Dialipon solution for inf. 3% of amp. 20 ml No. 5

Pharmacological properties

Pharmacodynamics. alpha lipoic acid acts as coenzyme in oxidizing decarboxylation of α-ketonic acids; plays an important role in energy balance of a cell. in an amide form (lipoamid) is an essential cofactor of the multienzymatic complexes catalyzing decarboxylation of α-ketonic acids of a tricarbonic acid cycle. anti-toxic and antioxidant properties are inherent in alpha lipoic acid, it is also capable to restore other antioxidants, in particular in diabetes. at patients with diabetes alpha lipoic acid reduces insulin resistance and slows down development of peripheral neuropathy. promotes decrease in content of glucose in blood and to accumulation of a glycogen in a liver. alpha lipoic acid influences exchange hs, participates in regulation of lipidic and carbohydrate metabolism, improves function of a liver (owing to hepatoprotective, antioxidant, disintoxication action). also alpha lipoic acid well influences regeneration processes.

Pharmacokinetics. T _½ medicament — 30 min. The general clearance is 694 ml/min. Distribution volume — 12.7 l. After disposable in/in introductions to the first 3–6 h with urine 93–97% of alpha lipoic acid or its derivatives are removed.

Indication

as a part of complex therapy of polineyropatiya of various genesis (diabetic polyneuropathy, alcoholic polyneuropathy), in atherosclerosis (as hypolipidemic means), liver diseases (hepatitis, cirrhosis, fat dystrophy of a liver in the absence of hepatitis v), in acute and chronic intoxications (poisonings with salts of heavy metals, mushrooms).

Use

Drug is appointed for in/in injections/infusions after preliminary cultivation in 0.9% chloride sodium solution.

In heavy diabetic polyneuropathy with infusion 20 ml of the solution (600 mg of alpha lipoic acid) divorced in 250 ml of 0.9% of solution of sodium of chloride, 1 time a day. Enter slowly — no more than 50 mg of alpha lipoic acid (1.7 ml of solution for infusions) in a minute. In very hard cases the daily dose is raised to 900–1200 mg/days

conduct the Initial course of treatment for 2–4 weeks. Subsequently pass to maintenance therapy with dosage forms of alpha lipoic acid for oral administration (Dialipon capsules) in a dose of 600 mg of medicament 1–3 times a day for 1–3 months

For prevention of diabetic polyneuropathy, in atherosclerosis, chronic intoxications, liver diseases establish a dose of medicament individually, depending on age, the body weight of the patient and severity of a disease. It is necessary to begin treatment with an initial dose of 10 ml of solution (300 mg of alpha lipoic acid) in day.

2 times a year.

Contraindication

Hypersensitivity to medicament or to one of its components, children's age, the period of pregnancy and feeding by a breast.

Side effects

heavy feelings in the head, increase in intracranial pressure, hot inflows, perspiration, nausea, vomiting, a short-term delay or difficulty of breath which take place independently.

from nervous system: in certain cases later in/in introductions noted a headache, dizziness, spasms, a diplopia, a disorder of vision.

from the system of a hemopoiesis: in certain cases later in/in introductions revealed petekhialny hemorrhages in a mucous membrane, skin, a trombotsitopatiya, dysfunction of thrombocytes, hypocoagulation, hemorrhagic rash (purple), thrombophlebitis.

from a metabolism: a hypoglycemia (dizziness, the increased sweating, a headache, a visual disturbance) owing to glucose utilization improvement.

Allergic reactions: at in in introduction in the injection site the appearance of a small tortoiseshell and development of eczema, petekhialny rash, an itching, dermatitis is possible; seldom — system allergic reactions up to an acute anaphylaxis.

Local reactions: sometimes — at patients with hypersensitivity in the place of an injection of Dialipon the feeling of a thermalgia is possible.

Disturbance from a cardiovascular system: pain in heart, tachycardia.

At treatment of patients with diabetes the frequent control of a glycemia is necessary for

. in certain cases it is required korrigirovany doses of hypoglycemic means for prevention of a hypoglycemia.

during treatment of polyneuropathy, thanks to regeneration processes, perhaps short-term strengthening of sensitivity which is followed by paresthesia with feeling of "crawling of goosebumps".

Constant alcohol intake is risk factor of developing polyneuropathy and can reduce Dialipon's efficiency. Therefore it is recommended to refrain from alcohol intake during medicament treatment. It is not necessary to appoint Dialipon along with the medicaments containing metals (preparations of iron, magnesium, calcium).

Drug is photosensitive therefore ampoules should be got from packing only just before use.

Infusional solutions needs to be protected from sunlight, covering them with light-protective packages. In these conditions the prepared infusional solution remains suitable for use during no more than 6 h

Use during pregnancy or feeding by a breast. The medicament Dialipon is contraindicated to use during pregnancy. In need of its use during a lactation it is necessary to stop feeding by a breast. In pilot studies on animals the teratogenic effect of thioctic acid is not revealed. Similar researches at people were not conducted. There are no data on discharge of thioctic acid in breast milk.

Children. Dialipon cannot appoint children and teenagers due to the lack of clinical experience of use of medicament for this category of patients.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Drug does not influence speed of response at control of vehicles or work with other mechanisms, but in case of signs of side effect of medicament (see. Side EFFECTS) it is necessary to refrain from this occupation.

strengthening of hypoglycemic effect at intake of insulin or oral hypoglycemic means Is possible

Interaction therefore constant control of level of a glycemia, especially in an initiation of treatment dialipony, and correction of doses of hypoglycemic means is necessary. simultaneous use can bring to loss of activity of Cisplatinum.

Overdose

At overdose the nausea, vomiting, a headache are possible

. at overdose or suspicion on development of serious side effects it is necessary to stop immediately an injection and, without taking out a syringe needle, to carry out through it slow injection of 0.9% of solution of sodium of chloride.

data that owing to accidental or intended use of lipoic acid in a dose of 10-40 g against the background of a drunkenness celebrated isolated cases with serious symptoms of intoxication up to a fatal outcome Are available. Clinical signs of intoxication were shown in the form of psychomotor disturbance or a faint with the subsequent generalized spasms and development of a lactacidemia. Lipoic acid the hypoglycemia, shock, a rhabdomyolysis, hemolysis, disseminate intravascular coagulation, oppression of marrow and organ insufficiency are a consequence of intoxication.

to

In acute poisoning with lipoic acid showed immediate hospitalization with holding all-therapeutic actions of a detoxication of an organism (artificial respiration, vomiting, gastric lavage, activated carbon, etc.). For treatment of generalized spasms, a lactacidemia and other consequences of intoxication it is necessary to be guided by means of modern intensive care and symptomatic approach for acceleration of removal of lipoic acid. Symptomatic further treatment.

Storage conditions

B the place protected from light at a temperature not above 25 °C.