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Apidra 100 IU/1 mL Vials

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Apidra® 100 IU/1 mL Vials

Apidra® is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Apidra® has the same glucose-lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Apidra®has a more rapid onset of action and a shorter duration of action than regular human insulin.

The dosage of Apidra® must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or co-administered drugs.

Apidra® should be given within 15 minutes before a meal or within 20 minutes after starting a meal.

Apidra® given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

Apidra® should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy.

Apidra® may be administered by continuous subcutaneous infusion. Do not use diluted or mixed insulin in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.

The following insulin pumps1 have been used in Apidra® clinical trials conducted by Sanofi-Aventis US LLC, the manufacturer of Apidra®:

  • Disetronic® H-Tron® plus V100 and D-Tron® with Disetronic catheters (Rapid™, Rapid C™, Rapid D™, and Tender™)
  • MiniMed® Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate QR™, and Quick-set™).

Before using a different insulin pump with Apidra®, read the pump label to make sure the pump has been evaluated with Apidra®.
Physicians and patients should carefully evaluate information on pump use in the Apidra®prescribing information, Patient Information Leaflet, and the pump manufacturer's manual. Apidra®-specific information should be followed for in-use time, frequency of changing infusion sets, or other details specific to Apidra® usage, because Apidra®-specific information may differ from general pump manual instructions.

Based on in vitro studies which have shown loss of the preservative, metacresol and insulin degradation, Apidra® in the reservoir should be changed at least every 48 hours. Apidra® in clinical use should not be exposed to temperatures greater than 98.6°F (37°C.)

Apidra® 100 units per mL (U-100) is available as:

  • 10 mL vials
  • 3 mL cartridges for use in the OptiClik® Insulin Delivery Device

The manufacturer is Sanofi-Aventis US LLC.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.