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
Lantus Indications, Dosage, Storage, Stability - Lantus - Insulin Glargine
Lantus Indications, Dosage, Storage, Stability - Lantus - Insulin Glargine
INDICATIONS
AND USES
LANTUS is indicated for once-daily subcutaneous administration at bedtime in
the treatment of adult and pediatric patients with type 1 diabetes mellitus
or adult patients with type 2 diabetes mellitus who require basal (long-acting)
insulin for the control of hyperglycemia.
DOSAGE AND ADMINISTRATION
LANTUS is a 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 should be administered subcutaneously once a day at bedtime. LANTUS
is not intended for intravenous administration. (See PRECAUTIONS ). 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 antidiabetic
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 insulins, 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 insulins,
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 diabetic ketoacidosis.
Intravenous short-acting insulin is the preferred treatment.
Pediatric Use
LANTUS can be safely administrated 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 LANTUS is the same as described for adults in
DOSAGE AND ADMINISTRATION
, Changeover to LANTUS .
Initiation of LANTUS Therapy
In a clinical study with insulin naive patients with type 2 diabetes already
treated with oral antidiabetic drugs, LANTUS was started at an average dose
of 10 IU once daily, and subsequently adjusted according to the patient's need
to a total daily dose ranging from 2 to 100 IU.
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 antidiabetic drug may need to be adjusted.
In clinical studies, when patients were transferred from once-daily NPH human
insulin or ultralente human insulin to once-daily LANTUS, the initial dose was
usually not changed. However, when patients were transferred from twice-daily
NPH human insulin to LANTUS once daily at bedtime, to reduce the risk of hypoglycemia,
the initial dose (IU) was usually reduced by approximately 20% (compared to
total daily IU of NPH human insulin) within the first week of treatment and
then adjusted based on patient response. (See PRECAUTIONS , Hypoglycemia )
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 insulins or oral antidiabetic drugs may be required; for
example, if the patient's weight or lifestyle changes or other circumstances
arise that increase susceptibility to hypoglycemia or hyperglycemia. (See PRECAUTIONS
, Hypoglycemia )
The dose may also have to be adjusted during intercurrent illness. (See PRECAUTIONS
, Intercurrent Conditions )
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.
The syringes must not contain any other medicinal product or residue.
Mixing and diluting. LANTUS must not be diluted or mixed with any other
insulin or solution. (See PRECAUTIONS , General )
Cartridge version only: If the OptiPen™ One Insulin Delivery Device malfunctions,
LANTUS may be drawn from the cartridge into a U 100 syringe and injected.
HOW SUPPLIED
LANTUS 100 units per mL (U 100) is available in the following package sizes:
10 mL vials (NDC 0088-2220-33)
3 mL cartridges*, package of 5 (NDC 0088-2220-52)
*Cartridges are for use only in the OptiPen™ One Insulin Delivery Device
Storage
Unopened LANTUS vials and cartridges should be stored in a refrigerator, 36°F-46°F
(2°C-8°C). LANTUS should not be stored in the freezer and it should not be allowed
to freeze.
If refrigeration is not possible, the 10 mL vial or cartridge of LANTUS 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 86°F (30°C). Unrefrigerated 10
mL vials and cartridges must be used within the 28-day period or they must be
discarded.
Once the cartridge is placed in an OptiPen One, it should not be put in the
refrigerator.
Manufactured by:
Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main
Germany
Manufactured for:
Aventis Pharmaceuticals Inc.
Kansas City, MO 64137 USA
Made in Germany
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