POTASSIUM CITRATE tablet, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

可用日期:

Zydus Pharmaceuticals (USA) Inc.

INN（国际名称）:

POTASSIUM CITRATE

组成:

POTASSIUM CITRATE 5 meq

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)]. Potassium citrate extended-release tablets are contraindicated: - In patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride). - In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tr

產品總結:

Potassium Citrate Extended-release Tablets USP, 5 mEq are tan to yellowish color, round shaped, biconvex uncoated tablets debossed with "536" on one side and plain on the other side and are supplied as follows:       NDC 68382-536-06 in bottle of 30 tablets with child-resistant closure       NDC 68382-536-16 in bottle of 90 tablets with child-resistant closure       NDC 68382-536-01 in bottle of 100 tablets with child-resistant closure       NDC 68382-536-05 in bottle of 500 tablets       NDC 68382-536-10 in bottle of 1,000 tablets       NDC 68382-536-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets Potassium Citrate Extended-release Tablets USP, 10 mEq are tan to yellowish color, oval shaped, biconvex uncoated tablets debossed with "537" on one side and plain on the other side and are supplied as follows:       NDC 68382-537-06 in bottle of 30 tablets with child-resistant closure       NDC 68382-537-16 in bottle of 90 tablets with child-resistant closure       NDC 68382-537-01 in bottle of 100 tablets with child-resistant closure       NDC 68382-537-05 in bottle of 500 tablets       NDC 68382-537-10 in bottle of 1,000 tablets       NDC 68382-537-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets Potassium Citrate Extended-release Tablets USP, 15 mEq are tan to yellowish color, oblong shaped, biconvex uncoated tablets debossed with "538" on one side and plain on the other side and are supplied as follows:       NDC 68382-538-06 in bottle of 30 tablets with child-resistant closure       NDC 68382-538-16 in bottle of 90 tablets with child-resistant closure       NDC 68382-538-01 in bottle of 100 tablets with child-resistant closure       NDC 68382-538-05 in bottle of 500 tablets       NDC 68382-538-10 in bottle of 1,000 tablets       NDC 68382-538-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

授权状态:

Abbreviated New Drug Application

产品特点

POTASSIUM CITRATE- POTASSIUM CITRATE TABLET, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CITRATE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS.
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Potassium citrate extended-release tablet is a citrate salt of
potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones (1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2)
Uric acid lithiasis with or without calcium stones (1.3)
DOSAGE AND ADMINISTRATION
Objective: To restore normal urinary citrate (greater than 320 mg/day
and as close to the normal mean of
640 mg/day as possible), and to increase urinary pH to a level of 6 to
7.
Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should
be initiated at 60 mEq per day; a
dose of 30 mEq two times per day or 20 mEq three times per day with
meals or within 30 minutes after
meals or bedtime snack (2.2)
Mild to moderate hypocitraturia (urinary citrate >150 mg/day): therapy
should be initiated at 30 mEq
per day; a dose of 15 mEq two times per day or 10 mEq three times per
day with meals or within 30
minutes after meals or bedtime snack (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mEq, 10 mEq and 15 mEq (3)
CONTRAINDICATIONS
Patients with hyperkalemia (or who have conditions predisposing them
to hyperkalemia). Such
conditions include chronic renal failure, uncontrolled diabetes
mellitus, acute dehydration, strenuous
physical exercise in unconditioned individuals, adrenal insufficiency,
extensive tissue breakdown (4)
Patients for whom there is cause for arrest or delay in tablet passage
through the gastrointestinal tract
such as those suffering from delayed gastric emptying, esophageal
compression, intestinal obstruction
or stricture (4)
Patients wit