POTASSIUM CHLORIDE 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:

VistaPharm, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 20 meq in 15 mL

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 are 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 a

Product summary:

Potassium Chloride Oral Solution, is an orange solution available as follows: (NDC# 66689-047-01), packaged in trays of 10 unit-dose cups each. NDC# 66689-047-30: Cases contains 30 unit-dose cups of 15 mL NDC# 66689-047-50: Cases contains 50 unit-dose cups of 15 mL NDC# 66689-047-80: Cases contains 80 unit-dose cups of 15 mL NDC# 66689-047-99: Cases contains 100 unit-dose cups of 15 mL (NDC# 66689-048-01), packaged in trays of 10 unit-dose cups each. NDC# 66689-048-30: Cases contains 30 unit-dose cups of 30 mL NDC# 66689-048-50: Cases contains 50 unit-dose cups of 30 mL NDC# 66689-048-80: Cases contains 80 unit-dose cups of 30 mL NDC# 66689-048-99: Cases contains 100 unit-dose cups of 30 mL 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 and FREEZING. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION
VISTAPHARM, INC.
----------
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 ORAL SOLUTION
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
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 are insufficient. (1)
DOSAGE AND ADMINISTRATION
Dilute prior to administration. (2.1, 5.1)
Monitor serum potassium and adjust dosage accordingly (2.2, 2.3)
_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 to exceed 3
mEq/kg/day (2.3)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 10%; 1.3 mEq potassium per mL (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, CONTACT VISTAPHARM, INC. AT
1-888-655-1505 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potassium sparing diuretics: Avoid concomitant use (7.1)
Renin-angiotensin-aldosterone inhibitors:Monitor for hyperkalemia
(7.2)
Nonste