Allopurinol (Page 4 of 4)

DOSAGE AND ADMINISTRATION

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

It should also be noted that allopurinol tablets are 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 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 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 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 tablet 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 are supplied as follows:

100 mg: White, flat, circular, uncoated tablets with “N020” debossed on one side and score line on the other side.

Bottle of 30 tablets NDC 16714-041-07
Bottle of 100 tablets NDC 16714-041-10
Bottle of 1000 tablets NDC 16714-041-12

300 mg: Orange color, biconvex, circular, uncoated tablets with “N021”debossed on one side and score line on the other side.

Bottle of 30 tablets NDC 16714-042-07
Bottle of 100 tablets NDC 16714-042-10
Bottle of 500 tablets NDC 16714-042-11

Store at 20° to 25°C (68 to 77°F). See USP Controlled room temperature.

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
Manufactured for: Northstar Rx LLC
Memphis, TN 38141
Manufactured by: Piramal Pharma Limited ,
Pithampur, Madhya Pradesh 454775
INDIA
October 2020

Principal Display Panel- Allopurinol Tablets USP, 100 mg-30s pack

LABELS OF PITHAMPUR

allopurinol-fig2
(click image for full-size original)

Rx only

NDC 16714-041-07

ALLOPURINOL TABLETS, USP 100 mg

30 Tablets

NORTHSTARX ®

Each tablet contains 100 mg of allopurinol, USP.

For indications, dosage, precautions, etc., see accompanying package insert.

Dispense in a tight, light-resistant container as defined in the USP.

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for: Northstar Rx LLC

Memphis TN 38141. Product of India

Manufactured by: Piramal Pharma Limited, Plot No.67-70,
Sector — 2, Pithampur 454 775, Dist. Dhar, Madhya Pradesh, INDIA.

Mfg Lic. No.: 25/10/92 20614960 EM 14782/d Rev. 10/2020

Bar Code
© 2018 Northstar Healthcare Holdings Ltd

Principal Display Panel- Allopurinol Tablets USP, 300 mg-30s pack

LABELS OF PITHAMPUR

allopurinol-fig3
(click image for full-size original)

Rx only

NDC 16714-042-07

ALLOPURINOL TABLETS, USP 300 mg

30 Tablets

NORTHSTARX ®

Each tablet contains 300 mg of allopurinol, USP.

For indications, dosage, precautions, etc., see accompanying package insert.
Usual Dose: One tablet daily.

Dispense in a tight, light-resistant container as defined in the USP.

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for: Northstar Rx LLC

Memphis TN 38141. Product of India

Manufactured by: Piramal Pharma Limited, Plot No. 67-70,

Sector — 2, Pithampur 454 775, Dist. Dhar, Madhya Pradesh, INDIA.

Mfg Lic. No.: 25/10/92 20614965 EM 14785/d Rev.10/2020
Bar Code © 2018 Northstar Healthcare Holdings Ltd

ALLOPURINOL allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-041
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
ALCOHOL
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape ROUND (Flat, Circular) Size 8mm
Flavor Imprint Code N020
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-041-07 30 TABLET in 1 BOTTLE None
2 NDC:16714-041-10 100 TABLET in 1 BOTTLE None
3 NDC:16714-041-12 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078253 11/16/2009
ALLOPURINOL allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-042
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
ALCOHOL
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
Product Characteristics
Color ORANGE (ORANGE) Score 2 pieces
Shape ROUND (Biconvex,Circular) Size 11mm
Flavor Imprint Code N021
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-042-07 30 TABLET in 1 BOTTLE None
2 NDC:16714-042-10 100 TABLET in 1 BOTTLE None
3 NDC:16714-042-11 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078253 11/16/2009
Labeler — Northstar RxLLC (830546433)
Registrant — Piramal Pharma Limited (862202793)

Revised: 10/2020 Northstar RxLLC

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