Drug Catalog - Product Detail
POTASSIUM CHLORIDE IV SOL 2MEQ/ML 20ML X 25
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 63323-0965-20 | FRESENIUS KABI USA | 20 | 2MEQ/ML | SOLUTION |
PACKAGE FILES
Generic Name
POTASSIUM CHLORIDE
Substance Name
POTASSIUM CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
ANDA088901
Description
Description Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K + and Cl – equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K + and Cl – equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.
How Supplied
How Supplied The following are packaged in plastic vials. These are Single Dose Vials, no preservative added, packaged 25 vials per tray. Unused portion of vial should be discarded. This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear, seal intact and undamaged. Vial stoppers do not contain natural rubber latex. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 63323-965-05 Unit of 25 NDC 0404-9936-10 1 5 mL in a 10 mL Single Dose Vial in a bag (Vial bears NDC 63323-965-01) 10 mEq (0.39 g) 149 mg per mL NDC 63323-965-20 Unit of 25 NDC 0404-9936-20 1 20 mL Single Dose Vial in a bag (Vial bears NDC 63323-965-02) 40 mEq (1.56 g) 149 mg per mL Image2.jpg Image3.jpg
Indications & Usage
Indications and Usage Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
Dosage and Administration
Dosage and Administration Potassium Chloride for Injection Concentrate must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft of bag type containers are used. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/L, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/L. The 24 hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2mEq/L and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as a dextrose may lower serum potassium levels. Prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.