Febustad 80 Stella medicine treats chronic 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

Indications for the treatment of chronic hyperuricemia in patients with urate deposits (including a history of disease or tophi and/or gout arthritis).

Febuxostat is not recommended for the treatment of asymptomatic hyper Uric acid.

Pharmacokological

Febuxostat inhibits xanthin oxidase, which is a catalyst to convert hypoxanthin into xanthin and xanthin into uric acid. By preventing uric acid production, Febuxostat reduces the serum concentration of uric acid. Febuxostat has very little impact on other enzymes participating in synthesis and transforming purin and pyrimidin.

pharmacokinetic

absorption

Febuxostat is absorbed quickly and well after drinking. Although the drug is used with a fat -rich meal that reduces the peak and the amount of drugs in plasma, this is not clinically significant, Febuxostat can be taken or not with food.

Distribution

The cohesion with plasma protein is about 99%.

Metabolism

Febuxostat is widely metabolized by the conjugate through the uridin diphosphate glucuronosyltransferase (UDPGT) and oxidation through the cytocrom P450 isoenzyme. Main metabolites are active formed by UGT1A1, UGT1A8. UGT1A9 and CYP1A1, CYP1A2, CYP2C8 or CYP2C9.

Elimination

Febuxostat has the final waste time about 5 - 8 hours. About half of the dose is eliminated through the urine and the rest is excreted through feces.

Before taking Febustad 80 Stella medicine treats chronic hyperuricemia (3 blisters x 10 tablets)

How to use

Febustad 80 is used orally, regardless of meals and antacids.

Dosage

recommend the starting dose of febuxostat in controlling blood uric acid in patients with gout is 40mg x 1 time/day.

The dose of Febuxostat can increase to 80mg x 1 time/day in patients who do not achieve serum urate levels below 6 mg/dL after 2 weeks of treatment with Febuxostat at a dose of 40mg x 1 time/day. Can consider increasing dose up to 120mg x 1 time/day if serum uric acid levels> 6mg/dl after 2-4 weeks of treatment.

Recommended the use of drugs for at least 6 months to prevent recurrent gout.

No need to adjust the dose in patients with mild to medium or mild liver failure.

Children

Efficiency and safety of Febuxostat has not been set for children under 18 years old.

Elderly

No dose adjustment.

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 Febuxostat has been reported in clinical studies. Patients should be monitored with symptoms and support care when overdose.

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 Febustad 80, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Metabolism and nutrition: recurrent gout.

nerve: headache. digestive: diarrhea, nausea. liver - bile: abnormal liver function.

Skin and subcutaneous tissue: rash.

Systemic: edema.

Uncommon, 1/1000

Endocrine: Increase thyroid hormone.

Metabolism and nutrition: diabetes, hyperlipidemia, reducing appetite, weight gain.

Mental: Sexual reduction, insomnia. nerve: dizziness, paresthesia, hemiplegia, sleep, change taste, numbness, olfactory reduction.

Heart: Atrial fibrillation, empty chest, abnormal ECG.

Hypertension, redness, hot burning.

Respiratory: Difficulty breathing, bronchitis, upper respiratory infection, cough. digestion: abdominal pain, bloating, gastroesophageal reflux syndrome, vomiting, dry mouth, indigestion, constipation, regular diarrhea, flatulence, digestive tract. liver - bile: gallstones.

Skin and subcutaneous tissue: dermatitis, urticaria, itching, skin discoloration, skin damage, hemorrhagic spots, yellow rash, lumpy rash, rash.

musculoskeletal and connective tissue: joint pain, arthritis, muscle pain, muscle pain, muscle weakness, muscle spasm, muscle tension, epidemic inflammation.

kidney and urinary: kidney failure, kidney stones, hematuria, urinating many times, urinary protena.

Reproduction and mammary gland: erectile dysfunction.

Body: fatigue, chest pain, uncomfortable chest.

Rare, ADR

Blood and lymphatic system: non -regenerated anemia, thrombocytopenia.

immune: Anaphylaxis, sensitivity to the drug.

Eyes: blurred vision.

Metabolism and nutrition: Losing weight, increasing appetite or anorexia. Mental: Stress.

ears and inner ears: tinnitus.

digestive: pancreatitis, mouth ulcer.

liver - bile: hepatitis, jaundice, liver damage.

Skin and subcutaneous tissue: Poisoned epidermal necrosis, Stevens - Johnson syndrome, angioedema, drug reaction with eosinophilia and general symptoms, full body rash, rash, skin rash, rash, blisters, rashes, rashes, rashes, rashes, hair loss, sweat.

musculoskeletal and connective tissue: muscle pattern, stiffness, muscle - bone hard.

kidney and urinary: interstitial nephritis, nephritis, urine.

Body: Thirst.

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

Febustad 80 contraindications in the following cases:

Hypersensitivity to any ingredients of the drug.

Used with azathioprin, mercaptopurin or theophyllin.

Precautions when using

recurrent gout

Rehabilitation increases recurrent gout is often noticed when starting with anti -hypertonic hyperuric hypertension agent, including Febuxostat. If the recurrent gout occurs during the tri, no need to stop Febuxostat. Preventive treatment (for example, nonsteroidal anti -inflammatory drugs (NSAID) or Colchicin at the beginning of treatment) can reduce gout recurrence to six months.

Cardiovascular effects

It is not recommended to use Febuxostat in patients with ischemic heart disease or chronic heart failure. The rate of vascular thrombosis has been noticed in patients treated with Febuxostat higher than Aliopurinol in clinical trials. Monitor signs and symptoms of myocardial infarction and stroke.

influence on the liver

There have been reports on liver failure, sometimes death. Do not exclude the cause of the use of the drug. If liver damage is detected, stop using Febuxostat and assess the cause may occur in patients, then treat if possible, to decide to stop the drug or maintain. Do not reuse Febuxostat if the liver damage is confirmed and not found another cause.

allergies/sensitivity to drugs

Patients should be known and closely monitor the signs and symptoms of allergic/sensitive reactions. Discontinue treatment with Febuxostat immediately if there is an allergic/sensitive reaction like the Stevens-Johnson syndrome. If allergic/sensitive reactions include Stevens-Johnson syndrome and anaphylactic shock, Febuxostat is not used again for patients any more.

thyroid disorders

Increase TSH value (> 5.5 μiu/ml) observed in patients using Febuxostat for a long time (5.5%). Be careful to use Febuxostat for patients to change thyroid function.

Febustad contains lactose. Patients with rare genetic galactose intolerance, Lapp Lactase deficiency or malposure of Glucose - Galactose do not use this product.

The ability to drive and operate machinery

Sleep, dizzy, abnormal and blurred vision has been reported with the use of Febuxostat. Patients should be cautious before driving, using machinery or participating in dangerous activities until they are sure that Febuxostat does not cause the above unwanted effects.

Pregnancy

There is no complete and well -controlled study in pregnant women. Febuxostat should only be used during pregnancy when considering the benefits and potential risks for the fetus.

Breastfeeding period

Febuxostat is excreted in mother mouse milk. It is unknown whether the drug is excreted in human milk or not. Because there are many drugs excreted on breast milk, cautious when using Febuxostat for nursing women.

Drug interaction

Due to the inhibition of oxidase xanthin, it increases the concentration of mercaptopurin or azathioprine, so it should not be used Febuxostat with the above drugs. Similarly, when using simultaneously Febuxostat with theophylllin, theoophyllin concentration should be monitored.

Febuxostat is metabolized through the uridin diphosphate glucuronosyltransferase enzyme system that can affect the effect of Febuxostat. Track serum uric acid after 1-2 weeks of treatment with strong glucuronid agents.

Storage

In closed packaging, dry place, temperature not exceeding 300C.

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