including central obesity, fat accumulation in the cervical vertebra (Buffalo Hump: Buffalo hunchback), causing damage to the face and border area, developing breasts (large) observed in treated patients in combination with ARV drugs.
Symptoms of immunity re -establishment:
Symptoms of immunosupplications have been reported in HIV-1-infected patients when treated with ARV, including Tenofovir. In the early stages of the combined ARV treatment, the recovery of the patient's immune system can lead to an easy response to inflammation or opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus ..., tuberculosis).
Products contain lactose excipients. Patients have rare genetic problems such as galactose intolerance, lactase deficiency or Glucose-Galactose under absorption should not be taken.
used for special groups
Used for the elderly:
Subclinical studies do not include enough people aged 65 and over to determine the difference that meets the same group of people. In general, choosing the dose for elderly patients should be careful because of the ability to impair liver, kidney or heart function and accompanying diseases or other medications.
The ability to drive and operate machinery
headache, dizziness can occur when using Tenofovir disoproxil fumarat so patients need to be cautious, although there is no study shows the effect of drugs affects the ability to drive and operate machinery.
Pregnancy
Mouse and rabbits are pregnant at 14 and 19 times the dose for humans, based on the body area, there is no evidence of fertility decline or damage to pregnancy due to tenofovir. However, there should be adequate and controlled studies on pregnant women. Because reproductive studies on pregnant animals are not always true for people, only Tenofovir is used when it is really necessary during pregnancy.
The period of breastfeeding
According to the World Health Organization's disease control and prevention centers recommended, HIV-1-infected mothers are not breastfeeding to avoid the risk of HIV-1 infection for children.
Research on the mother mouse proves that Tenofovir is excreted in mouse milk. In humans, there is clinical evidence Tenofovir secreted breast milk with low concentrations. Because both HIV-1's ability to transmit and transmit side effects for breastfeeding, the mother does not breastfeed if there is treatment with Tenofovir.
Drug interaction
Didanosin :
Due to unwanted effects, the use with Didanosin must be cautious and closely monitored. Didanosin must be stopped when these side effects have. When shared, the cmax concentration and the area under the curve (AUC) of the Didanosin increases significantly. This interaction mechanism is not clear. The higher the dividanosin concentration, the more prone to side effects, including pancreatitis and neuritis. In patients with weight> 60 kg, Didanosin dose can be reduced to 250 mg when used with Tenofovir. There is no recommendation to reduce the dose of didanosin in humans weight
Atazanavir:
Atazanavir increases the concentration of tenofovir when shared. This mechanism is unknown. Patients using Atazanavir and Tenofovir have an unwanted effect. At that time, it should be temporarily stopped using Tenofovir. Tenofovir reduces AUC and CMAX of Atazanavir when shared. When used in combination with Tenofovir, 300 mg of Atazanavir should be used with 100 mg of Ritonavir. Do not use Atazanavir alone with Tenofovir but must use additional ritonavir.
liponavir + ritonavir:
Liponavir + ritonavir mixture increases tenofovir concentration when shared. The patient in this mode shows a combination side effect. Then stop using Tenofovir to avoid combining side effects.
lamivudin :
Tenofovir reduces lamivudine levels in plasma.
lndinir:
Concentrated with Tenofovir increases tenofovir concentration and reduces indinavir levels in plasma.
Ledipasvir + Sofosbuvir:
Simultaneously used with Tenofovir increases the side effects of Tenofovir.
Medications affect kidney function:
When tenofovir is excreted mainly through the kidney, using with drugs that reduce the kidney function can increase the serum tenofovir concentration. Tenofovir simultaneously used with drugs is mainly discharged through the kidneys (Aciclovir, Cidofovir, Ganciclovir, Valacyclovir, Valganciclovir) that can increase the serum concentration of Tenofovir or increase the concentration of drugs excreted through the kidney due to rusty lines. In the treatment of hepatitis B, Tenofovir is not used with Adefovir Dipivoxil.Storage
In a dry place, the temperature does not exceed 30 ° C, avoiding light.
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