Generic

Insulin Glargine [rDNA]

Indications

Insulin Glargine is used to treat type 1 diabetes in adults and children, as well as type 2 diabetes in adults.

Pharmacology

Insulin Glargine is a sterile insulin glargine solution intended for subcutaneous injection. Insulin glargine is a long-acting (up to 24-hour duration of action) parenteral blood glucose lowering medication made from recombinant human insulin analogues. Recombinant DNA technology is used to make Insulin Glargine. Insulin glargine’s primary role is to regulate glucose metabolism. Insulin and its analogues reduce blood glucose levels by stimulating peripheral glucose absorption, particularly in skeletal muscle and fat, and blocking hepatic glucose synthesis. Insulin promotes protein synthesis while inhibiting lipolysis and proteolysis.

Dosage & Administration

Insulin Glargine exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing. Potency of insulin glargine is approximately the same as human insulin.

Insulin Glargine is recommended for once daily subcutaneous administration & may be administered at any time during the day. However, once started should be administered at the same time every day. The dose of Insulin Glargine must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Insulin Glargine must be used in regimens with short-acting insulin. Insulin Glargine is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Initiation of Insulin Glargine therapy:

• The recommended starting dose of Insulin Glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
• The recommended starting dose of Insulin Glargine in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient’s needs.

Converting to Insulin Glargine from other insulin therapies: If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with Insulin Glargine , the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

• If transferring patients from once-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is the same as the dose of NPH that is being discontinued.
• If transferring patients from twice-daily NPH insulin to once-daily Insulin Glargine , the recommended initial Insulin Glargine dose is 80% of the total NPH dose that is being discontinued.

Insulin Glargine should be injected subcutaneously once daily at any time of day, but at the same time everyday.

Cartridge:

• Insert the Insulin Glargine cartridge into the pen correctly and equip the needle. Gently turn the pen upside down for 8-10 times until the insulin in the cartridge becomes uniformly mixed.
• Adjust the dosage button to get correct dose. After removal of the needle cap and discharge air bubbles in the cartridge, it is ready to be injected. In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

Vial:

• Firstly, clean your hands. Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
• If using a new Insulin Glargine bottle then flip off the plastic protective cap and wipe the rubber stopper with an alcohol swab.
• Draw air into your syringe equal to the amount of Insulin Glargine needed. Puncture the needle into the vial and inject the air.
• Turn the bottle and syringe upside down. Withdraw correct dose of Insulin Glargine into the syringe. Before pulling out the needle, check if there are any bubbles remain in the syringe.
• If so, put the syringe upright and tap the syringe to discharge the air bubbles.

Injection Site: Choose the area where skin is less tight, such as the upper arm, thigh, buttock and abdomen, etc. To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.

Injection Method: Cleanse the skin with alcohol where the injection is to be made. Put the needle in such a position as to form 45° angle with the skin. Puncture the needle into skin and inject insulin. Then pull the needle out and apply gentle pressure over the injected site for several seconds. Do not rub the injection site.

Interaction

Many medications affect glucose metabolism and dosage adjustments may be necessary.

The following substances may reduce the need for insulin and insulin glargine: oral antidiabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, and sulfa antibiotics.

The following substances may increase the demand for insulin and insulin glargine: thiazides, glucocorticoids, thyroid hormones, beta sympathomimetic drugs, growth hormone, and danazol. Beta-blockers, clonidine, lithium salts, and alcohol can increase or decrease the hypoglycemic effect of insulin.

Contraindications

Insulin glargine is contraindicated in patients with hypersensitivity to insulin glargine or any of its excipients.

Side Effects

Hypoglycemia, allergic responses, injection site reaction, lipodystrophy, pruritus, and rash are among side effects of Insulin glargine.

Pregnancy & Lactation

Category C pregnancy. During pregnancy, insulin glargine should only be taken if the possible benefit outweighs the danger to the baby.

It is uncertain if insulin glargine is secreted in human milk during lactation. Because many medications, including human insulin, are excreted in human milk, Insulin glargine should be provided with caution to a breastfeeding mother. Insulin dosage and nutrition may need to be adjusted for lactating mothers.

Precautions & Warnings

Many medications affect glucose metabolism and dosage adjustments may be necessary.

The following substances may reduce the need for insulin and insulin glargine: oral antidiabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, and sulfa antibiotics.

The following substances may increase the demand for insulin and insulin glargine: thiazides, glucocorticoids, thyroid hormones, beta sympathomimetic drugs, growth hormone, and danazol. Beta-blockers, clonidine, lithium salts, and alcohol can increase or decrease the hypoglycemic effect of insulin.

Therapeutic Class

Long Acting Insulin

Storage Conditions

Store at 2° C to 8° C in a refrigerator. Do not freeze. In case of insulin for recent use need not to be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.

Pharmaceutical Name

ACI Limited