POTASSIUM CHLORIDE tablet, 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:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride Extended-release Tablets, USP 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 Tablets, USP 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 2-4% and 15-20%, respectively. Risk Summary The normal potassium ion content of

Product summary:

Potassium Chloride Extended Release Tablets, 750 mg potassium chloride (equivalent to 10 mEq) are available in bottles of 14(NDC 70934-747-14) and 90 (NDC 70934-747-90), Store at 25ºC (77ºF) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight container as defined in the USP with a child resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
EXTENDED-RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP.
POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium Chloride Extended-release Tablets, USP 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) (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 40-100 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) (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 STRIDES PHARMA INC. AT
1-877-244-9825
OR GO TO WWW.STRIDES.COM OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH. (6)
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 POP