Berlithion 600 ED concentrate for solution for infusion – thioctic acid for diabetic polyneuropathy

Berlithion 600 ED is a concentrate for solution for infusion containing 600 mg thioctic (alpha-lipoic) acid in a 24 mL ampoule, as the ethylenediamine salt. Thioctic acid influences certain metabolic processes and may protect nerve cells from reactive breakdown products (antioxidant effect). It is made by Berlin-Chemie AG, Germany.

According to the official leaflet, Berlithion 600 ED is used in adults to treat sensory disturbances (paraesthesia – tingling, burning, pins and needles) caused by damage to peripheral nerves due to diabetes (diabetic polyneuropathy). It is used in healthcare facilities as an intravenous infusion.

What is Berlithion 600 ED used for and how is it given?

Key facts about the medicine

What is Berlithion 600 ED used for?

To treat paraesthesia (tingling, burning, pins and needles) in diabetic polyneuropathy in adults. According to the leaflet, optimal diabetes treatment is the basic therapy of diabetic polyneuropathy.

How is it given and dosed?

• For marked paraesthesia the recommended dose is one ampoule (600 mg thioctic acid) daily.
• The ampoule is diluted in 250 mL normal saline (0.9% sodium chloride) and given as a short intravenous infusion over at least 30 minutes.
• The solution is prepared immediately before use and protected from light with aluminium foil; protected in this way it is stable for about 6 hours. Only normal saline may be used for dilution.
• The initial phase lasts 2–4 weeks; treatment continues with oral forms of thioctic acid at 300 to 600 mg a day, as decided by the doctor.

Special patient groups

• Children and adolescents: should not be used, as there is no adequate clinical experience.
• Patients with a certain HLA genotype (more common in patients from Japan and Korea, but also found in Caucasians) are more prone to insulin autoimmune syndrome with a marked drop in blood sugar.

Contraindications – when the medicine must not be used

Berlithion 600 ED must not be given if you are allergic to thioctic acid or any of the excipients.

Precautions and warnings

• During the infusion the doctor watches for early signs of hypersensitivity (itching, nausea, malaise); if they appear, the infusion is stopped immediately.
• Too fast an infusion may cause a feeling of pressure in the head and difficulty breathing – so the infusion lasts at least 30 minutes.
• Monitor blood sugar, particularly at the start of treatment; sometimes the dose of insulin or oral antidiabetic needs to be reduced.

Interactions with other medicines, food and drink

• Insulin and oral antidiabetics: their blood-sugar-lowering effect may be increased – hypoglycaemia is possible.
• Cisplatin: a loss of its effect cannot be ruled out.
• The medicine is incompatible with glucose solution, Ringer's solution and solutions that react with SH groups or disulphide bridges.
• Alcohol: regular alcohol intake is a risk factor for progression of nerve damage and may reduce the success of treatment – avoid alcohol, also in periods when you are not receiving the medicine.

Pregnancy and breastfeeding

In pregnant and breastfeeding women thioctic acid may be used only after careful assessment of benefits and risks, on the recommendation and under the supervision of a doctor, as there is no experience in this group. It is not known whether it passes into breast milk. Animal studies have shown no harmful effects on fertility or the unborn baby.

Driving and using machines

Berlithion 600 ED has no or negligible influence on the ability to drive and use machines.

Possible side effects

• Common (up to 1 in 10): pressure in the head and difficulty breathing after a rapid infusion, which resolve spontaneously.
• Very rare (up to 1 in 10,000): injection site reactions; pinpoint skin bleeding (purpura) and platelet dysfunction; taste changes, seizures, double vision; hypoglycaemia-like symptoms (dizziness, sweating, headache, visual disturbance).
• Not known: insulin autoimmune syndrome with a marked drop in blood sugar; allergic reactions (rash, hives, itching) and whole-body hypersensitivity reactions, including shock.

At the first signs of hypersensitivity tell your doctor immediately. Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• The medicine is given by a doctor or nurse, so overdose is unlikely; overdose may cause nausea, vomiting and headache.
• The infusion schedule and the switch to oral treatment are decided by the doctor.

Related information

For additional care and support with diabetic neuropathy and foot care, see also the Creams for diabetics and diabetic foot care category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• One 24 mL ampoule contains 600 mg thioctic acid, as the ethylenediamine salt.
• Excipients: water for injections, nitrogen, argon.
• Appearance: clear yellow-green solution in a dark glass ampoule; the carton contains a plastic tray with 5 ampoules.
• Marketing authorisation holder: Berlin-Chemie A. Menarini Distribution d.o.o., Đorđa Stanojevića 14, Belgrade – Novi Beograd. Manufacturer: Berlin-Chemie AG, Glienicker Weg 125, Berlin, Germany.

Storage

• Keep the ampoules in the outer carton to protect from light.
• After opening or dilution, use the solution immediately and protect it from light.
• Shelf life: 3 years. Keep out of the sight and reach of children.

Frequently asked questions

How long does treatment with Berlithion 600 ED infusions last?

The initial phase usually lasts 2 to 4 weeks, one infusion a day; the doctor may then continue treatment with oral forms of thioctic acid (300–600 mg a day).

Why must the infusion last at least 30 minutes?

A rapid infusion may cause a feeling of pressure in the head and difficulty breathing, so the medicine is given slowly.

Does Berlithion affect blood sugar?

Yes. It may increase the effect of insulin and oral antidiabetics, so careful blood sugar monitoring is needed, especially at the start of treatment.

May I drink alcohol during treatment?

It is not recommended. Alcohol is a risk factor for progression of nerve damage and reduces the success of treatment.

Sources

• ALIMS – Package leaflet Berlithion® 600 ED, concentrate for solution for infusion (August 2024, in Serbian)
• ALIMS – Summary of Product Characteristics Berlithion® 600 ED (in Serbian)

Date sources were checked: 24.10.2026.