Febuday 40 MSN treat hyperuricemia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Febuxostat

Ingredient

Composition information	Content
Febuxostat	40mg

Uses

indications

Febuday 40 drugs are indicated in the following case:

Treatment of hyperuric hyperglycemia when urate crystals have formed (including a history, the presence of lumps (Tophi seeds) and/or arthritis due to gout ).

Pharmacological

Febuxostat is an oxidase inhibitor, its treatment effect is achieved by reducing serum uric acid. At the concentration of Febuxostat treatment does not inhibit other enzymes involved in the synthesis and metabolism of purin and pyrimidine.

Effects on uric and xanthin acid levels: In healthy people, Febuxostat causes a decrease in dosage dependence on average serum uric acid levels within 24 hours and increases the average serum xanthin level within 24 hours. In addition, there is a reduction in urine uric acid daily. Similarly, there is an increase in the excretion of xanthin in everyday urine. The average percentage of serum uric acid within 24 hours in about 40% - 50% at the dose of 40 mg and 80 mg.

Effects on the reduction of the heart: Febuxostat influence on the reducing reducing in the heart is assessed by the QTC range that has been reported in normal healthy people and gout patients. Febuxostat at the dose up to 300mg/day, in a stable state, does not show the effect on QTC.

Dynamic pharmacokinetics

In healthy people, maximum plasma concentrations (cmax) and AUC of Febuxostat increases proportional to the dosage after single and multi -dose 10 mg to 120mg. There is no accumulation in the treatment dose used every 24 hours. Febuxostat has an average selling life cycle (T1/2) variable type about 5-8 hours.

Absorption: The absorption of Febuxostat has radioactive attachment after the predictive dose of at least 49% (based on the total radioactive activity is reabsorbed from urine). The maximum plasma concentration of Febuxostat is reached from 1 to 1.5 hours after drinking. After drinking 40 mg and 80 mg, once a day, cmax reaches about 1.6 ± 0.6 mcg/ml and 2.6 ± 1.7 mcg/ml respectively. The absolute bioavailability of Febuxostat tablets has not been reported.

Distribution: The average variable distribution integral of Febuxostat (VSS/F) is about 50 l (CV ~ 40%). Febuxostat bonds with plasma proteins are about 99.2% (mainly with albumin) and unchanged within the concentration reached when used by 40mg and 80mg.

Metabolism: Febuxostat is widely metabolized by connection through urrin diphosphat glucuronosyltransferase (UGT) enzymes including UGT1A1, UGT1A3, UGT1A9 and UGT2B7 and oxidation through cytochrome P450 (CYP) enzymes including CYP1A2, 2C8 and 2C9 and non-non-P450 enzymes. The role of each enzyme isotope in the metabolism of Febuxostat is unclear. The oxidation of the isobutyl chain leads to the formation of medicinal hydroxy metabolites, all occur in human plasma at a much lower level than Febuxostat.

Elimination: Febuxostat is excreted by both liver and kidneys. After taking the dose of 80 mg of Febuxostat, there are 14C mounted, about 49%of the dose found in urine in the form of febuxostat constant (3%), glucuronid acyl form (30%), oxidation forms and its combined form (13%), other non -known metabolites (3%). In addition to the excretion in the urine, about 45%of the dose is found in the form of febuxostat (12%), glucuronid acyl form (1%), oxidative metabolites and its conjugated form (25%) and other unknown substances (7%).

Before taking Febuday 40 MSN treat hyperuricemia (3 blisters x 10 tablets)

How to use

can take medicine without caring for food or using antacids.

Dosage

The recommended dose of Febuxostat is 40 mg or 80 mg/time/day.

The dose of Febuxostat 80 mg is recommended for use in patients who do not meet the level of blood uric acid (sua) less than 6 mg/dl after 2 weeks of doses of 40 mg.

Febuxostat 120 mg dose once a day can be considered if the serum uric acid index> 6 mg/dl (357μmol/l) after 2-4 weeks of dose 80 mg.

The goal of treatment is to reduce and maintain serum uric acid below 6 mg/dl (357μmol/l). Check to achieve this goal, Sua

Preventing acute gout attacks: After the beginning of treatment with Febuxostat, the increase in acute gout attacks is regularly reported. This increase is due to changes in serum uric acid index, the result of mobilizing urate from tissue reserves. Preventing acute gout attacks with 1 nonsteroidal anti -inflammatory drug (NSAID) or Colchicine is recommended at the beginning of treatment with Febuxostat. Preventive recommendations still gain at least 6 months. If acute gout attacks occur during treatment with Frbuxostat, it is necessary to stop using. Acute gout attacks should be controlled simultaneously, when suitable in each patient.

Special patient groups:

Patients with renal impairment: No need for dosage in patients with mild to moderate renal failure. Efficiency and safety are not fully evaluated in patients with severe renal impairment (creatinine clearance

Patients with liver failure: The recommended dose in patients with mild liver failure is 80mg. The information available in patients with average liver failure is limited. Efficiency and safety of Febuxostat has not been reported in patients with severe liver failure.

Elderly: No dose needed.

Children and adolescents: Inexperienced in children and teenagers, the use of Febuxostat in these patients is not recommended.

Patients with organ transplantation: Inexperienced in organ transplant patients, using Febuxostat in these patients is not 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 overdose? No overdose of Febuxostat is reported in clinical studies. In case of overdose, patients need symptoms and support care.

What to do when forgetting 1 dose?

Not recorded

Side Effects

When using Febuday 40, you may experience unwanted effects (ADR).

Common, ADR> 1/100

The digestive system: nausea.

blood and lymphatic disorders: Anemia , spontaneous platelet hemorrhage, leukopenia/leukopenia, neutropenia, all bloody hemorrhage, spleen hypertrophy, thrombocytopenia. Chest drums, Seafood heartbeat Sinus, tachycardia. Gums, blood, gastric juice, bloody stools, mouth ulcers, pancreatitis, stomach ulcers, vomiting and diarrhea. liver, liver enlargement.

The immune system: Hypersensitivity. Mechanical muscle Myasthenia , muscle and muscle muscle pain, muscle pain. Anxiety, depression , insomnia, ease of irritation, reduced libido, stress, panic, personality change. Skin pigmentation, skin damage, abnormal smell, urticaria.

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

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

Contraindicated

Febuday 40 contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using

Acute gout: To prevent acute gout attacks at the beginning of treatment with Febuxostat, preventive treatment simultaneously with an anti -inflammatory anti -inflammatory (NSAID) or Colchicine recommended.

Cardiovascular pathology: In randomly controlled studies reported, there is a higher proportion of cases of cardiovascular thrombosis (death from cardiovascular disease, non-fatal myocardial infarction and non-fatal stroke) in patients treated with Febuxostat [0.74/100 P-Y (95% CI 0.36-17)] 0.16-1.53)]. A causal relationship with Febuxostat has not been established. Monitor the signs and symptoms of myocardial infarction (MI) and stroke.

Increasing liver enzymes: In randomly controlled studies reported, transaminase increases more than 3 times the upper limit of normal levels (UN) has been reported (AST: 2%, 2%, and ALT: 3%, 2%respectively in patients treated with Febuxostat and Allopurinol). There is no report on the relationship between the dosage-use of this transaminase increase. Liver function test is recommended, for example: 2 and 4 months after starting treatment with Febuxostat and periodically later.

Thyroid disorders: Increasing TSH value (> 5.5 IU/mL) is reported in patients with long -term treatment with Febuxostat (5.0%). Be careful when using Febuxostat in patients with changes in thyroid function.

Children: The efficiency and safety of Febuxostat has not been established in children under 18 years old.

Secondary hyperuricemia: There is no study reported in patients with secondary hyperuricemia (including organ transplant); It is not recommended to use Febuxostat in patients whose urate formation rate has been greatly increased (for example, malignant disease and treatment, Lesch-Nyhan syndrome). In very few cases, the concentration of xanthin in the urine may increase enough to have deposits in the urinary tract.

The ability to drive and operate machinery

Febuxostat can affect the ability to drive or operate machinery.

Pregnancy

There is no complete research of Febuxostat in pregnant women. Febuxostat should not be used during pregnancy unless the benefits are higher than the potential risk to the fetus.

The period of breastfeeding

It is not known whether the drug is excreted in breast milk or not. Febuxostat should not be used in nursing women.

Interactive drug

Xanthin oxidase (XO): Febuxostat is an oxidase Xanthin inhibitor. Febuxostat drug interaction research with drugs metabolized by XO (for example, theophylllin, mercaptopurin, azathioprin) has not been reported. The inhibition of XO is possible that it can increase the plasma concentration of these drugs that leads to toxicity. Febuxostat is contraindicated in patients treated with azathioprin, mercaptopurin, or theophyllin.

Cell toxic chemotherapy: Febuxostat's interaction research with cytotoxic chemotherapy is not reported. There is no data on the safety of Febuxostat during chemotherapy.

In Vivo interactive studies: Based on drug interaction studies in healthy people, Febuxostat has no clinical interactions with Colchicin, Indomethacin, Hydrochlorothiazide, Warfarin or Desipramin. Therefore, Febuxostat can be used simultaneously with these drugs.

Storage

Storage below 30 ° C. Avoid moisture and light.

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