Espa-Lipon injection 600 solution for injection 25 mg/ml, 24ml x 5 ampoules — Made in Germany — Free Delivery

(Espa-Lipon)

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Brand: Esparma GmbH

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Description Espa-Lipon injection 600 solution for injection 25 mg/ml, 24ml x 5 ampoules — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Thioctic acid is a substance that is formed in the human body and acts as a coenzyme during the oxidative decarboxylation of α-keto acids. Hyperglycemia caused by diabetes mellitus leads to the deposition of glucose on the matrix proteins of blood vessels and the formation of advanced glycosylation end products. this process leads to a decrease in endoneural blood flow and endoneural hypoxia / ischemia associated with an increased production of free oxygen radicals that damage the nerve, as well as a decrease in the amount of antioxidant such as glutathione in peripheral nerves. In 1995, a multicenter, placebo-controlled study was carried out to investigate the efficacy of thioctic acid in the symptomatic treatment of diabetic polyneuropathy, in which data were obtained on the beneficial effects of thioctic acid on such test symptoms as paresthesia, burning, numbness and pain.

Pharmacokinetics. Thioctic acid is highly susceptible to the effect of the primary passage through the liver. There are significant individual differences in the systemic availability of thioctic acid. The metabolism of thioctic acid occurs by oxidation of side links and fusion. Excretion is carried out mainly by the kidneys.

In humans, T½ in blood plasma is about 25 minutes, the total clearance for blood plasma is 10-15 ml / min · kg. At the time of completion of a 30-minute infusion at a dose of 600 mg, the detectable level in blood plasma is about 20 μg / ml. By means of radioactive labeling in the course of studies on animals (rats, dogs), the predominant release of 80–90% of the preparation in the form of metabolites was revealed. A person has a small amount of unchanged substance that is excreted in the urine. Metabolism occurs mainly by oxidative reduction of side units (β-oxidation) and / or S-methylation of thiol groups.

Indications

Treatment of diabetic polyneuropathy.

Application

Tablets. adults are prescribed 1 tablet of Espalipon 600 (corresponding to 600 mg of thioctic acid) once a day.

Do not chew the tablets and drink plenty of liquid, such as a glass of water. Simultaneous food intake can affect the absorption of the preparation, so it is important to take the tablets on an empty stomach (30 minutes before breakfast). The duration of treatment is determined by the doctor depending on the course of the disease. Since diabetic polyneuropathy is a chronic disease, therapy can be lengthy.

Solution for injection. Adults use once a day 12-24 ml of the preparation, diluted in 250 ml of 0.9% sodium chloride solution (equivalent to 300 or 600 mg of thioctic acid per day).

The solution is to be administered as an intravenous infusion; used for 2-4 weeks at the initial stage of treatment.

As a further continuation of therapy, Espalipon 600 can be used (in the form of tablets).

Infusion rules. To prepare an infusion solution, only 0.9% sodium chloride solution should be used. The preparation should be administered intravenously drip for at least 30 minutes, before that the ampoule of the preparation Espalipon injekts. 300 or Espa-lipon injection. 600 is diluted in 250 ml of 0.9% sodium chloride solution. The preparation is sensitive to sunlight, therefore, the solution should be prepared immediately before the start of administration and the prepared bottle should be protected with a light-protective bag. The infusion solution, protected from light, can be stored for about 6 hours.

Contraindications

Hypersensitivity to thioctic acid or to one of the components of the preparation

Side effects

Tablets

From the side of the nervous system: very rarely - a change or violation of taste.

From the gastrointestinal tract: very rarely - nausea, vomiting, abdominal pain and gastrointestinal pain, diarrhea.

Metabolic disorders: very rarely - a decrease in blood glucose levels. There have been reports of complaints indicative of a hypoglycemic state, namely dizziness, increased sweating, headache and visual impairment.

From the immune system: very rarely - allergic reactions such as rash, hives (urticaria) and itching.

Others: shortness of breath, eczema, malaise.

Solution for injection

On the part of the digestive tract: in some cases, with a quick intravenous injection, nausea, vomiting, abdominal pain, which pass on their own, are observed; diarrhea.

From the nervous system: with a quick intravenous injection, a feeling of heaviness in the head, headache, increased intracranial pressure, hot flashes, increased sweating, shortness of breath are possible. In some cases, after administration, weakness, dizziness, convulsions, taste disturbances, diplopia, and visual impairment were noted. In most cases, all of these manifestations go away on their own.

From the side of the blood system: in some cases, after intravenous administration, petechial hemorrhages in the mucous membrane, skin, thrombocytopathy, dysfunction of platelets, hypocoagulation, hemorrhagic rash (purpura), thrombophlebitis were noted.

Metabolic disorders: hypoglycemia is possible (dizziness, increased sweating, headache, visual impairment) due to improved glucose utilization.

Cases of hypoglycemia due to thioctic acid-induced autoimmune syndrome (positive test for autoantibodies to insulin) have been reported, mainly in Mongoloid patients.

On the part of the immune system: at the injection site, allergic reactions (urticaria, eczema, petechial rash, itching, dermatitis), including systemic ones, up to the development of anaphylactic shock may occur.

Local reactions: reactions may develop at the injection site; in patients with hypersensitivity to thioctic acid at the injection site, a sensation of burning pain may occur, which disappears on its own or with a decrease in the rate of administration of the preparation.

From the side of the cardiovascular system: pain in the region of the heart, tachycardia.

After intravenous administration, in some cases, punctate hemorrhages in the mucous membrane and skin, thrombopathy were detected. As a result of improved glucose uptake, in some cases, blood glucose levels may decrease.

special instructions

The basic principle of therapy for diabetic polyneuropathy is optimal control of diabetes mellitus. in the treatment of patients with diabetes mellitus, frequent glycemic control is required. in some cases, a dose adjustment of hypoglycemic preparations is required to prevent hypoglycemia.

During the treatment of polyneuropathy, thanks to regeneration processes, a short-term increase in sensitivity is possible, which is accompanied by paresthesia with a feeling of "creeping". When using thioctic acid, diabetic patients need frequent monitoring of blood glucose levels. In some cases, it is necessary to reduce the dose of antidiabetic preparations in order to prevent the development of hypoglycemia.

The constant use of alcohol is a risk factor for the onset and progression of polyneuropathy and can reduce the effectiveness of the preparation. Therefore, it is recommended to refrain from drinking alcohol during and between courses of preparation treatment.

The preparation is in the form of a photosensitive solution, therefore, the bottles should be removed from the package only immediately before use.

The solution prepared for infusion must be protected from sunlight, covering it with light-protective bags. Under these conditions, it remains usable for a maximum of 6 hours.

The preparation in the form of tablets contains lactose, so it should not be used by patients with such rare hereditary diseases as galactose intolerance, lactase deficiency or glucose-galactose absorption insufficiency syndrome.

Certain restrictions for intravenous administration of thioctic acid preparations are elderly age (over 75 years).

In connection with the parenteral use of the preparation Espalipon injekts. 300 / Espa-lipon inject. 600 noted hypersensitivity reactions, including anaphylactic shock (see SIDE EFFECTS). Adequate screening of patients is required. In the event of early symptoms (for example, itching, nausea, discomfort, etc.), therapy is urgently stopped; the need for additional therapeutic measures may arise.

Use during pregnancy and lactation. The use of thioctic acid during pregnancy is not recommended due to the lack of relevant clinical data. There is no data on the penetration of thioctic acid into breast milk; therefore, it is not recommended to use it during breastfeeding.

Children. Since there are no data on the safety and efficacy of thioctic acid in children, the preparation is not recommended for this age group of patients.

The ability to influence the reaction rate when driving or operating other mechanisms. During treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Interactions

The effectiveness of cisplatin decreases with simultaneous use with the preparation. thioctic acid is a metal complexing agent and therefore (according to the basic principles of pharmacotherapy) it should not be used simultaneously with metal compounds (for example, with food additives containing iron or magnesium, with dairy products, since they contain calcium). if the total daily dose of the preparation is used 30 minutes before breakfast, then food supplements containing iron and magnesium should be used in the middle of the day or in the evening. when using thioctic acid in patients with diabetes mellitus, it is possible to increase the hypoglycemic effect of insulin and oral antidiabetic agents, therefore (especially at the initial stage of treatment), careful monitoring of blood glucose levels is recommended. to avoid symptoms of hypoglycemia in some cases, it may be necessary to reduce the dose of insulin or oral antidiabetic agents.

Note. Regular alcohol consumption is a significant risk factor for the development and progression of neuropathic syndrome and thus may affect the success of treatment with Espalipon Injecz. 300 / Espa-lipon inject. 600. Therefore, as a rule, patients with diabetic polyneuropathy are advised to avoid alcohol consumption. This also applies to periods when therapy is not carried out.

Incompatibility. Thioctic acid reacts in vitro with metal ion complexes (eg, cisplatin).

Thioctic acid forms complex compounds with molecules of poorly soluble sugars (for example, solution of levulose).

An injection solution of thioctic acid is incompatible with glucose solution, Ringer's solution, as well as with solutions known to react with SH groups or disulfide bridges.

As a solution - a carrier for the use of injections Espalipon injekts. 300 / Espa-lipon inject. 600 - only 0.9% sodium chloride solution should be used.

Overdose

In case of an overdose, nausea, vomiting, and headache are possible. after accidental ingestion or attempted suicide with oral administration of thioctic acid in doses of 10–40 g in combination with alcohol, significant intoxication was observed, in some cases with a lethal outcome. at the initial stage, the clinical picture of intoxication can manifest itself as psychomotor agitation or clouding of consciousness. in the future, generalized convulsions and lactic acidosis occur. in addition, hypoglycemia, shock, acute skeletal muscle necrosis, hemolysis, disseminated intravascular coagulation syndrome, bone marrow suppression and multiple organ failure have been described in cases of intoxication with high doses of thioctic acid.

Treatment. If severe preparation intoxication is suspected, immediate hospitalization is recommended and measures are taken in accordance with general principles in case of accidental poisoning (for example, induction of vomiting, gastric lavage, intake of activated charcoal). For the treatment of generalized seizures, lactic acidosis and other life-threatening consequences of intoxication, it is necessary to be guided by the principles of modern intensive care and a symptomatic approach. The benefits of the use of hemodialysis, hemoperfusion or hemofiltration methods for the forced excretion of thioctic acid have not been proven at present. Therapy is symptomatic.

Storage conditions

Tablets. in original packaging at temperatures up to 25 ° C. solution for injection. at a temperature not exceeding 25 ° C in the original packaging to protect from light. The shelf life after dissolving in a physiological saline solution under conditions of protection from light is 6 hours.

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