POTASSIUM CHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Available from:

AvKARE

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene.

Product summary:

Potassium Chloride Extended-release Capsules, USP, 8 mEq are white opaque capsules, imprinted with Andrx logo on the cap and 559 on the body, each containing 600mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 90 (NDC 42291-678-90). Potassium Chloride Extended-release Capsules, USP, 10 mEq are dark blue opaque capsules, imprinted with Andrx logo on the cap and 560 on the body, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 90 (42291-679-90), bottles of 500 (42291-679-50). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 02/15 AV Rev. 03/16 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE
AVKARE, INC.
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POTASSIUM CHLORIDE EXTENDED-RELEASE CAPSULES, USP
RX ONLY
DESCRIPTION:
Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq are
oral dosage
forms of
microencapsulated potassium chloride containing 600 mg and 750 mg of
potassium
chloride, USP
equivalent to 8 mEq and 10 mEq of potassium, respectively.
Dispersibility of potassium chloride (KCl) is accomplished by
microencapsulation and a
dispersing
agent. The resultant flow characteristics of the KCl microcapsules and
the controlled
release of K+
ions by the microcapsular membrane are intended to avoid the
possibility that excessive
amounts of KCl
can be localized at any point on the mucosa of the gastrointestinal
tract.
Each crystal of KCl is microencapsulated by a process with an
insoluble polymeric
coating which
functions as a semi-permeable membrane; it allows for the controlled
release of
potassium and chloride
ions over an eight-to-ten-hour period. Fluids pass through the
membrane and gradually
dissolve the
potassium chloride within the micro-capsules. The resulting potassium
chloride solution
slowly
diffuses outward through the membrane. Potassium Chloride
Extended-release
Capsules, USP, 8 mEq
and 10 mEq are electrolyte replenishers.
The chemical name of the active ingredient is potassium chloride and
the structural
formula is KCl. It
has a molecular mass of 74.55. Potassium chloride, USP occurs as a
white granular
powder or as
colorless crystals. It is odorless and has a saline taste. Its
solutions are neutral to litmus.
It is freely
soluble in water and insoluble in alcohol.
The inactive ingredients are, ethylcellulose, FD&C blue #1, FD&C red #
40, gelatin,
sodium lauryl
sulfate, titanium oxide and triacetin.
CLINICAL PHARMACOLOGY:
12.1 Mechanis m of Action
The potassium ion (K+) is the principal intracellular cation of most
body tissues.
Potassium ions
participate in a number of essential physiological processes,
including the maintenance
of intracellular