Thiogamma I.V. Special Precautions

Hypersensitivity reactions including anaphylactic shock reactions have been reported in conjunction with parenteral administration of Thioctic acid 600 mg/50 ml, solution for infusion (see Adverse Reactions). Therefore, patients must be strictly monitored. In case of early symptoms (e.g. pruritus, nausea, malaise, etc.) therapy must be immediately suspended and other therapeutic measures started, if required (see Incompatibilities under Cautions for Usage).
In single cases, in decompensated or poorly controlled diabetic patients in poor general condition, severe anaphylactic reactions may occur in association with the use of Thioctic acid 600 mg/50 ml, solution for infusion.
Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with alpha-lipoic acid (thioctic acid). Patients with human leukocyte antigen genotypes such as HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles are more susceptible to develop IAS when treated with alpha-lipoic acid. HLA-DRB1*04:03 allele (susceptibility to IAS odds ratio: 1.6) is especially found in Caucasians, with a higher prevalence in southern than in northern Europe; and HLA-DRB1*04:06 allele (susceptibility to IAS odds ratio: 56.6) is especially found in Japanese and Korean patients.
Insulin Autoimmune Syndrome (IAS) should be considered in the differential diagnosis of spontaneous hypoglycaemia in patients using alpha-lipoic acid (see Adverse Reactions).
Effects on ability to drive and use machines: Thioctic acid 600 mg/50 ml, solution for infusion has no or negligible influence on the ability to drive and use machines.