Description
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
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Fezolinetant
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
- Benzhydrocodone
- Buprenorphine
- Capecitabine
- Captopril
- Carbamazepine
- Clarithromycin
- Codeine
- Cyclosporine
- Desogestrel
- Dienogest
- Dihydrocodeine
- Diltiazem
- Drospirenone
- Enalapril
- Enalaprilat
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fedratinib
- Fentanyl
- Fluorouracil
- Gestodene
- Hydrocodone
- Levoketoconazole
- Levonorgestrel
- Mavacamten
- Medroxyprogesterone
- Meperidine
- Mercaptopurine
- Mestranol
- Methadone
- Methotrexate
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
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
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.
- For lowering uric acid levels in the blood:
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
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
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.
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