Insunova Dosage/Direction for Use

insulin glargine

insulin human, isophane


Mega Lifesciences


Full Prescribing Info
Dosage/Direction for Use
Dosage is individualized and determined by the physician in accordance with the needs of the patient. The average insulin requirement for diabetes therapy ranges between 0.3 and 1 IU/kg, depending on the individual metabolic status and glycaemic control.
In geriatric patients, the primary aim of treatment may be relief of symptoms and avoidance of hypoglycaemic events.
Insunova-R and Insunova-N are administered SC into the thigh or abdominal wall, preferably before meals. If convenient, the gluteal region or deltoid region may be used.
Subcutaneous injection of Insunova-R into the abdominal wall results in faster absorption than from other injection sites. Injection into a lifted skin fold minimises the risk of an IM injection.
Insunova-30/70 and Insunova-N cannot be given IV.
Injection sites should be rotated within anatomic region and also amongst various other sites in order to avoid lipodystrophy.
In patients with diabetes mellitus, optimised glucose control delays the onset and slows progression of late diabetic complications. Close blood glucose monitoring is therefore recommended.
The injection should ideally but not always, followed within 30 min by a meal or a snack containing carbohydrates.
Insunova-R (vial): May be taken 1-4 times daily, before meals and possible at bedtime. Regular (or rapid-acting) insulin should be administered 30-45 min before a meal. It can be mixed in the same syringe with immediate-acting insulins, but in such situations, the regular insulin is drawn first.
Insunova-R (cartridge): 1-2 times daily depending upon the requirement of the individual, preferably before meals. May also be used along with Insupen to administer Insunova-R cartridge IV but it should be an exception only in situations where vials are not available. In this case, Insunova-R cartridge should be drawn into an insulin syringe, provided air is avoided, or infused with an infusion system. This procedure should only be carried out by healthcare professionals.
Insunova-N (vial and cartridge): 1-2 times daily depending upon the requirement of the individual, preferably 30 min before meals.
Insunova-N (vial) can also be mixed in the same syringe with short-acting soluble insulins, and in such situations, the regular insulin is drawn first.
Insunova-30/70 (vial and cartridge): A premixed insulin is usually given 1-2 times daily, preferably just before meals when a rapid initial effect together with a more prolonged effect is desired.
Insunova-G: Insunova-G contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Insunova-G should be administered once daily at any time but at the same time each day.
The Insunova-G dose regimen (dose and timing should be individually adjusted. In patients with type 2 diabetes mellitus, Insunova-G can also be given together with orally active antidiabetic medicinal products.
Initiation of Insunova-G Therapy: The recommended starting dose of lnsunova-G in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
Based on published information the recommended starting dose on an average is 10 IU once daily and subsequently adjusted according to the patient's need to a total daily dose ranging from 2-100 IU, however doses needs to be individualized by the physician for a particular patient.
Transition From Other Insulins to Insunova-G:
When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Insunova-G, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from twice daily NPH insulin to a once daily regimen with Insunova-G should reduce their daily dose of basal insulin by 20-30% during the 1st week of treatment. During the 1st week the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. As with other insulin analogues, patients with high insulin doses may experience an improved insulin response with Insunova-G because of antibodies to human insulin. Close metabolic monitoring is recommended during transition and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo- or hyperglycaemia (see Precautions).
Children: Safety and efficacy of insulin glargine have been established in adolescents and children of ≥6 years. In children, efficacy and safety of insulin glargine have only been demonstrated when given in the evening.
Due to limited experience on the efficacy and safety of insulin glargine in children <6 years, Insunova-G should only be used in this age group under careful medical supervision.
Elderly (≥65 years): In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Renal Impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Hepatic Impairment: In patients with hepatic impairment, insulin requirements may be diminished due to capacity for gluconeogenesis and reduced insulin metabolism.
Administration: How to Inject the Insulin: Inject the insulin under the skin. Use the injection technique described in the InsuPen manual.
Keep the needle under the skin for at least 10 sec to make sure that the full dose has been delivered.
After each injection, be sure to remove and discard the needle appropriately. Store Insunova-R (Regular) cartridge in InsuPen without any needle attached, otherwise, the liquid may leak out which can cause inaccurate dosing.
Insunova-G: Insunova-G is administered SC and should not be given IV. The prolonged duration of action of Insunova-G is dependent on injection into SC tissue. Intravenous administration of the usual SC dose could result in severe hypoglycaemia.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Insunova-G. The prolonged duration of action of Insunova-G is dependent on injection into SC space. As with all insulins, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from 1 injection to the next.
In published clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, deltoid or thigh SC 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.
Insunova-G must not be mixed with any other insulin or diluted. Mixing or diluting can change its time or action profile and mixing can cause precipitation.
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