POTASSIUM CITRATE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CITRATE (UNII: EE90ONI6FF) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Physicians Total Care, Inc.

INN (International Name):

POTASSIUM CITRATE

Composition:

POTASSIUM CITRATE 1080 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. 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). Potassium citrate extended-release tablets are contraindicated 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, esoph

Product summary:

Bottles of 30 (NDC 54868-5644-1) Bottles of 90 (NDC 54868-5644-0) Store at 20°C to 25°C (68°F to 77°F).excursions permitted to 15 to 30°C(59 to 86°F) [see USP Controlled Room Temperature]. Store in a tight container as defined in the USP. Keep this and all drugs out of the reach of children. Manufactured by: Corepharma LLC Middlesex, NJ 08846 Distributed by: Rising Pharmaceuticals,Inc Allendale,NJ 07401 MF # 718 May 2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CITRATE - POTASSIUM CITRATE TABLET, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
POTASSIUM CITRATE EXTENDED-RELEASE TABLETS USP
5 MEQ (540 MG) AND 10 MEQ (1080 MG)
RX ONLY
DESCRIPTION
Potassium citrate USP is a citrate salt of potassium and has the
chemical name 1,2,3-
Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate.
Its molecular formula is K C H
O .H O , and its structural formula is: M.W. 324.41
Potassium citrate USP is a white granular powder that is soluble in
water at 154 g/100 ml, almost
insoluble in alcohol, and insoluble in organic solvents.
Potassium citrate extended-release tablets USP are supplied as wax
matrix tablets, containing 5 mEq
(540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate, for
oral administration. In addition,
potassium citrate extended-release tablets USP contain the inactive
ingredients carnauba wax,
magnesium stearate and stearic acid.
CLINICAL PHARMACOLOGY
When potassium citrate is given orally, the metabolism of absorbed
citrate produces an alkaline load.
The induced alkaline load in turn increases urinary pH and raises
urinary citrate by augmenting citrate
clearance without measurably altering ultrafilterable serum citrate.
Thus, potassium citrate therapy
appears to increase urinary citrate principally by modifying the renal
handling of citrate, rather than by
increasing the filtered load of citrate. The increased filtered load
of citrate may play some role,
however, as in small comparisons of oral citrate and oral bicarbonate,
citrate had a greater effect on
urinary citrate.
In addition to raising urinary pH and citrate, potassium citrate
increases urinary potassium by
approximately the amount contained in the medication. In some
patients, potassium citrate causes a
transient reduction in urinary calcium.
The changes induced by potassium citrate produce a urine that is less
conducive to the crystallization of
3
6
5
7
2
stone-forming salts (calcium oxalate, calcium phosphate and uric
acid). Increased citrate in the urine, by