Potassium Chloride in Lactated Ringers and Dextrose

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown below:

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP have value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP produce a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

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.

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

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.

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) for 20 mEq potassium added and 605 mOsmol/L (calc) for 40 mEq potassium added. 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 hypercalemia, 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.

Pediatric Use

Safety and effectiveness of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.

In newborns, the risk of hyperglycemia due to infusion of dextrose-containing solutions appears to be greater with lower birth weight. In these patients, hyperglycemia and increased serum osmolarity have been associated with an increased risk of intraventricular cerebral hemorrhage.

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.

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

Pregnancy Category C.

Animal reproduction studies have not been conducted with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. It is also not known whether Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP should be given to a pregnant woman only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP. Studies to evaluate the possible impairment of fertility have not been performed.

Labor and Delivery

Studies have not been conducted to evaluate the effects of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted 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.

Post-Marketing Adverse Reactions

The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC).
Immune System Disorders: 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
General Disorders and Administration Site Conditions:
Infusion site reactions, including infusion site pruritus, infusion site erythema, infusion site anesthesia (numbness)

Class Reactions

• Other manifestations of hypersensitivity/infusion reactions: decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, flushing, throat irritation, paresthesias, hypoesthesia oral, dysgeusia, anxiety and headache
• Hyperkalemia
• Hypervolemia
• Other infusion site reactions: infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pain, infusion site burning

Overdose

An excessive volume or too high a rate of administration of Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.

Excessive administration of lactate may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia.

Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.

Excessive administration of calcium salts may lead to hypercalcemia.

Excessive administration of a dextrose-containing solution may lead to hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.

When assessing overdose, any additives in the solution must also be considered.

The effects of overdose may require immediate medical attention and treatment.