Basalog One 100 Iu/ml 3 Ml Pen

BASALOG ONE 100 IU/ML 3 ML PEN by BIOCON BIOLOGICS LIMITED

Name

• Brand Name: BASALOG ONE
• Common Name: Insulin Glargine (rDNA origin)

Composition

• Active Ingredient: Insulin Glargine (rDNA) 100 IU per mL
• Preservative: m-Cresol 2.7 mg per mL
• Excipients: Glycerol, zinc chloride, hydrochloric acid, sodium hydroxide, and water for injection

Uses

BASALOG ONE is a long-acting insulin analogue prescribed for the treatment of diabetes mellitus:

• Type 1 Diabetes Mellitus: In adults, adolescents, and children 2 years of age and above, where insulin treatment is required.
• Type 2 Diabetes Mellitus: In adults, to improve glycemic control, often in combination with orally active antidiabetic medicinal products. It provides a steady, peakless, and predictable blood glucose lowering effect for an entire day, helping to prevent complications associated with diabetes.

Dosage and Administration

BASALOG ONE should be administered once daily at any time, but at the same time each day.

• The dose regimen (dose and timing) must be individually adjusted by a healthcare professional.
• It is administered by subcutaneous injection into the abdominal area, thigh, or deltoid.
• Injection sites must be rotated within the chosen area to prevent lipodystrophy and other skin reactions.
• BASALOG ONE must not be mixed with any other insulin or diluted, as this can alter its time/action profile and cause precipitation.
• For patients switching from a twice-daily NPH insulin regimen to once-daily BASALOG ONE, a 20% to 30% reduction in the daily basal insulin dose may be necessary during the first week to reduce the risk of nocturnal and early morning hypoglycemia.

Side Effects

Common Side Effects:

• Hypoglycemia (low blood sugar levels), characterized by dizziness, sweating, anxiety, confusion, headache, blurred vision, shakiness, and fast heartbeat.
• Injection site reactions (pain, redness, swelling, itching, rash).
• Lipodystrophy (skin thickening or pits at the injection site).
• Weight gain.
• Peripheral edema (swelling).

Serious Side Effects (rare):

• Severe allergic reactions, which may include rash, hives, itching all over the body, trouble breathing (wheezing), a fast heart rate, and low blood pressure.
• Severe hypoglycaemic attacks, especially if recurrent, which may lead to neurological damage.

Precautions

• Hypersensitivity: Do not use if allergic to insulin glargine or any excipients.
• Diabetic Ketoacidosis: BASALOG ONE is not the insulin of choice for treating diabetic ketoacidosis; regular insulin administered intravenously is recommended in such cases.
• Alcohol Consumption: Alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin and should be consumed with caution.
• Pregnancy and Breastfeeding: Consult a doctor if pregnant or contemplating pregnancy. The use of insulin glargine may be considered during pregnancy if necessary, with close monitoring. It is generally considered safe during breastfeeding if prescribed.
• Renal and Hepatic Impairment: Insulin requirements may be diminished in patients with kidney or liver impairment, requiring cautious use and potential dose adjustment.
• Driving and Operating Machinery: Hypoglycemia can impair concentration and reaction time. Patients should exercise caution when driving or operating machinery.
• Intercurrent Illness: Illnesses often require intensive metabolic monitoring and potential insulin dose adjustment.
• Drug Interactions: Beta-blockers, clonidine, lithium salts, and alcohol may affect blood glucose levels. Pioglitazone in combination with insulin may cause cardiac failure in patients with risk factors.

Storage

• Unopened Pens: Store in a refrigerator between 2°C and 8°C (36°F to 46°F). Do not freeze.
• After First Use: Store the pen at room temperature (below 30°C or 86°F) for up to 28 days. Do not refrigerate after first use.
• General: Keep the pen cap on to protect from light and contamination. Never leave the needle attached to the pen during storage to prevent contamination or needle blockage. Do not use if the solution appears colored, cloudy, or contains particles.

BASALOG ONE 100 IU/ML 3 ML PEN: Frequently Asked Questions

What is BASALOG ONE used for?

BASALOG ONE 100 IU/ML 3 ML PEN is a long-acting insulin used to manage diabetes mellitus in adults, adolescents, and children aged two years and above. It helps control high blood sugar levels in both Type 1 and Type 2 diabetes by providing a steady, all-day supply of insulin.

How does BASALOG ONE work?

BASALOG ONE contains insulin glargine, a human insulin analogue designed to have a prolonged duration of action. After subcutaneous injection, it forms tiny deposits at the injection site that slowly release active insulin over approximately 24 hours. This insulin works by stimulating the uptake of glucose from the bloodstream into muscle and fat cells and by reducing glucose production by the liver, thereby lowering blood sugar levels.

What is the usual dosage for BASALOG ONE?

The daily dose of BASALOG ONE should be administered once daily at the same time each day, as prescribed by your doctor. The dosage is individualized based on your type of diabetes, blood glucose levels, and how you respond to the treatment. It is crucial to follow your doctor's instructions carefully and never adjust the dose without consulting them.

What are the possible side effects of BASALOG ONE?

The most common side effect of BASALOG ONE is hypoglycemia (low blood sugar), which can cause shakiness, sweating, confusion, hunger, and dizziness. Other common side effects include injection site reactions (redness, swelling, itching), weight gain, and peripheral edema (swelling in feet, ankles, or legs due to fluid retention). Less common side effects can include lipodystrophy (changes in fat tissue at injection sites). Serious side effects are rare but can include severe allergic reactions.

Is BASALOG ONE safe during pregnancy or breastfeeding?

Caution is advised when using BASALOG ONE during pregnancy, as insulin requirements often change, and your doctor may need to adjust your dosage. However, it can generally be used safely during breastfeeding, as insulin glargine does not pass into breast milk in significant amounts. Regular monitoring of insulin needs is important during this period.

Can BASALOG ONE be taken with other medications?

BASALOG ONE can interact with certain medications. For example, oral antidiabetic agents (like metformin and glimepiride) and ACE inhibitors (like enalapril and lisinopril) may increase the risk of hypoglycemia when used with BASALOG ONE. Beta-blockers (like propranolol and metoprolol) may mask the symptoms of hypoglycemia. It is important to inform your doctor about all medicines you are taking to avoid potential drug interactions.

What precautions should be taken with BASALOG ONE?

Before using BASALOG ONE, inform your doctor if you have kidney, liver, or heart problems, or thyroid disorders. Alcohol consumption should be avoided or limited as it can alter blood sugar levels. Always rotate injection sites to reduce skin irritation and improve absorption. Exercise caution when driving or operating machinery, as hypoglycemia can affect concentration and reaction time. Do not use if you are allergic to insulin glargine or any other ingredients.

What happens if a dose of BASALOG ONE is missed?

If you forget to administer your dose of BASALOG ONE, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed one. Never administer a double dose to make up for a missed one. It is important to monitor your blood glucose levels more regularly after a missed dose and consult your healthcare team if you have any doubts.

How should BASALOG ONE be stored?

Unopened BASALOG ONE pens should be stored in a refrigerator between 2°C and 8°C. Do not freeze it, and protect it from direct sunlight. Once in use, the pen can be kept at room temperature (below 30°C) for up to 28 days. After 28 days of first use, the pen should be disposed of. Never leave the needle attached to the pen during storage.