Berlithion 300mg ampoules №5

Description for Berlithion 300mg ampoules №5

Pharmacological properties: The Pharmacodynamics. α-Lipoic acid (DL-5-(1,2-ditiolan-3-yl)-valeric acid) - vitamin-like substance, which is endogenously produced in the body. As a coenzyme involved in oxidative decarboxylation of α-keto acids. In experimental diabetes mellitus α-lipoic acid reduces blood glucose and increased glycogen content in the liver and in humans - to change the concentration of pyruvic acid in blood serum.
Caused by diabetes mellitus hyperglycemia leads to the deposition of glucose on matrix proteins of blood vessels and the formation of glycosylation end products of a progressive, resulting in decreased blood flow endonevralny arises endonevralnaya ischemia and increases the formation of free radicals that damage the peripheral nerve. Application of α-lipoic acid reduces the formation of products of glycation, improve endonevralnogo blood flow, improve the content of antioxidant glutathione, which causes improved function of peripheral nerves in diabetic sensory polyneuropathy, namely: reduced severity of pain, burning, numbness and "crawling" in the extremities . Application of α-lipoic acid also improves liver function if it is damaged.
Pharmacokinetics. After oral application of α-lipoic acid is rapidly absorbed in the gastrointestinal tract. Due to the significant effect of the primary passage through the liver absolute biodostupnist α-lipoic acid compared with IV administration is 20%. Due to the rapid distribution in tissues half-life in humans is about 25 minutes, and total clearance in the blood plasma - 10-15 ml / min / kg body weight. Maximum content in blood plasma is 4 mg / ml, achieved 30 minutes after oral administration of 600 mg α-lipoic acid. At the end of a 30-minute infusion of 600 mg α-lipoic acid, its content in blood plasma is approximately 20 ug / ml. 80-90% α-lipoic acid excreted by the kidneys as metabolites. Biotransformation occurs via oxidative reduction of the side chain and / or by S-methylation of the corresponding thiols.

INDICATIONS: Prevention and treatment of diabetic and alcoholic polyneuropathy, liver disease, namely acute hepatitis of various etiologies of mild or moderate, chronic hepatitis and cirrhosis.

APPLICATION: diabetic and alcoholic polyneuropathy.
The drug Valium 300 capsules Oral Valium 300 - in the form of tablets, coated tablets, taken orally, 2 capsules 1 time per day; drug Valium 600 capsules - 1 capsule 1 time a day for 30 minutes before the first meal.
In severe disease during the first 1-2 weeks of treatment, we use a combined infusion (IV and oral): in the morning / in the introduction of 24 ml / day the drug Valium 600 units in the form of a concentrate for preparing a p-pa for infusion or 12 - 24 ml p-pa drug Valium 300 units in the form of a concentrate for preparing a p-pa infusion, and at night - take the medication in the form of capsules or tablets of Valium 300 or 600 mg.
For dilution of the drug Valium 300 or 600 IU use only 0,9% p-r sodium chloride. The contents of the ampoule is diluted 250 ml of p-pa, and injected iv for at least 30 minutes. P-p drug must be protected from exposure to sunlight (eg wrap the bottle with aluminum foil). Subject to this condition ravedenny rr may persist for up to 6 hours for further treatment applied to 300-600 mg of α-lipoic acid in the form of tablets or capsules Valium 300 or 600 mg. The course of treatment - at least 2 months, and if necessary it can be carried out 2 times a year.
V / m input Valium 300 units can be by injection at a dose no higher than 2 ml; place in the IM injections must be constantly changing. Course of treatment - 2-4 weeks. As supportive therapy shows oral Valium 300 Oral: 1-2 tablets a day for 1-2 months.
Liver disease. The drug is prescribed in accordance with the above scheme in a dose of 600-1200 mg α-lipoic acid per day, depending on the severity of the condition and laboratory parameters of the functional state of the patient's liver.

Contraindications: hypersensitivity to α-lipoic acid and other ingredients. Due to the lack of clinical experience is not recommended to prescribe a drug to children, as well as during pregnancy and lactation.

SIDE EFFECTS: to assess the frequency of adverse action was taken as a basis for such classification: Very common: ≤ 1 / 10; often: ≤ 1 / 100 but 1 / 10; times: ≤ 1 / 1000, but 1 / 100, rarely: ≤ 1 / 10 000, but 1 / 1000, very rare, including isolated cases: ≤ 1 / 10 000.
Reaction at the injection site: messages were very rare.
Hypersensitivity reactions: allergic skin reactions as hives, itching, eczema and skin rashes, and systemic allergic reactions up to shock.
Violations of the CNS: very rarely - to change the taste; seizures, diplopia after iv injection.
From the hemopoietic system: a very rare after iv administration - purple and thrombocytopathies.
Side-effects of a general nature: after a rapid iv injection there is a feeling of heaviness in the head and dyspnea, who are alone. In some cases, lowered blood sugar levels due to the increased intensity of glucose uptake, which may be accompanied by symptoms similar to symptoms of hypoglycemia - dizziness, sweating, headache and blurred vision.

Cautions: Valium in the treatment period is strictly prohibited alcohol, since ethanol and its metabolites reduce the therapeutic efficacy of the drug, as well as the risk of onset and progression of polyneuropathy. Under the influence of α-lipoic acid may increase hypoglycemic effect of insulin or oral antidiabetic agents, so that at the initial stage of treatment, Valium should conduct more frequent monitoring of blood sugar levels. In some cases, to prevent the onset of symptoms of hypoglycemia may need to decrease insulin doses or oral antidiabetic agents.
Special security measures. When parenteral application of α-lipoic acid observed hypersensitivity reactions up to the development of anaphylactic shock, so patients require proper medical supervision. In the case of early symptoms such as itching, nausea, general malaise, you should immediately discontinue administration of the drug.
APPLICATION:
During pregnancy or breastfeeding. Drug is prescribed only under strict indications and under the supervision of a physician. Information regarding the penetration of α-lipoic acid in breast milk there.
Children. Children and adolescents under the age of 18 years are excluded from the number of patients for the treatment of whom use the drug Valium, due to lack of sufficient experience in the application.
Ability to influence the reaction rate at operating a vehicle or other mechanisms: None.

INTERACTION: α-lipoic acid forms complex compounds with metals (eg cisplatin), so it is recommended that simultaneous use with cisplatin, with iron, magnesium, as well as dairy products due to their content of calcium. Cisplatin should not be administered simultaneously with the use of Valium because of the reduction of its actions under the influence of α-lipoic acid.
α-Lipoic acid is able to form with the sugar contained in certain infusion of p-tures poorly soluble complex compounds, and the drug is incompatible with p-ramie fructose, glucose, etc., as well as with p-ramie products, which are known to enter reaction with SH-groups or disulfide bridges.

OVERDOSE: If overdose can be nausea, vomiting and headache. In the application of α-lipoic acid in very high doses (10-40 g), in combination with alcohol, noted the severe toxicity in some fatal cases. The clinical picture of intoxication in the early manifest psychomotor excitation, or the eclipse of consciousness, further gains during the attacks with generalized seizures and the development of laktatatsidoza. The result of such intoxication could be hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, inhibition of bone marrow function and multiorgan failure. Treatment of intoxication is performed according to general principles: vomit, wash the stomach, used sorbents. If necessary, symptomatic treatment. Currently, data on the usefulness of hemodialysis, hemoperfusion or hemofiltration techniques in the forced removal α-lipoic acid is not.

STORAGE: at or above 30 ° C. In order to protect the contents from light ampoules should be stored in a cardboard box. Cooked pp infusion fit for use for up to 6 hours, subject to protection from light.