Lipotocin Inj.

(Thioctic acid tromethamine)

리포토신주 (티옥트산트로메타민)

Component

Thioctic acid tromethamine 476.4mg

(300mg as thioctic acid) in 12mL

Identification

Injection containing light yellow, clear liquid in a brown glass ampoule

Efficacy / Effect

Relief of diabetic polyneuropathy

Dosage

In the vein of a patient with severe symptoms, thioctic acid 600 mg per day is injected for 2 to 4 weeks, after which the drug 600 mg per day is administered orally to the patient.

·Intravenous Infusion

One ampoule of this drug should be diluted in 100-250 mL of physiological saline injection solution, and then continuously injected into a vein slowly over at least 12 minutes.

Thioctic acid should not be injected at a rate of more than 50 mg (2 mL of injectable solution) per minute.

·Intravenous injection

Thioctic acid can be injected directly into a vein using a syringe and perfusor, even with a minimum injection time of 12 minutes.

Precautions for Use

1. Warnings When cutting the container of the ampoule injection, the container should be carefully cut so that the incorporation of the glass fragments is minimized because adverse effects may be caused by the incorporation of the fragments. In particular, the use of children and the elderly should be especially careful (only for glass ampoule injections).

2. It should not be given to the following patients. 1) Patients with hypersensitivity reaction to thioctic acid (α-lipoic acid) and components of this drug 2) Children and adolescents (less clinical experience)

3. Adverse Effects Adverse effects are classified as Very Frequently: 10% or more, Frequently : 1% or more ~ less than 10%, Sometimes: 0.1% or more ~ less than 1 %, Rarely: 0.01 % or more ~ less than 0.1%, and Very Rarely: less than 0.01% based on the frequency of the effects.

1) Injection Site : Injection site reactions have been reported very rarely.

2) Hypersensitivity Reaction : Hypersensitivity reactions such as skin rash, hives, itching, eczema, and fever, as well as systemic reactions leading to shock can occur very rarely.

3) Digestive System : Nausea and vomiting were sometimes reported.

4) Psychoneural System: After intravenous administration of thioctic acid, taste change or disturbance was sometimes observed, and spasm and diplopia were very rarely observed.

5) Blood System : Purpura and platelet dysfunction were observed very rarely after administration of this drug.

6) Systemic

Head congestion and breathing disorders can occur frequently after rapid infusion, but these adverse effects disappear by themselves over time. This drug has an effect of improving glucose utilization,

and blood sugar is very rarely lowered. In this case, dizziness, sweating, headache, and visual impairment due to hypoglycemia may appear.

Storage / Shelf life

Light-resistant hermetic container, Storage at room temperature (1 - 30℃) / 36 months from the date of manufacture

Packing Unit

12mL * 10A