Prescription Drugs

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 Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in 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.

BACTERIOSTATIC WATER (bacteriostatic nacl) for Injection, USP Multiple-dose Plastic Vial WARNING NOT FOR USE IN NEONATES. DESCRIPTION The following 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. Bacteriostatic Water (bacteriostatic nacl) for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The pH is 5.7 (4.5 to 7.0). Water for Injection, USP is chemically designated H2O. 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 labeled volume.

INDICATIONS 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. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS. HOW SUPPLIED Bacteriostatic Water for Injection, USP is supplied in a multiple-dose 30 mL plastic fliptop vial (List No. 3977). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Hospira, Inc., Lake Forest, IL 60045 USA. FDA rev date: 6/15/2000

PATIENT INFORMATION See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.

OVERDOSE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS. CONTRAINDICATIONS Due to the potential toxicity of benzyl alcohol in newborns, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.

SIDE EFFECTS 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 counter-measures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant is potentially capable of producing blood pressure changes. 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.

WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in newborns, only preservative-free Sodium Chloride Injection should be used. PRECAUTIONS Consult the manufacturers 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 Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed. 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.