Sansulin Log-G

Sansulin Log-G Adverse Reactions

insulin glargine

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Adverse Reactions
Hypoglycaemia: Hypoglycaemia, in general the most frequent undesirable effect of Insulin therapy, may occur if the Insulin dose is too high in relation to the Insulin requirement. Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episode may be life-threatening.
In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counterregulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Eyes: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.
Long-term improved glycaemic control decrease the risk of progression of diabetic retinopathy. However, intensification of Insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Lipodystrophy: As with any Insulin therapy, lipodystrophy may occur at the injection site and delay local Insulin absorption. In clinical studies, in regimens which included SANSULIN Log-G, lipohypertrophy was observed in 1-2% of patients, whereas lipoatrophy was uncommon. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
Injection site and allergic reactions: In clinical studies, in regimens which included SANSULIN Log-G, reactions at the injection site were observed in 3-4% of patients. Such reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to Insulins at the injection site usually resolve in a few days to a few weeks.
Immediate-type allergic reactions to Insulin are rare. Such reactions to Insulin (include Insulin Glargine) or the expecients may, for example, be associated with generalized skin reactions, angiooedema, bronchospasm, hypotension and shock, and may be lifethreatening.
Other reactions: Insulin administration may cause Insulin antibodies to form. In clinical studies, antibodies that cross-react with human Insulin and Insulin Glargine were observed with the same frequency in the both NPH-Insulin and Insulin Glargine treatment groups. 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.
Rarely, Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified Insulin therapy.
Medication errors have been reported in which other Insulins, particularly short-acting Insulins, have been accidentally administered instead of Insulin Glargine.
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