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:

Biocomp Pharma, Inc.

INN (International Name):

POTASSIUM CITRATE

Composition:

POTASSIUM CITRATE 15 meq

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1 INDICATIONS AND USAGE 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium Citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)]. 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 is contraindicated: - In patients with hyperkalemia (or who have conditions pre-disposing 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 tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication. - In patients with peptic ulcer disease because of its ulcerogenic potential. - In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth. - In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia. Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed. The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed. Safety and effectiveness in children have not been established.

Product summary:

Potassium Citrate 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as: NDC 44523-415-01 Bottle of 100 Storage: Store in a tight container.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

POTASSIUM CITRATE- POTASSIUM CITRATE TABLET
BIOCOMP PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
POTASSIUM CITRATE 15 MEQ EXTENDED RELEASE TABLETS FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CITRATE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR POTASSIUM
CITRATE.
INITIAL U.S. APPROVAL: 1985
RECENT MAJOR CHANGES
Highlights
Warnings and Precautions (5.2)
Drug Interactions (7.2, 7.3)
Description (molecular formula image)
Clinical Studies (Table 1)
INDICATIONS AND USAGE
Potassium Citrate 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 6.0
to 7.0.
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: 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
compr