FEBUXOSTAT

COMMON BRAND NAME(S): Uloric

GENERIC NAME(S): FEBUXOSTAT

 

Description: Febuxostat inhibits xanthine oxidase, and works by blocking an enzyme in the body (xanthine oxidase), which lowers levels of uric acid in the blood and prevent gout flare-ups.

Pharmacokinetics:

Absorption: Rapidly and well absorbed (≥49%). High-fat meal may decrease peak plasma concentration. Time to peak plasma concentration: 1-1.5 hr.

Distribution: Plasma protein binding: Approx 99%.

Metabolism: Extensively metabolised via conjugation by the uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and via oxidation via the CYP450 isoenzyme system.

Excretion: Via urine (approx 49% as metabolites and 3% as unchanged drug); faeces (approx 45% as metabolites and 12% as unchanged drug). Mean terminal half-life: Approx 5-8 hr.

Febuxostat is used to lower uric acid levels in people with gout. Febuxostat works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout.

 

How to use febuxostat

Read the Patient Information Leaflet provided by your pharmacist before you start febuxostat and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

 

Take 40 mg of this medication by mouth with or without food, usually once daily or as directed by your doctor.

 

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 it at the same time each day.

 

You may have more gout attacks for several months after starting this medicine while the body removes extra uric acid. Febuxostat is not a pain reliever. Your doctor may prescribe medication (such as colchicine, NSAIDs such as ibuprofen, naproxen, or indomethacin) to prevent/treat a gout attack during the first several months you are taking febuxostat. Continue to take your prescribed medicines for gout attacks as directed by your doctor.

 

Tell your doctor if your condition persists or worsens.

Pregnancy Risk: Category C (Risk cannot be ruled out)

You should check with your doctor immediately if any of these side effects occur when taking febuxostat:

Rare

  • Abdominal or stomach fullness or pain
  • arm, back, or jaw pain
  • black, tarry stools
  • bloody nose
  • blurred vision
  • chest pain or discomfort
  • chills
  • cloudy urine
  • confusion
  • cough
  • dark urine
  • decreased frequency or amount of urine
  • diarrhea
  • difficult or labored breathing
  • difficulty with moving
  • dizziness
  • dry mouth
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of fullness
  • fever
  • gaseous abdominal or stomach pain
  • general tiredness and weakness
  • headache
  • heavier menstrual periods
  • inability to speak
  • increase in heart rate
  • increased thirst
  • itching
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • loss of appetite
  • loss of bladder control
  • muscle aching or cramping
  • nausea and vomiting
  • nervousness
  • pain, swelling, or redness in the joints
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid breathing
  • rash
  • redness of the skin
  • right upper abdominal or stomach pain and fullness
  • runny nose
  • seizures
  • severe or sudden headache
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sunken eyes
  • sweating
  • swelling
  • temporary blindness
  • thirst
  • tightness in the chest
  • trouble sleeping
  • troubled breathing or swallowing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weight gain
  • wheezing
  • wrinkled skin
  • yellow eyes and skin

Some of the side effects that can occur with febuxostat may not need medical attention:

Rare

  • Acid or sour stomach
  • anxiety
  • bad, unusual, or unpleasant (after) taste
  • blistering, crusting, irritation, itching, or reddening of the skin
  • body aches or pain
  • breast pain
  • bruising
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • change in taste
  • changes in hair color
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough producing mucus
  • cracked, dry, or scaly skin
  • decrease in smell
  • decreased interest in sexual intercourse
  • depression
  • ear congestion
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • fruit-like breath odor
  • gum pain
  • hair loss or thinning of the hair
  • hearing loss
  • heartburn
  • hyperventilation
  • inability to have or keep an erection
  • inability to move the arms and legs
  • increased or decreased appetite
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • increased urination
  • irritability
  • large, flat, blue, or purplish patches in the skin
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • loss of consciousness
  • loss of voice
  • muscle or bone pain or stiffness
  • muscle spasm, tightness, or weakness
  • muscle twitching
  • nasal congestion
  • painful blisters on the trunk of the body
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • sensation of spinning
  • severe or continuing stomach pain
  • severe sunburn
  • shakiness in the legs, arms, hands, or feet
  • skin rash, encrusted, scaly, and oozing
  • sleepiness or unusual drowsiness
  • small red or purple spots on the skin
  • sneezing
  • stomach discomfort, upset, or pain
  • sudden numbness and weakness in the arms and legs
  • sweating
  • swelling of the breasts or breast soreness in both females and males
  • throat irritation
  • trembling or shaking of the hands or feet
  • trouble sleeping
  • unexplained weight loss
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

weight loss

Before taking febuxostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

 

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. Discuss the risks and benefits with your doctor.

 

It is not known if febuxostat passes into breast milk. Consult your doctor before breast-feeding.

 

Interactions

 

 

Some products that may interact with this drug include: azathioprine, mercaptopurine.

If overdose is suspected, contact a poison control center or emergency room immediately.

 

Notes

Do not share this medication with others.

 

Laboratory and/or medical tests (such as uric acid blood levels, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

Storage

Store at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.

 

Keep all medicines away from children and pets.

 

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Brands

 

Available Brands

Atenurix [ Ajanta Pharma Phil ] Furic [ Multicare ]
Urinorm [ LR Imperial ]

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