Human Insulatard 40i.u.

HUMAN INSULATARD 40I.U. by NOVO NORDISK

HUMAN INSULATARD 40I.U. by Novo Nordisk is an intermediate-acting insulin suspension used for the management of diabetes mellitus. It helps to regulate blood sugar levels and prevent associated complications.

Name

• Common Name: Isophane Insulin Human (rDNA)
• Brand Name: Insulatard

Composition

HUMAN INSULATARD 40I.U. contains 40 International Units (IU) of isophane (NPH) human insulin per ml, produced by recombinant DNA technology in Saccharomyces cerevisiae. Excipients: Zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide/hydrochloric acid (for pH adjustment), protamine sulfate, and water for injections. The suspension is cloudy, white, and aqueous.

Uses

Insulatard is indicated for the treatment of diabetes mellitus. It is used to lower high blood sugar levels in patients with:

• Type 1 diabetes
• Type 2 diabetes (when not adequately controlled by diet and/or oral hypoglycemic agents)
• Gestational diabetes
• For initial stabilization of diabetes in cases of diabetic ketoacidosis, hyperosmolar non-ketotic syndrome, and during periods of stress such as severe infections or major surgery.

This intermediate-acting insulin helps glucose enter muscle and fat cells for energy and decreases glucose production in the liver, thereby controlling blood sugar levels and reducing the risk of complications such as kidney damage, nerve problems, eye damage, and loss of limbs.

Dosage and Administration

Insulatard is administered via subcutaneous injection.

• Dosage: The dosage is individualized based on the patient's needs, typically ranging from 0.3 to 1.0 IU/kg/day. The physician determines the necessity of one or several daily injections.
• Method: It is usually injected into the thigh, abdominal wall, gluteal region, or deltoid region. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy and cutaneous amyloidosis.
• Preparation: Before use, the suspension should appear uniformly white and cloudy after resuspension. Insulin suspensions must never be administered intravenously.
• Insulatard can be used alone or in combination with fast-acting insulin.

Side Effects

The most frequently reported adverse reaction is hypoglycemia (low blood sugar). Symptoms include cold sweat, pale skin, headache, rapid heartbeat, nausea, extreme hunger, temporary vision changes, drowsiness, unusual tiredness, nervousness, tremor, anxiety, confusion, and difficulty concentrating.

Common (injection site reactions):

• Pain, redness, hives, inflammation, bruising, swelling, and itching at the injection site. These usually resolve within a few weeks.

Uncommon:

• Lipodystrophy (fatty tissue shrinking or thickening) and cutaneous amyloidosis at the injection site, which can delay insulin absorption.
• Allergic reactions, if widespread across the body, require immediate medical attention.
• Diabetic retinopathy worsening if blood sugar levels improve too rapidly.

Rare (Serious):

• Systemic allergic reactions to Insulatard or its ingredients are very rare but potentially life-threatening.

Precautions

• Hypoglycemia: Be aware of symptoms and take precautions. This can be caused by too much insulin, eating too little or missing a meal, increased exercise, or alcohol consumption. Always carry glucose tablets or sugary products.
• Hyperglycemia: Inadequate dosing or discontinuation, particularly in type 1 diabetes, can lead to hyperglycemia and diabetic ketoacidosis.
• Injection Site Rotation: Continuously rotate injection sites within the same area to reduce the risk of lipodystrophy and cutaneous amyloidosis.
• Travel: Consult a doctor before traveling across different time zones to adjust insulin administration times and diet.
• Renal/Hepatic Impairment: Insulin requirements may be reduced, necessitating dose adjustments.
• Pregnancy and Breastfeeding: Insulatard can be used during pregnancy and breastfeeding, but insulin dose adjustments may be necessary.
• Alcohol: Alcohol may intensify or prolong the hypoglycemic effect of insulin, or cause hyperglycemia.
• Drug Interactions: Several medications can interact with glucose metabolism and may increase or decrease insulin requirements (e.g., thiazides, glucocorticoids, beta-blockers, thyroid hormones, growth hormone, danazol, pioglitazone, octreotide/lanreotide). Beta-blockers may mask hypoglycemia symptoms.
• Not for Infusion Pumps: Insulin suspensions, including Insulatard, are not suitable for use in insulin infusion pumps.
• Needle and Pen Sharing: Needles and insulin pens (e.g., FlexPen, Penfill) must never be shared to prevent contamination and inaccurate dosing.

Storage

• Before Opening: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial or cartridge in the outer carton to protect from light.
• During Use (Vial): Store below 25°C for a maximum of 6 weeks. Do not refrigerate or freeze.
• During Use (Penfill/FlexPen): Store below 30°C for a maximum of 6 weeks. Do not refrigerate. Keep the pen cap on to protect from light.
• Protect from excessive heat and direct sunlight. Insulin that has been frozen must not be used. Allow the product to reach room temperature before resuspending for first-time use.

HUMAN INSULATARD 40I.U. by NOVO NORDISK is an intermediate-acting human insulin used to manage blood sugar levels in individuals with diabetes mellitus.

What is HUMAN INSULATARD used for?

HUMAN INSULATARD 40I.U. is used to improve blood sugar control in both adults and children with Type 1 and Type 2 diabetes mellitus. It can also be used for the management of gestational diabetes. This medication helps prevent serious complications associated with diabetes, such as kidney damage, nerve problems, and eye damage.

How does HUMAN INSULATARD work?

HUMAN INSULATARD contains Insulin Isophane (also known as NPH insulin), which acts similarly to the insulin naturally produced by the body. It facilitates the uptake of glucose (sugar) from the bloodstream into muscle and fat cells for energy and simultaneously suppresses the production of glucose by the liver. This is an intermediate-acting insulin, meaning its effect begins gradually, within approximately 1.5 hours, reaches a maximum effect between 4 to 12 hours, and its entire duration of action is around 24 hours.

What is the usual dosage of HUMAN INSULATARD?

The dosage of HUMAN INSULATARD is highly individualized and determined by your doctor based on your specific needs, blood glucose tests, diet, and activity level. It can be used alone or in combination with fast-acting insulin. The individual insulin requirement typically ranges between 0.3 and 1.0 International Unit/kg/day. Dose adjustments may be necessary if you increase physical activity, change your diet, or during illness.

What are the possible side effects of HUMAN INSULATARD?

The most common side effect is hypoglycemia (low blood sugar), which can cause symptoms like cold sweats, cool pale skin, nervousness, tremor, confusion, drowsiness, excessive hunger, headache, and palpitations. Other potential side effects include injection site reactions such as pain, redness, swelling, hives, or itching. Weight gain and fluid retention (oedema) can also occur. Rarely, lipodystrophy (changes in fat tissue at the injection site) may develop if injection sites are not rotated.

Is HUMAN INSULATARD safe during pregnancy or breastfeeding?

HUMAN INSULATARD is generally considered safe for use during pregnancy when prescribed by a doctor. Close monitoring of blood glucose levels is recommended during pregnancy, as insulin requirements can change (often falling in the first trimester and increasing in the second and third). There are no restrictions on using HUMAN INSULATARD during breastfeeding, as insulin treatment for the nursing mother poses no risk to the baby.

Can HUMAN INSULATARD be taken with other medications?

Yes, HUMAN INSULATARD can interact with other medications. Some medicines, such as oral antidiabetic agents (like metformin and glibenclamide), ACE inhibitors, salicylates, and certain antidepressants (e.g., fluoxetine), may increase its blood sugar-lowering effect, potentially leading to hypoglycemia. Conversely, certain drugs like oral contraceptives, thiazides, glucocorticoids, thyroid hormones, and sympathomimetics can increase insulin requirements, reducing its effectiveness. It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements.

What precautions should be taken with HUMAN INSULATARD?

• Hypoglycemia: Be aware of the symptoms of low blood sugar and always carry a quick source of sugar (like glucose tablets or juice).
• Injection Site Rotation: Always rotate injection sites within the same region (thigh, abdomen, gluteal, or deltoid area) to minimize the risk of lipodystrophy.
• Alcohol: Avoid or limit alcohol consumption as it can significantly affect blood sugar levels, either increasing or decreasing them.
• Kidney and Liver Impairment: If you have reduced kidney or liver function, your insulin requirements may change, and your doctor may need to adjust your dose.
• Driving and Operating Machinery: Your ability to concentrate and react might be affected if your blood sugar is too low or too high, so exercise caution when driving or operating machinery.

What happens if a dose is missed?

If you miss a dose of HUMAN INSULATARD, take it as soon as you remember. If it's almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one, as this can lead to a dangerous drop in blood glucose levels. Monitor your blood sugar levels closely if a dose is missed.

How should HUMAN INSULATARD be stored?

Unopened vials or cartridges of HUMAN INSULATARD should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze the medicine. Once opened or in use, vials can be stored at room temperature (below 25°C) for a maximum of 4 weeks. Penfill/InnoLet/FlexPen devices, once opened, can be stored below 30°C for a maximum of 6 weeks. Always keep it out of the sight and reach of children.