NDC 0264-2301 Sorbitol

Sorbitol

NDC Product Code 0264-2301

NDC 0264-2301-50

Package Description: 8 CONTAINER in 1 CASE > 2000 mL in 1 CONTAINER

NDC 0264-2301-70

Package Description: 4 CONTAINER in 1 CASE > 4000 mL in 1 CONTAINER

NDC Product Information

Sorbitol with NDC 0264-2301 is a a human prescription drug product labeled by B. Braun Medical Inc.. The generic name of Sorbitol is sorbitol. The product's dosage form is irrigant and is administered via irrigation form.

Labeler Name: B. Braun Medical Inc.

Dosage Form: Irrigant - A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sorbitol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SORBITOL 3.3 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Irrigation - Administration to bathe or flush open wounds or body cavities.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: B. Braun Medical Inc.
Labeler Code: 0264
FDA Application Number: NDA016741 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-16-1978 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Sorbitol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Each 100 mL contains:Sorbitol (from Sorbitol Solution USP) 3.3 g Water for Injection USP qspH: 5.3 (5.0–7.0)Calculated Osmolarity: 185 mOsmol/liter, hypotonicThe formula of the active ingredient is:IngredientMolecular FormulaMolecular WeightSorbitol182.17Sorbitol 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.

Indications And Usage

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

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.

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 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.

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.

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.NDCCat. No.Size3.3% Sorbitol Irrigation0264-2301-50R6015-012000 mL0264-2301-70R60174000 mL

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 USAY36-002-700

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