Insulin Glargine (rDNA origin) Injection
(in' su lin) (glar' geen)
P / L : Caution during pregnancy and lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
A10AE04 - insulin glargine; Belongs to the class of long-acting insulins and analogues. Used in the treatment of diabetes.
Recent major changes with US FDA:
Warnings and Precautions................. 10/2013
Insulin Glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Important Limitations of Use: Insulin Glargine is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.
Renal impairment: CrCl 10-50 mL/min: 75% of normal dose; <10 mL/min: 25-50% of normal dose and monitor glucose closely.
Hepatic impairment: Decreased dose may be necessary.
|Dosage & Administration||
DOSAGE FORMS AND STRENGTHS
Insulin Glargine solution for injection 100 Units per mL may be available as:
Insulin Glargine is a recombinant human insulin analog for once daily subcutaneous administration with potency that is approximately the same as the potency of human insulin. It exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.
This may be administered at any time during the day and should be administered subcutaneously once a day at the same time every day. The dose of Insulin Glargine must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.
Patients adjusting the amount or timing of dosing, should only do so under medical supervision with appropriate glucose monitoring.
In patients with type 1 diabetes, Insulin Glargine must be used in regimens with short-acting insulin.
The intended duration of activity of Insulin Glargine is dependent on injection into subcutaneous tissue. It should not be administered intravenously or via an insulin pump. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.
As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy.
In clinical studies, there was no clinically relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered drugs or meal patterns.
Initiation of therapy
The recommended starting dose of Insulin Glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
The recommended starting dose in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.
The dose should be adjusted according to blood glucose measurements. The dosage should be individualized under the supervision of a healthcare provider in accordance with the needs of the patient.
Converting to Insulin Glargine from other insulin therapies
If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with Insulin Glargine, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.
If transferring patients from once-daily NPH insulin to once-daily Insulin Glargine, the recommended initial Insulin Glargine dose is the same as the dose of NPH that is being discontinued.
If transferring patients from twice-daily NPH insulin to once-daily Insulin Glargine, the recommended initial Insulin Glargine dose is 80% of the total NPH dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia.
Insulin Glargine is contraindicated in patients with hypersensitivity to Insulin Glargine or one of its excipients; in hypoglycaemia; IV route.
|Warnings & Precautions||
Dosage adjustment and monitoring
Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision.
Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.
As with all insulin preparations, the time course of action for Insulin Glargine may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the local blood supply, local temperature, and physical activity.
Do not administer Insulin Glargine intravenously or via an insulin pump. The intended duration of activity is dependent on injection into subcutaneous tissue
Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.
Do not dilute or mix Insulin Glargine with any other insulin or solution. If Insulin Glargine is diluted or mixed, the solution may become cloudy, and the pharmacokinetic or pharmacodynamic profile (e.g., onset of action, time to peak effect) and the mixed insulin may be altered in an unpredictable manner. When Insulin Glargine and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and a delayed time to maximum effect for regular human insulin was observed. The total bioavailability of the mixture was also slightly decreased compared to separate injections and regular human insulin. The relevance of these observations in dogs to humans is unknown.
Do not share disposable or reusable insulin devices or needles between patients, because doing so carries a risk for transmission of blood-borne pathogens.
Hypoglycemia is the most common adverse reaction of insulin, including Insulin Glargine. The risk of hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and manage hypoglycemia. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with Insulin Glargine.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), exercise, and concomitant medications may also alter the risk of hypoglycemia.
The prolonged effect of subcutaneous Insulin Glargine may delay recovery from hypoglycemia. Patients being switched from twice daily NPH insulin to once-daily Insulin Glargine should have their initial Insulin Glargine dose reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycemia.
As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important,s uch as driving or operating other machinery.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as beta-blockers, or intensified glycemic control. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia.
Hypersensitivity and allergic reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Insulin Glargine.
Due to its long duration of action, Insulin Glargine is not recommended during periods of rapidly declining renal function because of the risk for prolonged hypoglycemia.
Although studies have not been performed in patients with diabetes and renal impairment, a reduction in the Insulin Glargine dose may be required in patients with renal impairment because of reduced insulin metabolism, similar to observations found with other insulins.
Due to its long duration of action, Insulin Glargine is not recommended during periods of rapidly declining hepatic function because of the risk for prolonged hypoglycemia.
Although studies have not been performed in patients with diabetes and hepatic impairment, a reduction in the Insulin Glargine dose may be required in patients with hepatic impairment because of reduced capacity for gluconeogenesis and reduced insulin metabolism, similar to observations found with other insulins.
Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia.
|Adverse Drug Reaction(s)||
Hypoglycaemia; oedema; pruritus; rash; hypersensitivity reactions; lipoatrophy or lipohypertrophy with SC Inj (rotate Inj site).
Effects may be increased by: oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, salicylates, somatostatin analog (e.g. octreotide), sulfonamide antibiotics. Effects may be decreased by: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, oral contraceptives, lithium. Signs of hypoglycaemia may be masked by Î²-blockers, clonidine.
|Pregnancy Category (FDA)
||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
Insulin glargine, a long-acting analog of human insulin, regulates carbohydrate, protein and fat metabolism by inhibiting hepatic glucose production and lipolysis, and enhancing peripheral glucose disposal.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|INSUL GLARGINE||Popular Pharmaceuticals Ltd.||Insulin Glargine INN (recombinant human insulin analogue) 100 unit/ml||Injection||3ml vial (with D/Syringe): 600.00 MRP|
|INSUL GLARGINE Cartridge||Popular Pharmaceuticals Ltd.||Insulin Glargine INN (recombinant human insulin analogue) 100 unit/ml||Injection||3ml cartridge x3's: 1,800.00 MRP|
|LANTUS Optiset||Sanofi||Insulin Glargine (recombinant human insulin analogue) 100 unit/ml||Injection||3ml x5's: 5395.76 MRP|
|LANTUS SoloStar||Sanofi||Insulin Glargine (recombinant human insulin analogue) 100 unit/ml||Injection||3ml vial (with D/Syringe) x5's: 5,588.00 MRP|
|Vibrenta||Incepta Pharmaceuticals Limited||Insulin Glargine (rDNA) INN 100 IU/ml||Injection||1x3ml:MRP 600 Tk|
Why is Insulin Glargine prescribed?
Insulin glargine is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). It is also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In patients with type 1 diabetes, insulin glargine must be used with another type of insulin (a short-acting insulin). In patients with type 2 diabetes, insulin glargine also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin glargine is a long-acting, man-made version of human insulin. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.
How should Insulin Glargine be used?
Insulin glargine comes as a solution (liquid) to inject subcutaneously (under the skin). It is injected once a day. You should use insulin glargine at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Use insulin glargine exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Insulin glargine controls diabetes but does not cure it. Continue to use insulin glargine even if you feel well. Do not stop using insulin glargine without talking to your doctor. Do not switch to another brand or type of insulin or change the dose of any type of insulin you are using without talking to your doctor. Always check the insulin label to make sure you received the right type of insulin from the pharmacy.
Insulin glargine comes in vials and in dosing pens that contain cartridges of medication. Be sure you know what type of container your insulin glargine comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.
If your insulin glargine comes in vials, you will need to use syringes to inject your dose. Ask your doctor to show you how to inject insulin glargine using a syringe. Ask your doctor if you have questions about the type of syringe you should use.
If your insulin glargine comes in pens, be sure to read and understand the manufacturer's instructions. Ask your doctor to show you how to use the pen. Follow the directions carefully, and always perform the safety test before use.
Never reuse needles or syringes and never share needles, syringes, or pens. If you are using an insulin pen, always remove the needle right after you inject your dose. Throw away needles and syringes in a puncture-resistant container. Ask your doctor how to dispose of the puncture-resistant container.
Do not dilute insulin glargine and do not mix insulin glargine with any other type of insulin.
You can inject your insulin glargine in your upper arm, thigh, or stomach. Never inject insulin glargine into a vein or muscle. Change (rotate) the injection site within the chosen area with each dose; try to avoid injecting the same site more often than once every 1 to 2 weeks.
Always look at your insulin glargine before you inject it. It should be clear and colorless. Do not use your insulin glargine if it is colored, cloudy, or contains solid particles, or if the expiration date on the bottle has passed.
Do not use insulin glargine in an external insulin pump.
Other uses for Insulin Glargine
Insulin Glargine may be prescribed for other uses; ask your doctor for more information.
What special precautions to follow?
Before using insulin glargine,
- tell your doctor if you are allergic to insulin (Humulin, Novolin, others), any of the ingredients of insulin glargine, or any other medications. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: AIDS antiviral medications; angiotensin-converting enzyme inhibitors such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, and trandolapril; beta-blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol; certain cholesterol-lowering medications such as fenofibrate, gemfibrozil, and niacin; clonidine; danazol; disopyramide; diuretics; fluoxetine; glucagon; hormone replacement therapy; isoniazid; lithium; medications for asthma and colds; medications for mental illness and nausea; monoamine oxidase inhibitors, including isocarboxazid, phenelzine, selegiline and tranylcypromine; octreotide; oral contraceptives; oral medications for diabetes; oral steroids such as dexamethasone, methylprednisolone, and prednisone; pentamidine; pentoxifylline; pramlintide; reserpine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate, diflunisal, magnesium salicylate, and salsalate; somatropin; sulfa antibiotics; sulfinpyrazone; and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had nerve damage caused by your diabetes or any other medical conditions, including liver or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using insulin glargine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin glargine.
- alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine.
- ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule. These changes can affect your blood sugar and the amount of insulin you will need.
- ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.
What special dietary instructions to follow?
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.
What to do if I forget a dose?
Before you start using insulin glargine, ask your doctor what to do if you forget to use a dose or if you accidentally use an extra dose. Write these directions down so you can refer to them later.
What side effects can Insulin Glargine cause?
Insulin Glargine may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
Insulin glargine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
redness, swelling, pain, or itching at the injection site
changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)
swelling of the hands or feet
Some side effects can be serious. If you experience these symptoms, call your doctor immediately or get emergency treatment:
skin rash, hives, or itching all over the body
wheezing (trouble breathing)
shortness of breath
low blood pressure
swelling of the eyes, face, lips, tongue, or throat
Insulin glargine may cause other side effects. Call your doctor if you have any unusual problems while using Insulin Glargine.
What to know about storage and disposal of Insulin Glargine?
Store unopened insulin glargine vials and pens in the refrigerator. Never allow insulin glargine to freeze; do not use insulin glargine that has been frozen and thawed. Unopened refrigerated insulin glargine can be stored until the date shown on the company's label.
If no refrigerator is available (for example, when on vacation), store the vials or pens at room temperature and away from direct sunlight and extreme heat. Unrefrigerated vials or pens can be used within 28 days or after that time they must be thrown away. Insulin glargine pens that have been used must be stored at room temperature and may be used for up to 28 days after the first use. Throw away any insulin that has been exposed to extreme heat or cold.
Throw away any medication that is outdated or no longer needed.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Insulin Glargine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: MedlinePlus, U.S. Natl. Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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