Alpha Lipoic Acid 600 mg (Thiogamma 600 Injekt)

Alpha lipoic acid is a powerful antioxidant. Endogenously, alpha lipoic acid regenerates vitamin C and glutathione thereby increasing their levels in the body, which in turn amplifies their overall antioxidant properties. Some have also used them as an adjuct in cancer treatment, relying on its antioxidant properties, in the hope of decreasing the side effects of chemotheraphy as well as in the hope of fighting the disease itself. Others have even promoted the product as something that can aid slimming, believing that the effect of alpha lipoic acid in reducing blood sugar content will assist in weight reduction, although this is an off label use and perhaps without justification. 

Instructions for Use

Thiogamma® 600 Injection
Active ingredient: α-lipoic acid, meglumine salt

Composition
Medically effective components:
1 ampoule of 20 ml injection solution contains:
1167.70 mg α-lipoic acid, meglumine salt, corresponding to 600 mg α-lipoic acid
Administrative Form and Content
5 ampoules of 20 ml
α-lipoic acid is a substance formed in the body‘s own metabolism which influences certain metabolic effects in the body.

Sensory disturbances as a result of nerve damage (diabetic polyneuropathy) caused by diabetes mellitus.

Contraindications
When must Thiogamma® 600 Injekt not be used?
Thiogamma® 600 Injekt must not be used in known cases of hypersensitiveness to α-lipoic acid or to any other ingredients of Thiogamma® 600 Injekt.

What precautions must be taken during pregnancy?
As it is not known whether it is safe to take the medication during pregnancy, upon becoming pregnant the patient should inform the doctor, who must then decide on whether to continue treatment with Thiogamma® 600 Injekt. The use of Thiogamma® 600 Injekt should only be continued with medical advice.


What precautions should be taken during breast-feeding?
It is not known whether α-lipoic acid passes into the mother‘s milk. Thiogamma® 600 Injekt should therefore never be taken while breast-feeding.

What precautions should be taken in the case of children?
Children and juveniles should not be treated with Thiogamma® 600 Injekt as there is no clinical experience of this.

Precautionary Measures and Warnings
Which precautionary measures must be observed?
α-lipoic acid combines with sugar molecules (e.g. laevulose solution) to form difficult-to-dissolve complex compounds. Furthermore, the infusion solution is incompatible with glucose solution, Ringer‘s solution and solutions which are known to react with SH groups and disulphide bridges.
What precautions must be taken while driving, working with machines or in areas without support?
No particular precautionary measures are required.

Interactions
Which other medications change the effects of Thiogamma® 600 Injekt , and what precautions must be observed when you are taking other medication?
Please note that the following may also apply to medication taken until recently.
It cannot be excluded that the simultaneous use of Thiogamma® 600 Injekt may result in Cisplatin losing its effect. The blood-sugar lowering effect of insulin or oral antidiabetics may be intensified. Therefore a close-meshed blood- sugar analysis is advisable, particularly at the start of the therapy with Thiogamma® 600 Injekt. In individual cases it may become necessary to reduce the insulin dose or the dose of the oral antidiabetic in accordance with the instructions of the doctor treating the patient in order to avoid symptoms of hypoglycaemia.

Which stimulants, foods and drinks should be avoided?
Alcohol should be avoided during treatment with Thiogamma® 600 Injekt, as the therapeutic effect of α-lipoic acid is weakened by alcohol and its decomposition products.

Dosage, Type and Duration of Use
The following applies unless your doctor has given you other instructions concerning the use of Thiogamma® 600 Injekt . Please adhere to these instructions, as otherwise Thiogamma® 600 Injekt cannot act correctly.


How much and how often should Thiogamma® 600 Injekt be administered?
In cases of severe sensory disturbances associated with severe diabetic polyneuropathy, it is recommended that adults receive 1 ampoule of Thiogamma® 600 Injekt, corresponding to 600 mg of α-lipoic acid, several times weekly up to once daily. The injections are applied over a period of 2-4 weeks in the initial phase of the treatment.

How and when should Thiogamma® 600 Injekt be administered?
The injections are administered intravenously, preferably in the form of a short infusion (see „Information on the Infusion Application“).
The intravenous administration should be performed slowly, i.e. not faster than 50 mg of α-lipoic acid (corresponding to 1.7 ml of injection solution) per minute.

Information on the Infusion Application
Thiogamma® 600 Injekt is best administered in the form of a short infusion in physiological saline solution. To this purpose, 1 ampoule (corresponding to 600 mg of α-lipoic acid) is mixed with 50-250 ml of 0.9% saline solution and infused at least 30 minutes.

Overdose and other Types of Incorrect Use
What should be done if Thiogamma® 600 Injekt has been administered in too large quantities?
So far there have been no known specific cases of poisoning with α-lipoic acid, and this is not to be expected from the action properties of the substance.


What measures should be taken if you interrupt treatment or terminate it prematurely?
If you wish to terminate the treatment, please consult your doctor. Regular injection is important for the treatment of sensory disturbances in the case of diabetic polyneuropathy.

Side Effects 
What side-effects may occur during the administration of Thiogamma® 600 Injekt?

Occasionally, after rapid intravenous injection a feeling of pressure in the head and respiratory oppression may occur, but these subside again spontaneously. Allergic reactions with itching and reddening local to the point of injection or over the entire body may occur, or even shock.


In individual cases cramps, double vision, spontaneous haemorrhaging over small areas of the skin (purpura) and functional disturbances to the blood platelets (thrombopathies) have been observed.

Owing to a possible improvement in blood sugar utilisation, the blood-sugar level may drop in individual cases. Alteration or disturbance of taste and epileptic fits.
If you observe side effects which are not listed in these instructions, please inform your doctor or pharmacist.


Which countermeasures should be taken if side effects occur?
If you observe the above side effects, Thiogamma® 600 Injekt should not be used again. Inform your doctor so that he or she can decide on the seriousness and any necessary measures.Upon the first signs of a hypersensitiveness reaction, use of the medication should be terminated and the doctor consulted immediately.

Information concerning the Shelf Life of the Medication
• The use-by date is printed on this pack. Do not use the medication after this date!
• The infusion solution is intended for immediate use and must be protected by the enclosed light-screening cover
owing to the sensitiveness to light of the α-lipoic acid. (The light-protected infusion solution can be used for approximately 6 hours.)

How must Thiogamma® 600 Injekt be stored?
• Owing to the sensitivity to light of α-lipoic acid, the ampoules should only be removed from the folding boxes immediately before use.
Do not store above 25°C.
Please store this medication carefully out of the reach of children.

For the Information of our Patients
Sooner or later many diabetics experience disturbances to the nerve metabolism which are not of an organic origin, and which cause various types of unpleasant sensory disturbances. Typical problems are formication, pins and needles, a „furry“ feeling, burning of the soles of the feet, restless legs and feelings of numbness. These disturbances generally affect the legs strongest of all.
Thiogamma® 600 Injekt can counteract these sensory disturbances. The active substance which it contains is α-lipoic acid, a substance produced by the body itself. α-lipoic acid is a component of important enzyme complexes, i.e. biocatalysts which are essential for correct energy metabolism, in particular sugar metabolism.