POTASSIUM CHLORIDE tablet, film coated, 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:

Sandoz Inc.

INN (International Name):

Potassium Chloride

Composition:

Potassium Chloride 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride is contraindicated in patients on triamterene and amiloride. Risk Summary There are no human data related to use of potassium chloride extended-release during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary The normal potassium ion content of human milk is abo

Product summary:

Potassium chloride extended-release tablets, USP contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq of potassium respectively). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container with a child-resistant closure. Keep tightly closed.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE EXTENDED-
RELEASE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
POTASSIUM CHLORIDE EXTENDED-
RELEASE.
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium chloride extended-release is a potassium salt, indicated for
the treatment and prophylaxis of hypokalemia with
or without metabolic alkalosis in patients for whom dietary management
with potassium-rich foods or diuretic dose
reduction is insufficient. (1)
DOSAGE AND ADMINISTRATION
Monitor serum potassium and adjust dosages accordingly. (2.1)
If serum potassium is less than 2.5 mEq/L, use intravenous potassium
instead of oral supplementation. (2.1)
Take with meals and with a glass of water or other liquid. Swallow
tablets whole without crushing, chewing or sucking.
(2.1)
Treatment of hypokalemia: Doses range from 40 to 100 mEq/day in
divided doses. Limit doses to 40 mEq per dose.
(2.2)
Prevention of hypokalemia: Typical dose is 20 mEq per day. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)
CONTRAINDICATIONS
Concomitant use with triamterene and amiloride (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Irritation: Take with meals. (5.1)
ADVERSE REACTIONS
The most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort and diarrhea. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT UPSHER-SMITH
LABORATORIES, LLC AT 1-855-899-9180 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Triamterene and amiloride: Concomitant use is contraindicated (7.1)
Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia
(7.2)
Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3)
USE IN SPECIFIC POPULATIONS
Cirrhosis: Initiate therapy at the low end of the dosing range (8.6)
Renal Impa