"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
Subcutaneous Fluid Administration
Amphadase® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
Dispersion and Absorption of Injected Drugs
Amphadase® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Subcutaneous Fluid Administration (Hypodermoclysis)
Insert needle with aseptic precautions. With tip lying free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject Amphadase® (hyaluronidase injection) into rubber tubing close to needle.
An alternate method is to inject Amphadase® under skin prior to clysis. 150 U will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.
Amphadase® may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion.
Absorption and Dispersion of Injected Drugs
Absorption and dispersion of other injected drugs may be enhanced by adding 50-300 Units, most typically 150 U hyaluronidase, to the injection solution.
The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 U of Amphadase® (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
Dosage Forms And Strengths
150 USP units/mL single dose vials
Storage And Handling
Amphadase® (hyaluronidase injection) is supplied sterile as 150 USP units of hyaluronidase per mL in a 2 mL single-use glass vial with a gray rubber stopper and aluminum flip-off seal.
NDC 0548-9090-10, 1 mL vial, 10 vials/carton.
NDC 0548-9090-00, 1 mL vial, 25 vials/carton.
Store unopened in a refrigerator at 2° to 8°C (36° to 46° F).
Amphastar Pharmaceuticals, Inc. Rancho Cucamonga, CA 91730, U.S.A. Rev. 3/12
Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Amphadase Information
Report Problems to the Food and Drug Administration
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