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Bacteriostatic Water
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 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.
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. The small volume of
fluid provided by Bacteriostatic
Water for Injection, USP when used only as a pharmaceutic aid
for diluting or dissolving drugs for parenteral
injection, is unlikely
to exert a significant
effect on fluid balance
except possibly in very small infants.
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.
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 controlled room temperature 15° to 30°C(59° to 86°F). Caution: Federal (USA) law
prohibits dispensing without prescription.
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. 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 6kg infant is potentially capable of producing blood pressure changes.
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.
Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used. Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.
Do not use Bacteriostatic Water for Injection, USP for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. 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 Bacteriostatic Water for Injection. It is also not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic Water for Injection, USP 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.
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