POTASSIUM CITRATE tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

XLCare Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 t

Vörulýsing:

Potassium Citrate Extended-Release Tablets, USP 5 mEq (540 mg) tablets - Off white to tan yellowish color round shaped uncoated tablet, debossed with ‘T’ on one side and ‘399’ on the other, supplied in bottles as: NDC 72865-191-01                 Bottle of 100 tablets Potassium Citrate Extended-Release Tablets, USP 10 mEq (1080 mg) tablets - Off white to tan yellowish color capsule shaped uncoated tablet, debossed with ‘T400’ on one side and plain on the other side, supplied in bottles as: NDC 72865-192-01                 Bottle of 100 tablets Potassium Citrate Extended-Release Tablets, USP 15 mEq (1620 mg) tablets - Off white to tan yellowish color oval shaped uncoated tablet, debossed with ‘T’ on one side and ‘401’ on the other side, supplied in bottles as: NDC 72865-193-01                 Bottle of 100 tablets Storage:  Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Store in a tight container.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

POTASSIUM CITRATE- POTASSIUM CITRATE TABLET, EXTENDED RELEASE
XLCARE PHARMACEUTICALS, INC.
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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 tablets are a citrate salt of
potassium indicated for the management
of: (1)
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 6.0
to 7.0. (2)
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)
Pa