Insulatard Sc.
Insulatard Sc. Uses, Dosage, Side Effects, Food Interaction and all others data.
Insulin Human (rDNA) is human insulin made by recombinant DNA technology. It has the same structure and function as natural insulin. Insulin regulates the glucose metabolism and stimulates the ingestion and utilization of glucose by liver, muscle and fat tissue. It also lowers blood glucose by accelerating glycogenesis and inhibiting gluconeogenesis.
Insulin Human (rDNA) R starts action within 30 minutes after injection, reaches its peak within 1.5-3.5 hours and lasts about 7-8 hours. Insulin Human (rDNA) N starts action within 1.5 hours after injection, reaches its peak within 4-12 hours & lasts about 24 hours.
Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Postprandial insulin spikes are responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis).
| Trade Name | Insulatard Sc. |
| Generic | Insulin human |
| Insulin human Other Names | High molecular weight insulin human, Human insulin, Insulin (human), Insulin human, Insulin Human Regular, Insulin recombinant human, Insulin recombinant purified human, Insulin regular, Insulin, human, Insulina regular, Neutral insulin, Regular Insulin, human, Soluble insulin |
| Type | Injection |
| Formula | C257H383N65O77S6 |
| Weight | 5808.0 Da |
| Groups | Approved, Investigational |
| Therapeutic Class | Medium Acting Insulin |
| Manufacturer | Novo Nordisk India Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Treatment of all patients with type 1 diabetes. Treatment of patients with type 2 diabetes who are not adequately controlled by diet and/ or oral hypoglycemic agents.
For the initial stabilization of diabetes in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients. Treatment of gestational diabetes.
Insulatard Sc. is also used to associated treatment for these conditions: Diabetes Mellitus, Type 1 Diabetes Mellitus
How Insulatard Sc. works
The primary activity of insulin is the regulation of glucose metabolism. Insulin promotes glucose and amino acid uptake into muscle and adipose tissues, and other tissues except brain and liver. It also has an anabolic role in stimulating glycogen, fatty acid, and protein synthesis. Insulin inhibits gluconeogenesis in the liver. Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism and catabolism.
Dosage
Insulatard Sc. dosage
The average range of total daily insulin requirement for maintenance therapy in type 1 diabetic patients lies between 0.5 and 1.0 IU/kg. In pre-pubertal children it usually varies from 0.7 to 1.0 IU/kg, whereas in insulin resistant cases, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for type 2 diabetic patients are often lower, e.g. 0.3 to 0.6 IU/kg/day.
The dosage form, the dosage and the administration time of the insulin are different due to the individual differences of each patient. In addition, the dosage is also affected by food, working style and exercising intensity. Therefore, patients should use the insulin under doctor's instruction.
An injection should be followed by a meal or snack containing carbohydrates within 30 minutes. Injection is administered subcutaneously in the upper arm, thigh, buttock or abdominal wall. A subcutaneous injection into the abdominal wall results in a faster absorption than from other injection sites. Insulin Human (rDNA) R can be given intravenously only by the physician in emergency situations. However, Insulin Human (rDNA) N, is never to be administered intravenously.Preparation before use:
- Clean your hands.
- Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
- In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab.
- Draw air into your syringe equal to the amount of insulin needed.
- Puncture the needle into the vial and inject the air.
- Turn the bottle and syringe upside down and withdraw correct dose of insulin into the syringe.
- Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles.
Injection site:
- Choose the area where skin is less tight, such as the upper arm, thigh, buttock or abdomen.
- To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.
Injection method:
- Cleanse the skin with alcohol where the injection is to be made.
- Put the needle in such a position as to form 45° angle with the skin.
- Puncture the needle into skin and inject insulin.
- Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected.
- Pull the needle out and apply gentle pressure over the injected site for several seconds.
- Do not rub the injection site.
Side Effects
Hypoglycemia is the most common adverse effect during insulin treatment and symptoms of hypoglycemia may occur suddenly. Few cases of the allergic reaction such as red and swollen or itching are reported. It usually disappears in a few days. In some instances, the allergy may be caused by other reasons rather than insulin, such as disinfectant and poor injection technique.
Precaution
Inadequate dosing or discontinuation especially in type 1 diabetes, may lead to hyperglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycemia.
Interaction
When using oral contraceptive drug, adrenal cortical hormone, thyroid hormone, etc., the drugs that can result in the rise of blood glucose; you might need to increase the amount of Insulin. When using drugs with hypoglycemic activities, salicylate, sulfanilamide and other anti-depressants, which will result in the decrease of blood glucose, the dosage of insulin should be reduced.
Food Interaction
- Avoid alcohol. Alcohol may impair blood glucose control.
Elimination Route
When injected subcutaneously, the glucose-lowering effect of human insulin begins approximately 30 minutes post-dose. After a single subcutaneous administration of 0.1 unit/kg of human insulin to healthy subjects, peak insulin concentrations occurred between 1.5 to 2.5 hours post-dose.
When administered in an inhaled form (as the product Afrezza), the time to maximum serum insulin concentration ranges from 10-20 minutes after oral inhalation of 4 to 48 units of human insulin. Serum insulin concentrations declined to baseline by approximately 60-240 minutes for these dose levels. Intrapatient variability in insulin exposure measured by AUC and Cmax is approximately 16% (95% CI 12-23%) and 21% (95% CI 16-30%), respectively.
Half Life
Systemic insulin disposition (apparent terminal half-life) following oral inhalation of 4 to 48 units of human insulin was 120-206 minutes.
Elimination Route
Following oral inhalation of human insulin, a mean of 39% of the inhaled dose of carrier particles was distributed to the lungs and a mean of 7% of the dose was swallowed. The swallowed fraction was not absorbed from the GI tract and was eliminated unchanged in the feces.
Pregnancy & Breastfeeding use
There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. Insulin treatment of the nursing mother presents no risk to the baby.
Contraindication
Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.
Acute Overdose
Excessive use of insulin may lead to hypoglycemia during the treatment. Slight to moderate hypoglycemia may suddenly occur. It is important to get immediate treatment when hypoglycemia occurs. If you have frequent hypoglycemia, you should consult your doctor to discuss possible changes in therapy, diet plans, and/or exercise programs to help you avoid hypoglycemia.
Storage Condition
Store at 2°C - 8°C in a refrigerator. Do not freeze. In case of insulin for recent use need not be refrigerated, try to keep it in a cool place and keep away from heat and light. The insulin in use can be kept under the room temperature for a month.
Innovators Monograph
You find simplified version here Insulatard Sc.
Insulatard Sc. contains Insulin human see full prescribing information from innovator Insulatard Sc. Monograph, Insulatard Sc. MSDS, Insulatard Sc. FDA label
FAQ
What is Insulatard Sc. used for?
Insulatard Sc. is used to treat type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulatard Sc. is also used to control blood sugar in people who have type 1 diabetes (condition in which the body does not make insulin and therefore cannot control the amount of sugar in the blood) or in people who have type 2 diabetes.
How safe is Insulatard Sc.?
Insulatard Sc. is as safe and effective as newer, more expensive insulin analog drugs for people with type 2 diabetes, researchers report.
How does Insulatard Sc. work?
Insulatard Sc. works by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.
What are the common side effects of Insulatard Sc.?
Common side effects of Insulatard Sc. are include: Hypoglycemia, or low blood sugar, headache, hunger, dizziness, sweating, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal).
Is Insulatard Sc. safe during pregnancy?
The FDA has received sufficient human data allowing these to be considered low risk in pregnancy. Therefore, it is safe for the baby.
Is Insulatard Sc. safe during breastfeeding?
Insulatard Sc. is safe for use while breastfeeding. There are clinical studies that report a possible decreased risk of type 1 diabetes in infants breastfed by mothers treated with insulin.
Can I drink alcohol with Insulatard Sc.?
Unlike some medications (such as benzodiazepines, which are dangerous to consume alongside alcohol under any circumstances), insulin and alcohol “do not interact directly.
Can I drive after taking Insulatard Sc.?
Checking your blood sugar or treating a high or low blood sugar should not be done while driving. If low, don't begin driving again until you have treated it and your blood sugar is back to a safe level.
When should be taken of Insulatard Sc.?
Insulatard Sc. is usually taken before meals. You should eat your meal within 30 minutes after giving an injection.
Can I take Insulatard Sc. on an empty stomach?
Yes, you can take Insulatard Sc. on an empty stomach.
How many times a day can I take Insulatard Sc.?
Most people who have diabetes and take insulin need at least 2 insulin shots a day for good blood sugar control. Some people need 3 or 4 shots a day.
How long does Insulatard Sc. take to work?
Rapid-acting Insulatard Sc. starts working in about 15 minutes.
How long does Insulatard Sc. stay in my system?
Intermediate-acting insulin finds its way into your bloodstream within 2 to 4 hours and is effective for about 18 hours. Long-acting insulin starts working within a few hours and keeps glucose levels even for about 24 hours.
Can Insulatard Sc. be taken long term?
Insulatard Sc. regular injectable solution is used for long-term treatment.
Can a person stop taking Insulatard Sc.?
Injected Insulatard Sc. can be used for several days or weeks to reduce glucose and help the pancreas to revert back to its usual level of functioning a level that can control glucose supported by oral medicines. Once this occurs, insulin can be stopped.
Is Insulatard Sc. bad for my kidneys?
It controls how much sugar is in your blood. A high level of sugar in your blood can cause problems in many parts of your body, including your heart, kidneys, eyes, and brain. Over time, this can lead to kidney disease and kidney failure.
Who should not take Insulatard Sc.?
Adults with Type 1 diabetes. Adults with Type 2 diabetes. Children over 4 with Type 1 diabetes. Do not take Insulatard Sc. if you are having symptoms of low blood sugar.
What happen if I take too much Insulatard Sc.?
Excess Insulatard Sc. in the bloodstream causes cells in your body to absorb too much glucose (sugar) from your blood. It also causes the liver to release less glucose. These two effects together create dangerously low glucose levels in your blood. This condition is called hypoglycemia.
What happen If I missed Insulatard Sc.?
If you forget to take your long term Insulatard Sc. and you realise relatively soon, it should usually be fine to inject your usual dose if the dose is given within 2 hours of when it should have been done.
Can Insulatard Sc. affect my heart?
Take too much insulin in the blood (hyperinsulinemia) contributes to heart failure by triggering a molecular chain reaction that damages heart muscle cells.
