Zyloprim (Page 4 of 4)

OVERDOSAGE

Massive overdosing or acute poisoning by ZYLOPRIM has not been reported.

In mice, the 50% lethal dose (LD50 ) 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 LD50 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 ZYLOPRIM. There has been no clinical experience in the management of a patient who has taken massive amounts of ZYLOPRIM.

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

DOSAGE & ADMINISTRATION

The dosage of ZYLOPRIM 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 ZYLOPRIM (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 ZYLOPRIM 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 ZYLOPRIM, the dose of the uricosuric agent should be gradually reduced over a period of several weeks and the dose of ZYLOPRIM gradually increased to the required dose needed to maintain a normal serum uric acid level.

It should also be noted that ZYLOPRIM 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 ZYLOPRIM and its metabolites are primarily eliminated only by the kidney, accumulation of the drug can occur in renal failure, and the dose of ZYLOPRIM should consequently be reduced. With a creatinine clearance of 10 to 20 mL/min, a daily dosage of 200 mg of ZYLOPRIM 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 ZYLOPRIM 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, oxalaterich 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 ZYLOPRIM 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) scored, flat cylindrical tablets imprinted with “ZYLOPRIM 100” on a raised hexagon, bottles of 90 (NDC 70199-015-90).

Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place.

300-mg (peach) scored, flat, cylindrical tablets imprinted with “ZYLOPRIM 300” on a raised hexagon, bottles of 90 (NDC 70199-016-90) and 500 (NDC 70199-016-05).

Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place and protect from light.

Casper Pharma LLC

Manufactured by
Patheon Mfg. Services LLC
Greenville, NC 27834
for Casper Pharma LLC
East Brunswick, NJ 08816
ZYLOPRIM is a registered trademark of Casper Pharma LLC, East Brunswick, NJ
IMURAN is a registered trademark of Sebela International Bermuda Limited, Hamilton, Bermuda
PURINETHOL is a registered trademark of Stason Pharmaceutical, Inc., Irvine, CA
Made in U.S.A.

PIB01605-02

Revised: 12/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZYLOPRIM® (allopurinol)

100 mg 90 Tablets Bottle

NDC 70199-015-90

Rx Only

allopurinollabel1
(click image for full-size original)

ZYLOPRIM® (allopurinol)

300 mg 90 Tablets Bottle

NDC 70199-016-90

Rx Only

allopurinollabel2
(click image for full-size original)

ZYLOPRIM
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70199-015
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
MAGNESIUM STEARATE
STARCH, POTATO
POVIDONE
LACTOSE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 3mm
Flavor Imprint Code ZYLOPRIM;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70199-015-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016084 08/06/2018
ZYLOPRIM
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70199-016
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
STARCH, CORN
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
POVIDONE
LACTOSE
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 4mm
Flavor Imprint Code ZYLOPRIM;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70199-016-90 90 TABLET in 1 BOTTLE None
2 NDC:70199-016-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016084 08/06/2018
Labeler — Casper Pharma LLC (080025838)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 ANALYSIS (70199-015), ANALYSIS (70199-016), MANUFACTURE (70199-015), MANUFACTURE (70199-016)

Revised: 12/2018 Casper Pharma LLC

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