POTASSIUM CHLORIDE FOR ORAL SOLUTION powder, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Dostupné s:

Belcher Pharmaceuticals LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. Pregnancy Category C Animal reproduction studies have not been conducted with potassium chloride. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity. The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition f

Přehled produktů:

Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as follows: 20 mEq NDC# 62250-690-34 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 62250-690-32 carton of 30 pouches NDC# 62250-690-33 carton of 100 pouches 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. Rx only Manufactured by: Belcher Pharmaceuticals LLC Largo, FL 33777 USA Revised December 2018 L67I D-1812

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

POTASSIUM CHLORIDE FOR ORAL SOLUTION- POTASSIUM CHLORIDE FOR ORAL
SOLUTION POWDER, FOR SOLUTION
BELCHER PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE
FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR POTASSIUM
CHLORIDE FOR ORAL SOLUTION.
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 to 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