Donifoxate tablets for the treatment of gout and to reduce high levels of urate salts

Donifoxate is prescribed to treat gout (gouty arthritis). This medicine lowers uric acid levels in the blood.

Uric acid is formed in the body as a result of the metabolism of some types of proteins called (purines) in the body. Hyperuricemia occurs when the body produces more uric acid than it can remove. When uric acid levels rise in the blood, it begins to crystallize, forming crystals that are deposited in joints (gouty arthritis) and tissues, causing joint inflammation and pain. High levels of uric acid in the blood can also cause kidney disease and kidney stones.

Donifoxate prevents the production of uric acid by blocking the activity of an enzyme called (xanthine oxidase) that converts purines to uric acid.

Indications

  • Gout treatment (Gouty Arthritis).
  • Prevention of kidney stones and joint damage due to high levels of uric acid in the blood.

The goal of treatment with Donifoxate is to reduce and maintain serum uric acid levels below 6 mg/dL.

Instructions For Use

  • Read the patient information leaflet inserted in the medicine package, before you start taking this medicine, and if you have any questions, ask your doctor or pharmacist.
  • Take this medication by mouth with or without food as directed by your doctor, usually once daily.
  • The dosage is based on your medical condition and response to treatment.
  • Use this medication regularly to get the most benefit from it. To help you remember, take your dose at the same time each day.
  • You may experience more pain when you start your treatment with Donifoxate, so your doctor will prescribe some other medicines (eg colchicine, NSAIDs such as ibuprofen, naproxen, or indomethacin) to prevent/treat a gout attack during the first few months.
  • Continue to take prescribed medications for gout as directed by your doctor.
  • Tell your doctor if your condition does not improve or gets worse.

Dosage & Administration

  • The usual adult dose of this medicine is one ( 40 or 80mg) tablet, once daily.
  • If, after treatment with the above dose, for 2 to 4 weeks, serum uric acid levels are greater than 6 mg/dL, the dose may be increased to 120 mg, once a day.
  • Uric acid levels usually return to levels less than 6 mg/dL, about two weeks after starting treatment with Donifoxate.
  • Doctors usually prescribe other medicines with Donifoxate during the initial treatment period, such as colchicine or diclofenac, to prevent gout attacks.
  • Dosage adjustment is required in patients with mild or moderate renal impairment. No, efficacy and safety have not been fully evaluated in patients with severe renal impairment.
  • The recommended dose in patients with moderate hepatic impairment is one 80-mg tablet, once daily. The efficacy and safety of Donifoxate has not been studied in patients with severe hepatic impairment.
  • Elderly dosage (over 60 years old): No dose adjustment is required in this group of patients.
  • Dosage for children and adolescents: As the safety of this medicine in children and adolescents is unknown, it is not recommended to use this medicine in children under 18 years of age.
  • Kidney Transplant Dosage: It is not recommended to use this medicine in patients who have received organs (i.e. after transplantation of kidneys, liver lobes, etc.).

Warnings & Precautions

  • Before you start using this medicine, you must tell your doctor or pharmacist if you are allergic to any medicines.
  • Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, heart disease, liver disease, kidney disease, organ transplant, stroke.
  • Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
  • During pregnancy, this medication should be used only when clearly needed. You can discuss the risks and benefits with your doctor.
  • It is not known if the ingredients in Donifoxate pass into breast milk. You should consult your doctor before breastfeeding.

Side Effects

Nausea (tendency to vomit) is the most common side effect, and this nausea often ends with continuing treatment, but if this effect persists or becomes worse, tell your doctor or pharmacist immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Also, many people who use this medicine do not experience any serious side effects.

In rare cases, Donifoxate may cause serious (and possibly fatal) side effects on the liver. It may also lead to an increase in liver enzymes. So your doctor will ask you to take blood tests to measure these enzymes. Tell your doctor right away if you have symptoms of liver failure, including nausea that doesn’t stop, stomach/abdominal pain, dark urine, yellowing eyes/skin.

Tell your doctor right away if you notice any serious side effects, including: pink/bloody urine, painful urination.

A small number of people who have taken this medicine have experienced heart problems or stroke. However, it is not known whether this drug caused these problems. Get medical help right away if you have any signs of heart or circulatory problems, including: weakness on one side of the body, sudden changes in vision, confusion (difficulty concentrating), chest/jaw pain, pain in the left side of your body , unusual sweating, signs of heart failure (such as shortness of breath, swollen ankles/feet, unusual tiredness, sudden weight gain).

Rash is a sign of a severe reaction, and you should get medical help right away if you get any rash after taking this medicine.

This medicine may rarely cause a serious allergic reaction. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

For Arabic information: فبيوريك لعلاج النقرص وخفض مستويات حمض اليوريك فى الدم

Referances

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