Physiolyte (Page 2 of 2)

Nursing Mothers

Caution should be exercised when Physiolyte is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Physiolyte in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use

Clinical studies of Physiolyte™ (A Physiological Irrigating Solution) have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Use in Patients with Renal Insufficiency/Failure

Clinical studies of Physiolyte™ (A Physiological Irrigation Solution) have not been performed to determine whether patients with renal failure respond differently from those with normal renal function. Given the potential for systemic absorption, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Increased caution should be exercised when administering Physiolyte to patients with impaired fluid and electrolyte homeostasis.

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.

OVERDOSAGE

In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

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.

HOW SUPPLIED

Physiolyte™ (A Physiological Irrigating Solution) is supplied sterile and nonpyrogenic in 1000 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case.

NDC REF Size
Physiolyte™ (A Physiological Irrigating Solution)
0264-2205-00 R5510-01 1000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Rx only

Revised: October 2015
Isolyte is a registered trademark and Physiolyte and PIC are trademarks of
B. Braun Medical Inc.

Directions For Use of PIC Containers

Not for injection.

Aseptic technique is required.

1. Caution – Before use, perform the following checks:

(a) Read the label. Ensure solution is the one ordered and is within the expiration date.
(b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate
matter; check the container for leakage or damage. Any container which is suspect should
not be used.

Use only if solution is clear and container and seal are intact.

Single unit container. Discard unused portion.

2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway
ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the
container in the opposite direction, turn the breakaway ring sharply until the entire outer
cap is loose and can be lifted off.

Figure 1

3. Connect the administration set through the sterile set port according to set instructions or remove
screw cap and pour.

Figure 2

4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-002-907 LD-515-1

PRINCIPAL DISPLAY PANEL — 1000 mL Container Label

Physiolyte™ (A Physiological Irrigating Solution)
Isotonic Solution for Irrigation

REF R5510-01
NDC 0264-2205-00

1000 mL
PIC™ Container

Lot
Exp.

Each 100 mL contains:
Sodium Chloride USP 0.53 g; Sodium
Gluconate USP 0.5 g; Sodium
Acetate•3H2 O USP 0.37 g; Potassium
Chloride USP 0.037 g; Magnesium
Chloride•6H2 O USP 0.03g; Water for
Injection USP qs
Glacial Acetic Acid USP to adjust pH
pH: 6.8 (6.3-7.3)
Calc. Osmolarity: 295 mOsmol/liter
Electrolytes (mEq/liter):
Na+ 140 K+ 5 Mg+ + 3
CI 98 Acetate 27 Gluconate 23

Sterile, nonpyrogenic. Single unit
container.

Not for injection. Use only if
solution is clear and container and
seal are intact.

Warning: Do not warm above
150°F (66°C).

Recommended Storage: Room
temperature (25°C). Avoid
excessive heat. Protect from
freezing. See Package Insert.

Rx only

Not made with natural rubber latex, PVC or DEHP.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Physiolyte and PIC
are trademarks of B. Braun Medical Inc.

Y37-002-508

LD-519-1

1000 mL Container Label R5510-01
(click image for full-size original)
PHYSIOLYTE sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-2205
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 0.53 g in 100 mL
SODIUM GLUCONATE (SODIUM CATION and GLUCONIC ACID) SODIUM GLUCONATE 0.5 g in 100 mL
SODIUM ACETATE (SODIUM CATION and ACETATE ION) SODIUM ACETATE 0.37 g in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.037 g in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.03 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ACETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0264-2205-00 16 CONTAINER in 1 CASE contains a CONTAINER
1 1000 mL in 1 CONTAINER This package is contained within the CASE (0264-2205-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019024 06/08/1984
Labeler — B. Braun Medical Inc. (002397347)

Revised: 11/2019 B. Braun Medical Inc.

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