Glaritus

Glaritus

insulin glargine

Manufacturer:

Wockhardt Limited

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
Contents
Insulin glargine.
Description
Each mL contains Insulin Glargine 100 IU.
A clear, colorless or almost colorless sterile solution or injection.
Action
Pharmacology: Pharmacodynamics: The primary activity of Insulin, including Insulin Glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis. Insulin Glargine differs from other Insulins because its unique structure provides a smooth and peakless profile with a prolonged duration of action of 24 hours (end of observation period) compared to 14.5 hours for NPH human Insulin. In clinical studies, intravenous Insulin Glargine and human Insulin have been shown to be equipotent when given at the same doses. The onset of action of Insulin Glargine is slower than NPH human Insulin. The effect profile of Insulin Glargine is smooth and peakless, and the duration of its effect is prolonged compared to NPH human Insulin.
Pharmacokinetics: After subcutaneous injection of Insulin Glargine, the Insulin serum concentrations indicate a slower, more prolonged absorption and a lack of a peak in comparison to NPH human Insulin. Concentrations are thus consistent with the time profile of the pharmacodynamic activity of Insulin Glargine. Insulin Glargine is a human Insulin analogue that has been designed to have low solubility at neutral pH. At pH 4, the pH of the Insulin Glargine injection solution, it is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralised, leading to formation of micro precipitates from which small amounts of Insulin Glargine are continuously released, providing a smooth, peakless, predictable time/concentration profile and a prolonged duration of action. This allows once daily dosing to meet a patient's basal Insulin needs. Insulin Glargine is partly degraded in the subcutaneous depot at the carboxyl terminus of the B chain to form the active metabolites, with similar in vitro activity to Insulin.
Indications/Uses
Insulin Glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 or type 2 diabetes mellitus patients who require insulin for the control of hyperglycemia.
Dosage/Direction for Use
Insulin Glargine is given subcutaneously once a day. It may be administered at any time during the day, however, at the same time every day. It is not intended for intravenous administration. The desired blood glucose levels as well as the doses and timing of Insulin Glargine, must be determined and adjusted individually by the physician. Insulin is usually administered in the abdominal wall, the thigh, the gluteal region or the deltoid region. Although absorption of Insulin Glargine does not differ between the injection sites, as with all insulin, injection sites must be rotated from one injection to the next to avoid lipodystrophy. The average range of total daily insulin requirement for maintenance in type 1 diabetic patients ranges between 0.5 and 1.0 IU/kg. Further, in insulin resistance, the daily requirement of insulin may be substantially higher. In patients with type 2 diabetes treated with insulin and other oral antidiabetic agents, the requirements of insulin are lower i.e. approximately 0.3-0.6 IU/kg/day. Dose adjustment may be required, if patients undertake increased physical activity or change their usual diet or if the patient's weight or lifestyle change or other circumstances arise that increase susceptibility to hypo or hyperglycemia. Any change of insulin dose should be made cautiously and only under medical supervision.
Changeover to Insulin Glargine: The initial dose of Insulin Glargine should be determined individually, depending on the desired blood glucose levels. When changing from a treatment regimen with intermediate- or long-acting insulin to a regimen with insulin Glargine, the amount and timing of short-acting insulin or fast-acting insulin analogue or the dose of any oral antidiabetic drug may need to be adjusted. A close metabolic monitoring under medical supervision is recommended during changeover and in the initial weeks thereafter. With improved metabolic control and resultant increase in insulin sensitivity (reduced insulin requirements), further adjustment of the dose of Insulin Glargine and other insulin or oral antidiabetic agents in the regimen may become necessary. Internationally accepted label of Insulin Glargine suggest that on transferring patient from twice daily NPH human insulin to Insulin Glargine Injection once daily, to reduce the risk of hypoglycemia the initial dose (IU) was usually reduced by approximately 20% (compare to total daily IU of NPH human insulin) and then adjusted based on patient response.
Paediatric Use: Insulin Glargine can be administered to children aged 6 years and older. Administration to children less than 6 years of age has not been studied.
Overdosage
An excess of Insulin relative to food intake, energy expenditure or both may lead to severe and sometimes long-term and life-threatening hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral glucose/carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure or neurologic impairment must treated with concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. It is therefore recommended that the diabetic patient constantly carry some sugar lumps, sweets, biscuits, or sugary fruit juice. Adjustments in drug dosage, meal patterns, or exercise, may be needed.
Contraindications
Insulin Glargine must not be used in patients hypersensitive to Insulin Glargine or any of its excipients.
Warnings
This drug must be prescribed by physician only. If dizziness and fainting occur, please consult the physician immediately.
Special Precautions
Insulin Glargine is not intended for intravenous administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. Insulin Glargine is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, intravenous regular insulin is recommended in such cases.
Renal Impairment: In patients with renal impairment, insulin requirements may be diminished. In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Hepatic Impairment: In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced Insulin metabolism.
Intercurrent Conditions: Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances or stress.
Use In Pregnancy & Lactation
Pregnancy: To date, no relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal or fetal development, parturition or postnatal development. It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester, increase during the second and third trimesters and rapidly decline after delivery. Careful blood glucose control is essential in such patients.
Adverse Reactions
The adverse events most commonly associated with human Insulin therapy include the following: Hypoglycemia: Hypoglycemia is the most common adverse effect of Insulin. The incidence of hypoglycemia in regimens that include Insulin Glargine is significantly reduced compared with regimens containing NPH human Insulin. The time of occurrence of hypoglycemia depends on the action profile of the Insulin and may, therefore, change when the treatment regimen is changed.
Oedema: Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified Insulin therapy.
Hyperglycemia and Ketoacidosis: In patients with Insulin-dependent diabetes, prolonged hyperglycemia can result in diabetic acidosis. If uncorrected, prolonged hyperglycemia or diabetic acidosis can result in loss of consciousness or death. Therefore, it is important that one should obtain medical assistance immediately.
Allergic Reactions: Local Allergy: Patients occasionally experience redness, swelling, and itching at the site of injection of Insulin. This condition called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than Insulin, such as irritants in the skin cleansing agent.
Systemic Allergy: Less common, but potentially more serious, is generalized allergy to Insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening.
Injection Site Reactions: As with any Insulin therapy, lipodystrophy may occur at the injection site and delay Insulin absorption. Other injection site reactions with Insulin therapy include redness, pain, itching, hives, swelling and inflammation. Most minor reactions to Insulins usually resolve in a few days to a few weeks.
Insulin resistance: When insulin requirement is increased (>200 IU/day), insulin resistance is said to have developed.
Antibody Production Insulin: Administration may cause the formation of antibodies to insulin. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyperglycemia or hypoglycemia.
Other: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. Intensification of Insulin therapy with abrupt improvement in glycaemic control may be associated wtth temporary worsening of diabetic retinopathy.
Drug Interactions
A number of substances affect glucose metabolism and may require insulin dose adjustment.
Substances that may enhance the blood glucose lowering effect and susceptibility to hypoglycemia include: Oral antidiabetic agents, ACE inhibitors, pentoxifylline, perhexiline, disopyramide, fibrates, fluoxetine, MAO inhibitors, dextropropoxyphene, salicylates, sulfonamide antibiotics. Substances that may reduce the blood glucose lowering effect and susceptibility to hyperglycemia include: Corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oral contraceptives, phenothiazine derivatives, somatotrophin, sympathomimetic agents (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine). Beta­-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood glucose lowering effect of Insulin. Pentamidine may cause hypoglycemia, which may be sometimes be followed by hyperglycemia. In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Caution For Usage
Procedure for Insulin Administration Cartridge: Insert the Cartridge in the Pen as shown in the Insulin Pen instruction manual. Before inserting the Cartridge, inspect the Cartridge after removing from the sealed pack for any crystallization, clumping or discolouration. If present, discard and use a new Cartridge.
After attaching the needle, dial 2 units on the dose selector to remove any air that may be inside the needle.
Wash the hands and clean the skin with alcohol where the injection is to be made.
With one hand, lightly pinch up the skin, insert the needle as advised by the physician or educator and push the release button of the Pen. Wait for 5 seconds and pull out the needle.
Do not massage the area as this may cause back leakage of Insulin.
Dispose of the needle in the recommended way.
For additional information, read the instruction manual of insulin pen and also log on to www.wockhardtdiabetic.com
Storage
Insulin Glargine Injection Cartridge which is not in use should be stored in a refrigerator (2°C to 8°C) but not allowed to freeze. When in use, Cartridge may be used in Insulin Pen or may be carried at room temperature (up to 30°C) for up to 4 weeks. Do not expose to excessive heat or direct sunlight. Insulin Glargine cartridges must be kept out of reach of children.
If refrigeration is impossible, the cartridge of Insulin Glargine in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 30°C. Unrefrigerated cartridges must be discarded after 28 days.
Insulin Glargine must only be used if the solution is clear and colourless with no particles visible.
Insulin Glargine must not be mixed with any other Insulin nor be diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Do not refill the Insulin Glargine Cartridge.
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Inj (cartridge) 100 IU/mL x 3 mL x 5's, (pre-filled pen) 100 IU/mL x 3 mL x 1's.
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