Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Post-marketing Adverse Reactions The following adverse reactions associated with the use of 5% Dextrose and Electrolyte No.
48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) were identified in clinical trials or post marketing reports.
Because post marketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure: Hypersensitivity and Infusion Reactions: palpitations, feeling abnormal, piloerection, edema peripheral, hypotension, dyspnea, wheezing, urticaria, cold sweet, tachycardia, chest pain, chest discomfort, respiratory rate increased, flushing, hyperemia, asthenia, pyrexia, chills.
General Disorders and Administration Site Conditions : infusion site pain, burning sensation, febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from site of injection, extravasation and hypervolemia.
Metabolism and nutrition disorders : hyperkalemia, hyperglycemia, hyponatremia.
Nervous System Disorders : hyponatremic encephalopathy.
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.
Overdose Excessive administration of 5% Dextrose and Electrolyte No.
48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause: • fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.
• hyperglycemia, hyperosmolarity, and osmotic diuresis, dehydration and electrolyte loss.
WARNINGS Hypersensitivity Reactions Hypersensitivity and infusion reactions have been reported with 5% Dextrose and Electrolyte No.
48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP).
See ADVERSE REACTIONS .
Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing.
Institute appropriate therapeutic countermeasures as clinically indicated.
Like all medications, Dextrose And Electrolyte No. 48 can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: