Sodium Chloride Injection

0.9% Sodium Chloride 0.9% Injection, USP Single Dose vial

Description

This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in singledose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0).

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Clinical Pharmacology

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl#) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.

The distribution and excretion of sodium (Na+) and chloride (Cl#) are largely under the control of the kidney which maintains a balance between intake and output.

The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Precautions

Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

Pregnancy Category C.

Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.

Pediatric Use:

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Drug Interactions

Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

Use aseptic technique for single or multiple entry and withdrawal from all containers.

When diluting or dissolving drugs, mix thoroughly and use promptly.

Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.

Adverse Reactions

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.


If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Overdosage

Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.

Dosage and Administration

The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied

0.9% Sodium Chloride Injection, USP is supplied in the following:

NDC No.	Container	Size
0409-4888-10	Fliptop Plastic Vial	10 mL
0409-4888-20	Fliptop Plastic Vial	20 mL
0409-4888-50	Fliptop Plastic Vial	50 mL
Intended for use with the LifeShield blunt cannula:
0409-4888-12	LifeShield Fliptop Plastic Vial	10 mL

Store at controlled room temperature 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.]


Revised: November, 2009


EN-2319


Printed in USA


HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Sample Outer Label

SODIUM CHLORIDE  sodium chloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-888 (0409-4888) Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (Sodium Cation) Sodium Chloride 9 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52584-888-10 1 VIAL In 1 BAG contains a VIAL, SINGLE-DOSE 1 10 mL In 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-888-10) 2 52584-888-20 1 VIAL In 1 BAG contains a VIAL, SINGLE-DOSE 2 20 mL In 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-888-20) 3 52584-888-50 1 VIAL In 1 BAG contains a VIAL, SINGLE-DOSE 3 50 mL In 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-888-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018803	08/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 02/2012General Injectables & Vaccines, Inc

Sodium Chloride

Pronunciation: SO-dee-um KLOR-ride
Generic Name: Sodium Chloride
Brand Name: Generic only. No brands available.

Sodium Chloride is used for:

Preventing or treating sodium loss due to excessive sweating or dehydration. It may also be used for other conditions as determined by your doctor.

Sodium Chloride is an electrolyte supplement. It works by supplying a source of sodium for the body.

Do NOT use Sodium Chloride if:

• you are allergic to any ingredient in Sodium Chloride


• you have high blood sodium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sodium Chloride:

Some medical conditions may interact with Sodium Chloride. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are on a low-sodium diet


• if you have congestive heart failure, high blood pressure, decreased kidney function, liver problems (eg, cirrhosis), fluid buildup in the lungs or legs, or a certain pregnancy complication (preeclampsia)

Some MEDICINES MAY INTERACT with Sodium Chloride. However, no specific interactions with Sodium Chloride are known at this time.

Ask your health care provider if Sodium Chloride may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sodium Chloride:

Use Sodium Chloride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sodium Chloride by mouth with or without food.


• Take Sodium Chloride with a full glass of water (8 oz/240 mL).


• Sodium Chloride may be dissolved in water to make a solution for drinking. Ask your doctor for proper mixing instructions.


• If you miss a dose of Sodium Chloride, take it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Sodium Chloride.

Important safety information:

• Misuse of Sodium Chloride may be harmful. Be sure you know how to properly use Sodium Chloride. Talk with your doctor or pharmacist if you have any questions.


• In a hot environment it is necessary to have adequate hydration and balanced electrolyte replacement.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Lab tests, including electrolyte levels, may be performed while you use Sodium Chloride. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Sodium Chloride should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sodium Chloride while you are pregnant. It is not known if Sodium Chloride is found in breast milk. If you are or will be breast-feeding while you use Sodium Chloride, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sodium Chloride:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Sodium Chloride. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nausea; stomach pain; swelling in the hands, ankles, feet, or legs; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; fast or irregular heartbeat; irritability; nausea; restlessness; seizures; shortness of breath; slow or irregular breathing; stomach cramps; swelling in the hands, ankles, feet, or legs; vomiting; weakness.

Proper storage of Sodium Chloride:

Store Sodium Chloride at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Chloride out of the reach of children and away from pets.

General information:

• If you have any questions about Sodium Chloride, please talk with your doctor, pharmacist, or other health care provider.


• Sodium Chloride is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sodium Chloride. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Sodium Chloride Irrigation Hospira

0.45% SODIUM CHLORIDE IRRIGATION, USP

0.9% SODIUM CHLORIDE IRRIGATION, USP

For All General Irrigation, Washing, Rinsing and Dilution Purposes

Not For Injection By Usual Parenteral Routes

Flexible Irrigation Container

Semi-rigid Irrigation Container

Rx only

Sodium Chloride Irrigation Hospira Description

These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes.

Each 100 mL of 0.45% Sodium Chloride Irrigation, USP contains: Sodium chloride 450 mg; pH 5.6 (4.5 to 7.0). The solution is hypotonic (154 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 77; Cl− 77.

Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154.

These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Sodium Chloride Irrigation Hospira - Clinical Pharmacology

Each of these irrigation solutions exert a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. Each also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.45% Sodium Chloride Irrigation, USP provides a hypotonic half-strength saline irrigation identical in composition with 0.45% Sodium Chloride Injection, USP.

0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline).

0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs; 0.45% Sodium Chloride Irrigation, USP may be used alone or combined with appropriate additives when 0.9% sodium chloride is considered too irritating for wounds or other altered structures.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Sodium Chloride Irrigation Hospira

Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Entry of a hypotonic solution into the circulation may cause hemolysis.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Do not heat container over 66°C (150°F).

Precautions

Do not use for irrigation that may result in absorption into the blood.

Caution should be observed when a hypotonic solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload.

Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.

When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via 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.

Do not administer unless solution is clear, seal is intact and container is undamaged.

Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers:

Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman.

Pregnancy:

Teratogenic Effects.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Safety and effectiveness of Sodium Chloride irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride irrigation solution in the pediatric population is referenced in the medical literature. The Warnings, Precautions, and Adverse Reactions identified in the label should be observed in the pediatric population.

Geriatric Use:

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.

This drug is known to be substantially secreted 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.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable 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.

Should any adverse reaction occur, discontinue 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, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Sodium Chloride Irrigation Hospira Dosage and Administration

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 diluent or vehicle for other drugs, the manufacturer’s recommendations should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

How is Sodium Chloride Irrigation Hospira Supplied

0.45% Sodium Chloride Irrigation, USP:

Container Size	NDC
Single-dose 2000 mL flexible irrigation container	0409-7975-07

0.9% Sodium Chloride Irrigation, USP:

Container Size	NDC
Single-dose 500 mL semi-rigid irrigation container	0409-6138-03
Single-dose 250 mL semi-rigid irrigation container	0409-6138-22
Single-dose 1000 mL semi-rigid irrigation container	0409-7138-09
Single-dose 1500 mL semi-rigid irrigation container	0409-7138-36
Single-dose 1000 mL flexible irrigation container	0409-7972-05
Single-dose 2000 mL flexible irrigation container	0409-7972-07

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: May, 2009

Printed in USA	EN-2130
Hospira, Inc., Lake Forest, IL 60045 USA

IM-0687

IM-1153

RL-2095

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7972 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 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7972-05 12 BAG In 1 CASE contains a BAG 1 1000 mL In 1 BAG This package is contained within the CASE (0409-7972-05) 2 0409-7972-07 6 BAG In 1 CASE contains a BAG 2 2000 mL In 1 BAG This package is contained within the CASE (0409-7972-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA018314	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7975 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 450 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7975-07 6 BAG In 1 CASE contains a BAG 1 2000 mL In 1 BAG This package is contained within the CASE (0409-7975-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA018380	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7138 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 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7138-09 12 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 1000 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-7138-09) 2 0409-7138-36 9 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 2 1500 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-7138-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017514	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6138 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 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6138-22 24 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 250 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-6138-22) 2 0409-6138-03 24 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 2 500 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-6138-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017514	05/17/2010

Labeler - Hospira, Inc. (141588017)

Revised: 05/2011Hospira, Inc.

sodium iodide i 131

SOE-dee-um EYE-oh-dide I 131

Commonly used brand name(s)

In the U.S.

• Iodotope

Available Dosage Forms:

• Capsule


• Kit


• Solution

Therapeutic Class: Diagnostic Agent, Thyroid Function

Uses For sodium iodide i 131

Sodium iodide I 131, also called radioactive iodine or radioiodide, is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to diagnose some diseases by studying the function of the body's organs or to treat certain diseases.

Sodium iodide I 131 is used to treat an overactive thyroid gland and certain kinds of thyroid cancer. It is taken up mainly by the thyroid gland. In the treatment of hyperactive thyroid gland, radiation from the radioactive iodine damages the thyroid gland to bring its activity back down to normal. Larger doses of radioiodide are usually used after thyroid cancer surgery to destroy any remaining diseased thyroid tissue or to destroy thyroid cancer that has spread to other tissues.

When very small doses are given, a measure of the radioactivity taken up by the gland helps your doctor decide whether your thyroid gland is working properly. Also, an image of the organ on paper or a computer printout can be provided.

The information that follows applies only to the use of sodium iodide I 131 in treating an overactive or cancerous thyroid gland .

Sodium iodide I 131 is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology.

Before Using sodium iodide i 131

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sodium iodide i 131, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sodium iodide i 131 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Sodium iodide I 131 has been used in children and has not been shown to cause different side effects or problems than it does in adults. However, vomiting may be more difficult to manage in younger children.

Geriatric

Sodium iodide I 131 has been used in older people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sodium iodide i 131. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or


• Vomiting—The radioactive iodine will be present in the diarrhea and vomit and will put you and others at a higher risk of radiation contamination; also, some of the dose will be lost, making the treatment less effective

• Kidney disease—Kidney disease may cause the radioiodide to stay in the body longer than usual, which may increase the risk of side effects

• If you have heart disease and are receiving sodium iodide I 131 to treat an overactive thyroid—The radiation may worsen the thyroid condition if antithyroid medicine and/or beta-blockers, such as propranolol, are not given before and after treatment

Proper Use of sodium iodide i 131

Your doctor may have special instructions for you to get ready for your treatment. If you have not received such instructions or you do not understand them, check with your doctor ahead of time.

If you eat large amounts of iodine-containing foods, such as iodized salt and seafoods, or cabbage, kale, rape (turnip-like vegetable), or turnips, the iodine contained in these foods will reduce the amount of this radiopharmaceutical that your thyroid gland will accept. Avoid these foods for at least 2 to 4 weeks before the treatment with radioiodide.

Dosing

The dose of sodium iodide i 131 will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sodium iodide i 131. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using sodium iodide i 131

There are no special precautions when sodium iodide i 131 is used in very small doses to help study the function of the thyroid. However, if you are receiving sodium iodide I 131 for an overactive thyroid or cancer of the thyroid, your doctor may tell you to follow some or all of these guidelines for 48 to 96 hours after receiving the medicine, to help reduce the chance of contaminating other persons:

• Do not kiss anyone, or handle or use another person's eating or drinking utensils, toothbrush, or bathroom glass.


• Do not have sex.


• Do not sit close to others, especially pregnant women, and do not hold children in your lap for long periods of time.


• Sleep alone.


• Wash the tub and sink after each use (including after brushing teeth).


• Wash your hands after using or cleaning the toilet .


• Use a separate towel and washcloth.


• Wash your clothes, bed linens, and eating utensils separately.


• Sodium iodide I 131 is passed in the urine. To prevent contamination of your home, flush the toilet twice after you urinate .

To increase the flow of urine and lessen the amount of radioactive iodine in your body, drink plenty of liquids and urinate often.

If you were treated with sodium iodide I 131 for an overactive thyroid, your doctor may want to check the level of thyroid hormone in your blood every 2 to 3 months during the first year, and once a year thereafter. This is to make sure that your thyroid has not become underactive.

sodium iodide i 131 Side Effects

Studies have not shown that sodium iodide I 131 increases the chance of cancer or other long-term problems. When used to treat an overactive thyroid gland, sodium iodide I 131 may cause the patient to have an underactive thyroid gland after treatment. The thyroid gland may become underactive even several years after treatment for hyperthyroidism. Before receiving sodium iodide i 131, be sure you have discussed its use with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

After treatment of overactive thyroidSymptoms of an underactive thyroid

• Changes in menstrual periods


• clumsiness


• coldness


• drowsiness


• dry, puffy skin


• headache


• listlessness


• muscle aches


• thinning of hair (temporary)—may occur 2 to 3 months after treatment


• unusual tiredness or weakness


• weight gain

RareAfter treatment of overactive thyroid

• Excessive sweating


• fast heartbeat


• fever


• palpitations


• unusual irritability


• unusual tiredness

After treatment of cancer of the thyroid

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less commonAfter treatment of overactive thyroid or cancer of the thyroid

• Neck tenderness or swelling


• sore throat

After treatment of cancer of the thyroid

• Loss of taste (temporary)


• nausea and vomiting (temporary)


• tenderness of salivary glands

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More sodium iodide i 131 resources

• Sodium iodide i 131 Use in Pregnancy & Breastfeeding
• Sodium iodide i 131 Drug Interactions
• Sodium iodide i 131 Support Group
• 0 Reviews for Sodium iodide i31 - Add your own review/rating

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• Diagnosis and Investigation
• Hyperthyroidism
• Thyroid Cancer

sodium hyaluronate topical

Generic Name: sodium hyaluronate topical (SOE dee um HYE al ure ON ate)

Brand names: Bionect, Gelclair, Hylira, RadiaPlexRx, Xclair, Seprafilm (obsolete)

What is sodium hyaluronate topical?

Sodium hyaluronate is similar to the fluid that surrounds your joints. Sodium hyaluronate acts as a lubricant on the skin by restoring moisture and preventing friction or abrasion.

Sodium hyaluronate is used to treat skin ulcers such as bed sores or diabetic foot ulcers, as well as burn wounds, surgical incisions, cuts, abrasions, and other skin irritations.

Sodium hyaluronate topical is also used to treat dry or scaly skin.

Sodium hyaluronate oral gel is used to treat mouth sores or other irritation caused by infection, chemotherapy or radiation treatments, or dental work.

Sodium hyaluronate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about sodium hyaluronate topical?

You should not use this medication if you are allergic to sodium hyaluronate. Clean and disinfect the skin area before applying sodium hyaluronate topical. Avoid using a wound disinfectant that contains quarternary ammonium salts. Use only the wound disinfecting method your doctor recommends.

To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying sodium hyaluronate topical. Also do not share the medication with other people.

Avoid getting sodium hyaluronate skin medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water. Only the oral gel form of sodium hyaluronate is safe to use in the mouth. Stop using the medication and call your doctor if your symptoms do not improve or if they get worse, or if you develop any new signs of skin infection such as redness, warmth, swelling, or oozing.

What should I discuss with my health care provider before taking sodium hyaluronate topical?

You should not use this medication if you are allergic to sodium hyaluronate. FDA pregnancy category C. Before using sodium hyaluronate, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sodium hyaluronate topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sodium hyaluronate topical?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

To use this medication on the skin:

• 
  

  Clean and disinfect the skin area before applying sodium hyaluronate topical cream, gel, film, or spray.

  
  


• 
  

  Apply enough of the medication to cover the wound or affected skin area entirely.

  
  


• 
  

  If you use sodium hyaluronate gel or cream on an open skin wound, dab a thin layer of the medicine onto the affected area with as little rubbing as possible.

  
  


• 
  

  To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying sodium hyaluronate topical. Also do not share the medication with other people.

  
  


• 
  

  Cover the treated skin area with a sterile gauze pad or other dressing recommended by your doctor.

  
  


• 
  

  Sodium hyaluronate topical for use on the skin is usually applied 2 or 3 times per day. Follow your doctor's instructions.

  
  

To use the sodium hyaluronate oral gel:

• 
  

  Tear open the gel packet and pour the entire contents into a drinking glass. Add 1 or 2 tablespoons of water and stir this mixture well.

  
  


• 
  

  If you do not have water available while using the oral gel, you may use it undiluted.

  
  


• 
  

  Rinse your mouth thoroughly by swishing and gargling with the mixture in your mouth for at least 1 minute.

  
  


• 
  

  Make sure your gums, teeth, tongue, and insides of your cheeks are well coated with the medicine before spitting it out.

  
  


• 
  

  Avoid eating or drinking anything for at least 1 hour after using the oral gel.

  
  


• 
  

  Sodium hyaluronate oral gel may be used 3 times per day. Follow your doctor's instructions.

  
  

Stop using the medication and call your doctor if your symptoms do not improve or if they get worse while using this medication. Store sodium hyaluronate at room temperature away from moisture and heat. Keep the tube or bottle tightly closed when not in use. Do not tear open an oral gel packet until you are ready to use it.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of sodium hyaluronate applied to the skin or used as a mouth rinse is not likely to cause life-threatening symptoms.

What should I avoid while taking sodium hyaluronate topical?

Avoid getting sodium hyaluronate skin medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water. Only the oral gel form of sodium hyaluronate is safe to use in the mouth.

Avoid using a wound disinfectant that contains quarternary ammonium salts. Use only the wound disinfecting method your doctor recommends.

Sodium hyaluronate topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using the medication and call your doctor if your symptoms do not improve or if they get worse, or if you develop any new signs of skin infection such as redness, warmth, swelling, or oozing.

Sodium hyaluronate oral gel may cause a mild burning sensation in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Sodium hyaluronate topical Dosing Information

Usual Adult Dose for Dermatologic Lesion:

Sodium hyaluronate topical 0.2% cream, gel, spray:
Clean, disinfect and debride area. Apply thin layer to affected area 2 or 3 times daily. Cover with sterile gauze pad and, if needed, a compressive bandage.

Usual Adult Dose for Dermatological Disorders:

Sodium hyaluronate topical 0.2% cream, gel, spray:
Clean, disinfect and debride area. Apply thin layer to affected area 2 or 3 times daily. Cover with sterile gauze pad and, if needed, a compressive bandage.

Usual Adult Dose for Burns - External:

Sodium hyaluronate topical 0.2% cream, gel, spray:
Clean, disinfect and debride area. Apply thin layer to affected area 2 or 3 times daily. Cover with sterile gauze pad and, if needed, a compressive bandage.

Usual Adult Dose for Dermatitis:

Sodium hyaluronate topical 0.1% lotion:
Apply liberal amount topically 2 to 3 times daily to affected area. Rub in thoroughly.

What other drugs will affect sodium hyaluronate topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sodium hyaluronate. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More sodium hyaluronate topical resources

• Sodium hyaluronate topical Use in Pregnancy & Breastfeeding
• Sodium hyaluronate topical Support Group
• 4 Reviews for Sodium hyaluronate - Add your own review/rating

• Bionect Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Gelclair Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Hylira Gel MedFacts Consumer Leaflet (Wolters Kluwer)

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• Burns, External
• Dermatitis
• Dermatologic Lesion
• Dermatological Disorders
• Mucositis

Where can I get more information?

• Your pharmacist can provide more information about sodium hyaluronate topical.

Sodium Sulfacetamide and Sulfur Aqueous Gel

Dosage Form: gel
10% Sodium Sulfacetamide and Sulfur 5% Aqueous Gel (in a Urea vehicle)

Rx only

DESCRIPTION:  Sodium sulfacetamide is a sulfonamide with antibacterial activity.  Sulfur acts as a keratolytic agent.  Chemically, sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each mL of 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an emulsion base containing 10% Urea, propylene glycol, isopropyl myristate, mineral oil, polysorbate 60, sorbitan monostearate, cetyl alcohol, cocoglycerides, stearyl alcohol, benzyl alcohol, glyceryl stearate and PEG 100 stearate, dimethicone, fragrance, disodium EDTA, xanthan gum, zinc pyrithione, sodium thiosulfate, purified water, magnesium aluminum silicate, and methyl paraben.

CLINICAL PHARMACOLOGY:  The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth.  While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.  The biological half-life has variously been reported as 7 to 12.8 hours.  The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS: 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is contraindicated for patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.  10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is not to be used in patients with kidney disease.

WARNINGS: Rarely, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug tor patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Use particular caution on areas of denuded or abraded skin.

FOR EXTERNAL USE ONLY. Keep away from eyes.

Keep out of reach of children. Keep tube tightly closed.

PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted.  Patients should be carefully observed for possible local irritation or sensitization during long-term therapy.  The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening  and scaling of the epidermis.  These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy - Category C. Animal reproduction studies have not been conducted with 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle). It is also not known whether 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) should be given to a pregnant woman only if clearly needed.

Nursing Mothers - It is not known whether sodium sulfacetamide is excreted in human milk following topical use of 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle). However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. For this reason, and because many drugs are excreted in human milk, caution should be exercised when 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle) is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.

ADVERSE REACTIONS: Rarely, sodium sulfacetamide may cause local irritation.

Call your physician for medical advice about side effects.

DOSAGE AND ADMINISTRATION:

10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): Cleanse affected areas. Apply a thin film into affected areas 1 to 3 times daily, or as directed by a physician.

HOW SUPPLIED:

10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): is available in a 1.5 fl. oz (45 g) tube, NDC 42808-0111-45

Store 10% Sodium Sulfacetamide 5% Sulfur Aqueous Gel (in a Urea vehicle): at 15 to 30°C (59 to 86°F).

Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0111-45-205-00

Iss:6/11

PACKAGE LABEL - 1.5 oz (45 g)

For External Use Only

NDC 42808-0111-45        Rx Only

Sodium

Sulfacetamide

& Sulfur

(Sodium Sulfacetamide 10%

& Sulfur 5% in a Urea Vehicle)

10%/5%

AQUEOUS GEL

Exact-Rx.

INCORPORATED

Net Wt. 1.5 oz (45 g)

SODIUM SULFACETAMIDE, SULFUR   sodium sulfacetamide, sulfur  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42808-111 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g SULFUR (SULFUR) SULFUR 50 mg  in 1 g

Inactive Ingredients Ingredient Name Strength UREA   PROPYLENE GLYCOL   ISOPROPYL MYRISTATE   MINERAL OIL   POLYSORBATE 60   SORBITAN MONOSTEARATE   CETYL ALCOHOL   COCO-GLYCERIDES   STEARYL ALCOHOL   BENZYL ALCOHOL   GLYCERYL MONOSTEARATE   POLYOXYL 100 STEARATE   DIMETHICONE   EDETATE DISODIUM   XANTHAN GUM   PYRITHIONE ZINC   SODIUM THIOSULFATE   WATER   MAGNESIUM ALUMINUM SILICATE   METHYLPARABEN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42808-111-45 1 TUBE In 1 CARTON contains a TUBE 1 45 g In 1 TUBE This package is contained within the CARTON (42808-111-45)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2011

Labeler - Exact-Rx, Inc. (137953498)

Revised: 08/2011Exact-Rx, Inc.

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• Sodium Sulfacetamide and Sulfur Aqueous Gel Support Group
• 18 Reviews for Sodium Sulfacetamide and Sulfur Aqueous - Add your own review/rating

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Sodium Polystyrene Sulfonate Oral Powder

Sodium Polystyrene

Sulfonate Suspension, USP

Sorbitol Free

Sodium Polystyrene Sulfonate Oral Powder Description

Sodium Polystyrene Sulfonate Suspension, USP can be administered orally or in an enema. It is a raspberry-flavored suspension containing 15 grams of cation-exchange resin (sodium polystyrene sulfonate, USP); 0.12 mL (0.2%) of alcohol per 60 mL of suspension. Also contains purified water, propylene glycol, magnesium aluminum silicate, xanthan gum, sodium saccharin, citric acid, methylparaben, propylparaben, and flavor.

Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with anin-vitroexchange capacity of approximately 3.1 mEq (in-vivoapproximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

Sodium Polystyrene Sulfonate Oral Powder - Clinical Pharmacology

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

INDICATION AND USAGE

Sodium Polystyrene Sulfonate Suspension, USP is indicated for the treatment of hyperkalemia.

Contraindications

Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (seePRECAUTIONS).

Warnings

Alternative Therapy in Severe Hyperkalemia

Since the effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia

Serious potassium deficiency can occur from sodium polystyrene sulfonate therapy. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with sodium polystyrene sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances

Like all cation-exchange resins, sodium polystyrene sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative (seePRECAUTIONS, Drug Interactions).

Colonic Necrosis

Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (seePRECAUTIONS, Drug Interactions).

Precautions

Caution is advised when sodium polystyrene sulfonate is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances, compensatory restriction of sodium intake from other sources may be indicated.

Caution is advised when Sodium Polystyrene Sulfonate Suspension, USP is administered to patients with end stage diabetic renal disease.

Sodium Polystyrene Sulfonate Suspension, USP should not be administered to patients following surgery until normal bowel function resumes.

Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

In the event of clinically significant constipation, treatment with Sodium Polystyrene Sulfonate Suspension, USP should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives should not be used (seePRECAUTIONS, Drug Interactions).

Drug Interactions

Antacids

The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

Non-absorbable cation-donating antacids and laxatives

Systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported.

Digitalis

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (seeWARNINGS).

Sorbitol

Concomitant use of sorbitol with Sodium Polystyrene Sulfonate Suspension, USP is not recommended.

Lithium

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of lithium.

Thyroxine

Sodium Polystyrene Sulfonate Suspension, USP may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with sodium polystyrene sulfonate. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium polystyrene sulfonate is administered to a nursing woman.

Pediatric Use

The effectiveness of Sodium Polystyrene Sulfonate Suspension, USP in pediatric patients has not been established. The use of Sodium Polystyrene Sulfonate Suspension, USP is contraindicated in neonates and especially in premature infants. In children, particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

Adverse Reactions

Sodium Polystyrene Sulfonate Suspension, USP may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur (seeWARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (seePRECAUTIONS). Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

The following events have been reported from worldwide post marketing experience:

• Fecal impaction following rectal administration, particularly in children;


• Gastrointestinal concretions (bezoars) following oral administration;


• Gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and


• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate.

Overdosage

Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.

Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

Sodium Polystyrene Sulfonate Oral Powder Dosage and Administration

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Sodium Polystyrene Sulfonate Suspension, USP one to four times daily. Each 60 mL of Sodium Polystyrene Sulfonate Suspension, USP contains 1500 mg (65 mEq) of sodium. Since thein-vivoefficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Sodium Polystyrene Sulfonate Suspension, USP may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

Sodium Polystyrene Sulfonate Suspension, USP may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Sodium Polystyrene Sulfonate Suspension, USP should not be heated for to do so may alter the exchange properties of the resin.

How is Sodium Polystyrene Sulfonate Oral Powder Supplied

Sodium Polystyrene Sulfonate Suspension, USP is a light brown, raspberry-flavored suspension supplied as follows:

480 mL (16 Fluid Ounce)	NDC 0574-2003-16
Unit-Dose 60 mL (2 Fluid Ounce), 10 bottles per carton	NDC 0574-2003-02

Dispense in tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

SHAKE WELL BEFORE USING.

Store at 20 to 25 C (68 to 77 F) [see USP controlled room temperature].

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(04-11A)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

NDC 0574-2003-02

SODIUM POLYSTYRENE

SULFONATE SUSPENSION, USP

15 g/60 mL

Does not contain Sorbitol

Dispense in tight container.

SHAKE WELL BEFORE USING

See package insert for complete prescribing information.

FOR ORAL OR RECTAL USE

Protect from freezing and excessive heat.

NET CONTENTS 60 mL (2 fl oz)

Rx ONLY

Paddock

Laboratories, Inc.

SODIUM POLYSTYRENE SULFONATE  sodium polystyrene sulfonate  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-2003 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Polystyrene Sulfonate (Sodium Cation) Sodium Polystyrene Sulfonate 15 g  in 60 mL

Inactive Ingredients Ingredient Name Strength Alcohol 0.12 mL  in 60 mL water   propylene glycol   magnesium aluminum silicate   xanthan gum   saccharin sodium   citric acid monohydrate   methylparaben   propylparaben

Product Characteristics Color BROWN (Light-brown) Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-2003-02 60 mL In 1 BOTTLE None 2 0574-2003-16 480 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090590	09/21/2011

Labeler - Paddock Laboratories, LLC (967694121)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, LLC		967694121	Manufacture

Revised: 09/2011Paddock Laboratories, LLC

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