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:

Strides Pharma Science Limited

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, USP 8 mEq [600mg] are blue colored, circular biconvex film coated tablets plain on one side and debossed "P8" on another side. 600 mg potassium chloride (equivalent to 8 mEq) are available in bottles of 100 (NDC 64380-860-06), bottles of 500 (NDC 64380-860-07), bottles of 1000 (NDC 64380-860-08). Potassium Chloride Extended Release Tablets, USP 10 mEq [750mg] are yellow colored, circular biconvex film coated tablets plain on one side and debossed "P10" on another side. 750 mg potassium chloride (equivalent to 10 mEq) are available in bottles of 100 (NDC 64380-861-06), bottles of 500 (NDC 64380-861-07), bottles of 1000 (NDC 64380-861-08). 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
STRIDES PHARMA SCIENCE LIMITED
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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 POPULATIONS
Cirrhosis: