Forgout drug 40mg Tw3 treatment of chronic uric acid, gout arthritis (2 blisters x 15 tablets)

Dosage form Box of 2 blisters x 15 tablets
Specifications Febuxostat

Ingredient

Composition information	Content
Febuxostat	40mg

Uses

indications

Forgout drug indicated in the following cases:

Treatment of chronic uric acid in adults has occurred urate deposits (including people with a history or suffering from urate and/or gout arthritis).

Forgout drug is indicated for adults.

Pharmacokology

Uric acid is the final product of the human metabolism and is created in hypoxanthin - xanthin - uric acid steps. Both of the above stages are catalyzed by xanthin oxidase (XO). Febuxostat is a 2-reathiazol derivative that has a reduction of serum uric acid by inhibiting Xanthin oxidase selection. At the concentration of febuxostat treatment does not inhibit other enzymes involved in the metabolism of purin or pyrimidin such as: guanin deaminase, hypoxanthin guanin phosphoribosyltransferase, OROTATAT PHOSPHOribosyltransferase, OROTIDIN MONOMHOSPHATPHAT decarboxylase phosphorylase.

Pharmacokinetics

absorption

After drinking, Febuxostat is well absorbed (≥ 84%) and fast (trax 1.0 - 1.5 hours). After taking the single or multiple doses of 80 and 120 mg once a day, cmax is about 2.8 - 3.2 kg/ml, and 5.0 - 5.3 Ug/ml, corresponding. The absolute bioavailability of the forms of Febuxostat has not been studied.

Febuxostat can be used with food or not.

Distribution

The volume of distribution in stable state (VSS/F) of Febuxostat is 29 - 75 l in the dose of 10 - 300 mg. The ratio of cohesion with plasma protein is about 99.2%, (mainly with albumin). Metabolic substances have a plasma protein activity about 82 - 91%.

Metabolism

Febuxostat is strongly metabolized by the conjugate process by uridin diphosphate glucuronosyltransferase (UGT) and oxidation through the Cytochrom P450 (CYP). In Vitro liver mucous mucous microscope shows that oxidative metabolites are formed mainly by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and Glucuronic Febuxostat formed mainly by UGT 1A1, 1A8, and 149.

Elimination

Febuxostat is eliminated through the liver and kidneys. After taking a dose of 80 mg of Febuxostat, about 49%of the dose is recovered in urine, including constant Febuxostat (3%), acylglucuronic febuxostat (30%), oxidant and conjugated substances (13%), and other unknown metabolites (3%). In addition to excreting through the urine, about 45%of the dose found in the fertilizer including: Febuxostat format (12%), Acyl Glucuronic Febuxostat (1%), oxidative and conjugated substances (25%), and other unknown metabolites (7%). Final selling time of Febuxostat is about 5 - 8 hours.

Patients with renal failure

After taking multiple doses of Febuxostat 80mg in patients with mild, medium or severe renal failure, Febuxostat's CMAX does not change compared to those with normal kidney function. The average total AUC of Febuxostat increases about 1.8 times from 7.5 ug hours/ml in the group with normal kidney function to 13.2 µg/ml in the severe kidney dysfunction group.

CMAX of metabolites increased by 2 times and AUC of metabolites increased by 4 times. However, it is not necessary to adjust the dose in patients with mild and medium renal failure,

Patients with liver failure

After using multiple doses of Febuxostat 80mg in patients with mild or medium liver impairment, CMAX and AUC of Febuxostat and its metabolites have not changed significantly compared to those with normal liver function. No studies have been done in patients with severe liver failure.

Age

There is no significant change in the AUC of Febuxostat or its metabolites after many doses of Febuxostat in elderly subjects compared to healthy young people.

Gender

After taking multiple febuxostat oral doses, CMAX is 24% higher than in women and AUC is 12% higher than in women. However, CNAX and AUC are adjusted the same weight between gender. No need to adjust the dose based on gender.

Before taking Forgout drug 40mg Tw3 treatment of chronic uric acid, gout arthritis (2 blisters x 15 tablets)

How to use

oral medication.

Dosage

recommended dose

Forgout is recommended for 40 mg or 80 mg, once a day. The recommended dose of treatment is 40 mg. For patients, they do not reduce uric acid below 6 mg/dL after 2 weeks of doses of 40 mg, recommend the dose of 80 mg.

Forgout can be used without paying attention to food or antacids.

recommended doses for patients with liver and kidney failure:

Patients with mild to moderate renal function: No dose adjustment.

Determining testing of target uric acid levels below 6 mg/dL can be done as soon as two weeks after starting the beginning treatment with Forgout.

Preventy outbreak of gout outbreak

Gout outbreaks may occur after the beginning of Forgout due to changes in serum uric acid levels that lead to urate from the cumulative tissue transferred to the bloodstream. The prophylaxis outbreak of gout with nonsteroidal anti -inflammatory drugs (NSAID) or Colchicine is recommended when starting treatment with Forgout. Preventive treatment can bring benefits for up to six months.

If a gout outbreak occurs during Forgout treatment, there is no need to stop using the drug. Gout outbreak should be managed simultaneously, suitable for each patient.

Specific dose 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 an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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 the drug, there are common unwanted effects (ADR) such as:

Common: 1/100 Sadr

Metabolism and nutrition system: Acute gout. 1/100

Endocrine system: Increased thyroid stimulating hormones. The atrial heart, brushed chest drums, abnormal electrocardiograms. Bile: gallstones. Urinary.

Blood and lymphatic system: Reduce all bloody, thrombocytopenia. Gastrointestinal: Pancreatitis, mouth ulcer. Interstitial, urine.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Forgout drugs contraindicated in the following cases:

Hypersensitivity to Febuxostat or any ingredients of the drug.

Be cautious when using

cardiovascular disorders:

Do not recommend Febuxostat treatment in patients with myocardial orgardly anemia or congestive heart failure.

Hypersensitivity/allergies to drugs:

rarely occur allergic/hypersensitivity reactions, including Stevens - Johnson syndrome (life -threatening), toxic skin necrosis syndrome and acute anaphylactic shock. Patients need advice on signs, symptoms and closely monitor the symptoms of allergic/hypersensitivity reactions. Stop the drug if there is a serious allergic/hypersensitivity reaction, including Stevens - Johnson syndrome and does not reuse Febuxostat in this patient.Acute gout:

Do not start treatment with Febuxostat until acute gout attacks have completely decreased.

Acute gout may occur at the beginning of Febuxostat treatment. If acute gout attacks occur, do not stop the drug. Continue treatment with Febuxostat if acute gout attacks occur during treatment.

Xanthin deposits:

In patients with high risk of urate formation (such as malignant tumors and them, lesch-nylos syndrome) The absolute concentration of xanthin in the urine can increase enough to cause deposition in the urinary tract (rarely occur). Because there is no adequate information, Febuxostat should not be used in these patients.

Tibeters:

There is no adequate information, not recommended for these patients.

Theophyllin:

Simultaneous use of Febuxostat 80 mg and theophylllin single dose of 400 mg in healthy people do not see any drug interactions. Febuxostat 80 mg can be used with theophyllin, there is no risk of increasing theophyllin concentration in plasma. No information for febuxostat dose 120mg.

Liver dysfunction:

Check and periodically evaluate liver function when starting treatment with Febuxostat

thyroid disorders:

Be cautious when using Febuxostat in patients with thyroid dysfunction.

Authority warning:

This drug contains excipients:

Lactose: Patients with rare genetic diseases in galactose tolerance, Lapp lactase or glucose-Galactose should not use this medication.

Use drugs for women during pregnancy and lactation

Pregnant women:

Data on a very limited amount of pregnant women using Febuxostat did not see any disadvantage of Febuxostat for pregnancy or health of pregnancy/infant. Animal studies do not show direct or indirect effects on pregnancy, embryo/ fetal development or childbirth. It is unclear the potential risks to people. Febuxostat should not be used during pregnancy.

breastfeeding women:

It is unclear whether Febuxostat will be excreted in breast milk. Animal studies have shown the excretion of this active ingredient in breast milk and reduce the growth of an animal. Can not rule out the risk for breastfeeding. Febuxostat should not be used during breastfeeding.

reproductive ability:

In animals, reproductive studies up to 48mg/kg/day show that there is no adverse effect depending on the dose of fertility. The influence of Febuxostat is unknown on human fertility.

The effect of the drug on the ability to drive and operate machinery

Sleep, dizziness, paresthesia and blurred vision have been reported with the use of Febuxostat.

Patients need to be cautious before driving, operating machinery or participating in dangerous activities until they are sure that Forgout does not adversely affect performance.

Interactive drug

Interactive drugs and other types of interactions:

mercaptopurin/azathioprin:

Based on the mechanism of action of Febuxostat on the inhibition of oxidase xanthin (XQ), it is not recommended to use simultaneously. Inhibition of oxidase xanthin because Febuxostat may increase the concentration of these drugs in plasma, leading to toxicity. Studies on drug interaction between Febuxostat and drugs metabolized by xanthin oxidase have not been done. Studies on drug interaction between Febuxostat and chemotherapy have not been conducted. There is no data on the safety of Febuxostat in cytotoxic treatment.

Rosiglitazon and CYP2C8 substrate:

Febuxostat is seen as a weak inhibitor CYP2C8 in vitro. In a healthy study, simultaneously used 120mg of Febuxostat once a day with a single dose of 4mg Rosiglitazon without any effect on the pharmacokinetics of Rosiglitazon and N - Desmethyl Rosiglitazon metabolites, which indicates that Febuxostat does not inhibit the enzyme CYP2C8C8 In Vivo. Therefore, it is not required to reduce the dose of Rosiglitazon or other substrates of CYP2C8 when using Febuxostat simultaneously with these substances.

Theophyllin:

A study of drug interactions conducted on healthy people using Febuxostat to evaluate the inhibition of xanthin oxidase (XQ) may increase theophyllin concentration during circulating as reported with other septic inhibitors. Research results show that simultaneous use of Febuxostat 80mg once a day along with a single doophyllin 400mg dose does not affect the pharmacokinetics or the safety of theophyllin. Therefore, there is no special caution when using Febuxostat 80mg and theophyllin simultaneously.

naproxen and other glucuronic inhibitors:

Metabolism of febuxostat depends on the uridin glucuronosyl transferase enzyme (UGT).

Glucuronic inhibitors, such as NSAIDs and Probenecid, in theory, can affect Febuxostat elimination. In healthy people, the sharing of Febuxostat with Naproxen 250 mg 2 times/day related to increased contact with Febuxostat (CMAX 28%, AUC 41%, and T1/2 26%). In clinical studies, the use of Naproxen or other NSAIDs/Cox-2 inhibitors is not related to any clinical increase in side effects.

Febuxostat can be used simultaneously with Naproxen without adjusting the dose of Febuxostat or Naproxen.

Glucuronical induction substances:

Strong drugs that induce enzyme urrin glucuronosyl transferase (UGT) can lead to metabolic and reduce the effectiveness of Febuxostat. Therefore, it is recommended to monitor serum uric acid levels after 1-2 weeks when starting treatment with strong induction substances. In contrast, the stop treatment with glucuronic -induction substance can lead to increased febuxostat concentration in plasma.

colchicin/indomethacin/hydrochlorothiazide/warfarin:

Febuxostat can be used simultaneously with colchicin or indomethacin without adjusting the dose of febuxostat or active ingredient.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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