APIDRA Injection
Insulin Glulisine
100 Units/ml
SANOFI AVENTIS DEUTSCHLAND GmbH
| Pack size | 10ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | PHARMATRADE |
| Retail Price | 141.50 AED |
Available as:
Indications
APIDRA Injection is used for:
Diabetes mellitus
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.
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)
Contra Indications
Hypoglycaemia.Hypersensitivity to any of the components.
Precautions
Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation.
Lactation: Considered safe during breastfeeding
Pregnancy-Lactation
Pregnancy
Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity
Animal data
Animal reproduction studies have been conducted with insulin glulisine in rats and rabbits using regular human insulin as a comparator; insulin glulisine was given to female rats throughout pregnancy at subcutaneous doses up to 10 units/kg/day (2 times the average human dose, based on body surface area comparison) and to rabbits during organogenesis at subcutaneous doses up to 1.5 units/kg/day (0.5 times the average human dose, based on body surface area comparison); effects did not differ from those observed with subcutaneous regular human insulin
Lactation
Available data from published literature suggest that human insulin products are transferred into human milk; there are no adverse reactions reported in breastfed infants in literature; there are no data on effects of exogenous human insulin products, on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant or from underlying maternal condition
Interactions
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.
Adverse Effects
Side effects of Insulin Glulisine :
Hypoglycaemia, Inj site reactions, lipodystrophy, local and systemic hypersensitivity reactions.
Mechanism of Action
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.
Note
APIDRA 100 Units/ml Injection manufactured by SANOFI AVENTIS DEUTSCHLAND GmbH. Its generic name is Insulin Glulisine. APIDRA is availble in United Arab Emirates.
Farmaco UAE drug index information on APIDRA Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.