Basagine Special Precautions

Dosage adjustment and monitoring: Glucose monitoring is essential for all patients receiving insulin therapy.
Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.
As with all insulin preparations, the time course of action for Insulin Glargine (Basagine) may vary in different individuals or at different times in the same individual and is dependent on many conditions including the local blood supply, local temperature, and physical activity.
Administration: Do not administer Insulin Glargine intravenously or via an insulin pump. The intended duration of activity of Insulin Glargine is dependent on injection into subcutaneous tissue.
Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia. Do not dilute or mix Insulin Glargine with any other insulin or solution. If Insulin Glargine is diluted or mixed, the solution may become cloudy, and the pharmacokinetic or pharmacodynamic profile (e.g., onset of action, time to peak effect) of Insulin Glargine and the mixed insulin may be altered in an unpredictable manner.
Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Insulin Glargine. The risk of hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and manage hypoglycemia. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), exercise, and concomitant medications may also alter the risk of hypoglycemia.
The prolonged effect of subcutaneous Insulin Glargine may delay recovery from hypoglycemia. Patients being switched from twice daily NPH insulin to once-daily Insulin Glargine should have their initial Insulin Glargine dose reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycaemia.
As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as betablockers, or intensified glycemic control. These situations may result in severe hypo glycaemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia.
Hypersensitivity and allergic reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Insulin Glargine.
Renal impairment: Due to its long duration of action, Insulin Glargine is not recommended during periods of rapidly declining renal function because of the risk for prolonged hypoglycemia.
Although studies have not been performed in patients with diabetes and renal impairment, a reduction in the Insulin Glargine dose may be required in patients with renal impairment because of reduced insulin metabolism, similar to observations found with other insulins.
Hepatic impairment: Due to its long duration of action, Insulin Glargine is not recommended during periods of rapidly declining hepatic function because of the risk for prolonged hypoglycemia.
Although studies have not been performed in patients with diabetes and hepatic impairment, a reduction in the Insulin Glargine dose may be required in patients with hepatic impairment because of reduced capacity for gluconeogenesis and reduced insulin metabolism, similar to observations found with other insulins.
Drug interaction: Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia or hyperglycemia.
Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin Glargine, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
Use in Children: The safety and effectiveness of subcutaneous injections of Insulin Glargine have been established in pediatric patients (age 6 to 15years) with type 1 diabetes. Insulin Glargine has not been studied in pediatric patients younger than 6 years of age with type 1diabetes. Insulin Glargine has not been studied in pediatric patients with type 2 diabetes.
Use in Elderly: Caution should be exercised when c is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.