POTASSIUM CHLORIDE solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Fáanlegur frá:

Dr. Reddy’s Laboratories, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Potassium Chloride Oral Solution, 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 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 s

Vörulýsing:

Potassium Chloride Oral Solution, USP is a clear orange solution available in two strengths as follows: 10%: 20 mEq/15 mL oral solution NDC# 43598-891-16 of Unit Dose cup of 15 mL NDC# 43598-891-52 Each Case contains 50 unit dose cups of 15 mL, packaged in 5 trays, each tray containing 10 unit dose cups NDC# 43598-891-10 Each Case contains 100 unit dose cups of 15 mL, packaged in 10 trays, each tray containing 10 unit dose cups 20%: 40 mEq/30 mL oral solution NDC# 43598-160-31: Unit Dose Cup of 30 mL NDC# 43598-160-53: Each Case contains 50 unit dose cups of 30 mL in 35 mL cup, packaged in 5 trays, each tray containing 10 unit dose cups NDC# 43598-160-01: Each Case contains 100 unit dose cups of 30 mL in 35 mL cup, packaged in 10 trays, each tray containing 10 unit dose cups 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. Rx only Manufactured by: WES Pharma Inc. Westminster, MD 21157 USA Manufactured for: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Revision 05/2022

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION
DR. REDDY’S LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR POTASSIUM
CHLORIDE ORAL SOLUTIONPOTASSIUM CHLORIDE ORAL SOLUTION
INITIAL U.S. APPROVAL: 1948
INDICATIONS AND USAGE
Potassium Chloride Oral Solution, 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 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)
Oral Solution: 20%; 2.6 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 WES PHARMA INC AT
1-888-514-4727 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potassium sparing diure