Aloprim

Name: Aloprim

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What is the dosage for allopurinol?

The dose of allopurinol for treating gout is 200-600 mg daily depending on severity. The dose for treating high uric acid blood levels due to chemotherapy is 100-800 mg daily starting 1 or 2 days before chemotherapy. It should be taken with food to avoid irritation of the stomach. In order to avoid formation of kidney stones, patients should drink plenty of fluids while taking allopurinol.

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Reviewed on 7/29/2016 References REFERENCE: FDA Prescribing Information

Uses of Aloprim

Aloprim is also used to lower high levels of uric acid in the body due to cancer treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Aloprim Precautions

Serious allergic reactions including death have occurred with Aloprim. Stop taking this medication and talk to your doctor if you develop a skin rash.

Drink plenty of water or other fluids each day while taking Aloprim to prevent kidney stone formation.

Serious liver problems have occurred with Aloprim use. While these events are rare, tell your doctor if you experience weight loss, lack of appetite, and itching. Your doctor will likely run tests to check your liver function.

Kidney failure has occurred in some people who took Aloprim.

 

Aloprim and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aloprim falls into category C. There are no good studies that have been done in humans with Aloprim. In animals studies, pregnant animals were given this medication and had some babies born with problems. However, this medication may sometimes still help human mothers and their babies more than it might cause harm.

Aloprim Usage

Aloprim is available as an injectable form to be given into the vein (IV) by healthcare professional.

If you miss a dose, be sure to make a follow up appointment.

Aloprim Description

Aloprim (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. Aloprim (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophilized sodium salt of allopurinol equivalent to 500 mg of allopurinol. Aloprim (allopurinol sodium) for Injection contains no preservatives.

The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is:

The pKa of allopurinol sodium is 9.31.

Side effects

In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving ALOPRIM (allopurinol sodium) for Injection. Most of the patients had advanced malignancies or serious underlying diseases and were taking multiple concomitant medications. Side effects directly attributable to ALOPRIM (allopurinol sodium) for Injection were reported in 19 patients. Fifteen of these adverse experiences were allergic in nature (rash, eosinophilia, local injection site reaction). One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection. Two patients had serious adverse experiences (decreased renal function and generalized seizure) reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection.

A listing of the adverse reactions regardless of causality reported from clinical trials follows:

Incidence Greater Than 1%

Cutaneous/Dermatologic: rash (1.5%)

Genitourinary: renal failure/insufficiency (1.2%)

Gastrointestinal: nausea (1.3%), vomiting (1.2%)

Incidence Less Than 1%

Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia
Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECGabnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation
Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction
Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis
Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection
Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation
Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia
Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor
Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea
Musculoskeletal: arthralgia
Other: hypotonia, diaphoresis, tumor lysis syndrome

The most frequent adverse reaction to oral allopurinol is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with ALOPRIM (allopurinol sodium for injection) (allopurinol sodium) for Injection should be discontinued immediately if a rash develops (see WARNINGS). For further details on hypersensitivity reactions to treatment with oral allopurinol, refer to the package insert for allopurinol tablets.

Read the entire FDA prescribing information for Aloprim (Allopurinol Sodium for Injection)

Read More »

For the Consumer

Applies to allopurinol: oral capsule, oral tablet

Other dosage forms:

  • intravenous powder for solution

Along with its needed effects, allopurinol (the active ingredient contained in Aloprim) 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 while taking allopurinol:

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
  • Abdominal or stomach pain
  • 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 or discomfort
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • clay-colored stools
  • cloudy urine
  • coma
  • confusion
  • constipation
  • cough or hoarseness
  • coughing up blood
  • cracks in the skin
  • dark urine
  • decreased urine output
  • depression
  • diarrhea
  • difficulty with breathing
  • dizziness
  • drowsiness
  • dry mouth
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • fever
  • fever with or without chills
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • headache
  • hostility
  • incoherent speech
  • increased urination
  • irritability
  • itching
  • joint or muscle pain
  • large, flat, blue or purplish patches in the skin
  • lethargy
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • lower back or side pain
  • metallic taste
  • muscle twitching
  • muscle weakness
  • nausea or vomiting
  • pain, tenderness, or swelling of the foot or leg
  • painful or difficult urination
  • pinpoint red or purple spots on the skin
  • rapid weight gain
  • rash
  • red, irritated eyes
  • red, swollen skin
  • redness, soreness, or itching skin
  • right upper abdominal or stomach pain and fullness
  • scaly skin
  • seizures
  • severe stomach pain
  • shortness of breath
  • slow or irregular heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sores, welting, or blisters
  • stupor
  • 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
  • tightness in the chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
  • yellow eyes or skin

Some side effects of allopurinol 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
  • burning, numbness, tingling, or painful sensations
  • 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
  • hives or welts
  • 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 aching or cramping
  • muscle pain or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • noisy breathing
  • 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
  • swollen joints
  • tearing
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • throbbing pain
  • tightness in the chest
  • trouble getting pregnant
  • trouble with sleeping
  • trouble with swallowing
  • unable to sleep
  • unsteadiness or awkwardness
  • voice changes
  • weakness in the arms, hands, legs, or feet
  • weight loss

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