Finished product reference
Insulin Glargine
Injection · Parenteral · 300 IU/1mL · 3 mL
- List code
- 53504
- Pharmacologic class
- Insulin Analog
What it is and how it works
Mechanism of Action The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Indications
® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use : Not recommended for treating diabetic ketoacidosis. Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Dosage and administration (summary)
Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use. ( 2.2 , 2.3 , 2.4 ) Administer subcutaneously once daily at any time of day, but at the same time every day. Rotate injection sites into the abdominal area, thigh, or deltoid to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter. Do not dilute or mix with any other insulin or solution. Important Administration Instructions Always check insulin labels before administration .
Contraindications
is contraindicated: During episodes of hypoglycemia . In patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR . During episodes of hypoglycemia. Hypersensitivity to BASAGLAR or any of its excipients.
Warnings and precautions
Never share a BASAGLAR prefilled pen between patients, even if the needle is changed. Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity.
Pregnancy
Pregnancy Risk Summary Published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).
Storage and supply
Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect BASAGLAR from heat and light. Do not freeze BASAGLAR. In-use BASAGLAR prefilled pens must be used within 28 days or be discarded, even if they still contain BASAGLAR.
Source: Insulin Glargine (Basaglar Kwikpen) — US FDA prescribing information, 2026-06-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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