Glarine®

Insulin Glargine (rDNA) USP Sterile injection

Prescribing Details



Description

Glarine ® (Insulin glargine [rDNA] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. Glarine ® is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. It is a recombinant human insulin analog that is long acting (up to 24 hour duration of action), parenteral blood glucose lowering agent.
Primary function of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, primarily by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.


Uses

No Data


Indications

Glarine ® is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.


Dosage and administration

Procedure for Insulin Administration
Before going for administration of Glarine ® please follow the below mentioned check list:

  1. Insulin syringe of the right size (100 IU)
  2. Prescribed type of insulin injection
  3. Check the expiry date on Glarine ® vial
  4. Ensure that the flip-off cap on the Glarine® vial is intact


After that follow the below mentioned instructions as per given picture:

Glarine

Dosage
Glarine ® 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. Glarine ® 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 Glarine ® must be individualized based on clinical response. Blood glucose monitoring is essential in all patients with diabetes. In patients with type 1 diabetes, Glarine ® must be used in regimens with short-acting insulin. Glarine ® is not recommended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

Injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next.

Initiation of Glarine ® therapy:
The recommended starting dose of Glarine ® 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 Glarine ® 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 Glarine ® from other insulin therapies
If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with Glarine ® , 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 Glarine ® , the recommended initial Glarine ® dose is the same as the dose of NPH that is being discontinued.

- If transferring patients from twice-daily NPH insulin to once-daily Glarine ® , the recommended initial Glarine ® dose is 80% of the total NPH dose that is being discontinued.


Use in pregnancy & lactation

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

Lactation: It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Insulin glargine is administered to a nursing woman. Lactating women may require adjustments in insulin dose & diet.


Geriatric use
No Data

Precautions

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision.


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

Contraindications

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

Administration: Insulin glargine must not be diluted or mixed with any other insulin or solution. It should not be administered subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur.

Renal or hepatic impairment: Reduction in the Insulin glargine dose may require in these cases.


Drug interactions

A number of drugs affect glucose metabolism and may require dose adjustment. The following substances may reduce the Insulin as well as Insulin glargine requirements: oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics.

The following substances may increase the Insulin as well as Insulin glargine requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetic, growth hormone and danazol.

Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.


Overdose
Insulin glargine overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.

Preparation

No Data


Pharmaceutical precautions

Store at 2° C to 8° C in a refrigerator. Do not freeze. Protect from light.


Presentation
Glarine ® Injection 100 IU/ml: Each ml solution contains Insulin Glargine (rDNA) INN 100 IU (equivalent to 3.47 mg).

Package quantities
Glarine ® Injection 100 IU/ml: Each box contains 3 ml solution in glass vial.