Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152, Chloride Ion - UNII:Q32ZN48698)
ATLANTIC BIOLOGICALS CORP.
Potassium Chloride
Potassium Chloride 20 meq in 15 mL
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE SOLUTION ATLANTIC BIOLOGICALS CORP. ---------- 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 Lesen Sie das vollständige Dokument