POTASSIUM-CIT tablet, extended release POTASSIUM-CIT tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eywa Pharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is 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 tra

Product summary:

Potassium Citrate Extended-release Tablets USP, 5 mEq tablets are uncoated, tan to yellowish speckled in color, round shaped, with E34 debossed on one side and plain on the other side, supplied in bottles as:                     NDC 71930-048-12     Bottle of 100 Potassium Citrate Extended-release Tablets USP, 10 mEq tablets are uncoated, tan to yellowish speckled in color, elliptical shaped, with E35 debossed on one side and plain on the other side, supplied in bottles as: NDC 71930-049-12     Bottle of 100 Potassium Citrate Extended-release Tablets, USP 15 mEq tablets are uncoated, tan to yellowish speckled in color, modified rectangle shaped, with E36 debossed on one side and plain on the other side, supplied in bottles as: NDC 71930-050-12     Bottle of 100 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a tight container. Unit-of-use package. Dispense in this container without repackaging.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM-CIT - POTASSIUM-CIT TABLET, EXTENDED RELEASE
EYWA PHARMA 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 is 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)
Patients with peptic