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CAPRISULIN Log-G is not the Insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular Insulin administered intravenously is recommended in such cases. Safety and efficacy of CAPRISULIN Log-G have been established in adolescents and children aged 2 years and above. CAPRISULIN Log-G has not been studied in children below the age of 2 years.
In patients with renal impairment, Insulin requirements may be diminished due to reduce Insulin metabolism. In the elderly, progressive deterioration of renal function may lead to steady decrease in Insulin requirements.
In patients with severe hepatic impairment, Insulin requirements may be diminished due to reduce capacity for gluconeogenesis and reduced Insulin metabolism.
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.
Patients must be instructed in the skills necessary for the self-management of diabetes, such as blood sugar monitoring, proper injection technique, measures for recognizing and managing reduced or increased blood sugar levels (hypo- or hyperglycaemia) as described as follows. In addition, they must learn how to handle special situations such as skipped, inadequate or increase Insulin doses, inadequate food intake or missed meals.
Moreover, patients and their relatives must learn how to recognize the signs and symptoms of hypo- or hyperglycaemia, what corrective actions need to be taken and when they must speak with their doctor.
Hypoglycemia: 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 CAPRISULIN Log-G, less nocturnal but more early morning hypoglycaemia can be expected.
Hypoglycaemia is more likely to occur at the start of Insulin treatment, following transfer to a different Insulin preparation, where metabolic control is unstable, or in severe kidney or liver diseases.
Symptoms that may indicate the onset of hypoglycaemia may be e.g., sweating, clammy skin, anxiety, fast heart beat, chest pain (angina pectoris). In many patients, these signs and symptoms often develop before those of a low sugar level in the brain. The latter include headache, intense hunger nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behavior, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensation (paraesthesiae) numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after oneself, convulsions, and loss of consciousness.
The initial symptoms pointing to the onset of hypoglycaemia ('warning symptoms') may change be milder, or be entirely absent e.g., in the following circumstances: Markedly improved blood sugar control, slow-developing hypoglycemia, advance age, a certain type of nervous disease (autonomic neuropathy), long-standing diabetes, a psychiatric illness, or concurrent use of other medicines (see Interactions). In such circumstances severe hypoglycaemia (and even loss of consciousness) may develop without the patients noticing it. Affected patients should try to keep familiar at all times with their individual warning symptoms. More frequent blood sugar testing can help to identify mild hypoglycaemic episodes which otherwise might be overlooked. Patients not confident of recognizing their warning symptoms should avoid situations (e.g. driving a car) that might result in danger to themselves or others.
As with all Insulins, particular caution should be exercised, and intensified blood glucose monitoring is advisable, in patients in whom hypoglycaemic episodes might be of particular clinical relevance. For example these could be 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; After transfer 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 medical products.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of subcutaneous Insulin Glargine may delay recovery from hypoglycaemia. If normal or decreased value for glycated haemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dosage 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 (by e.g. removal of stress factors); Unaccustomed, increased or prolonged physical activity; Intercurrent illness (e.g. vomiting, diarrhea); Inadequate food intake; Missed meals; Alcohol consumption; Certain uncompensated endocrine disorders (e.g. in hypothyroidism and anterior pituitary or adrenocortical insufficiency); Concomitant treatment with certain other medical products.
A hypoglycaemic attack can be corrected by immediately taking sugar e.g., in the form of glucose, sugar cubes or sugar-sweetened beverages. In this regard, note that food or beverages containing artificial sweeteners (e.g. diet foods and drinks) are not suitable. Subsequently, some food having a long acting blood-sugar-raising effect (e.g. bread) should be taken. The long action of CAPRISULIN Log-G may delay recovery from hypoglycaemia. If hypoglycaemia recurs, another 10 to 20 g of sugar should be taken. If a hypoglycaemia attack cannot be corrected or if it recurs, speak to the doctor immediately.
The patient must carry at least 20 g of sugar at all times, together with some information identifying as a diabetic. Inability to swallow or unconsciousness will make necessary injections of glucose solution or glucagons (a medicine increasing blood sugar), even where the presence of hypoglycaemia is uncertain.
Following intake of glucose, hypoglycaemia should be conformed by means of blood sugar testing.
Inform the doctor in the event of intercurrent illness, since this situation necessitates intensified metabolic monitoring and, possibly, further special measures (e.g. dose adjustment, urine tests for ketones).
Hyperglycemia: Hyperglycemia may occur under certain circumstances. These include: Omission or reduction of injections or decrease insulin effectiveness (e.g. due to incorrect storage); Pen malfunction; Decreased physical activity, stress situations (emotional distress, excitement), injuries, operations, feverish illnesses or certain other diseases; Concurrent use of other medicines (see Interactions).
Thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and high concentrations of sugar and ketones bodies in the urine may be signs of hyperglycaemia. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious metabolic condition (ketoacidosis) resulting from lack of the Insulin. Blood sugar testing or tests for ketones in urine must be carried out as soon as any such symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Intercurrent illness: Intercurrent illness require intensified metabolic monitoring. In many cases urine tests for ketones are indicates, 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 are vomiting etc. and they must never omit Insulin entirely.
Effects on ability to drive and use machines: The patients' ability to concentrate and react may be impaired as a result of, for example hypoglycaemia or hyperglycaemia or as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Use in Pregnancy and lactation: For Insulin Glargine no clinical data on exposed pregnancies are available. Animal studies do not indicate reproductive toxicity. The use of CAPRISULIN Log-G may be considered during pregnancy if necessary.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, Insulin requirements decline rapidly (increase risk of hypoglycaemia), careful monitoring of glucose control is essential. It is unknown whether Insulin Glargine is excreted in human milk. No metabolic effect of ingested Insulin Glargine on the breastfed newborn infant are anticipated since Insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract. Breastfeeding women may require adjustment in insulin dose and diet.
