Allopurinol (Page 4 of 4)

OVERDOSAGE

Massive overdosing or acute poisoning by allopurinol tablets USP has not been reported.

In mice, the 50% lethal dose (LD 50 ) is 160 mg/kg given intraperitoneally (IP) with deaths delayed up to 5 days and 700 mg/kg orally (PO) (approximately 140 times the usual human dose) with deaths delayed up to 3 days. In rats, the acute LD 50 is 750 mg/kg IP and 6000 mg/kg PO (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 overdose of allopurinol is unknown.

DOSAGE AND ADMINISTRATION

The dosage of allopurinol tablets USP 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/day for patients with mild gout and 400 to 600 mg/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 minimal effective dosage is 100 to 200 mg daily and the maximal recommended dosage is 800 mg daily. To reduce the possibility of flare-up of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol tablets USP (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 1 to 3 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 tablets USP 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 tablets USP, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of allopurinol tablets USP gradually increased to the required dose needed to maintain a normal serum uric acid level.

It should also be noted that allopurinol tablet USP is generally better tolerated if taken following meals. A fluid intake sufficient to yield a daily urinary output of at least 2 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 tablets USP should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of allopurinol tablet USP 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 clearance 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 is 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 2 or 3 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 tablets USP 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 tablets USP 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

100-mg (white to off white) round, biconvex, uncoated tablet with inscription “AW” on one side and breakline on the other side, bottles of 30 (NDC 16729-134-10), 100 (NDC 16729-134-01), 500 (NDC 16729-134-16) and 1,000 (NDC 16729-134-17)

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

300-mg (white to off white) round, biconvex with beveled edge, uncoated tablet with inscription “AX” on one side and breakline on the other side, bottles of 30 (NDC 16729-135-10), 100 (NDC 16729-135-01), 500 (NDC 16729-135-16) and 1,000 (NDC 16729-135-17).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

For more information, go to: www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.

IMURAN is a registered trademark of Sebela International Bermuda Limited, Hamilton, Bermuda

PURINETHOL is a registered trademark of Stason Pharmaceutical, Inc., Irvine, CA

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Plot No : 457, 458,
Village — Matoda,
Bavla Road, Ta. — Sanand,
Dist. — Ahmedabad — 382210,
India.

10 0258 1 687720

Issued February 2019

100 mg 500 Tablets Bottle

100 mg 500 Tablets Bottle
(click image for full-size original)

300 mg 500 Tablets Bottle

300 mg 500 Tablets Bottle
(click image for full-size original)
ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-134
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLOPURINOL (ALLOPURINOL) ALLOPURINOL 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CROSPOVIDONE
STARCH, CORN
POVIDONE K30
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code AW
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-134-10 30 TABLET in 1 BOTTLE None
2 NDC:16729-134-01 100 TABLET in 1 BOTTLE None
3 NDC:16729-134-16 500 TABLET in 1 BOTTLE None
4 NDC:16729-134-17 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203154 04/29/2015
ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-135
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CROSPOVIDONE
STARCH, CORN
POVIDONE K30
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code AX
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-135-10 30 TABLET in 1 BOTTLE None
2 NDC:16729-135-01 100 TABLET in 1 BOTTLE None
3 NDC:16729-135-16 500 TABLET in 1 BOTTLE None
4 NDC:16729-135-17 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203154 04/29/2015
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-134), manufacture (16729-135), analysis (16729-134), analysis (16729-135)

Revised: 08/2019 Accord Healthcare Inc.

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