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INSUGET 70/30 Insulin Human (rDNA) 100IU / mL Suspension for IM/SC Injection 10mL

RXDRUG-BR-1088
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Features

Brand
Insuget 70/30
Full Details
Dosage Strength
100 IU / ml
Drug Ingredients
  • Insulin Human
Drug Packaging
Suspension for Injection (I.M./S.C.) 10ml
Generic Name
Insulin Human (rDNA)
Dosage Form
Suspension for Injection (I.M./S.C.)
Registration Number
BR-1088
Drug Classification
Prescription Drug (RX)
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Description

Indications/Uses

Treatment of patients with type I diabetes mellitus; type II diabetes mellitus either alone or in combination with oral antidiabetic agents; gestational diabetes.
Emergency management of diabetic ketoacidosis.
 

Dosage/Direction for Use

The type of formulation, its dose and the frequency of administration should be determined by the physician, according to the needs suitable to the patient. The dose should be adjusted as necessary according to the results of regular monitoring of glucose concentrations in the blood glucose (or occasionally urine concentrations). A total dose in excess of about 80 units daily would be unusual and may indicate the presence of a form of insulin resistance.
The average daily requirement for diabetes therapy ranges between 0.5 IU/kg and 0.1 IU/kg, depending on the individual needs of the patient. Optimized metabolic control, including glucose monitoring, is therefore recommended during insulin treatment.
Elderly: The primary aim of treatment may be relief of symptoms and avoidance of hypoglycemic events.
Insuget R: May be taken 1-4 times daily, before meals and possibly at bedtime. Regular or rapid-acting insulin should be administered 30-45 min before a meal. It can be mixed in the same syringe with intermediate-acting insulins, but in such situations, the regular insulin is drawn first. Insuget R should be given by SC injection but may, although not recommended, also be given by IM injection. It may also be administered IV. Insuget R is administered SC into the thigh or abdominal wall. If convenient, the gluteal or deltoid region may be used.
Insuget N (NPH): Administered SC into the thigh or abdominal wall, preferably before meals, 1-2 times daily depending upon the requirement of the individual. If convenient, the gluteal or deltoid region may be used. It should be administered about 30 min before a meal. It can also be mixed in the same syringe with short-acting soluble insulins, and in such situations, the regular insulin is drawn first. Insuget N (NPH) cannot be given IV.
Insuget 70/30: A premixed insulin is usually given once or twice daily, preferably just before meals when rapid initial effect together with a more prolonged effect is desired.
Ketoacidosis: Only Insuget R should be used. Treatment includes adequate fluid replacement, usually by infusing sodium chloride 0.9% initially and the administration of potassium salts to prevent or correct hypokalemia. Insulin should be given by continuous IV infusion if possible, although other routes have also been used. Insulin can also be given by IM injection.
Adults: Initial loading dose of 20 units is followed by 6 units every hour until the blood glucose concentration falls to 10 mmol/L, when the dose is given every 2 hrs.
Since insulin normally corrects hyperglycemia before ketosis, it is usually necessary to continue administration of insulin once normoglycemia has been achieved but to change the rehydration fluid to glucose-saline so that the additional glucose prevents the development of hypoglycemia.
Administration: Shake well before use.
Pinch the skin between 2 fingers, push the needle into the skinfold and inject the insulin under the skin.
Keep the needle under the skin for at least 6 sec to make sure all the insulin has been injected.
If blood appears after the needle has been withdrawn, press the injection site lightly with a finger.
 

Contraindications

Hypersensitivity to any components of Insuget R/Insuget N/Insuget 70/30.
Patients with hypoglycemia; coma due to hyperglycemia.
Under no circumstances should Insuget formulation, other than Insuget R, be given IV.
 

Special Precautions

Insulin requirements may change significantly in diseases of the adrenal, pituitary or thyroid glands and in the presence of renal or hepatic impairment.
Insulin requirements may be increased during illness or emotional disturbances.
Care is also necessary during excessive exercise. Hypoglycemia caused by metabolic effects and increased insulin absorption is the usual response, but hyperglycemia may sometimes occur. Adjustment of insulin dosage may also be necessary if patients change their level of physical activity or change their usual diet.
The use of insulin necessitates monitoring of therapy eg, testing of blood or urine for glucose concentrations and the urine for ketones, by the patient.
Local reactions, characterized hypersensitivity may produce urticaria, angioedema and very rarely anaphylactic reactions. If continued therapy with insulin is essential, hyposensitization procedures may need to be performed.
Missed Dose: Timing of insulin doses is extremely important. The best approach is to measure blood glucose and add a dose of regular insulin if glucose levels are too high. Otherwise, wait for the next scheduled dose.
Stopping Insuget: Do not stop taking insulin injections unless ordered by the doctor. Patients with diabetes are often given general instructions for modifying their insulin doses based on home blood glucose measurements.
Use in pregnancy: It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patients throughout pregnancy. Insulin requirements usually fall during the 1st trimester and increase during the 2nd and 3rd trimesters. Patients with diabetes should be advised to inform their doctors if they are pregnant or are contemplating pregnancy.
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Use in lactation: There are no restrictions in insulin treatment while treating a diabetic nursing mother, as it involves no risk to the baby. However, the insulin dosage may need to be reduced.
 

Use In Pregnancy & Lactation

Use in pregnancy: It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patients throughout pregnancy. Insulin requirements usually fall during the 1st trimester and increase during the 2nd and 3rd trimesters. Patients with diabetes should be advised to inform their doctors if they are pregnant or are contemplating pregnancy.
Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Use in lactation: There are no restrictions in insulin treatment while treating a diabetic nursing mother, as it involves no risk to the baby. However, the insulin dosage may need to be reduced.
 

Adverse Reactions

Hypoglycemia is the most frequently occurring undesirable effect of insulin therapy that a patient with diabetes may suffer. Symptoms of hypoglycemia usually occur suddenly. They may include cold sweat, cool pale skin, nervousness or tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, headache, nausea and palpitation.
Severe hypoglycemia may lead to unconsciousness and may result in temporary or permanent impairment of brain function or even death.
Weight gain is common when taking insulin.
Edema and refraction anomalies may occur upon initiation of insulin therapy. Local hypersensitivity reactions (redness, swelling and itching at the injection site) are those transitory reactions, which may occur during the treatment with insulin and normally disappear during continued treatment.
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection site within an area.
Generalized hypersensitivity reactions may occur occasionally and can cause generalized skin rash, itching, sweating, gastrointestinal upset, angioneurotic edema, difficulties in breathing, palpitation and reduction in blood pressure. These are potentially life-threatening.
 

Drug Interactions

Beta-blocking agent may mask the symptoms of hypoglycemia. Some of the drugs leading to reduced insulin requirement: Oral hypoglycemic agents. octreotide, monoamine oxidase inhibitor, nonselective β-blocking agents, angiotensin-converting enzyme inhibitors, salicylates, alcohol and alcohol steroids.
Some of the drugs leading to increase insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and sympathomimetics, danazol.
Incompatibilities: In general terms, insulin should only be added to compounds with which it is known to be compatible. Insulin suspensions should not be added in infusion fluids.
 

Caution For Usage

Direction for Use: Care should be taken when injecting any human insulin rDNA origin injection. The injection site should not be massaged. Patients must be educated to use proper injection techniques.
Before injecting the insulin: 1. Disinfect the rubber stopper.
2. Roll the vial between the palms of the hands, making sure that there are no suspended impurities. For Insuget N and Insuget 70/30, the liquid should be uniformly white and cloudy.
3. Draw into the syringe the same amount of air as the dose of insulin to be injected.
4. Inject the air to the vial.
5. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Withdraw the needle and expel the air from the syringe and check that the dose is correct.
6. Inject immediately.
Do not use if the insulin substance (white material) remains at the bottom after mixing. Do not use if there are changes in the insulin after mixing. Do not use if solid white particles stick to the bottom or wall of the bottle, giving it a frosted appearance.
Injection sites should be rotated within an anatomic region in order to avoid lipodystrophy. An injection should be followed within 30 min by a meal or a snack containing carbohydrates.
Do not reuse needles. Dispose needle in a responsible manner. Needles must not be shared.
 

Storage

Store at temperatures between 2-8°C. Do not freeze. Do not expose to excessive heat and direct sunlight.
Once in use, the vial can be kept at a room temperature (up to 25°C) for up to 6 weeks. Do not use beyond this period.
 

Action

Pharmacology: Mechanism of Action: The major effects of insulin on carbohydrate homeostasis following its binding to specific cell-surface receptors on insulin-sensitive tissues, notably the liver, muscles and adipose tissue. It inhibits hepatic glucose production and enhances peripheral glucose disposal thereby reducing blood-glucose concentration. It also inhibits lipolysis thereby preventing the formation of ketone bodies.
Pharmacokinetics: Absorption: Insulin is fairly rapidly absorbed from subcutaneous tissue following injection. Insulin in the blood stream has a t½ of a few minutes. The rate of absorption from different anatomical sites may be different depending on local blood flow, with absorption from the abdomen being faster than that from the arm and that from the arm faster than from the buttock or thigh. Absorption may also be increased by exercise. The absorption of insulin after IM administration is more rapid than that following SC administration.
Metabolism and Excretion: Insulin is rapidly metabolized, mainly in the liver but also in the kidneys, and muscle tissue. In the kidneys it is reabsorbed in the proximal tubule and either returned to venous blood or metabolized, with only a small amount excreted unchanged in the urine.
 

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