Sorbitol

B. Braun Medical Inc.

3.3% Sorbitol Irrigation

FULL PRESCRIBING INFORMATION: CONTENTS*

• SORBITOL DESCRIPTION
• CLINICAL PHARMACOLOGY
• SORBITOL INDICATIONS AND USAGE
• SORBITOL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• SORBITOL ADVERSE REACTIONS
• OVERDOSAGE
• SORBITOL DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Directions For Use of PIC™ (Plastic Irrigation Containers)
• PRINCIPAL DISPLAY PANEL - 2000 mL Label
• PRINCIPAL DISPLAY PANEL - 4000 mL Label

FULL PRESCRIBING INFORMATION

Nonelectrolyte Irrigating Fluid for Urologic Irrigation Only.
Not for Injection.

SORBITOL DESCRIPTION

Each 100 mL contains:
Sorbitol (from Sorbitol Solution USP) 3.3 g
Water for Injection USP qs

pH: 5.3 (5.0–7.0)
Calculated Osmolarity: 185 mOsmol/liter, hypotonic

The formula of the active ingredient is:

Ingredient	Molecular Formula	Molecular Weight
Sorbitol		182.17

Sorbitol is chemically designated D-glucitol (C₆H₁₄O₆).

Sorbitol, an isomer of mannitol, is a hexitol naturally occurring in many fruits, and is produced commercially by the reduction of glucose.

3.3% Sorbitol Irrigation is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. The solution is slightly hypotonic.

The solution contains no antimicrobial or bacteriostatic agents or added buffers.

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The PIC Container is PVC-free and DEHP-free.

CLINICAL PHARMACOLOGY

In humans, sorbitol is nontoxic and rapidly metabolized. Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose.

When sorbitol is absorbed intravascularly in amounts which depend primarily on the extent of the surgery, it produces osmotic diuresis.

As a 3.3% solution, sorbitol is recommended for irrigation of the urinary bladder and prostatic bed during transurethral prostatectomy. Unlike dextrose solutions, sorbitol solutions are not sticky, and if administered in the above dilution, are not hemolytic.

Sorbitol is nonelectrolytic and is therefore nonconductive making it suitable for urologic irrigation during electrosurgical procedures.

SORBITOL INDICATIONS AND USAGE

3.3% Sorbitol Irrigation is indicated for use as a urologic irrigation fluid.

SORBITOL CONTRAINDICATIONS

3.3% Sorbitol Irrigation is not for injection. It is contraindicated in patients with anuria.

WARNINGS

FOR UROLOGIC IRRIGATION ONLY. NOT FOR INJECTION.

Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction.

Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.

Absorption of large amounts of fluids containing sorbitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.

Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus.

Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients.

3.3% Sorbitol Irrigation must be used with caution in patients unable to metabolize sorbitol rapidly enough to avoid the development of hyperosmolar states.

Do not warm above 150°F (66°C).

After opening container, its 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.

PRECAUTIONS

General

Use aseptic technique when preparing and administering sterile irrigation solutions.

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

Cardiovascular status, especially in patients with cardiac disease, should be carefully determined before and during transurethral resection of the prostate when using sorbitol irrigation as an irrigant. The fluid absorbed into the systemic circulation via severed prostatic veins may produce significant extracellular fluid expansion and lead to fulminating congestive heart failure.

Shift of sodium-free intracellular fluid into the extracellular compartment following systemic absorption of 3.3% Sorbitol Irrigation may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 3.3% Sorbitol Irrigation may cause loss of water in excess of electrolytes and produce hypernatremia.

Sustained diuresis from transurethral irrigation with 3.3% Sorbitol Irrigation may obscure and intensify inadequate hydration or hypovolemia.

When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 3.3% Sorbitol Irrigation have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 3.3% Sorbitol Irrigation. It is also not known whether 3.3% Sorbitol Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

3.3% Sorbitol Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 3.3% Sorbitol Irrigation is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 3.3% Sorbitol Irrigation did not include a sufficient number of patients age 65 years and over to determine whether they 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. See WARNINGS .

SORBITOL ADVERSE REACTIONS

Occasional adverse reactions may occur which include slight increases in postoperative serum glucose, inhibition of intestinal absorption of vitamin B₁₂, fluid and electrolyte disturbances, such as acidosis, electrolyte loss, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia and angina-like pains. In addition, patients unable to metabolize sorbitol rapidly enough may develop hyperosmolar states.

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 dehydration or fluid or solute overload, discontinue the irrigant, evaluate the patient and institute appropriate corrective treatment. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS .

SORBITOL DOSAGE AND ADMINISTRATION

As required for urologic irrigation.

3.3% Sorbitol Irrigation should be administered only by the appropriate transurethraI urologic instrumentation.

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

3.3% Sorbitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case.

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: March 2009

PIC is a trademark of B. Braun Medical Inc.

Directions For Use of PIC™ (Plastic Irrigation Containers)

Not for injection.

Aseptic technique is required.

• 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 dose 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.

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

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

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y36-002-700

PRINCIPAL DISPLAY PANEL - 2000 mL Label

3.3% Sorbitol Irrigation

For Urologic Irrigation Only

REF R6015-01

NDC 0264-2301-50

2000 mL

Lot

Exp.

Each 100 mL contains: Sorbitol
(from Sorbitol Solution USP) 3.3 g
Water for Injection USP qs

pH: 5.3 (5.0–7.0)
Calc. Osmolarity: 185 mOsmol/liter,
hypotonic

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

Sterile, nonpyrogenic.
Single dose container.

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
PVC-free and DEHP-free

B|BRAUN

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y37-002-323

PRINCIPAL DISPLAY PANEL - 4000 mL Label

3.3% Sorbitol Irrigation

For Urologic Irrigation Only

REF R6017

NDC 0264-2301-70

4000 mL

Lot

Exp.

Each 100 mL contains: Sorbitol
(from Sorbitol Solution USP) 3.3 g
Water for Injection USP qs

pH: 5.3 (5.0–7.0)
Calc. Osmolarity: 185 mOsmol/liter,
hypotonic

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

Sterile, nonpyrogenic.
Single dose container.

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
PVC-free and DEHP-free

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y37-002-324