Glarine 100 IU/3 ml Injection

Glarine 100 IU/3ml – Insulin Glargine Injection by Incepta Pharmaceuticals

What is Glarine (Insulin Glargine)?

Glarine is a locally manufactured insulin glargine biosimilar produced by Incepta Pharmaceuticals Ltd., one of Bangladesh's leading pharmaceutical manufacturers. It contains insulin glargine 100 IU/ml — a long-acting basal insulin analogue with the same molecular structure as the originator product (Lantus by Sanofi). After subcutaneous injection, glargine's acidic formulation neutralises at physiological pH, forming a microcrystalline depot that releases insulin slowly over approximately 24 hours with no pronounced peak. This peakless profile closely mimics physiological basal insulin secretion, providing stable fasting and overnight glucose control with once-daily dosing. Glarine offers the clinical benefits of insulin glargine at a significantly more accessible price point for Bangladeshi patients.

Generic Name and Composition

Each ml: 100 IU insulin glargine (rDNA). Glargine differs from human insulin at two positions: A21 (asparagine replaced by glycine) and B30 (two arginine residues added). These modifications shift the isoelectric point to physiological pH, causing microprecipitation in subcutaneous tissue. The resulting microcrystalline depot dissolves gradually, releasing insulin monomers into capillaries at a constant, peakless rate over ~24 hours.

Indications

• Type 2 diabetes — once-daily basal insulin; alone or combined with oral antidiabetics or bolus insulin
• Type 1 diabetes — basal component in a basal-bolus regimen
• Adults, adolescents, and children aged 6 years and above
• Patients requiring a cost-effective locally manufactured glargine option

How It Works — Mechanism of Action

Glarine (insulin glargine) is formulated at pH 4, making it soluble in the vial. On SC injection into physiological pH 7.4 tissue, it microprecipitates into stable crystals, forming a subcutaneous insulin depot. These microcrystals slowly dissolve, releasing glargine monomers into capillaries at a steady, flat rate over ~24 hours. Glargine activates insulin receptors: promotes GLUT-4-mediated glucose uptake, suppresses hepatic gluconeogenesis and glycogenolysis, and stimulates glycogen and protein synthesis.

Dosage and Administration

Type 2 (insulin-naive): Start 10 IU once daily at the same time each day (bedtime preferred). Titrate by 2 IU every 3 days targeting fasting glucose. Type 1: Individualised dose; typically 40–50% of total daily insulin requirement. Administration: Draw up with insulin syringe, inject SC (abdomen, thigh, or upper arm). Do not administer IV or IM. Do not mix with other insulins.

Side Effects

Very common: Hypoglycaemia.

Common: Injection site reactions, lipohypertrophy, weight gain, peripheral oedema.

Uncommon: Lipoatrophy, visual refraction changes at initiation.

Rare: Generalised hypersensitivity, anaphylaxis.

Drug Interactions

Enhance hypoglycaemia: Oral antidiabetics, GLP-1 agonists, SGLT-2 inhibitors, ACE inhibitors, MAO inhibitors, salicylates, sulfonamides, alcohol.

Reduce effect: Corticosteroids, glucagon, thyroid hormones, sympathomimetics, danazol, oral contraceptives, thiazides.

Mask symptoms: Beta-blockers, clonidine.

Contraindications

• Hypersensitivity to insulin glargine or any excipient
• Active hypoglycaemia; IV or IM administration; mixing with other insulins

Pregnancy and Lactation

Pregnancy: Limited data; consider human insulin (NPH) under specialist supervision. Lactation: No clinically significant infant exposure via breast milk expected.

Precautions and Warnings

• Never mix Glarine with any other insulin — alters glargine's pH-dependent microprecipitation mechanism.
• Rotate injection sites to prevent lipohypertrophy and inconsistent absorption.
• Glarine is a clear solution — do not use if cloudy, discoloured, or particulate.
• Do not freeze. Protect from direct heat and sunlight.

Overdose

Hypoglycaemia. Mild: oral glucose. Severe: IV dextrose or IM glucagon 1 mg. Monitor every 2–4 hours given glargine's ~24 hour duration.

Storage Instructions

• Unopened vial: 2–8°C. Do not freeze.
• In-use vial: Below 25°C. Protect from light.
• Discard 28 days after first use.

Frequently Asked Questions

Q1: Is Glarine the same as Lantus?
Glarine contains the same insulin glargine molecule (100 IU/ml) as Lantus (Sanofi). As a biosimilar/follow-on product, it has demonstrated equivalent clinical efficacy. The key difference is that Glarine is manufactured locally by Incepta Pharmaceuticals in Bangladesh, making it significantly more affordable than the imported originator brand.

Q2: How does Glarine differ from NPH insulin?
Glarine (glargine) provides a flat, peakless ~24-hour profile with no pronounced peak, reducing nocturnal hypoglycaemia risk. NPH insulin has a pronounced peak at 4–8 hours and lasts only 12–18 hours, often requiring twice-daily dosing. Glargine generally offers better glycaemic predictability and lower hypoglycaemia rates than NPH.

Q3: Can Glarine be used in a pen device?
The 3 ml vial formulation requires a standard insulin syringe. For pen use, a compatible 3 ml pen cartridge format would be needed. Check with your pharmacist about available pen-compatible formats of Glarine.

Q4: Why is Glarine clearer (not cloudy) compared to Diasulin or Humulin N?
Glarine (glargine) is formulated as a clear acidic solution (pH 4), unlike NPH/isophane insulins which are cloudy suspensions. The cloudiness of NPH insulins is due to protamine-insulin crystals. Do not be concerned by Glarine's clear appearance — it is correct. Never shake or resuspend it.

Medical Disclaimer: For educational purposes only. Glarine is Rx-only. Consult your diabetologist before starting or changing insulin therapy. DiabetesStore.com.bd is a licensed online pharmacy in Bangladesh.