Diasulin®

Insulin Human (rDNA) USP Sterile injection

Prescribing Details



Description

Diasulin® is human insulin made by DNA recombinant technology so it has the same structure and function as natural insulin. The product can regulate the glucose metabolism and stimulate theingestion and utilization of glucose by liver, muscles, and fat tissue. It can accelerate the transformation from glucose to glycogen stored in muscles and liver and inhibit the gluconeogenesis, thus, to lower the blood glucose.
Pharmacokinetic profiles of different Diasulin® preparations are as follows:

  Onset of action Time to reach Cmax (Tmax) Duration of action
Diasulin® R 30 min 1 – 3 hours 4 – 6 hours
Diasulin® N 1-2 hours 6 – 12 hours 18 – 24 hours
Diasulin® 30/70 30 min 2 – 12 hours 18 – 24 hours

Uses

No Data


Indications

Diasulin ® is indicated for the following conditions:

  • Patients with type-1 Diabetes Mellitus.
  • Patients with type-2 Diabetes Mellitus who are not adequately controlled by diet and/oral hypoglycemic agents.
  • Diabetes Mellitus in patients with diabetic ketoacidosis, hyperosmolar non-ketotic syndrome and during periods of stress such as severe infections and major surgery in diabetic patients.
  • In gestational diabetes

Dosage and administration

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.

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 1.0IU/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.


Use in pregnancy & lactation

1. Diasulin ® should be injected subcutaneously 15 minutes to one hour before meal. The exact time for administration is suggested by doctors with regard to each individual's case.
2. Procedure for Insulin Administration
Before going for administration of Diasulin ® please follow the below mentioned check list:

  • Insulin syringe of the right size
  • Prescribed type of Diasulin ® injection
  • Check the expiry date on Diasulin® vial
  • Ensure that the flip-off cap on the Diasulin ® vial is intact


After that follow the below mentioned instructions as per given picture: acilog

Pregnancy & lactation
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.


Geriatric use
No Data

Precautions

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.


Side effects

Hypoglycemia is the most common side 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.


Contraindications

Hypoglycemia or the patients who have allergic reaction to insulin or any of the excipients.


Drug interactions

When using oral contraceptive drug, adrenal cortical hormone, hypothyroid 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.


Overdose

Insulin overdose may result in hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Severe hypoglycemia may be treated with parenteral glucose or injections of glucagon. Adjustments in drug dosage, meal patterns, or exercise may be needed.


Preparation

No Data


Pharmaceutical precautions

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.


Presentation
Diasulin® R Injection 40 IU/ml: Each ml solution contains Insulin Human (rDNA) USP 40 IU (equivalent to 1.388 mg) as Soluble Insulin Human (Regular).
Diasulin® R Injection 100 IU/ml: Each ml solution contains Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) as Soluble Insulin Human (Regular).
Diasulin® N Injection 40 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 40 IU (equivalent to 1.388 mg) as Isophane Insulin Human.
Diasulin® N Injection 100 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) as Isophane Insulin Human.
Diasulin® 30/70 Injection 40 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 40 IU (equivalent to 1.388 mg) as 30% Soluble Insulin Human (Regular) and 70% Isophane Insulin Human.
Diasulin® 30/70 Injection 100 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) as 30% Soluble Insulin Human (Regular) and 70% Isophane Insulin Human.
Diasulin® 50/50 Injection 40 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 40 IU (equivalent to 1.388 mg) as 50% Soluble Insulin Human (Regular) and 50% Isophane Insulin Human.
Diasulin® 50/50 Injection 100 IU/ml: Each ml suspension contains Insulin Human (rDNA) USP 100 IU (equivalent to 3.47 mg) as 50% Soluble Insulin Human (Regular) and 50% Isophane Insulin Human.

Package quantities
Diasulin ® R Injection 40 IU/ml: Each box contains 10 ml solution in glass vial.
Diasulin ® R Injection 100 IU/ml: Each box contains 10 ml solution in glass vial.
Diasulin ® N Injection 40 IU/ml: Each box contains 10 ml suspension in glass vial.
Diasulin ® N Injection 100 IU/ml: Each box contains 10 ml suspension in glass vial.
Diasulin ® 30/70 Injection 40 IU/ml: Each box contains 10 ml suspension in glass vial.
Diasulin ® 30/70 Injection 100 IU/ml: Each box contains 10 ml suspension in glass vial.
Diasulin ® 50/50 Injection 40 IU/ml: Each box contains 10 ml suspension in glass vial.
Diasulin ® 50/50 Injection 100 IU/ml: Each box contains 10 ml suspension in glass vial.