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Description

Generics:
Insulin Glargine [rDNA]

Dosage Form: Injectable solution.

Indications:
To improve blood sugar control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Pharmacology:
Insulin glargine is a sterile solution use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting parenteral blood sugar-lowering drug made by using recombinant DNA technology. The main function of insulin glargine is to regulate glucose metabolism. Insulin and its analogues lower blood sugar by stimulating peripheral glucose uptake, mainly by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and improves protein synthesis.

Dosage guideline:
Once-daily at any time during the day. Once started should be administered at the same time every day.

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.

Route of administration: S
hould be injected subcutaneously. It is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

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:
Several medications affect glucose metabolism and may require dose adjustments.

The following substances may reduce insulin and insulin glargine requirements: oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, and sulfonamide Antibiotics.

The following substances may increase insulin and insulin glargine requirements: thiazides, glucocorticoids, thyroid hormones, beta sympathomimetics, growth hormones, and danazol. Beta-blockers, clonidine, lithium salts, and alcohol can increase or decrease the hypoglycemic effects of insulin.

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

Side Effects:
Side effects of Insulin glargine are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash.

Pregnancy & Lactation
Pregnancy category C: Insulin glargine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when administering insulin glargine to a nursing woman. Women who breastfeed may require insulin dose and diet adjustments.

 Precautions & Warnings:
Dose adjustment and control: Blood glucose should be monitored in all insulin-treated patients. Insulin treatments should be changed with caution and only under medical supervision.

Application: Insulin glargine must not be diluted or mixed with other insulins or solutions. It should not be administered subcutaneously through an insulin pump or intravenously, as severe hypoglycemia may occur.

Renal or hepatic dysfunction: In these cases, a reduction of the insulin glargine dose may be necessary.

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.

Manufactured by: Healthcare Pharmaceuticals Ltd. (Mfg. by: Eli Lilly and Company)