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Cheap qualitative Insulin Glargine injections 100 IU / ml
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LANTUS (INSULIN GLARGINE): CLINICAL PHARMACOLOGY
Mechanism of Action
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Insulin Glargine is a human insulin analog that has been designed to have low aqueous solubility at neutral pH. At pH 4, as in the Lantus injection solution, insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a basal insulin.
In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of Lantus (Insulin Glargine) injections 100 IU / ml is approximately the same as that for human insulin. In euglycemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than NPH insulin. The effect profile of insulin glargine was relatively constant with no pronounced peak and the duration of its effect was prolonged compared to NPH insulin. The median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to > 24.0 hours) (24 hours was the end of the observation period) for insulin glargine.
The longer duration of action (up to 24 hours) of Insulin Glargine (Lantus) injections is directly related to its slower rate of absorption and supports once-daily subcutaneous administration. The time course of action of insulins, including Lantus injections, may vary between individuals and within the same individual.
Absorption and Bioavailability
After subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration / time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Serum insulin concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. After subcutaneous injection of 0.3 units / kg insulin glargine in patients with type 1 diabetes, a relatively constant concentration/time profile has been demonstrated. The duration of action after abdominal, deltoid, or thigh subcutaneous administration was similar.
A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30BThr-insulin). Unchanged drug and these degradation products are also present in the circulation.
Age, Race, and Gender
Information on the effect of age, race, and gender on the pharmacokinetics of Lantus is not available. However, in controlled clinical trials in adults (n=3890) and a controlled clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy between insulin glargine and NPH insulin.
The effect of smoking on the pharmacokinetics/pharmacodynamics of Lantus Insulin has not been studied.
The effect of pregnancy on the pharmacokinetics and pharmacodynamics of Lantus (Insulin Glargine) has not been studied.
In controlled clinical trials, which included patients with Body Mass Index (BMI) up to and including 49.6 kg / m2, subgroup analyses based on BMI did not show differences in safety and efficacy between insulin glargine and NPH insulin.
The effect of renal impairment on the pharmacokinetics of Insulin Glargine (Lantus) has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Careful glucose monitoring and dose adjustments of insulin, including Lantus (Insulin Glargine) injections, may be necessary in patients with renal impairment.
The effect of hepatic impairment on the pharmacokinetics of Lantus insulin injections has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure. Careful glucose monitoring and dose adjustments of insulin, including Lantus (Insulin Glargine) injections 100 IU / ml, may be necessary in patients with hepatic impairment.
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