Drugplain

Physiolyte .03 g/100mL

Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride · IRRIGANT · B. Braun Medical Inc.

No Recall HistoryCurrently in Shortage
Plain English

Physiolyte is a sterile irrigating solution used to rinse or flush body tissues and cavities during medical procedures. It contains a balanced blend of electrolytes including sodium, potassium, and magnesium to help maintain proper fluid balance in the area being irrigated.

Key Facts

Brand Name
Physiolyte
Generic Name
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
NDC Code (Product)
0264-2205
Manufacturer
B. Braun Medical Inc.
Strength
.03 g/100mL
Dosage Form
IRRIGANT
Route
IRRIGATION
Marketing Status
Application #
NDA019024
Marketing Start
06/08/1984

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Physiolyte™ (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Dosage & Administration

DOSAGE AND ADMINISTRATION As required for irrigation. The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

Warnings

WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations. Do not warm above 150°F (66°C). After opening container, it's contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.

Contraindications

CONTRAINDICATIONS Physiolyte is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Adverse Reactions

ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Frequently Asked Questions

What is Physiolyte used for?

Physiolyte is a sterile irrigating solution used to rinse or flush body tissues and cavities during medical procedures. It contains a balanced blend of electrolytes including sodium, potassium, and magnesium to help maintain proper fluid balance in the area being irrigated.

Is Physiolyte a controlled substance?

Physiolyte is not classified as a controlled substance by the DEA.

What is the generic name for Physiolyte?

The generic name for Physiolyte is Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride. There are 1 other brand versions of Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride.

What is the NDC code for Physiolyte .03 g/100mL?

The NDC (National Drug Code) for Physiolyte .03 g/100mL is 0264-2205, listed by B. Braun Medical Inc..

Product NDC

0264-2205

Package NDC

0264-2205-00

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)