Data from FDA - Curated by EPG Health - Last updated 09 February 2018

Indication(s)

INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP are indicated as a source of water, electrolytes, and calories or as alkalinizing agents.

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Advisory information

contraindications
CONTRAINDICATIONS As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream). In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP, through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is contraindicated in patients with a known hypersensitivity to sodium lactate. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is contraindicated in patients with hyperkalemia.
Special warnings and precautions
PRECAUTIONS General Precautions Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Lactate is a substrate for gluconeogenesis. Administration of solutions containing dextrose and lactate should be used with caution in patients with impaired glucose tolerance and diabetes mellitus, as it may result in hyperglycemia. Hyperglycemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery after acute ischemic strokes. Caution is recommended in using dextrose-containing solutions in such patients. Early hyperglycemia has been associated with poor outcomes in patients with severe traumatic brain injury. Dextrose-containing solutions should, therefore, be used with caution in patients with head injury, in particular during the first 24 hours following the trauma. If hyperglycemia occurs, the rate of dextrose administration should be reduced and/or insulin administered, or the insulin dose adjusted. For risk of hyper- and hypoglycemia in newborns, see Pediatric Use. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be administered with particular caution, if at all, to patients with conditions associated with increased lactate levels or impaired lactate utilization, such as severe hepatic insufficiency. Hyperlactatemia (i.e., high lactate levels) can develop in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. In addition Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may not produce its alkalinizing action in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. The osmolarity of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is 565 mOsmol/L (calc). Administration of substantially hypertonic solutions may cause venous irritation, including phlebitis. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states. Solutions containing calcium salts should be used with caution in patients with hypercalcemia or conditions predisposing to hypercalcemia, such as patients with severe renal impairment and granulomatous diseases associated with increased calcitriol synthesis such as sarcoidosis, calcium renal calculi or history of such calculi. Drug Interactions Ceftriaxone – see CONTRAINDICATIONS Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may interfere with the elimination of such drugs. - Renal clearance of acidic drugs such as salicylates and barbiturates may be increased. - Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased. Renal clearance of lithium may also be increased. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with lithium. Because of its potassium content, administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be avoided in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia. Pregnancy There are no adequate, well-controlled studies with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus. Labor and Delivery Intrapartum maternal intravenous infusion of glucose-containing solutions may produce maternal hyperglycemia with subsequent fetal hyperglycemia and fetal metabolic acidosis as well as rebound hypoglycemia in the neonate. Fetal hyperglycemia can result in increased fetal insulin levels which may result in neonatal hypoglycemia following delivery. Consider the potential risks and benefits for each specific patient before administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. Nursing Mothers It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is administered to a nursing mother. Pediatric Use The use of Lactated Ringer’s and 5% Dextrose Injection, USP in pediatric patients is based on clinical practice (see DOSAGE AND ADMINISTRATION). Newborns – especially those born premature and with low birth weight – are at risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infections, retinopathy of prematurity, necrotizing entercolitis, bronchopulmary dysplasia, prolonged length of hospital stay, and death. Lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age. Geriatric Use Clinical studies of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse reactions
ADVERSE REACTIONS Post-Marketing Adverse Reactions The following adverse reactions have been reported in the post-marketing experience during the use of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP: Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, nausea and pyrexia Also reported are: infusion site reactions, including infusion site pruritus, infusion site erythema, infusion site anesthesia (numbness) Other adverse reactions reported with Lactated Ringer’s without Dextrose and Sodium Lactate Injection are: - decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, flushing, throat irritation, paresthesia, hypoesthesia oral, dysgeusia, anxiety and headache, hyperkalemia, hypervolemia and other infusion site reactions, such as infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pain, infusion site burning.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION As directed by a physician. Dosage, rate, and duration of administration are to be individualized and dependent upon the indication for use, the patient’s age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations. All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment. After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion. The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy. See PRECAUTIONS, Pediatric Use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible. Do not administer unless the solution is clear and the seal is intact. When introducing additives to Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives. Additives may be incompatible with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is appropriate. After addition, check for possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is present in human milk. Because many drugs are present in human milk, caution should be exercised when Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is administered to a nursing mother.

Interactions

Drug Interactions Ceftriaxone – see CONTRAINDICATIONS Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may interfere with the elimination of such drugs. - Renal clearance of acidic drugs such as salicylates and barbiturates may be increased. - Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased. Renal clearance of lithium may also be increased. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with lithium. Because of its potassium content, administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be avoided in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency. Caution is advised when administering Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

More information

Category Value
Authorisation number NDA019367
Agency product number TU7HW0W0QT
Orphan designation No
Product NDC 0338-0811
Date Last Revised 06-12-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Baxter Healthcare Corporation