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Lesinurad and allopurinol (Oral route)

Pronunciation:

le-SIN-ure-ad, al-oh-PURE-i-nol

Brand Names:

  • Duzallo

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Acute renal failure has occurred with lesinurad, one of the components of lesinurad/allopurinol tablets .

Classifications:

Therapeutic—

Antigout

Pharmacologic—

Xanthine Oxidase Inhibitor

Uses of This Medicine:

Lesinurad and allopurinol combination is used to lower uric acid levels in the blood in people with gout, when allopurinol alone did not work well.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lesinurad and allopurinol combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lesinurad and allopurinol combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Allopurinol

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Lesinurad

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Didanosine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Azathioprine
  • Captopril
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Enalapril
  • Enalaprilat
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etonogestrel
  • Fluorouracil
  • Gestodene
  • Levonorgestrel
  • Mercaptopurine
  • Mestranol
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Pegloticase
  • Phenprocoumon
  • Tegafur
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Hydroxide
  • Cyclosporine
  • Vidarabine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease, severe (eg, end stage kidney disease, patients who are on dialysis, or patients who received a kidney transplant) or
  • Lesch-Nyhan syndrome (inherited condition that causes too much uric acid in the blood) or
  • Tumor lysis syndrome (electrolyte and metabolic problems)—Should not be used in patients with these conditions.
  • Heart and blood vessel disease or
  • Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine in the morning with food and water. Drink at least 2 liters (L) (68 ounces) of water each day to stay hydrated.

Your doctor may give you other medicines before starting treatment with this medicine to prevent flare-ups of gout.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (tablets):
    • For lowering uric acid levels in the blood:
      • Adults—1 tablet (200 milligrams [mg] lesinurad and 200 mg allopurinol) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have a bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Heart and blood vessel problems may occur with this medicine. Tell your doctor if you have chest pain or discomfort, confusion, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble speaking, or slow speech, or are unable to move your arms, legs, or facial muscles.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Birth control pills, patches, implants, and injections may not work as well while you are using lesinurad and allopurinol combination. Use another form of birth control to keep from getting pregnant. Check with your doctor if you have any questions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Rash
rash with flat lesions or small raised lesions on the skin
Less common
Chest pain or discomfort
confusion
difficulty in speaking
double vision
headache
inability to move the arms, legs, or facial muscles
inability to speak
nausea
pain or discomfort in the arms, jaw, back, or neck
slow speech
sweating
vomiting
Rare
Anxiety
black, tarry stools
bleeding gums
blistering, peeling, or loosening of the skin
bloating
blood in the urine or stools
bloody nose
blue or pale skin
bruising
chest pain, possibly moving to the left arm, neck, or shoulder
chills
clay-colored stools
constipation
cough
dark urine
depression
diarrhea
difficulty breathing
difficulty in moving
dizziness
dry mouth
eye pain
fast heartbeat
fever
general feeling of illness
general tiredness and weakness
incoherent speech
increased urination
indigestion
joint or muscle pain
large, flat, blue or purplish patches on the skin
lightheadedness, dizziness, or fainting
loss of appetite
metallic taste
muscle pain, stiffness, tenderness, wasting, or weakness
noisy breathing
painful or difficult urination
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
red skin lesions, often with a purple center
red, irritated eyes
right upper abdominal pain and fullness
slow or irregular heartbeat
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stomach pain
swelling of the feet or lower legs
swollen glands
thirst
tightness in the chest
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal pain
vomiting of blood
weight loss
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Runny nose
shivering
trouble sleeping
Rare
Belching
blurred vision
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
changes in vision
decreased appetite
heartburn
impaired vision
increased sweating
indigestion
loss of taste
redness, soreness, or itching of the skin
sleepiness or unusual drowsiness
sores, welts, or blisters
stomach discomfort, upset, or pain
swelling of the breasts or breast soreness in both females and males
tenderness in the stomach area
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/4/2017
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