Ricovir 300mg drugs Mylan treats HIV-1 virus infection, hepatitis B (30 tablets)
Dosage form Box of 30 tablets
Specifications Tenofovir disoproxil fumarate
Ingredient
| Composition information | Content |
| Tenofovir disoproxil fumarate | 300mg |
Uses
indications
Ricovir 300mg drug is indicated in the following cases:
Treatment of HIV-1 infection in patients from 18 years of age and older is in combination with other antacids.
The effect of Ricovir is based on the results of treatment studies for patients who have never been treated before, including patients with large number of viruses (> 100,000 copies/ml) and studies; In which Ricovir is used to be used to basic treatment (mainly combined therapy for 3 drugs) for patients who had previously had anti -Retrovirus treatment but failed (
Select Ricovir to treat patients who had previously treated anti -Retrovirus drugs must be based on viral sensitivity test results, and/or patient treatment history.
Treatment of hepatitis B in adults whose liver function is offset with evidence of the virus's human activity, the concentration of alanine aminotrasferase (ALT) increases continuously and the histological evidence of active inflammation and/or fibrosis.
This indication is based mainly on histological, viral, biochemical and serum response in adult patients who have not been treated with nucleoside with chronic hepatitis B positive and negative HBeAg with clear liver function.
Pharmacokology
Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate Deester similar to adenosine monophosphate. Initially, Tenofovir Disoproxil Fumarate needs a hydrolysis process to convert to tenofovir and then phosphorylation by enzymes of cells converted into tenofovir diphosphate.
Tenofovir diphosphate inhibits the enzyme activity to copy HIV-1 reverse by replacing the natural substrate of Deoxyadenosine 5 ', and ends the DNA chain after merging into DNA. Tenofovir diphosphate inhibits weak DNA polymerases α, β in mammals and DNA polymerase γ mitochondria.
Pharmacokinetics
absorption
Ricovir is a water -soluble precursor of Tenofovir active ingredient. Tenofovir's oral bioavailability is approximately 25%. After taking Ricovir 300 mg doses in patients with HIV-1 at an empty stomach, the peak concentration of the serum is achieved after about 1 ± 0.4 hours. The value of CMAX and AUC is 0.30 ± 0.09 μg/ml and 2.29 ± 0.69 PG.
The pharmacokinetic properties of Tenofovir Disoproxil Fumarate in the ricovir dose range of 75 - 600 mg and are not affected by repeated dose.
Distribution
In Vitro test, the cohesion of Tenofovir with plasma proteins or serum people is less than 0.7 and 7.2%, in order of Tenofovir concentration from 0.01 - 25 g/ml. The distribution voltage in a stable condition is 1.3 ± 0.6 l/kg and 1.2 ± 0.4 l/kg, after the Tenofovir intravenous injection of 1.0 mg/kg and 3.0 mg/kg.
Metabolism and elimination
In vitro test shows that both tenofovir disoproxil and tenofovir are not the substrate of the enzyme CYP. After the Tenofovir intravenous injection, about 70-80% of the dose found in urine in the form of unchanged Tenofovir within 72 hours. After taking the single dose of Ricovir, Tenofovir's final waste time is about 17 hours. After drinking multi -dose Ricovir 300 mg 1 time/day (in full conditions), 32 ± 10% of the dose found in urine after 24 hours.
Tenofovir is eliminated by a combination of glomerular filtration and excreted through the renal tubules. So there is competition to eliminate with substances that are also excreted through the kidneys.
Before taking Ricovir 300mg drugs Mylan treats HIV-1 virus infection, hepatitis B (30 tablets)
How to use
Take medicine during meals or when snacks. The drug is best absorbed when full and when food is high in fat.
In cases where patients cannot swallow the drug, Ricovir may be used in the form of dissolving tablets in at least 100 ml of water, orange juice or pressed grapes.
Dosage
Adults
Suggested dose for HIV or chronic hepatitis B: 300 mg (1 tablet) x 1 time/day.
Children
Ricovir is not recommended for children under 18 years of age due to lack of data on safety and efficiency for this object.
Older people
There are no data on dosage for elderly patients over 65 years old.
Patients with renal failure
Tenofovir is excreted through the kidneys and increases accumulation when patients with renal failure. Dosage distance should be adjusted for patients with creatinine clearance
The adjustment of the dose for patients with renal impairment is based on limited data and may not be the most optimal. The safety and effectiveness of these dose adjustment guidelines have not been clinically evaluated. Therefore, clinical response to the treatment and kidney function should be closely monitored in patients with renal failure:
Creatinine clearance (ml/minute)*
10 - 29
Every 48 hours
Each 72 - 96 hours
Every 7 days after the end of the hemorrhage **
** In general, the dosage 1 time/week in the case of hemolytic refinement 3 times/week, each time about 4 hours or after a total of 12 hours of hemorrhage.
There is no suggestion for patients without hemorrhage with creatinine clearance
Patients with liver failure
No dose adjustment requires patients with 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 do
do when overdose? Tenofovir can eliminate blood apart, the average clearance of Tenofovir through hemorrhage is about 134 ml/min. Eliminating Tenofovir by peritoneal separation has not been studied. 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
When using Ricovir often has unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 Skin and subcutaneous tissue: Red Red. Very rare, ADR Kidney and urinary: acute renal necrosis. Unknown frequency 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
contraindicated drugs for patients with active ingredients or any ingredients of the drug.
Be cautious when used
ricovir is not used with any other drug containing Tenofovir disoproxil fumarate.
Tenofovir disoproxil fumarate has not been studied in patients under 18 years old. Tenofovir is mainly excreted through the kidneys. Tenofovir accumulation may increase with patients with medium and severe renal impairment (creatinine clearance
It is necessary to carefully monitor the signs of poisoning, such as worsening renal failure, but can also use 1 Ricovir tablet with reasonable dose distance to treat HIV for patients with kidney failure. Safety and effectiveness of Ricovir in patients with renal failure has not been established.
Patients with renal impairment, which can reduce blood phosphate, have been reported when using Tenofovir Disoproxil Fumarate.
Need to monitor kidney function (creatinine and serum phosphate) before taking Ricovir, every 4 weeks in the first 1 year of treatment, and after every 3 months later. For patients at risk or a history of renal failure and patients with renal failure, should consider closer monitoring.
If serum phosphate concentration
Tenofovir disoproxil fumarate has not been evaluated in patients with drugs that are also toxic to the kidneys (such as aminoglycoside, amphotericin B, foscanet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). Avoid using Tenofovir Disoproxil Fumarate combined with drugs that are also toxic to the kidneys. If the combination of tenofovir disoproxil fumarate and drugs also poison the kidneys inevitable, the kidney function should be monitored weekly.
Tenofovir disoproxil fumarate has not been clinically evaluated for patients who are using the drug excreted by the kidneys by the same shipping factor (Hota1- Element of organic anion 1) (such as Adefovir Dipivoxil, Cidofovir are known factors that are toxic to the kidneys). This shipping factor (Hoat1) can be responsible for excreting through the renal tubules and partially, excreted through the kidneys of Tenofovir, Adefovir and Cidofovir. Therefore, pharmacokinetics of these drugs may be changed if used simultaneously.
In healthy volunteers, a single dose of Adefovir Dipivoxil along with Tenofovir Disoproxil Fumarate does not cause significant interaction with pharmacokinetics. However, clinical safety when combining the treatment of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate is not known. Only combine the drug when really necessary, if inevitable, you need to monitor the weekly kidney function.
Tenofovir disoproxil fumarate causes slight reduction in pelvic and spinal density more significantly than in combination with Lamivudin and Enfavirenz in patients without Retrovirus anti -drugs. However, there is no risk of fracture or abnormal evidence of the corresponding bone. If you suspect bone abnormalities, you should consult with experienced physicians.
Tenofovir disoproxil fumarate should be avoided for patients with potential K65R mutations that have been treated for Retrovirus.
Tenofovir disoproxil fumarate has not been studied in patients over 65 years old. Elderly patients often suffer from renal failure, so be careful when using Tenofovir Disoproxil Fumarate for this object.
Liver disease
Tenofovir and Tenofovir Disoproxil Fumarate are not metabolized by liver enzymes. There is no significant pharmacokinetic change in non -HIV -infected patients with different levels of liver failure.
Outbreaks during treatment
The outbreak in chronic hepatitis B is relatively popular and characterized by an increase in the ALT in the serum. After starting with antiviral treatment, the serum alt may increase in some patients because of the decrease in the HBV DNA in serum. Among the patients using Tenofovir, the outbreak treatment may occur during treatment after 4-8 weeks.
In patients with liver function is offset, increasing the concentration of alt in serum is often not accompanied by increased bilirubin levels in serum or liver function loss. Patients with cirrhosis may be at risk of hepatitis after an outbreak of hepatitis, and thus closely monitor during treatment.
Outbreaks after stopping treatment
The serious acute hepatitis is also reported in patients who stopped treating hepatitis B. However, the severe outbreak included deaths.Should regularly monitor the liver function both clinically and the next labo for at least 6 months after stopping the treatment of hepatitis B. If responded, it is possible to start treating hepatitis B B. In patients with progressive liver disease or cirrhosis, not recommended treatment because hepatitis can lead to loss of liver function.
The hepatitis outbreak is particularly serious, and sometimes lethal in patients with liver function is lost.
At the same time, Hepatitis C or D
There is no data on the effectiveness of tenofovir in patients and hepatitis C or D.
At the same time HIV-1 and hepatitis B
Due to the risk of HIV resistance, Tenofovir Disopoxil Fumarate should only be used as part of the appropriate treatment regime in Retroviral in patients at the same time with hepatitis B and HIV. Patients with liver failure previously include chronic hepatitis that increases the abnormal level of liver function while combining Retroviral treatment and should be monitored based on standard operation.
If there is more evidence of liver disease in these patients, interrupting or stopping treatment should be considered. However, note that increasing ALT can be part of HBV clearance during treatment with tenofovir.
Lactic acid infection
Lactic acid infection, often combined with fatty liver disease, has been reported when using similar drugs nucleosid. Precipable and clinical data shows the risk of lactic acid infection, a type of impact of nucleosid -similar drugs, which is low with tenofovir disoproxil fumarate. However, because Tenofovir has a structure related to nucleosid medications, this risk cannot be excluded.
Early symptoms (increased blood lactate symptoms) include gastrointestinal symptoms (nausea, vomiting and abdominal pain), uncomfortable discomfort, loss of appetite, weight loss, tribes of respiratory eggs (fast breathing and/or deep breathing) or millions of neurological eggs (including machinery control). Lactic acid infection can cause high death and may be associated with pancreatitis, liver failure or renal failure. Lactic acid infections usually occur after a few months of treatment.
Treatment with nucleosid medications, should stop when there are symptoms of hyperlact blood and metabolic lactic infections, progression of liver, or rapidly increasing the concentration of aminotransferase.
Be cautious when treating nucleosid similar drugs for any patient (especially obese women) with large liver, hepatitis or other risk factors for liver disease and fatty liver (including some drugs and alcohol). Patients who are also infected with hepatitis C are treated with Alpha Interferon and Ribavin may have special risks.
Patients who are likely to increase risks should be closely monitored. Retrovirus combined therapy is related to the redistribution of fat (lipid dysplasia) in the body of HIV -infected patients. The mechanism of this is also unclear. Perhaps due to the relationship between the fat in internal organs and protease inhibition and the fat consumption and nucleoside inhibition.
The risk of high lipid dysplasia is related to old age, factors related to drugs such as prolonged treatment of Retrovirus and related to metabolic disorders. Clinical tests should include evaluation of physical signs of body fat re -distribution. Consider checking lipid concentration in serum when hungry and glucose in the blood. Lipid disorders should be properly treated depending on clinical.
Tenofovir has a structure related to nucleoside drugs, so the risk of lipid disorders cannot be excluded. However, the risk of lipid disorders of Tenofovir Disoproxil Fumarate is lower with stavudin when combined with lamivudine and enfavirenz.
Similar to nucleoside and nucleotide drugs can cause damage to mitocular companies at different degrees. There have been reports on mitochondria disorders in children who are not infected with HIV in the uterus and babies caused by nucleoside drugs. The harmful effects are mainly reported as blood disorders (anemia, neutropenia), metabolic disorders (hyperlactemia, hyperlipse of blood). These phenomena are often transient. Some late neurological disorders have been reported (increasing tone, convulsions, abnormal behaviors). It is not known that these disorders will be transient or prolonged.
The fetus in the uterus of the mother has used nucleoside medications, even the fetus is not infected with HIV, should be monitored both clinically and considered, and should also check the chromosomal disorders when there are millions of eggs and relevant signs. These results currently do not affect the recommendations when using Retrovius resistance for pregnant women to prevent mother -to -child transmission.
Immune reaction syndrome
For patients with HIV infection, immunodeficiency at the time of establishing a combination of Retrovirus (Cart), asymptomatic inflammatory reactions or opportunistic pathogens may arise and cause serious clinical conditions or seriously add symptoms. Such reactions usually occur within a few weeks or the first few months to set up cartons. For example, cytomegalovirus retinitis, common and/ or local tuberculosis infections, or pneumocystis carinii pneumonia. Any symptoms of inflammation should be evaluated and replaced when necessary.
Bone necrosis
Although the cause is a multi -factor (including the use of corticosteroids, the destruction of alcohol, severe immune system weakening, high body mass index), cases of bone necrosis have been specially reported in patients with HIV disease that is progressing and/or treatment combined with long -term retroviral resistance (Cart). Patients are advised to check medical examination if there are signs of joint pain, stiffness or difficulty moving.
The ability to drive and operate machinery
There are no studies on the effects of drugs on driving and operating machinery. However, patients should be informed that dizziness may occur during the use of Tenofovir.
Pregnancy
There is no clinical information about the use of Tenofovir Disoproxil Fumarate on pregnant people.
Tenofovir disoproxil fumarate should only be used during pregnancy if the benefits bring higher risk to the fetus risk.
Although the risks for the fetus, the use of Tenofovir Disoproxil Fumarate for people who are likely to be pregnant must be combined with effective contraception.Breastfeeding period
Unknown ability to excrete through human milk of Tenofovir. Therefore, people who are using Tenofovir should not breastfeed.
A general principle, HIV -infected women should not breastfeed to avoid HIV transmission to the child.
Drug interaction
Medicine interactive studies are only performed on adults. Based on the results of in vitro research and the elimination process, the Tenofovir can interact with other drugs through the CYP 450 system related to Tenofovir and other drugs.
Ricovir should not be used with Adefovir Dipivoxil.
Tenofovir is filtered in the glomerular, excreted through the kidneys and positive excretion thanks to organic anion transport factors (Hoat1). Combining Tenofovir Disoproxil Fumarate with drugs that are also positively excreted through the kidneys thanks to the factor of Hoat1 (such as Cidofovir) that can cause increased tenofovir concentration or combined drugs.
Combined with other antiviral drugs
Emtricitabine, Lamivudine, Indinavir, Enfavirenz, Nelfinavir and Saquinavir (Ritonavir's conductor) combine treatment with Tenofovir Disoproxil Fumarate without clinical value interactions.
When Tenofovir Disoproxil Fumarate is used in combination with Lopinavir/Ritonavir, there is no change in pharmacokinetics of Lopinavir and Ritonavir, while the AUC of Tenofovir increases approximately 30%. Higher concentrations are related to the harmful effects of tenofovir, including renal disorders.
When the Didanosine -soluble capsule is taken 2 hours before or simultaneously with Tenofovir Disoproxil Fumarate, the AUC of the Didanosine increases and the dynamic parameters of Tenofovir have also changed. Therefore, it is not advisable to combine tenofovir disoproxil fumarate and didanosine.
When Tenofovir Disoproxil Fumarate is used with Atazanavir, Atazanavir concentration is reduced. Combining Atazanavir/Ritonavir with Tenofovir causing increased Tenofovir accumulation. Higher concentrations are related to the harmful effects of tenofovir, including renal disorders.
Other interactions
Combining Tenofovir Disoproxil Fumarate, with methazone, ribavirin, rifampicin, adefovir dipivoxil or birth control hormone containing norgestimate/ethinyl estradiol does not cause pharmacokinetics.
Tenofovir disoproxil fumarate is taken with food, due to food that increases the bioavailability of Tenofovir.
Storage
Store less than 30 ° C, in closed packaging. Avoid light.
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