ACTRAPID FLEXPEN

Name

• Brand Name: Actrapid FlexPen
• Common Name: Human Insulin (rDNA), Soluble Insulin

Composition

Actrapid FlexPen contains human insulin, 100 international units per milliliter (equivalent to 3.5 mg). This human insulin is produced using recombinant DNA technology in Saccharomyces cerevisiae.

Uses

Actrapid FlexPen is prescribed for the treatment of diabetes mellitus, including both Type 1 and Type 2 diabetes. It works to lower and control high blood sugar levels by facilitating glucose uptake into muscle and fat cells and inhibiting glucose production by the liver. It is also used for initial stabilization in conditions such as diabetic ketoacidosis, hyperosmolar non-ketotic syndrome, during periods of severe illness or major surgery in diabetic patients, and for gestational diabetes. Effective glycemic control helps reduce the risk of diabetes-related complications.

Dosage and Administration

The dosage of Actrapid FlexPen is individualized based on the patient's needs, as determined by a healthcare professional. It is administered via subcutaneous injection (under the skin) into the abdominal wall, thigh, gluteal region, or upper arm. To prevent skin damage like lipodystrophy, injection sites should be rotated within the chosen anatomical region. It typically has an onset of action within 30 minutes, reaches its maximum effect in 1.5 to 3.5 hours, and has an overall duration of action of approximately 7-8 hours. Actrapid FlexPen should be taken 20-30 minutes before a meal or carbohydrate-containing snack. Needles and pens should never be reused or shared.

Side Effects

• Common Side Effects:
  • Hypoglycemia (low blood sugar), characterized by symptoms such as cold sweats, pale skin, headache, rapid heartbeat, nausea, extreme hunger, visual disturbances, fatigue, anxiety, tremor, confusion, or difficulty concentrating.
  • Injection site reactions, including pain, redness, swelling, itching, hives, inflammation, or bruising.
  • Weight gain.
  • Lipodystrophy (thickening or thinning of fat tissue) at the injection site.
  • Oedema (swelling in hands or feet).
• Serious Side Effects (primarily due to severe hypoglycemia):
  • Loss of consciousness.
  • Seizures.
  • Temporary or permanent impairment of brain function or death.

Precautions

• Patients should be vigilant for symptoms of hypoglycemia, as severe cases can be life-threatening. Alcohol consumption can increase the risk of hypoglycemia.
• Inform your doctor if you have kidney or liver impairment, as dose adjustments may be necessary.
• Changes in diet, physical activity, illness, or stress may require adjustment of insulin dosage.
• Do not stop using Actrapid FlexPen without consulting your doctor.
• Use with caution if pregnant or breastfeeding, and dose adjustments may be required; consult your doctor.
• Patients with adrenal, pituitary, thyroid gland issues, or hypokalemia should use this medicine with caution.
• Driving or operating machinery may be impaired if blood sugar levels are too high or too low.
• Actrapid FlexPen should not be interchanged with other insulin types without medical supervision.
• Combination with thiazolidinediones should be approached with caution due to an increased risk of heart failure.

Storage

• Unopened: Store Actrapid FlexPen in a refrigerator between 2°C to 8°C. Do not freeze. Discard if it has been frozen.
• In-use (once opened or inserted into the injection pen): It can be stored at room temperature (below 30°C or 25°C, depending on the source) for up to 28 days (4-6 weeks). Do not refrigerate once in use. Protect from excessive heat and direct sunlight.
• Do not use if the solution appears cloudy or discolored. Keep out of the reach of children.

ACTRAPID FLEXPEN by ABBOTT INDIA LIMITED (NOVO NORDISK) - Frequently Asked Questions

What is Actrapid FlexPen used for?

Actrapid FlexPen is a rapid-acting human insulin used to treat diabetes mellitus (high blood sugar levels) in both Type 1 and Type 2 diabetes. It is also used for initial stabilization of diabetes in conditions like diabetic ketoacidosis and hyperosmolar non-ketotic syndrome, during stressful periods such as serious illnesses or major surgery, and for gestational diabetes.

How does Actrapid FlexPen work?

Actrapid FlexPen contains human insulin, a hormone that helps your body utilize glucose (sugar) for energy. It works by binding to receptors on muscle and fat cells, facilitating the uptake of glucose, and simultaneously reducing the liver's production of glucose. This helps lower and control blood sugar levels. Its action typically begins within 30 minutes after injection and can last for approximately 7-8 hours.

What is the usual dosage for Actrapid FlexPen?

The dosage of Actrapid FlexPen is individualized and determined by your doctor based on your specific needs. It can be used alone or in combination with intermediate-acting or long-acting insulin before a meal or snack. It is crucial to follow your doctor's instructions precisely and to consume a meal or snack containing carbohydrates within 30 minutes of the injection to prevent low blood sugar. Do not adjust your insulin dose without consulting your doctor.

What are the possible side effects of Actrapid FlexPen?

The most common side effect is hypoglycemia (low blood sugar), which can manifest as cold sweats, pale skin, headache, rapid heartbeat, nausea, extreme hunger, temporary vision changes, fatigue, unusual weakness, anxiety, tremor, agitation, confusion, or difficulty concentrating. Other possible side effects include injection site reactions like redness, swelling, or pain, and rarely, lipodystrophy (changes in fatty tissue under the skin) if injections are repeatedly given in the same area. Weight gain and decreased potassium levels are also possible side effects.

Is Actrapid FlexPen safe during pregnancy or breastfeeding?

Yes, Actrapid FlexPen is generally considered safe to use during pregnancy if prescribed by a doctor. Insulin does not cross the placental barrier, and careful control of diabetes, including preventing hypoglycemia, is important for the baby's health. It is also safe to use during breastfeeding, as insulin treatment in nursing mothers poses no risk to the baby. However, your insulin dosage may need adjustments during pregnancy and after delivery.

Can Actrapid FlexPen be taken with other medications?

Yes, Actrapid FlexPen can be used with other diabetes medications, including long-acting insulin or oral antidiabetic drugs, as part of a comprehensive treatment plan with diet and exercise. However, many medications can interact with glucose metabolism and affect your insulin requirements. Some substances may reduce insulin requirements (e.g., oral antidiabetic products, ACE inhibitors, salicylates), while others may increase them (e.g., oral contraceptives, glucocorticoids, thyroid hormones). Beta-blockers may mask the symptoms of hypoglycemia. Always inform your doctor, pharmacist, or nurse about all medicines you are taking, including over-the-counter drugs and herbal supplements.

What precautions should be taken with Actrapid FlexPen?

• Hypoglycemia: Be vigilant for symptoms of low blood sugar, especially if you vary your diet, engage in more exercise, or feel unwell. Always carry sugary snacks.
• Injection Site Rotation: Rotate injection sites within the same anatomical region (thigh, abdomen, gluteal area, upper arm) to minimize the risk of lipodystrophy (changes in fatty tissue).
• Alcohol Consumption: Avoid consuming alcohol as it can intensify or reduce the hypoglycemic effect of insulin.
• Medical Conditions: Inform your doctor if you have kidney, liver, adrenal, pituitary, or thyroid gland issues, as these can affect your insulin needs.
• Travel: If traveling across time zones, consult your doctor as your insulin requirements and injection timings may change.
• Never Share: Never reuse or share needles, syringes, cartridges, or pens.
• Check Label: Always check the insulin label before each injection to avoid accidental mix-ups.

What happens if a dose is missed?

If you miss a dose, your blood sugar levels may become too high (hyperglycemia). Take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate, as this can lead to a dangerous drop in blood glucose.

How should Actrapid FlexPen be stored?

Unopened Actrapid FlexPens should be stored in a refrigerator at 2°C to 8°C. Do not freeze it. Once an Actrapid FlexPen is in use, it should not be refrigerated again and can be kept at room temperature (not exceeding 30°C) for up to 28 days. Protect it from light and keep it out of the reach of children.