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Lantus® is recombinant human insulin analog. Its potency is approximately the same as human insulin. It exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.
Lantus® may be administered at any time during the day. Lantus® should be administered subcutaneously once a day at the same time every day. Lantus® is not intended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. The desired blood glucose levels as well as the doses and timing of antidiabetes medications must be determined individually. Blood glucose monitoring is recommended for all patients with diabetes. The prolonged duration of activity of Lantus® is dependent on injection into subcutaneous space.
As with all insulin, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from one injection to the next.
In clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for all insulin, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.
Lantus® is not the insulin of choice for the treatment of diabetes ketoacidosis. Intravenous short-acting insulin is the preferred treatment.
Lantus® can be safely administered to pediatric patients ≥6 years of age. Administration to pediatric patients <6 years has not been studied. Based on the results of a study in pediatric patients, the dose recommendation for changeover to L ® is the same as described for adults.
Changeover to Lantus®
If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with Lantus®, the amount and timing of short-acting insulin or fast-acting insulin analog or the dose of any oral antidiabetes drug may need to be adjusted. A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. The amount and timing of short-acting insulin or fast-acting insulin analog may need to be adjusted. This is particularly true for patients with acquired antibodies to human insulin needing high-insulin doses and occurs with all insulin analogs. Dose adjustment of Lantus® and other insulin or oral antidiabetes drugs may be required; for example, if the patient's timing of dosing, weight or lifestyle changes, or other circumstances arise that increase susceptibility to hypoglycemia or hyperglycemia.
Preparation and Handling
Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. Lantus® must only be used if the solution is clear and colorless with no particles visible.
Mixing and diluting: Lantus® must NOT be diluted or mixed with any other insulin or solution.
Vial: The syringes must not contain any other medicinal product or residue.
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.