Febuxotid vk 80 An Thien treats chronic blood uric acid hypertrophy (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Febuxostat
Ingredient
| Composition information | Content |
| Febuxostat | 80mg |
Uses
indications
Febuxotid 80 mg is indicated for treatment of chronic hyperuricemia in patients with gout.
Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.
Pharmacokic
Uric acid is the final product of the human metabolism and is created in the hypoxanthin reaction chain -> xanthin -> uric acid. Both metabolic steps are catalyzed by xanthin oxidase enzyme (XO).
Febuxostat is a 2-anlthiazol derivative, which reduces serum uric acid by inhibiting septic selection. Febuxostat has been shown to inhibit both oxidative and non -oxidant forms of XO.
At the concentration of febuxostat treatment does not inhibit other enzymes involved in the metabolism of purin or pyrimidin, namely guanin deaminase, hypoxanthin guanin phosphoribosyltransferase, OROTATOAT phosphoribosyltransferase, orotidin monophose decarboxylase phosphorylase.
pharmacokinetics
absorption:
Febuxostat is quickly absorbed (TMAX 1.0-1.5 hours) and good (at least 84%). After taking the dose of 80 and 120 mg once a day (single or multiple dose), cmax is about 2.8-3.2 mg/ml, and 5.0-5.3 mg/ml, respectively.
Distribution:
The volume of distribution in the stable state of Febuxostat is 29-75 l after the oral dose of 10-300 mg. The ratio of cohesion to plasma proteins is about 99.2% (mainly with albumin), and unchanged within the range of concentrations achieved at a dose of 80 and 120 mg.
Metabolism:
Febuxostat is widely metabolized through the uridin diphosphate glucuronosyl - Transferase (UDPGT) system and oxidation through the Cytochrom P450 (CYP) system.
Era:
Febuxostat is removed by both liver and kidney lines. After the dose of Febuxostat 80 mg, about 49%of the dose is released in the urine in the form of febuxostat constant (3%), Glucuronid Acyl derivatives (30%), oxidative metabolites and their compounds (13%) and other unknown metabolites (3%).
In addition to appearing in urine, about 45%of the dose found in stools in the form of tebuxostat is constant (12%), derivatives of glucuronid acyl (1%), oxidant metabolites and their compounds (25%) and other unknown metabolites (7%).
Before taking Febuxotid vk 80 An Thien treats chronic blood uric acid hypertrophy (3 blisters x 10 tablets)
How to use
Take oral use.
Dosage
Adults (18 years old)
Febuxostat recommended dose is 80 mg once a day, used with food or not.
If after 2-4 weeks of treatment, serum uric acid remains higher than 6 mg/dL (357 PMOL/L), may consider using Febuxostat 120 mg once a day.
Febuxostat has a quick impact, allowing the concentration of uric acid in the serum after only 2 weeks. The goal of treatment is to reduce and maintain serum uric acid levels below 6 mg/dl (357 pmol/l), prevent gout from outbreaking for at least 6 months.
Children
Safety and effectiveness of Febuxostat in children aged under 18 have not been determined.
Other objects
No dose adjustment for the elderly.
Efficiency and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance
Effective and safety Febuxostat has not been studied in patients with severe liver failure (Child Pugh De C). The recommended dose in patients with mild liver failure is 80 mg. Research data is limited in medium liver failure patients.
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? However, the recommended overdose should not be used. Patients should be treated for symptoms and support treatment if an overdose occurs.
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 Febuxotid 80 mg, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Disorders of the digestive system: diarrhea, nausea. Abnormal liver function. Systemic: edema. Uncommon, 1/1000 Mental disorders: Reduce libido, insomnia. Cardiovascular disorders: Atrial fibrillation, chest drum, abnormal electrocardiogram. Respiratory disorders: shortness of breath, bronchitis, upper respiratory infection, cough. Skin and subcutaneous tissue disorders: dermatitis, urticaria, itching, skin pigmentation, skin damage, hemorrhage, yellow rash, papules, small acne rash. Disorders of musculoskeletal and connective tissue: joint pain, arthritis, muscle pain, musculoskeletal pain, muscle weakness, muscle spasm, muscle tension, epidemic inflammation. renal and urinary disorders: kidney failure, kidney stones, bleeding, urination, proteinuria. Genital disorders: erectile dysfunction. Rare, 1/10000 Immune system disorders: Anaphylaxis, hypersensitivity. Skin and subcutaneous disorders: Poisoned epidermal necrosis, Stevens-Johnson syndrome, angioedema, drug reaction with eosin hypernage and systemic symptoms, systemic rashes (serious), erythema, flaky skin, red rash, pustules, itching, pink, hair loss. Kidney and urinary disorders: interstitial nephritis, urine. 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. To prevent acute gout occurs during treatment, it is advisable to start treatment with Febuxostat when acute gout attacks have completely dropped. If acute gout occurs during febuxostat treatment, patients should not stop the drug. Control acute gout suitable for each patient. Continue treatment with Febuxostat to reduce the frequency and intensity of acute gout. Must stop Febuxostat immediately when the skin appears, accompanied by more severe allergies, especially those with kidney damage or are taking thiazide diuretics. Patients must be instructed on signs and symptoms and closely monitor the symptoms of allergic/hypersensitivity reactions. Febuxostat treatment should be stopped immediately if allergic/hypersensitivity reactions, including Stevens-Johnson syndrome, stops early to have better prognosis. If the patient has developed allergic/hypersensitivity reactions, including Stevens-Johnson syndrome and acute anaphylactic reaction/reaction, stop using Febuxostat in this patient at any time. Treatment of hypersensitivity reactions with glucocorticoids, severe reactions must be used for prolonged use. In some patients, if a mild skin reaction can be used carefully with low doses, but immediately stop if the reaction reappears.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Febuxotid 80 mg contraindicated in the case: Patients treated with azathioprine or mercapto-purin.
Caution when using
cardiovascular disorders
A large number of cardiovascular events have been recorded in the febuxostat group compared to the group using allopurinol (including cardiovascular death, non -death myocardial infarction, non -death stroke). Therefore, Febuxostat should not be used in patients with anemia or congestive heart failure.
Allergy/ Hypersensitivity
Serious allergic/ hypersensitivity reactions, including Stevens-Johnson's life-threatening syndrome, poisoned epidermis and acute anaphylactic/ shocking reactions were reported when treated with Febuxostat.
In most cases, reactions occur in the first month of treatment.
Patients must be notified of signs and symptoms and closely monitor the symptoms of allergic/ hypersensitivity reactions. Febuxostat should be stopped immediately if there are serious reactions, including Stevens-Johnson syndrome, which occurs when the drug is stopped early due to good prognosis.
If the patient has an allergic/ hypersensitivity reaction, including Stevens-Johnson syndrome and acute/ shocking anaphylactic reaction, Febuxostat must not start in this patient group.
Gout level
Febuxostat treatment should not start until acute gout attacks are completely controlled. The acute gout may occur at the beginning of the treatment due to changes in serum uric acid levels that leads to the release of urate crystals at tissue. Recommendation when starting with Febuxostat, should be used with NSAID or Colchicin for at least 6 months.
If acute gout occurs during Febuxostat treatment, do not stop the drug. The treatment of acute gout should be managed simultaneously in each patient. Continuous treatment with Febuxostat reduces the frequency and intensity of the acute gout attack.
Xanthin deposits
In patients at risk of increased urate formation (for example, malignant diseases and treatment of malignant diseases, lesch-anyhan syndrome), the absolute concentration of xanthin in urine can, in rare cases, increase enough to accumulate in urinary tract. Without experience with Febuxostat, the use of drugs in this patient group is not recommended.
Using Mercaptopurine/Azathioprin
Febuxostat is not recommended for patients treated simultaneously with mercaptopurine/ azathioprin. In case of combination, it is impossible to avoid the patient should be closely monitored. Reducing the dose of mercaptopurine or azathioprin is recommended to avoid hematological complications.
Patients with organ transplants
should not be used because there is not enough data to conclude.
are using theophylin
At the same time, Febuxostat 80 mg and thexylin single dose of 400 mg in healthy people do not show any drug interactions. Febuxostat 80 mg can be used in patients and treated with theophylin without increasing theophylin concentration in plasma. There is no data for Febuxostat 120 mg.
Liver system disorders
Mild liver failure has been observed in patients treated with Febuxostat. Liver function tests are recommended before starting treatment with Febuxostat and periodically based on clinical evaluation.
thyroid dysfunction
Increasing TSH value (> 5.5 plu/ml) is observed in long -term patients with Febuxostat in long -term expansion studies. Be careful when using Febuxostat in patients with changes in thyroid function.
Lactose intolerance
This drug contains lactose. Patients with rare genetic problems are galactose intolerance, patients with lactase shortage or malposure-galactose should not take this drug.
The ability to drive and operate machinery
The drug can cause dizziness, drowsiness, blurred vision, numbness or tingling feeling during treatment. So do not drive or operate machinery if affected.
Pregnancy
data on a very limited number of unwanted pregnancy cases has not shown any febuxostat side effects on pregnancy or fetal health.
Animal research does not show direct or indirect harm to pregnancy, the development of fetus/ embryos. The potential risks to humans are unknown. Febuxostat should not be used during pregnancy.
breastfeeding period
There is no data on the output of Febuxostat into breast milk. Animal studies have shown the elimination of this active ingredient in breast milk and decreased the growth of the child. Risks for breastfed babies can not be excluded. Febuxostat should not be used when breastfeeding.
Interactive drug
mercaptopurine/azathioprin
Based on the mechanism of Febuxostat activity, inhibiting Xanthin oxidase, simultaneous use with these two drugs is not recommended. The inhibition of oxidase xanthin by Febuxostat can cause an increase in plasma concentrations of these drugs leading to poisoning.
Febuxostat drug interaction research with drugs metabolized by xanthin oxidase has not been done. Febuxostat drug interaction research with cytotoxic chemotherapy has not been done. There is no data related to the safety of Febuxostat in cytotoxic treatment.
Rosiglitazon/ substrate of CYP2C8
Febuxostat is thought to be a weak inhibitor CYP2C8 in the test tube. In a study in a healthy person, shared 120 mg of Febuxostat QD with a single dose of 4 mg Rosiglitazon shows no effect on the pharmacokinetics of Rosiglitazon and N-Desmethyl (Rosiglitazon metabolites), so Febuxostat is not an enzyme inhibitor in the body. Therefore, sharing Febuxostat with Rosiglitazon or other substrates of CYP2C8 may not need to adjust the dose.
Theophylin
Shared Febuxostat 80 mg QD with a single dose Theophylin 400 mg has no effect on pharmacokinetics and the safety of theophylin. There is no data for Febuxostat 120 mg.
Naproxen and glucuronid inhibitors
The metabolism of Febuxostat depends on the enzyme urrin glucuronosyl transferase (UGT). Glucuronids inhibitors, such as NSAID and Probenecid, maybe, in theory, affecting Febuxostat elimination. On healthy objects and using Febuxostat and Naproxen 250 mg twice a day, there is an increase in contact with Febuxostat (increasing CMAX 28%, AUC 41%and T1/2 26%). In clinical studies, the use of Naproxen or other COX-2 NSAID/ drugs does not increase any clinical significance.
Febuxostat can be used with Naproxen without adjusting the dose of either of the two drugs.
Glucuronid processes
Powerful drug -induced drugs can lead to increased febuxostat metabolism and reduce the effectiveness of the drug. Therefore serum uric acid should be monitored 1-2 weeks after starting treatment with glucuronide touch. In contrast, stop treatment with touch substance can lead to increased concentration of febuxostat.
Colchicin/ indomethacin/ hydrochlorothiazide/ warfarin
Febuxostat can be used with Colchicin or Indomethacin without having to adjust the dose of either of the drug.
No dose adjustments when using Febuxostat with hydrochlorothiazid.
No need to adjust the dose of warfarin when used with Febuxostat. Indication of Febuxostat (80 mg or 120 mg once a day) with warfarin does not affect the pharmacokinetics of Warfarin in healthy people. Inr and the activity of factor VII are not affected when combined with Febuxostat.
Desipramin/ substrate of CYP2D6
Febuxostat has a very weak inhibitor effect of CYP2D6 enzyme in the body. Therefore, the use of Febuxostat with the substrates of CYP2D6 is expected to not require dose adjustment.
antacid
Sharing antacids containing magnesi hydroxid and hydroxid aluminum has been shown to slow down the absorption of Febuxostat (about 1 hour) and reduce 32%mineral CMAX, but there is no significant change in AUC. Therefore, Febuxostat can be used without caring about the use of antacids.
Storage
In a dry place, the temperature does not exceed 30 ° C, avoiding light.
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