Pregnancy (insulin requirements tend to fall during the 1st trimester, increase during the 2nd and 3rd) and lactation. Caution with decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment
Hypokalemia may occur
Not for IV or IM administration
Use with caution in renal and hepatic impairment (dosage requirements may be reduced)
Caution with increased insulin requirements: Fever, hyperthyroidism, trauma, infection, surgery
Lactation: Safe to use while breastfeeding
Indication
Diabetes mellitus
Contra Indication
Hypoglycaemia.Hypersensitivity to any of the components.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Insulin lowers blood glucose levels. It regulates carbohydrate, protein and fat metabolism by inhibiting hepatic glucose production and lipolysis, and enhancing peripheral glucose disposal. The various insulin formulations are classified according to their durations of action after SC Inj. They are divided into short-, intermediate-, or long-acting insulin. Soluble insulin (also known as 'neutral insulin' or 'regular insulin') is a short-acting preparation.
To extend the duration of action of insulin, preparations are formulated as suspensions in 2 methods. The 1st method involves complexing insulin with a protein so that it is slowly released, e.g. protamine zinc insulin (contains an excess of protamine) and isophane insulin (or NPH insulin which contains equal amounts of protamine and insulin). An alternative method is particle size modification e.g. insulin zinc suspensions. While all the formulations can be admin by SC inj, most by IM inj, only soluble insulin can be admin by IV. Compared to SC inj, IM admin usually has a faster onset of action, with a shorter duration of action.
Interaction
Oral hypoglycemic agents, MAOIs, nonselective beta-blocker, ACE inhibitors, salicylates, alcohol, anabolic steroids & sulphonamides may reduce insulin requirement. OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics & danazol may increase insulin requirements.
Octreotide/lanreotide may both decrease & increase insulin requirement. beta-blockers may mask symptoms of hypoglycemia. Alcohol may intensify or reduce hypoglycemic effect of insulin.
Pregnancy Category Note
Pregnancy
Available data from published studies over decades have not established association with human insulin 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; animal reproduction studies were not performed
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
Lactation
Available data from published literature suggests that exogenous human insulin products, are transferred into human milk; there are no adverse reactions reported in breastfed infants in the literature; there are no data on effects of exogenous human insulin products, on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother?s clinical need for therapy, and any potential adverse effects on breastfed infant from drug, or from underlying maternal condition
Adult Dose
Subcutaneous
Type 1 Diabetes Mellitus
Suggested guidelines for beginning dose
Ketones moderate or less: 0.5 U/kg/day SC
Ketones large: 0.7 U/kg/day SC
Typically, 50-75% of total daily dose is given as intermediate- or long-acting insulin
Type 2 Diabetes Mellitus
Suggested guidelines for beginning dose; adjust according to blood glucose levels
Initial dose: 0.5-1 units/kg/day in divided doses
Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
Typically, 50-75% of total daily dose is given as intermediate- or long-acting insulin
Morning
Give two thirds of daily insulin SC
Ratio of regular insulin to NPH insulin 1:2
Evening
Give one third of daily insulin SC
Ratio of regular insulin to NPH insulin 1:1
Dosing Considerations
Dosage of human insulin, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect
Dose adjustments should be based on regular blood glucose testing
Change insulin doses in small increments: Type 1 diabetes (2 unit change); type 2 diabetes (2-4 unit change). Look for consistent pattern in blood sugars for >3 days
Adjust to achieve appropriate glucose control
Hepatic impairment: Dosage reduction may be needed.
Child Dose
Subcutaneous
Type 1 Diabetes Mellitus
Suggested guidelines for beginning dose
Ketones moderate or less: 0.5 U/kg/day SC
Ketones large: 0.7 U/kg/day SC
Renal Dose
Renal impairment: Dose adjustments may be needed.
Administration
Administer within 15 min before a meal or immediately after a meal. Administer subcutaneously in the upper arm, thigh or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.