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:

ATLANTIC BIOLOGICALS CORP.

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 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 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. The safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to18 years. Clinical studies of Potassium Chloride did not include s

Product summary:

Potassium Chloride Oral Solution, is an orange solution available in two strengths as follows: 10%: 20 mEq/15 mL oral solution NDC# 17856-1543-1 Unit Dose Cup 15mL 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.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION
ATLANTIC BIOLOGICALS CORP.
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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.
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 20 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 PHARM-OLAM AT
1-866-511-6754 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Potassium sparing diuretics: Avoid concomitant use (7.1)
Angiotensin converting e