Nicotears Nicodosis Eye Gel

Mannitol:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Directions for use of pic (plastic irrigation containers)
• Nicotears Nicodosis Eye Gel (Mannitol) reviews

INDICATIONS AND USAGE

5% Nicotears Nicodosis Eye Gel (Mannitol) is indicated for use as a urologic irrigation fluid for transurethral prostatic resection and other transurethral surgical procedures.

CONTRAINDICATIONS

5% Nicotears Nicodosis Eye Gel (Mannitol) 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 Nicotears Nicodosis Eye Gel (Mannitol) and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.

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 preservative.

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 5% Nicotears Nicodosis Eye Gel 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 5% Nicotears Nicodosis Eye Gel (Mannitol) may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Excessive loss of water and electrolytes may lead to serious imbalances. Continuous administration of 5% Nicotears Nicodosis Eye Gel (Mannitol) may cause loss of water in excess of electrolytes and produce hypernatremia.

Sustained diuresis from transurethral irrigation with 5% Nicotears Nicodosis Eye Gel (Mannitol) 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 5% Nicotears Nicodosis Eye Gel (Mannitol) 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 5% Nicotears Nicodosis Eye Gel Irrigation. It is also not known whether 5% Nicotears Nicodosis Eye Gel (Mannitol) Irrigation can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Nicotears Nicodosis Eye Gel (Mannitol) Irrigation should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 5% Nicotears Nicodosis Eye Gel (Mannitol) Irrigation is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 5% Nicotears Nicodosis Eye Gel (Mannitol) 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 .

ADVERSE REACTIONS

Occasional adverse reactions to intravenous Nicotears Nicodosis Eye Gel (Mannitol) infusions have been reported. These include fluid and electrolyte disturbances, such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of the mouth, thirst and dehydration, cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain, and thrombophlebitis, and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, and urticaria.

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 .

DOSAGE AND ADMINISTRATION

As required for urologic irrigation.

5% Nicotears Nicodosis Eye Gel (Mannitol) 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

5% Nicotears Nicodosis Eye Gel (Mannitol) 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

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 dose container.

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 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.

Figure 1 Figure 2

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y36-002-697

5% Nicotears Nicodosis Eye Gel (Mannitol) Irrigation

For Urologic Irrigation

REF R6515-01

NDC 0264-2303-50

DIN 01963953

2000 mL

Lot

Exp.

Each 100 mL contains:

Nicotears Nicodosis Eye Gel (Mannitol) USP 5 g

Water for Injection USP qs

pH: 5.5 (4.5-7.0)

Calc. Osmolarity: 275 mOsmol/liter

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

In Canada, distributed by:

B. Braun Medical Inc.

Scarborough, Ontario M1H 2W4

Y37-002-334