ZYLOPRIM Tablet (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Casper Pharma LLC

Λέξεις κλειδιά

70199-015 70199-016

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1. Description

ZYLOPRIM (allopurinol) has the following structural formula: ZYLOPRIM is known chemically as 1,5-dihydro-4Hpyrazolo [3,4d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is ...

2. Clinical Pharmacology

ZYLOPRIM acts on purine catabolism, without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation. ...

3. Indications and Usage

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. ZYLOPRIM reduces serum and urinary uric acid concentrations. Its use should be individualized for each ...

4. Contraindications

Patients who have developed a severe reaction to ZYLOPRIM should not be restarted on the drug.

5. Warnings

ZYLOPRIM SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances a skin rash may be followed by more severe hypersensitivity ...

6.1. General

An increase in acute attacks of gout has been reported during the early stages of administration of ZYLOPRIM , even when normal or subnormal serum uric acid levels have been attained. Accordingly, maintenance ...

6.2. Information for Patients

Patients should be informed of the following: 1) They should be cautioned to discontinue ZYLOPRIM and to consult their physician immediately at the first sign of a skin rash, painful urination, blood in ...

6.3. Laboratory Tests

The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index. In patients with pre-existing liver disease, periodic ...

6.4. Drug Interactions

In patients receiving mercaptopurine or IMURAN (azathioprine), the concomitant administration of 300 to 600 mg of ZYLOPRIM per day will require a reduction in dose to approximately one third to one fourth ...

6.5. Drug/Laboratory Test Interactions

ZYLOPRIM is not known to alter the accuracy of laboratory tests.

6.7. Pregnancy

Teratogenic Effects: Reproductive studies have been performed in rats and rabbits at doses up to twenty times the usual human dose (5 mg/kg per day), and it was concluded that there was no impaired ...

6.9. Nursing Mothers

Allopurinol and oxipurinol have been found in the milk of a mother who was receiving ZYLOPRIM. Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when ZYLOPRIM ...

6.10. Pediatric Use

ZYLOPRIM is rarely indicated for use in children with the exception of those with hyperuricemia secondary to malignancy or to certain rare inborn errors of purine metabolism (see INDICATIONS AND USAGE ...

7. Adverse Reactions

Data upon which the following estimates of incidence of adverse reactions are made are derived from experiences reported in the literature, unpublished clinical trials and voluntary reports since marketing ...

9. 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 ...

10. Dosage and 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 ...

11. How Supplied

100-mg (white) scored, flat cylindrical tablets imprinted with ZYLOPRIM 100 on a raised hexagon, bottles of 90 (NDC 70199-015-90). 300-mg (peach) scored, flat, cylindrical tablets imprinted with ZYLOPRIM ...

12. Storage and Handling

100-mg: Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place. 300-mg: Store at 20° to 25°C (USP Controlled Room Temperature) (68° to 77°F) in a dry place and protect from ...