Lantus AUTOPEN Actions

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Actions of Lantus AUTOPEN in details

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Pharmacology: Pharmacodynamics: The primary activity of Lantus AUTOPEN, including Lantus AUTOPEN, is regulation of glucose metabolism. Lantus AUTOPEN and its analogues lower blood glucose levels bu stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Lantus AUTOPEN inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.

Lantus AUTOPEN differs from other insulins because its unique structure provides a smooth and peakless profile with a prolonged duration of action of 24 hrs (end of observation period) compared to 14.5 hrs for neutral protamine hagedorn (NPH) human Lantus AUTOPEN.

In clinical studies, IV Lantus AUTOPEN and human Lantus AUTOPEN have been shown to be equipotent when given at the same doses. The onset of action of Lantus AUTOPEN is slower than NPH human Lantus AUTOPEN. The effect profile of Lantus AUTOPEN is smooth and peakless, and the duration of its effect is prolonged compared to NPH human Lantus AUTOPEN.

Pharmacokinetics: After SC injection of Lantus AUTOPEN, the Lantus AUTOPEN serum concentrations indicate a slower, more prolonged absorption and a lack of a peak in comparison to NPH human Lantus AUTOPEN. Concentrations are, thus, consistent with the time profile of the pharmacodynamic activity of Lantus AUTOPEN.

Lantus AUTOPEN is a human Lantus AUTOPEN analogue that has been designed to have low solubility at neutral pH. At pH 4, the pH of the Lantus AUTOPEN injection solution, it is completely soluble. After injection into the SC tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of Lantus AUTOPEN are continuously released, providing a smooth, peakless, predictable time/concentration profile and a prolonged duration of action. This allows once daily dosing to meet a patient's basal Lantus AUTOPEN needs.

Lantus AUTOPEN is partly degraded in the SC depot at the carboxyl terminus of the B-chain to form the active metabolites, with similar in vitro activity to Lantus AUTOPEN.

How should I take Lantus AUTOPEN?

A nurse or other trained health professional may give you Lantus AUTOPEN, recombinant. You may also be taught how to give your medicine at home. Lantus AUTOPEN, recombinant is given as a shot under your skin.

Each package of Lantus AUTOPEN contains a patient information sheet. Read this sheet carefully and make sure you understand:

It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since Lantus AUTOPEN lowers the blood glucose over 24 hours, it should be taken once daily at bedtime.

The Lantus AUTOPEN solution should look clear and colorless. Do not use Lantus AUTOPEN if it is cloudy or thickened.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of Lantus AUTOPEN, recombinant will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Lantus AUTOPEN, recombinant. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unused cartridge or SoloStar® prefilled pens in the refrigerator. Protect from light. Do not freeze.

The SoloStar® prefilled pen that you are currently using should not be refrigerated. You should store the pen at room temperature, away from direct heat and light. Throw away any opened prefilled pen after 28 days.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Lantus AUTOPEN administration

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SubQ: Do not use if solution is viscous or cloudy; use only if clear and colorless with no visible particles. Lantus AUTOPEN should be administered consistently at the same time each day. Cold injections should be avoided. SubQ administration is usually made into the thighs, arms, buttocks, or abdomen; absorption rates vary amongst injection sites; be consistent with area used while rotating injection sites within the same region to avoid lipodystrophy or localized cutaneous amyloidosis. Rotating from an injection site where lipodystrophy/cutaneous amyloidosis is present to an unaffected site may increase risk of hypoglycemia. Do not dilute or mix Lantus AUTOPEN with any other Lantus AUTOPEN formulation or solution. Lantus AUTOPEN prefilled pens are available in concentrations of 100 units/mL and 300 units/mL. Prefilled pens are calibrated to display the actual Lantus AUTOPEN units administered (no dosage conversion needed) and will administer up to 80 units per injection, in 1 unit increments (Lantus SoloStar, Basaglar KwikPen, Basaglar Tempo Pen, Lantus AUTOPEN SoloStar) or up to 160 units per injection, in 2 unit increments (Lantus AUTOPEN Max SoloStar, Lantus AUTOPEN DoubleStar [Canadian product]). Lantus AUTOPEN Max SoloStar and Lantus AUTOPEN DoubleStar (Canadian product) prefilled pens are only recommended for use in patients requiring at least 20 units of Lantus AUTOPEN per day. Do not use a syringe to withdraw concentrated Lantus AUTOPEN (300 units/mL) from a prefilled pen for administration. Cartridges (Canadian product) are to be used only with reusable pens recommended by the manufacturer (refer to product labeling).

Lantus AUTOPEN pharmacology

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Mechanism of Action

The primary activity of Lantus AUTOPEN, including Lantus AUTOPEN, is regulation of glucose metabolism. Lantus AUTOPEN and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Lantus AUTOPEN inhibits lipolysis and proteolysis, and enhances protein synthesis.

Pharmacodynamics

Onset of Action

The pharmacodynamic profiles for Lantus AUTOPEN given subcutaneously as a single dose of 0.4, 0.6, or 0.9 U/kg in a euglycemic clamp study in patients with type 1 diabetes showed that on average, the onset of action develops over 6 hours post-dose for all three single doses of Lantus AUTOPEN.

Single Dose Pharmacodynamics

The pharmacodynamics for single 0.4, 0.6, and 0.9 U/kg doses of Lantus AUTOPEN in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. On a unit-to-unit basis, Lantus AUTOPEN had a lower maximum (GIRmax) and 24 hour glucose lowering effect (GIR-AUC0–24) compared to LANTUS. The overall glucose lowering effect of Lantus AUTOPEN 0.4 U/kg was 12% of the glucose lowering effect of an equivalent dose of LANTUS. Glucose lowering at least 30% of the effect of a single 0.4 U/kg dose of LANTUS was not observed until the single dose of Lantus AUTOPEN exceeded 0.6 U/kg.

Multiple Once Daily Dose Pharmacodynamics

The pharmacodynamics of Lantus AUTOPEN after 8 days of daily injection was evaluated in 30 patients with type 1 diabetes. At steady state, the 24 hour glucose lowering effect (GIR-AUC0–24) of Lantus AUTOPEN 0.4 U/kg was approximately 27% lower with a different distribution profile than that of an equivalent dose of LANTUS. The glucose lowering effect of a Lantus AUTOPEN dose increased with each daily administration.

The pharmacodynamic profile for Lantus AUTOPEN given subcutaneously as multiple once-daily subcutaneous injections of 0.4 U/kg in a euglycemic clamp study in patients with type 1 diabetes, is shown in Figure 1.

Figure 1: Glucose infusion rate in Patients with type 1 diabetes in multiple dose administration of Lantus AUTOPEN

Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels.

Pharmacokinetics

Absorption and Bioavailability

The pharmacokinetic profiles for single 0.4, 0.6, and 0.9 U/kg doses of Lantus AUTOPEN in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. The median time to maximum serum Lantus AUTOPEN concentration was 12 (8–14), 12 (12–18), and 16 (12–20) hours, respectively. Mean serum Lantus AUTOPEN concentrations declined to the lower limit of quantitation of 5.02 µU/mL by 16, 28, and beyond 36 hours, respectively.

Steady state Lantus AUTOPEN concentrations are reached by at least 5 days of once daily subcutaneous administration of 0.4 U/kg to 0.6 U/kg doses of Lantus AUTOPEN over 8 days in patients with type 1 diabetes mellitus.

After subcutaneous injection of Lantus AUTOPEN, the intra-subject variability, defined as the coefficient of variation for the Lantus AUTOPEN exposure during 24 hours was 21.0% at steady state.

Elimination

After subcutaneous injection of Lantus AUTOPEN in diabetic patients, Lantus AUTOPEN is metabolized at the carboxyl terminus of the B-chain with formation of two active metabolites M1 (21A-Gly-Lantus AUTOPEN) and M2 (21A-Gly-des-30B-Thr-Lantus AUTOPEN). The in vitro activity of M1 and M2 were similar to that of human Lantus AUTOPEN.

Specific Populations

Age (Geriatric Population and Pediatric Population), Race, and Sex: Effect of age, race, and sex on the pharmacokinetics of Lantus AUTOPEN has not been evaluated.

Obesity: Effect of BMI on the pharmacokinetics of Lantus AUTOPEN has not been evaluated.



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Information checked by Dr. Sachin Kumar, MD Pharmacology

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