Sterile Water

Hospira, Inc.

STERILE WATER

FULL PRESCRIBING INFORMATION: CONTENTS*

• STERILE WATER DESCRIPTION
• CLINICAL PHARMACOLOGY
• STERILE WATER INDICATIONS AND USAGE
• STERILE WATER CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• STERILE WATER ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• STERILE WATER DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

for Injection, USP

R_x only

FOR DRUG DILUENT USE ONLY

STERILE WATER DESCRIPTION

Sterile Water for Injection, USP is sterile, nonpyrogenic distilled water for injection and contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.8 (5.0 to 7.0). It is a pharmaceutic aid (vehicle) for diluting or dissolving drugs and parenteral fluid replenisher for intravenous administration only after addition of a solute.

Water for Injection, USP is chemically designated H₂O.        

CLINICAL PHARMACOLOGY

Sterile Water for Injection, USP serves as a pharmaceutic aid (vehicle) for diluting or dissolving drugs prior to administration and as a parenteral fluid replenisher after addition of a suitable solute.

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.

STERILE WATER INDICATIONS AND USAGE

Sterile Water for Injection, USP is used as a vehicle for diluting or dissolving drugs and for parenteral fluid replacement only after suitable additives are introduced.  An osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid  (280 mOsmol/liter) is essential to avoid intravascular hemolysis.

STERILE WATER CONTRAINDICATIONS

Do not use unless the solution is clear and seal is intact. Discard unused portion.

WARNINGS

Intravenous administration of Sterile Water for Injection, USP without additives may result in hemolysis. 

The intravenous administration of sterile water for injection with additives 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.

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

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Do not use for intravenous injection unless the osmolar concentration of additives totals at least 112 mOsmol/liter (two-fifths of the normal osmolarity of the extracellular fluid — 280 mOsmol/liter).

Pregnancy Category C . Animal reproduction studies have not been conducted with sterile water for injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile water for injection with additives should be given to a pregnant woman only if clearly needed.

Contains no more than 25 µg/L of aluminum.

Pediatric Use

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

STERILE WATER ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS.

STERILE WATER DOSAGE AND ADMINISTRATION

Following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient.

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

HOW SUPPLIED

Sterile Water for Injection, USP is supplied in 250 and 1000 mL single dose containers, List No. 1590.

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

Revised: November, 2005

©Hospira 2005                                                            EN-1077                                                                Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA                                   

RL-1845