POTASSIUM CHLORIDE solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Belcher Pharmaceuticals LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Potassium chloride oral solution 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 supp

उत्पाद समीक्षा:

Potassium Chloride Oral Solution USP, is a clear, orange solution available in two strengths as follows: 10%: 20 mEq/15 mL oral solution  NDC# 62250-713-35 Bottle of 473 mL 20%: 40 mEq/15 mL oral solution NDC# 62250-714-35 Bottle of 473 mL Storage Store at 25ºC (77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT from LIGHT and FREEZING.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION
BELCHER PHARMACEUTICALS LLC
----------
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 oral solution 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 to 100 mEq/day in 2 to 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 to 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 BELCHER PHARMACEUTICALS
AT (727) 471-
0850 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potassium Sparing Diuretics: Avoid