Uses of Apidra (5cartridges of 3ml): - Diabetes mellitus (Type 1 & Type 2) Diabetes mellitus Hypoglycaemia.Hypersensitivity to any of the components.

Rapid Acting Insulin

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis. The glucose lowering activities of Insulin Glulisine and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Insulin Glulisine is more rapid in onset and of shorter duration compared to regular human insulin.

How to use Insulin Glulisine: Your doctor or nurse will guide you how to use this medicine. Administration: SC injection Administer within 15 minutes before a meal or within 20 minutes after starting a meal When administered by SC injection, insulin glulisine should generally be used in regimens with an intermediate- or long-acting insulin Administered by SC injection in the abdominal wall, thigh, or upper arm Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy IV administration May be administered IV while under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia When administered IV, use concentrations of 0.05-1 unit/mL in infusion systems using PVC bags Stable only in 0.9% NaCl (normal saline) Adult Dose: Subcutaneous Diabetes mellitus Dose should be individualised and depends on patient's needs. Usual range: 0.5-1 u/kg/day. Dosing considerations Equipotent to regular human insulin (ie, elicits same glucose lowering effects on unit per unit basis) when administered IV Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin Dosage must be individualized; blood glucose monitoring is essential in all patients receiving insulin therapy Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs Hepatic impairment: Dose reduction may be needed. Child Dose: Type 1 Diabetes Mellitus Indicated to improve glycemic control in adults and children with diabetes mellitus <4 years: Safety and efficacy not established 4-17 years: May require 0.8-1.2 units/kg/day SC during growth spurts; otherwise use adult dosing (0.5-1 unit/kg/day) Renal Dose: Renal impairment: Dose reduction may be needed.

Possible absence of hypoglycaemic warning symptoms with beta-blockers. Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotics (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.

Hypoglycaemia.Hypersensitivity to any of the components.

Common - Hypoglycemia (low blood glucose level) - Injection site allergic reaction - Itching - Rash - Lipodystrophy (skin thickening or pits at the injection site) Hypoglycaemia, Inj site reactions, lipodystrophy, local and systemic hypersensitivity reactions.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risksNursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Precaution: Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation. Lactation: Considered safe during breastfeeding

Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Unopened Insulin Glulisine vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Insulin Glulisine should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.

Rapid Acting Insulin

Insulin glulisine is a rapid acting human insulin analog produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine and insulin human are equipotent on a unit-for-unit basis. Insulin glulisine has a more rapid onset and shorter duration of action compared with insulin human after subcutaneous admin.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risksNursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.