Pronunciation:

al-oh-PURE-i-nol

Brand Names:

• Zyloprim

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antigout

Pharmacologic—

Xanthine Oxidase Inhibitor

Uses of This Medicine:

Allopurinol is used to prevent or lower high uric acid levels in the blood. It is also used to prevent or lower excess uric acid levels caused by cancer medicines or in patients with kidney stones. A high uric acid level can cause gout or gouty arthritis (joint pain and inflammation). Allopurinol is a xanthine oxidase inhibitor that works by decreasing the uric acid produced by the body.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of allopurinol in children with high uric acid levels caused by cancer.

Older adults—

No information is available on the relationship of age to the effects of allopurinol in geriatric patients.

Breast-feeding—

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
• Capecitabine
• Captopril
• Enalapril
• Enalaprilat
• Fluorouracil
• Levoketoconazole
• Mercaptopurine
• Methotrexate
• 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:

• Bone marrow problems or
• Liver disease—Use with caution. May make these conditions worse.

• Cancer (eg, multiple myeloma) or
• Congestive heart disease or
• Diabetes or
• Hypertension (high blood pressure) or
• Hyperuricemia (high uric acid level in the blood) or
• Kidney problems, chronic (eg, glomerulonephritis, pyelonephritis)—Use with caution. May cause side effects to become worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly 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. To do so may increase the chance of side effects.

You may take this medicine after meals to avoid stomach upset.

Take this medicine with plenty of liquids to help prevent kidney stones. Check with your doctor about the amount of liquid you should drink each day. You should also increase your fiber intake.

You may need to lessen your intake of animal protein, sodium, refined sugars, or foods rich in oxalate and calcium, especially if you have kidney stones that keep coming back.

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 form (tablets):
  • For gout:
    • Adults—At first, 100 to 300 milligrams (mg) per day, taken once a day or in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For high uric acid levels caused by cancer medicines:
    • Adults and children 11 years of age and older—300 to 800 milligrams (mg) per day. Your doctor may adjust your dose as needed.
    • Children—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 100 milligrams per square meter (mg/m[2]) every 8 to 12 hours. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
  • For kidney stones:
    • Adults—200 to 300 milligrams (mg) per day, taken once a day or in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Serious skin reactions can occur with this medicine, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

When you start using this medicine, you may have more gout attacks. Keep using the medicine even if this happens. Your doctor may give you other medicines (eg, colchicine, pain medicines [NSAIDs]) to help prevent the gout attacks.

This medicine may cause serious kidney problem. Check with your doctor right away if you have blood in the urine, change in frequency of urination or amount of urine, difficulty in breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness.

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

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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

Ankle, knee, or great toe joint pain

joint stiffness or swelling

rash

rash with flat lesions or small raised lesions on the skin

Rare

Agitation

ammonia-like breath odor

anxiety

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

bloody nose

bloody or black, tarry stools

blue or pale skin

bruising

changes in skin color

chest pain, tightness, or discomfort

chest pain, possibly moving to the left arm, neck, or shoulder

chills

clay-colored stools

cloudy urine

confusion

constipation

cough

coughing up blood

cracks in the skin

dark urine

decreased awareness or responsiveness

decreased urine output

depression

diarrhea

difficulty with breathing

dizziness

drowsiness

dry mouth

feeling of warmth or heat

fever

flushing or redness of the skin, especially on the face and neck

general feeling of discomfort or illness

headache

hives or welts, itching, skin rash

hoarseness

hostility

incoherent speech

increased urination

irritability

joint or muscle pain

large, flat, blue or purplish patches in the skin

light-colored stools

loss of appetite

loss of consciousness

loss of heat from the body

lower back or side pain

metallic taste

muscle twitching or weakness

nausea

noisy breathing

pain, tenderness, or swelling of the foot or leg

painful or difficult urination

pinpoint red or purple spots on the skin

rapid weight gain

red, irritated eyes

red, swollen skin

redness, soreness, or itching skin

right upper abdominal or stomach pain and fullness

scaly skin

seizures

severe sleepiness

severe stomach pain

slow or irregular heartbeat

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sores, welting, or blisters

stomach pain

sweating

swelling of the face, ankles, hands, or lower legs

swollen or painful glands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thirst

unpleasant breath odor

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual weight gain or loss

vomiting

vomiting of blood or material that looks like coffee grounds

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:

Rare

Bad, unusual, or unpleasant (after) taste

blindness

blue-yellow color blindness

blurred vision

body aches or pain

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in taste

change in vision

congestion

continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

decreased vision

difficulty with moving

discharge or excessive tearing

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

hearing loss

impaired vision

inability to have or keep an erection

indigestion

lack or loss of strength

loss in sexual ability, desire, drive, or performance

loss of appetite

loss of memory

multiple swollen and inflamed skin lesions

muscle pain, cramps, stiffness, tenderness, or wasting

problems with memory

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

runny nose

sensation of spinning

sensitivity to light

sleepiness or unusual drowsiness

sleeplessness

sneezing

stomach upset

stuffy nose

sweating

swelling of the breasts or breast soreness in both females and males

swelling of the salivary glands

swelling or inflammation of the mouth

tearing

tender, swollen glands in the neck

tenderness in the stomach area

throbbing pain

trouble getting pregnant

trouble with sleeping

trouble with swallowing

unsteadiness or awkwardness

voice changes

weakness in the arms, hands, legs, or feet

weight loss

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.