POTASSIUM CHLORIDE powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152, Chloride Ion - UNII:Q32ZN48698)

Available from:

Par Pharmaceutical

INN (International Name):

Potassium Chloride

Composition:

Potassium Chloride 1.5 g in 1.58 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride 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 potassium sparing diuretics. There are no human data related to use of Potassium Chloride during pregnancy, and animal 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 human milk is about 13 mEq per liter. Since potassium from oral supplements such as

Product summary:

Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as follows: 20 mEq NDC# 0603-1554-10 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 0603-1554-16 carton of 30 pouches NDC# 0603-1554-04 carton of 100 pouches Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). Dispense in a tight, light-resistant container as defined in the USP PROTECT from LIGHT.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE POWDER, FOR SOLUTION
PAR PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR POTASSIUM CHLORIDE.
POTASSIUM CHLORIDE FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium Chloride 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
Dilute prior to administration. (2.1, 5.1)
Monitor serum potassium and adjust dosage accordingly (2.2, 2.3)
If serum potassium concentration is <2.5 mEq/L, use intravenous
potassium instead of oral supplementation (2.1)
_Treatment of hypokalemia:_
Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses:
limit doses to 40 mEq per dose. Total daily dose
should not exceed 200 mEq (2.2)
Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in
divided doses; not to exceed 1 mEq/kg as a single dose
or 40 mEq whichever is lower; if deficits are severe or ongoing losses
are great, consider intravenous therapy. Total
daily dose should not exceed 100 mEq (2.3)
_Maintenance or Prophylaxis of hypokalemia:_
Adults: Typical dose is 20 mEq per day (2.2)
Pediatric patients aged birth to 16 years old: typical dose is 1
mEq/kg/day. Do not exceed 3 mEq/kg/day (2.3)
DOSAGE FORMS AND STRENGTHS
Potassium Chloride for Oral Solution, USP 20 mEq: Each pouch contains
1.5 g of Potassium Chloride providing
potassium 20 mEq and chloride 20 mEq. (3)
CONTRAINDICATIONS
Concomitant use with potassium sparing diuretics. (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Irritation: Dilute before use, take with meals (5.1)
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, flatulence,
abdominal pain/discomfort, and diarrhea. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CO