A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Apidra Indications, Dosage, Storage, Stability - Insulin glulisine
Apidra Indications, Dosage, Storage, Stability - Insulin glulisine
INDICATIONS AND USAGE
APIDRA is indicated for the treatment of adult patients with
diabetes mellitus for the control of hyperglycemia.
APIDRA has a more rapid onset of action and a shorter duration
of action than regular human insulin. APIDRA should normally be used in regimens
that include a longer-acting insulin or basal insulin analog. (See WARNINGS
and DOSAGE AND
ADMINISTRATION.)
APIDRA may also be infused subcutaneously by external insulin
infusion pumps. (See WARNINGS,
PRECAUTIONS, Usage in Pumps, Information
for Patients, Mixing of Insulins, DOSAGE AND ADMINISTRATION,
RECOMMENDED STORAGE.)
DOSAGE AND ADMINISTRATION
APIDRA is a recombinant insulin analog that has been shown
to be equipotent to human insulin. One unit of APIDRA has the same glucose-lowering
effect as one unit of regular human insulin. After subcutaneous administration,
it has a more rapid onset and shorter duration of action.
APIDRA should be given within 15 minutes before a meal or within
20 minutes after starting a meal.
APIDRA is intended for subcutaneous administration and for
use by external infusion pump.
The dosage of APIDRA should be individualized and determined
based on the physician’s advice in accordance with the needs of the patient.
APIDRA should normally be used in regimens that include a longer-acting insulin
or basal insulin analog.
APIDRA should be administered by subcutaneous injection in
the abdominal wall, the thigh or the deltoid or by continuous subcutaneous infusion
in the abdominal wall. As with all insulins, injection sites and infusion sites
within an injection area (abdomen, thigh or deltoid) should be rotated from
one injection to the next.
As for all insulins, the rate of absorption, and consequently
the onset and duration of action, may be affected by injection site, exercise
and other variables. Blood glucose monitoring is recommended for all patients
with diabetes.
Preparation and Handling
Parenteral drug products should be inspected visually prior
to administration whenever the solution and the container permit. APIDRA must
only be used if the solution is clear and colorless with no particles visible.
When it is used in a pump, Apidra should not be mixed with
other insulins or with a diluent.
HOW SUPPLIED
APIDRA 100 units per mL (U-100) is available in the following
package size: 10 mL vials NDC 0088-2500-33
Storage: Unopened Vial:
Unopened APIDRA vials should be stored in a refrigerator, 36°F-46°F
(2°C-8°C). Protect from light. APIDRA should not be stored in the freezer and
it should not be allowed to freeze. Discard vial if frozen.
Open (In Use) Vial:
Opened vials, whether or not refrigerated, must be used within
28 days. They must be discarded if not used within 28 days. If refrigeration
is not possible, the open vial in use can be kept unrefrigerated for up to 28
days away from direct heat and light, as long as the temperature is not greater
than 77°F (25°C).
|
|
Not in-use (unopened) Refrigerated
|
Not in-use (unopened) Room Temperature, below 77°F (25°C)
|
In-use (opened) Room Temperature, below 77°F (25°C)
|
|
10 mL Vial
|
Until expiration date
|
28 days
|
28 days, refrigerated/room temperature
|
Infusion sets:
Infusion sets (reservoirs, tubing, and catheters) and the APIDRA
in the reservoir should be discarded after no more than 48 hours of use or after
exposure to temperatures that exceed 98.6°F (37°C).
Rev. April 2004:, Manufactured by: Aventis
Pharma Deutschland GmbH D-65926 Frankfurt am Main Frankfurt, Germany., Manufactured
for: Aventis Pharmaceuticals Inc. Kansas City, MO 64137 USA, US Patent Number
6,221,633 www.aventis-us.com ©2004 Aventis Pharmaceuticals Inc.
† Lantus® is a trademark of Aventis Pharmaceuticals
Inc.
‡ The brands listed are the registered trademarks
of their respective owners and are not trademarks of Aventis Pharmaceuticals
Inc.
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