POTASSIUM CHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals,Inc.

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. The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chl

Product summary:

Potassium chloride is a clear, orange colored solution with an orange flavor, available in two strengths as follows: 10%: 20 mEq/15 mL oral solution NDC# 43386-168-01 Bottle of 473 mL 20%: 40 mEq/15 mL oral solution NDC# 43386-169-01- Bottle of 473 mL Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT from LIGHT AND FREEZING. Rx only Manufactured by: Novel Laboratories, Inc. Somerset, NJ. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP code: 266002 Rev: 07/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION
LUPIN PHARMACEUTICALS,INC.
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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
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 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 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 Lupin Pharmaceuticals,
Inc. at 1-866-403-7592 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch. (6)
DRUG INTERACTIONS
Potassium sparing diuretics: Avoid concomitant use ( 7.1)
Reni-angiotensin-al