POTASSIUM CITRATE EXTENDED RELEASE- potassium citrate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Strides Pharma Inc.

INN (International Name):

POTASSIUM CITRATE

Composition:

POTASSIUM CITRATE 5 meq

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 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

Product summary:

Potassium citrate extended-release tablets USP 5 mEq are uncoated, pale yellow colored, round shaped, bi-Convex, debossed with 'S406' on one side and plain on the other side, supplied in bottles as:              NDC 42543-406-01 Bottle of 100 tablets Potassium citrate extended-release tablets USP 10 mEq are uncoated, pale yellow colored, caplet shaped, bi-Convex, debossed with 'S407' on one side and plain on the other side, supplied in bottles as:              NDC 42543-407-01 Bottle of 100 tablets Potassium citrate extended-release tablets USP 15 mEq are uncoated, pale yellow colored, caplet shaped, bi-Convex, debossed with 'S408' on one side and plain on the other side, supplied in bottles as:              NDC 42543-408-01 Bottle of 100 tablets Storage : Store in a tight container at 20°–25°C (68°–77°F), Excursions permitted between 15° and 30°C (59° and 86°F) [See USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CITRATE EXTENDED RELEASE- POTASSIUM CITRATE TABLET
STRIDES 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 is a citrate salt of potassium indicated for the
management of: (1)
• Renal tubular acidosis (RTA) with calcium stones (1.1) (1)
• Hypocitraturic calcium oxalate nephrolithiasis of any etiology
(1.2) (1)
• Uric acid lithiasis with or without calcium stones (1.3) (1)
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) (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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mEq, 10 mEq and 15 mEq (3) (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) (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