Insulatard Flexpen

INSULATARD FLEXPEN 100 IU/ml

Insulatard Flexpen is an intermediate-acting human insulin preparation used to manage blood sugar levels in individuals with diabetes mellitus. It is presented in a pre-filled pen for convenient administration.

Name

• Common Name: Isophane Insulin Human (NPH insulin)
• Brand Name: Insulatard Flexpen
• Manufacturer: Novo Nordisk India Pvt Ltd

Composition

• Active Ingredient: Human insulin (isophane/NPH insulin) 100 International Units (IU) per ml. Each 3 ml pre-filled pen contains 300 IU of human insulin.
• Other Ingredients: Zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), protamine sulphate, and water for injections. The human insulin is produced using recombinant DNA technology in Saccharomyces cerevisiae.

Uses

Insulatard Flexpen is prescribed for the treatment of:

• Type 1 Diabetes Mellitus: To provide basal insulin coverage and help regulate glucose metabolism.
• Type 2 Diabetes Mellitus: When blood sugar levels are not adequately controlled by diet and/or oral hypoglycemic agents.
• Gestational Diabetes: For management during pregnancy.
• Diabetic Ketoacidosis and Hyperosmolar Non-Ketotic Syndrome: For initial stabilization.
• Periods of Stress: During severe infections or major surgery in diabetic patients.

Insulatard is an intermediate-acting insulin that begins to lower blood sugar approximately 1.5 hours after injection, with its effects lasting for about 24 hours. It works by facilitating glucose uptake into muscle and fat cells and inhibiting glucose production by the liver.

Dosage and Administration

• Dosage: Individualized based on patient needs, usually ranging from 0.3 to 1.0 IU/kg/day, as determined by a physician. It can be used alone or combined with fast-acting insulin.
• Administration: Administered via subcutaneous injection (under the skin) into the thigh, abdominal wall, gluteal region, or deltoid region. Injection sites should be rotated within the chosen area to minimize risks like lipodystrophy.
• FlexPen Use: The Flexpen allows dose selection from 1 to 60 units in 1-unit increments. Before each injection, the insulin suspension must be resuspended by moving the pen up and down until it appears uniformly white and cloudy. The needle should remain under the skin for at least 6 seconds after injection to ensure full dose delivery.
• Important: Insulatard Flexpen is for subcutaneous use only and should not be injected intravenously (directly into a vein) or intramuscularly. It should not be used in insulin infusion pumps.

Side Effects

• Common:
  • Hypoglycemia (low blood sugar), characterized by cold sweats, pale skin, nervousness, tremors, anxiety, unusual tiredness, confusion, headache, nausea, and palpitations.
  • Injection site reactions such as redness, itching, pain, and swelling.
• Other: Weight gain, edema (fluid retention), and lipodystrophy (abnormal fat tissue changes at injection sites).
• Serious (rare): Hypokalemia (low potassium levels) which can lead to serious cardiac or respiratory issues.

Precautions

• Hyperglycemia and Ketoacidosis: Inadequate dosing or abrupt discontinuation, particularly in Type 1 diabetes, can lead to hyperglycemia and potentially fatal diabetic ketoacidosis.
• Hypoglycemia: Risk is increased by high insulin doses, missed meals, strenuous exercise, or alcohol consumption. Patients with significantly improved blood glucose control or long-standing diabetes may experience altered warning signs of hypoglycemia.
• Special Populations: Caution is advised in patients with kidney or liver impairment, and in the elderly, requiring intensified glucose monitoring and potential dose adjustments.
• Pregnancy and Lactation: Generally considered safe, but dose adjustments may be necessary.
• Alcohol: Can intensify or reduce the hypoglycemic effect of insulin; caution is advised.
• Drug Interactions: Certain medications (e.g., thiazides, glucocorticoids, beta-blockers, some growth hormones) can affect insulin requirements.
• Driving: Hypoglycemia or hyperglycemia can impair concentration and reaction time, posing a risk when driving or operating machinery.
• General: Needles and Insulatard Flexpens should not be shared. Do not use the product if it has been frozen or if the resuspended insulin does not appear uniformly white and cloudy.

Storage

• Unopened: Store in a refrigerator between 2°C and 8°C. Do not freeze. Protect from light by keeping the pen in its outer carton.
• In-use/Opened/Spare: Do not refrigerate. Can be stored at room temperature (below 30°C, some sources state below 25°C) for a maximum of 6 weeks. Keep the pen cap on to protect from light and excessive heat.

Here are the most frequently asked questions about Insulatard Flexpen by Novo Nordisk India Pvt Ltd, along with their concise answers:

What is Insulatard Flexpen used for?

Insulatard Flexpen is an intermediate-acting human insulin used to improve blood sugar control in adults and children with Type 1 and Type 2 diabetes mellitus. It can also be used during gestational diabetes and for initial stabilization in patients with diabetic ketoacidosis or during periods of stress like severe infections or major surgery.

How does Insulatard Flexpen work?

Insulatard Flexpen contains insulin isophane (NPH insulin), which is an intermediate-acting insulin. It works by replacing the insulin naturally produced by the body. This insulin facilitates the uptake of sugar from the blood into muscle and fat cells, where it is used for energy. It also suppresses the production of glucose by the liver, thereby lowering blood sugar levels. The effect typically starts within 1.5 hours, reaches a maximum effect between 4 and 12 hours, and lasts for approximately 24 hours.

What is the usual dosage of Insulatard Flexpen?

The dosage of Insulatard Flexpen is highly individual and determined by your physician based on your specific needs. The typical daily insulin requirement usually ranges between 0.3 and 1.0 International Units (IU) per kg of body weight per day. This requirement can be higher in individuals with insulin resistance (e.g., during puberty or due to obesity) and lower in those with some natural insulin production. Your doctor will determine if one or multiple daily injections are necessary, and it can be used alone or in combination with fast-acting insulin. The FlexPen allows for dialing doses from 1 to 60 units in 1-unit increments.

What are the possible side effects of Insulatard Flexpen?

The most common side effect is hypoglycemia (low blood sugar), which can cause symptoms like cold sweats, cool pale skin, nervousness, tremor, anxiety, unusual tiredness, confusion, difficulty concentrating, drowsiness, excessive hunger, vision changes, headache, nausea, and palpitation. Other possible side effects include injection site reactions such as redness, itching, pain, swelling, and lipodystrophy (changes in fat tissue under the skin due to repeated injections in the same area). Rarely, more generalized allergic reactions, weight gain, or changes in vision may occur.

Is Insulatard Flexpen safe during pregnancy or breastfeeding?

Pregnancy: Insulatard Flexpen is generally considered safe for use during pregnancy. Maintaining good blood sugar control is crucial for the health of both the mother and the baby. Your doctor may need to adjust your insulin dose as pregnancy progresses. Breastfeeding: It is safe to use Insulatard Flexpen while breastfeeding. Insulin is a natural component of breast milk, and the amount of exogenous insulin that passes into breast milk is not expected to cause harm to the infant. However, the mother's insulin dose may need adjustment during this period.

Can Insulatard Flexpen be taken with other medications?

Many medications can interact with Insulatard Flexpen, either reducing or increasing your insulin requirements.

• Medicines that may reduce insulin requirements (increasing hypoglycemic effect): Oral hypoglycemic agents, MAO inhibitors, non-selective beta-blocking agents, ACE inhibitors, salicylates, and alcohol.
• Medicines that may increase insulin requirements (decreasing hypoglycemic effect): Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone, and danazol.
• Beta-blocking agents can also mask the symptoms of hypoglycemia.
• Alcohol can intensify and prolong the hypoglycemic effect of insulin.
• Using pioglitazone with insulin has been associated with an increased risk of heart failure in certain patients. Always inform your doctor about all medications you are taking.

What precautions should be taken while using Insulatard Flexpen?

Always ensure you are using the correct type of insulin by checking the label before each injection. Rotate injection sites within the same region (e.g., abdomen, thigh, upper arm, buttocks) to minimize the risk of lipodystrophy. Needles and the FlexPen itself should never be shared between individuals. Do not use the insulin if it has been frozen or if the resuspended liquid is not uniformly white and cloudy. Closely monitor your blood sugar levels, especially when there are changes in diet, exercise, stress, illness, or if you have kidney or liver problems. Be prepared for hypoglycemia by carrying a sugary snack or glucose tablets. Inadequate dosing or stopping treatment, particularly for Type 1 diabetes, can lead to dangerously high blood sugar (hyperglycemia) and diabetic ketoacidosis. Avoid excessive alcohol consumption as it can impact blood glucose levels.

What happens if a dose is missed?

If you miss a dose of Insulatard Flexpen:

• If the missed dose is less than 4 hours overdue, you can typically administer the usual dose.
• If it's more than 4 hours overdue, administer 50% of your normal dose. Afterward, return to your regular dosing schedule. It is important to monitor your blood glucose levels more closely. If blood glucose is high, you may need to check for ketones and consider a correction dose of fast-acting insulin, as advised by your healthcare provider.

How should Insulatard Flexpen be stored?

Before opening: Store Insulatard Flexpen in a refrigerator between 2°C and 8°C. Do not freeze it, and keep it in its outer carton to protect it from light. Once in use (or as a spare): Do not refrigerate it. It can be stored at room temperature (below 30°C, or below 25°C according to some sources) for up to 6 weeks. Always keep the pen cap on when not in use to protect it from light and excessive heat.