Lantus contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day.
The dosage and timing of dose of Lantus should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.
The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues.
Special population: Elderly population (≥65 years old): In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Renal impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Hepatic impairment: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Paediatric population: Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older. Lantus has not been studied in children below the age of 2 years.
Change-over to Lantus: When changing from a treatment regimen with an intermediate or another long-acting insulin to a regimen with Lantus, the amount and timing of short acting insulin or fast-acting insulin analogue or of the dose of any oral antidiabetic drug may need to be adjusted.
Switch from twice daily NPH insulin to Lantus: To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Switch from insulin glargine 300 units/ml to Lantus: Lantus (100 units/ml) and insulin glargine 300 U/ml are not bioequivalent and are not directly interchangeable. When switching from Lantus XR to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.
During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. As with all insulin analogues, this is particularly true for patients which, due to antibodies to human insulin, need high insulin doses and may experience a markedly improved insulin response with insulin glargine.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dosage regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo-or hyperglycaemia.
Method of Administration: Lantus is administered by subcutaneous tissue injection.
Lantus is not intended for intravenous administration. The prolonged duration of action of insulin glargine is dependent on injection into the subcutaneous space. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions).
Mixing, diluting: Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Lantus 100 units/ml solution for injection in a vial: For further details on handling, see Special precautions for disposal and other handling under Cautions for Usage.
Lantus 100 units/ml solution for injection in a cartridge: Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used (see Special warnings and precautions for use under Cautions for Usage).
For further details on handling, see Special precautions for disposal and other handling under Cautions for Usage.
Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen: Lantus SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see Special warnings and precautions for use under Cautions for Usage).
Before using SoloStar, the instructions for use must be read carefully (see Special precautions for disposal and other handling under Cautions for Usage).
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