Insunova Special Precautions

insulin glargine

insulin human, isophane


Mega Lifesciences


Full Prescribing Info
Special Precautions
The insulin vials have protective color-coded, tamper proof plastic caps, which must be removed before insulin can be withdrawn. The patient must be instructed to return the vial to the pharmacy if the plastic cap is loose or missing.
Inadequate dosage or discontinuation of treatment, especially in type 1 diabetes may lead to hyperglycemia and diabetic ketoacidosis. Usually the 1st symptoms of hyperglycemia set in gradually over a period of hrs or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odor of the breath.
Cartridges should only be used in combination with products that are compatible with them and allow the cartridge to function safely and effectively. Insunova-R (Regular) is a clear solution of human insulin. Never use Insulin-R (Regular) if the liquid appears white and cloudy or has some visible suspended particles.
Insunova-30/70 and Insunova-N contain a cloudy, white, aqueous suspension of human insulin. Never use Insunova-30/70 or Insunova-N (NPH) if the liquid is not white and uniformly cloudy after gentle rolling.
Insunova-R (Regular), Insunova-N (NPH) and Insunova-30/70 (Biphasic) contain m-cresol, which may cause Type IV (delayed hypersensitivity) allergic reactions.
Missed Dose: Timing of insulin doses is extremely important. The best approach is to measure blood glucose and add a dose of regular insulin if glucose levels are too high. Otherwise, wait for the next scheduled dose.
Stopping the Drug: Do not stop taking insulin injections unless ordered by the doctor. Patients with diabetes are often given general instructions for modifying their insulin doses based on home blood glucose measurements.
Switching Types of Insulin: Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (rapid-acting, immediate-acting, short-acting insulin, etc), species (animal, human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in the dose.
Patients switching to and from Insunova-R (Regular)/Insunova-N (NPH)/Insunova-30/70 (Biphasic) may require a change in their usual insulin dosage. If an adjustment is needed, it may occur within the first few days to few weeks. Patients whose blood glucose control has greatly improved eg, by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycemia and should be advised accordingly.
A few patients who have experienced hypoglycemic reactions after transfer from animal source insulin have reported that early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.
Changes in the Dose Requirement: Adjustment of dosage may also be necessary if patients increase their physical activities or change their usual diet. Concomitant illnesses especially infection and other feverish conditions usually increase the patient's insulin requirement. Alcohol may intensify and prolong the hypoglycemic effect of insulin.
Prolonged Use: After many years with diabetes, some patients become insensitive to the symptoms of hypoglycemia and are at risk for serious brain complications of prolonged, unrecognized hypoglycemia.
Alcohol: Moderate alcohol intake, especially when taken with large meals, does not adversely affect control of diabetes or alter the dose of insulin. However, large amounts of alcohol increase the risk of hypoglycemia.
Insunova-G: lnsunova-G is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered IV is recommended in such cases.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see Adverse Reactions).
Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may therefore, change when the treatment regimen is changed. Due to more sustained basal insulin supply with lnsunova-G, less nocturnal but early morning hypoglycaemia can be expected.
Particular caution should be exercised and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance eg, in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients: In whom glycaemic control is markedly improved, in whom hypoglycaemia develops gradually, who are elderly, who are transferred from animal insulin to human insulin, in whom an autonomic neuropathy is present, with a long history of diabetes, suffering from a psychiatric illness, receiving concurrent treatment with certain other medicinal products (see Interactions).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia. The prolonged effect of SC insulin glargine may delay recovery from hypoglycaemia. If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include: Change in the injection area, improved insulin sensitivity (eg, by removal of stress factors), unaccustomed, increased or prolonged physical activity, intercurrent illness (eg, vomiting, diarrhoea), inadequate food intake, missed meals, alcohol consumption, certain uncompensated endocrine disorders, (eg, in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), concomitant treatment with certain other medicinal products.
lnsunova-G contains metacresol, which may cause allergic reactions.
Intercurrent Illness: Intercurrent illnesses requires intensive metabolic monitoring. In many cases urine tests for ketones are indicated and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food or in conditions where they are vomiting and they must never omit insulin entirely.
Combination of Insunova-G with Pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Insunova-G is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react quickly may be impaired as a result of hypoglycemia or hyperglycemia or as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycemia whilst driving. It should be considered whether it is advisable to drive or operate machines in these circumstances.
Impairment of Fertility: Animal studies do not indicate direct harmful effects with respect to fertility.
Use in pregnancy & lactation: There are no restrictions on the treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier. In the treatment of pregnant women with diabetes, intensified control of blood sugar is recommended throughout pregnancy and the same type of control even when contemplating pregnancy. Strict metabolic control, using insulin injections in most women, must be maintained during pregnancy to reduce the risk of birth defects, fetal complications or death at the time of delivery.
Requirements of insulin usually fall in the 1st trimester and subsequently increase during the 2nd and 3rd trimester. When diabetes first develop during pregnancy (gestational diabetes), insulin requirements drop rapidly after delivery and most do not need to continue with insulin treatment.
Postpartum insulin requirements return rapidly to pre-conception levels. There are no restrictions in insulin treatment while treating a lactating diabetic mother, as it involves no risk to the baby. Insulin requirements tend to be lower during breastfeeding. Home glucose monitoring is important to avoid hypoglycemia. However, the insulin dosage may need to be reduced. Insulin is not present in breast milk.
Insunova-G: No clinical data on insulin glargine exposed during pregnancies from controlled clinical trials are available. A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) exposed to marketed insulin glargine indicate no adverse effects on pregnancy and no malformative, nor feto- or neonatal-toxicity.
Animal data do not indicate reproductive toxicity.
Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.
The use of Insunova-G may be considered during pregnancy, if necessary.
It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the 1st trimester and generally increase during the 2nd and 3rd trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn or infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breastfeeding women may require adjustments in insulin dose and diet.
Use in children: Treatment with insulin in young patients is the same as that in older people with diabetes.
Use in the elderly: Patients >60 years: No special warnings. However, some older people may have vision problems that may make it difficult to draw up the correct dose of insulin.
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