Prescription Drug Information: Allopurinol (Page 3 of 3)

Incidence Less Than 1% Causal Relationship Unknown

Body as a whole: malaise.

Cardiovascular: pericarditis, peripheral vascular disease, thrombophlebitis, bradycardia, vasodilation.

Endocrine: infertility (male), hypercalcemia, gynecomastia (male).

Gastrointestinal: hemorrhagic pancreatitis, gastrointestinal bleeding, stomatitis, salivary gland swelling, hyperlipidemia, tongue edema, anorexia.

Hemic and Lymphatic: aplastic anemia, agranulocytosis, eosinophilic fibrohistiocytic lesion of bone marrow, pancytopenia, prothrombin decrease, anemia, hemolytic anemia, reticulocytosis, lymphadenopathy, lymphocytosis.

Musculoskeletal: myalgia.

Nervous: optic neuritis, confusion, dizziness, vertigo, foot drop, decrease in libido, depression, amnesia, tinnitis, asthenia, insomnia.

Respiratory: bronchospasm, asthma, pharyngitis, rhinitis.

Skin and Appendages: furunculosis, facial edema, sweating, skin edema.

Special Senses: cataracts, macular retinitis, iritis, conjunctivitis, amblyopia.

Urogenital: nephritis, impotence, primary hematuria, albuminuria.

OVERDOSAGE

Massive overdosing or acute poisoning by allopurinol has not been reported. In mice the 50% lethal dose (LD50 ) is 160 mg/kg given intraperitoneally (i.p.) with deaths delayed up to five days and 700 mg/kg orally (p.o.) (approximately 140 times the usual human dose) with deaths delayed up to three days. In rats the acute LD50 is 750 mg/kg i.p. and 6000 mg/kg p.o. (approximately 1200 times the human dose).

In the management of overdosage there is no specific antidote for allopurinol. There has been no clinical experience in the management of a patient who has taken massive amounts of allopurinol.

Both allopurinol and oxipurinol are dialyzable, however, the usefulness of hemodialysis or peritoneal dialysis in the management of an allopurinol overdose is unknown.

DOSAGE AND ADMINISTRATION

The dosage of allopurinol to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg per day for patients with mild gout and 400 to 600 mg per day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The maximal recommended dosage is 800 mg daily. To reduce the possibility of flareup of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximal recommended dosage.

Normal serum urate levels are usually achieved in one to three weeks. The upper limit of normal is about 7 mg/dL for men and postmenopausal women and 6 mg/dL for premenopausal women. Too much reliance should not be placed on a single serum uric acid determination since, for technical reasons, estimation of uric acid may be difficult. By selecting the appropriate dosage and, in certain patients, using uricosuric agents concurrently, it is possible to reduce serum uric acid to normal or, if desired, to as low as 2 to 3 mg/dL and keep it there indefinitely.

While adjusting the dosage of allopurinol in patients who are being treated with colchicine and/or anti-inflammatory agents, it is wise to continue the latter therapy until serum uric acid has been normalized and there has been freedom from acute gouty attacks for several months.

In transferring a patient from a uricosuric agent to allopurinol, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of allopurinol gradually increased to the required dose needed to maintain a normal serum uric acid level.

It should also be noted that allopurinol is generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least two liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.

Since allopurinol and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of allopurinol should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of allopurinol is suitable. When the creatinine clearance is less than 10 mL/min, the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clear- ance less than 3 mL/min) the interval between doses may also need to be lengthened.

The correct size and frequency of dosage for maintaining the serum uric acid just within the normal range are best determined by using the serum uric acid level as an index.

For the prevention of uric acid nephropathy during the vigorous therapy of neoplastic disease, treatment with 600 to 800 mg daily for two or three days is advisable together with a high fluid intake. Otherwise similar considerations to the above recommendations for treating patients with gout govern the regulation of dosage for maintenance purposes in secondary hyperuricemia.

The dose of allopurinol recommended for management of recurrent calcium oxalate stones in hyperuricosuric patients is 200 to 300 mg/day in divided doses or as the single equivalent. This dose may be adjusted up or down depending upon the resultant control of the hyperuricosuria based upon subsequent 24 hour urinary urate determinations. Clinical experience suggests that patients with recurrent calcium oxalate stones may also benefit from dietary changes such as the reduction of animal protein, sodium, refined sugars, oxalate-rich foods, and excessive calcium intake as well as an increase in oral fluids and dietary fiber.

Children, 6 to 10 years of age, with secondary hyperuricemia associated with malignancies may be given 300 mg allopurinol daily while those under 6 years are generally given 150 mg daily. The response is evaluated after approximately 48 hours of therapy and a dosage adjustment is made if necessary.

HOW SUPPLIED

Allopurinol Tablets, USP; 100 mg, round, flat, off-white, scored tablet, debossed ‘0524’ over ‘0405’.

Bottles of 100 NDC 55111-729-01

Bottles of 1000 NDC 55111-729-10

300 mg; round, convex, off-white tablet, debossed ‘AL3’.

Bottles of 100 NDC 55111-730-01

Bottles of 500 NDC 55111-730-05

Bottles of 1000 NDC 55111-730-10

Store at 15°-30°C (59°-86°F) and protect from moisture.

QUESTIONS OR COMMENTS? Call toll free 1-888-375-3784.You may report side effects to FDA at 1-800-FDA-1088.

Rx Only

Manufactured by
Dr. Reddy’s Laboratories Louisiana, LLC

Shreveport, LA 71106 USA

Issued August, 2014

150019989-03

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count300 mg
4571610-064-45
9071610-064-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20220422JK

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 71610-064 — Allopurinol 300 mg — Rx Only

Bottle Label 300 mg
(click image for full-size original)

ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-064(NDC:55111-730)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allopurinol (Allopurinol) Allopurinol 300 mg
Inactive Ingredients
Ingredient Name Strength
Magnesium stearate
Lactose
povidone
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AL3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-064-45 45 TABLET in 1 BOTTLE None
2 NDC:71610-064-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071587 10/01/2009
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-064)

Revised: 05/2022 Aphena Pharma Solutions — Tennessee, LLC

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