Febuday 80 MSN treat hyperuricemia (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Febuxostat

Ingredient

Composition information	Content
Febuxostat	80mg

Uses

indications

Febuday 80 MSN 3x10 is indicated for treatment of hyperuricemia Uric acid when the urate crystal has been formed (including a history, the presence of lumps (tophi seeds) and/or gout arthritis).

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.

Dynamic pharmacokinetics

The absorption of Febuxostat has radioactive attachment after the dose of predicted at least 49%. The maximum plasma concentration of Febuxostat is reached from 1 to 1.5 hours after drinking. The absolute bioavailability of Febuxostat tablets has not been reported.

The average variable distribution 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 reaching the dose of 40 mg and 80 mg.

Febuxostat is widely metabolized by the bonding through Uridin Diphosphate Glucuronosyltransferase (UGT) Enzymes including UGT1A1, UGT1A3, UGT1A9 and UGT2B7 and oxidation through cytochrome P450 (CYP) Enzymes including CYP1A2, 2C8 and 2C9 and 2C9 and Non-P450 and Non-P4 Enzymes

Febuxostat is excreted by both liver and kidney. 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 through the urine, about 45%of the dose found in feces in the form of febuxostat is constant (12%), glucuronid acyl form (1%), oxidative metabolites and its conjugated form (25%) and other unknown metabolites (7%).

Before taking Febuday 80 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 dose 120 mg once a day may be considered if the serum uric acid index (sua)> 6 mg/dL (357 μmol/l) after 2-4 weeks use the dose of 80 mg.

The goal of treatment is to reduce and maintain serum uric acid below 6 mg/dl (357 μmol/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 for acute gout attacks for 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 insufficiency: No dose adjustment in patients with mild to moderate renal failure. Efficiency and safety are not fully evaluated in patients with severe renal impairment (Creatinine clearance

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 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 Febuday 80 MSN 3x10, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive system: nausea.

Liver system: abnormal liver function.

Musculoskeletal system: joint pain.

DA: rash.

Uncommon, 1/1000

Blood and disorders of lymphatic system: Anemia, spontaneous thrombocytopenia, leukopenia/leukopenia, neutropenia, all bloody hemorrhage, spleen hypertrophy, thrombocytopenia.

Cardiovascular system: flushing, hypertension, hypotension, angina, atrial fibrillation/Heartwind, heart blowing, abnormal ECG, breast drum, sinus slow heartbeat, fast heartbeat.

ears and puppets (inner ears): deaf, tinnitus, dizziness.

Eye disorders: vision is blurred.

Digestive system: abdominal distention, abdominal pain, constipation, dry mouth, indigestion, flatulence, gastritis, gastroesophageal reflux disease, discomfort, gastrointestinal pain, gum pain, blood, gastric juice, bloody stool, mouth ulcers, pancreatitis, vomiting and diarrhea.

Systemic disorders and at the position of use: weakness, chest pain/discomfort, edema, fatigue, feel abnormal, gait disorders, symptoms like flu, pain, thirst.

Bile liver system: gallbladder/cholecystitis, fatty liver, hepatitis, enlarged liver.

The immune system: hypersensitivity.

Metabolic and nutrient disorders: anorexia, decrease/increase appetite, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypereminemia, blood triglycerides, hypokalemia, decrease/increase weight.

musculoskeletal system: arthritis, joint stiffness, swelling of joints, muscle spasms/convulsions/muscle tension/muscle muscle, musculoskeletal/muscle muscle pain, muscle pain.

Nervous system: tastes change, balance disorders, stroke, guillain-barré syndrome, headache, mild paralysis, sensory decrease, sense of smell, coma, mental impairment, migraine, severe, airy, transient ischemia, tremor.

Mental disorders: agitation, anxiety, depression, insomnia, prone to irritation, reduced libido, stress, panic, personality change.

Skin and disorders of subcutaneous tissues: hair loss, angioedema, dermatitis, floating skin, bruising, eczema, hair color change, abnormal growth hair, sweating, skin peeling, hemorrhage under the skin, light sensitivity, itching, hemorrhage, skin discoloration/skin pigmentation change, skin damage, skin with abnormal odds.

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 80 MSN 3x10 contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Patients who are being treated with azathioprin, mercaptopurin or theophyllin.

Caution when using

acute gout attacks

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

Cardiovascular disease

In randomized 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. The causal relationship with Febuxostat has not been established. Monitor the signs and symptoms of myocardial infarction (MI) and stroke.

Liver enzyme

In randomly controlled studies reported, transaminase increases greater than 3 times the upper limit of normal level (UN) has been reported. Liver function test is recommended, for example: 2 and 4 months after starting treatment with Febuxostat and periodically later.

thyroid disorders

Increase 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

Efficiency and safety of Febuxostat has not been established in children under 18 years old.

Secondary hyper uric acid

There is no research reported in patients with secondary hyperuricemia (including organ transplants); 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.

Drug interaction

Febuxostat is a Xanthin oxidase inhibitor (XO). 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.

Storage

Storage below 30 ° C. Avoid moisture and light.

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