Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride

Description

DESCRIPTION Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6

What Is Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride Used For?

INDICATIONS AND USAGE These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.

Dosage and Administration

DOSAGE AND ADMINISTRATION These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24- hour dose should not generally exceed 200 mEq of potassium. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Reactions which may occur because of the solutions or technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

Contraindications

CONTRAINDICATIONS Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.

Pregnancy and Breastfeeding

Pregnancy Animal reproduction studies have not been conducted with dextrose, potassium chloride or sodium chloride. It is also not known whether dextrose, potassium chloride or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose, potassium chloride or sodium chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Caution should be exercised when solutions from flexible plastic containers are administered to a nursing mother.

Overdosage

OVERDOSAGE In the event of potassium overdosage, discontinue the infusion immediately and institute intensive corrective therapy to reduce serum potassium levels. See WARNINGS and PRECAUTIONS .

How Supplied

HOW SUPPLIED Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Product Code Unit of Use Strength Unit of Sale 219118 NDC 65219-118-01 One 1000 mL free flex ® bag 20 mEq Potassium Chloride NDC 65219-118-10 Package of 10 free flex ® bags 219119 NDC 65219-119-01 One 1000 mL free flex ® bag 40 mEq Potassium Chloride NDC 65219-119-10 Package of 10 free flex ® bags Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.