Anvimax powder for internal use lemon №6

Trade name of the drug:

AnviMax

International non-proprietary name:

AnviMax

Dosage Form:

Powder for the preparation of oral solution

Pharmacotherapeutic group:

ARI and cold symptoms remedy

Composition:

The composition of the contents of one bag Active ingredients:
Paracetamol - 360 mg, Ascorbic acid - 300 mg, Calcium gluconate monohydrate - 100 mg, Rimantadine hydrochloride - 50 mg, rutoside trihydrate (in terms of rutoside) - 20 mg, loratadine - 3 mg;
Excipients: aspartame - 30 mg, hypromellose - 10 mg, colloidal silicon dioxide - 20 mg, lactose monohydrate - 4086 mg, food flavor (lemon or lemon and honey, or raspberry, or black currant) - 21 mg.

Description:

Bag contents - a mixture of powder and granules from almost white to yellow with a greenish tint color with a characteristic odor (lemon, lemon with honey, raspberry, black currant). The presence of single pink granules.
The solution after dissolving the powder is a colorless or slightly yellowish solution with a characteristic odor (lemon, lemon with honey, raspberry, black currant). The presence of undissolved yellow particles is allowed.

Pharmacodynamics

The combined drug has antiviral, interferonogenic, antipyretic, analgesic, antihistamine and angioprotective effects.

Paracetamol has analgesic and antipyretic effects.

Vitamin C participates in the regulation of redox processes, contributes to the normal permeability of capillaries, blood clotting, tissue regeneration, plays a positive role in the development of immune reactions of the body, compensates for vitamin C deficiency

Calcium gluconateas a source of calcium ions, prevents the development of increased permeability and fragility of blood vessels, causing hemorrhagic processes during influenza and acute respiratory viral infection (ARVI), has antiallergic effect (mechanism is unclear).

Rimantadine possesses antiviral activity against the influenza A virus. Blocking the M2 channels of the influenza A virus, violates its ability to penetrate cells and release ribonucleoprotein, thereby inhibiting the most important stage of viral replication. Induces the production of Interferon alpha and gamma. With influenza B virus, rimantadine has an antitoxic effect.

Rutoside is an angioprotector. Reduces capillary permeability, swelling and inflammation, strengthens the vascular wall. It inhibits aggregation and increases the degree of red blood cell deformation.

Loratadine - blocker H1-histamine receptors, prevents the development of tissue edema associated with the release of histamine.

Pharmacokinetics

Paracetamol. Absorption is high. Communication with plasma proteins - 15%. It penetrates the blood-brain barrier. Metabolized in the liver in three main ways: conjugation with glucuronides, conjugation with sulfates, oxidation by microsomal liver enzymes. In the latter case, toxic intermediate metabolites are formed, which are subsequently conjugated with glutathione, and then with cysteine ​​and mercapturic acid. The main isoenzymes of cytochrome P450 for this pathway are the isoenzyme CYP2E1 (predominantly), CYP1A2, and CYP3A4 (secondary role). When glutathione is deficient, these metabolites can cause damage and necrosis of hepatocytes. Additional metabolic pathways are hydroxylation to 3-hydroxy paracetamol and methoxylation to 3-methoxy paracetamol, which are subsequently conjugated with glucuronides or sulfates. In adults, glucuronidation prevails. Conjugated paracetamol metabolites (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. Excreted by the kidneys as metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases. According to the results of clinical studies, the following pharmacokinetic parameters of paracetamol were established: the maximum plasma concentration is achieved with the use of powder after 0.7 ± 0.39 h and is 4.79 ± 1.81 mcg / ml, the half-life is 2.73 ± 0, 76 hours

Vitamin C absorbed in the gastrointestinal tract (mainly in the jejunum). Communication with plasma proteins - 25%. Diseases of the gastrointestinal tract (peptic ulcer and 12 duodenal ulcers, constipation or diarrhea, worm infestation, giardiasis), the use of fresh fruit and vegetable juices, alkaline drinking reduces the absorption of ascorbic acid in the intestine. The plasma ascorbic acid concentration is normally around 10-20 μg / ml. The time of maximum concentration in the blood plasma after oral administration is 4 h. It penetrates easily into leukocytes, platelets, and then into all tissues; the greatest concentration is reached in the glandular organs, leukocytes, liver and lens of the eye; penetrates through the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in plasma. In deficient states, the concentration in leukocytes decreases later and more slowly and is considered as a better criterion for assessing the deficit than the concentration in plasma. Metabolized predominantly in the liver to deoxyascorbic and then to oxaloacetic acid and ascorbate 2-sulfate. Excreted by the kidneys, through the intestines, with then unchanged and in the form of metabolites. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (turning into inactive metabolites), sharply reducing reserves in the body. It is derived during hemodialysis.

Calcium gluconate Approximately 1 / 5-1 / 3 of orally administered Calcium gluconate is absorbed in the small intestine; this process depends on the presence of ergocalciferol, the pH, dietary patterns and the presence of factors capable of binding calcium ions.Absorption of calcium ions increases with its deficiency and the use of a diet with a reduced content of calcium ions. About 20% is excreted by the kidneys, the rest (80%) - by the intestines.

Rimantadine After ingestion is almost completely absorbed in the intestine. Absorption is slow. Communication with plasma proteins is about 40%. Distribution volume - 17-25 l / kg. Concentration in nasal secretion is 50% higher than plasma. Metabolized in the liver. More than 90% is excreted by the kidneys within 72 hours, mainly in the form of metabolites, 15% - unchanged. In chronic renal failure, the half-life increases by 2 times. In patients with renal insufficiency and in elderly people, it can accumulate in toxic concentrations if the dose is not adjusted in proportion to the decrease in creatinine clearance. Hemodialysis has a minor effect on the clearance of rimantadine. According to the results of clinical studies, the following pharmacokinetic parameters of rimantadine were established: the maximum plasma concentration is achieved with the use of the powder after 5.28 ± 2.54 h and is 69.0 ± 19.7 ng / ml, the half-life is 33.26 ± 12, 76 hours

Rutoside. The time of maximum concentration in the blood plasma after oral administration is 1–9 h. It is excreted mainly with bile and to a lesser extent by the kidneys. The half-life is 10-25 hours.

Loratadine. Quickly and completely absorbed in the gastrointestinal tract. The maximum concentration in the elderly increases by 50%. Communication with plasma proteins - 97%.Metabolized in the liver to form the active metabolite of descarboethoxyloratadine with the participation of cytochrome CYP3A4 isoenzymes and to a lesser extent CYP2D6. Does not penetrate the blood-brain barrier. Excreted by the kidneys and with bile. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics are virtually unchanged. According to the results of clinical studies, the following pharmacokinetic parameters of loratadine were established: the maximum plasma concentration is reached after 3.28 ± 1.25 h and is 1.85 ± 0.95 ng / ml, the half-life is 11.29 ± 5.52 h .

Indications for use

Etiotropic treatment of influenza type A, symptomatic treatment of “cold” diseases, influenza and ARVI, accompanied by fever, muscle pain, headache, chills in adults.

Contraindications

Hypersensitivity to one or more components that make up the drug; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; Gastrointestinal bleeding ; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; portal hypertension; vitamin deficiency; renal failure; pregnancy, breastfeeding period; thyroid diseases, acute diseases of the kidneys, liver (acute glomerulonephritis, acute pyelonephritis, acute hepatitis, or exacerbation of chronic diseases of these organs); chronic alcoholism; hypercalcemia,pronounced hypercalciuria, nephrolourithiasis, sarcoidosis, simultaneous administration of cardiac glycosides (risk of arrhythmias); lactose intolerance, lactase deficiency, glucose-galactose malabsorption; phenylketonuria. Children's age up to 18 years.

Carefully

Restricting use of epilepsy ), hypercalciuria. Elderly patients with arterial hypertension (increased risk of hemorrhagic stroke due to rimantadine, which is part of the drug).

Use during pregnancy and during breastfeeding

Use during pregnancy and during breastfeeding is contraindicated.

Dosage and administration

Inside

Dissolve the contents of one sachet in half a glass of boiled warm water. Use immediately after dissolving. Before use, stir the solution. Adults: take 1 sachet 2-3 times a day after meals for 3-5 days (no more than 5 days) until the symptoms of the disease disappear.

In the absence of improvement in health, taking the drug should be stopped and consult a doctor.

Side effect

In accordance with the constituent components.

From the side of the central nervous system: Increased excitability, drowsiness, tremor, hyperkinesia, dizziness, headache, "flushes" of blood to the face.

From the digestive system: Lesions of the mucous membrane of the stomach and duodenum, dyspepsia, dry mucous membranes in the mouth, lack of appetite, bloating (flatulence), diarrhea (diarrhea).

From the urinary system: Moderate pollakiuria.

From the side of blood-forming organs: Changes in blood counts. Control is needed

Other: Inhibition of the insular apparatus of the pancreas (hyperglycemia, glycosuria).

Allergic reactions: Skin rash, itching, urticaria.

If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform the doctor immediately.

Overdose

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, diarrhea, vomiting, pain in the epigastric region; violation of glucose metabolism, metabolic acidosis, tachycardia, arrhythmia, headache, exacerbation of concomitant chronic diseases. Symptoms of abnormal liver function may appear 12-48 hours after an overdose. In severe overdose - liver failure with progressive encephalopathy, coma; acute renal failure with tubular necrosis (including in the absence of severe liver damage).

Treatment: the introduction of SH-group donators and precursors of the synthesis of glutathione - methionine within 8-9 hours after overdose and acetylcysteine ​​- within 8 hours. Gastric lavage, symptomatic therapy. The need for additional therapeutic measures (further introduction of methionine, acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its administration.

Interaction with other drugs

Paracetamol reduces the effectiveness of uricosuric drugs. The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs. Inductors of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a small overdose. With simultaneous use with Metoclopramide may increase the rate of absorption of paracetamol. Prolonged use of barbiturates reduces the effectiveness of paracetamol. Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action. Rimantadine enhances the stimulating effect of caffeine. Cimetidine reduces the clearance of rimantadine by 18%.

Vitamin C increases the concentration of benzylpenicillin in the blood.Improves the absorption in the intestines of iron preparations (converts ferric iron into ferrous); may increase the excretion of iron while using with deferoxamine. Increases the risk of crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the kidneys excretion of acids, increases the excretion of drugs having an alkaline reaction (including alkaloids). Reduces the concentration in the blood of oral contraceptives. Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. With simultaneous use reduces the chronotropic effect of isoprenaline. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Loratadine. Inhibitors of CYP3A4 and CYP2D6 increase the concentration of loratadine in the blood.

special instructions

Duration of use - no more than 5 days. Do not use in the presence of metastatic tumors. Persons prone to ethanol use should consult a doctor before starting treatment with the drug, since paracetamol may have a damaging effect on the liver.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.

Storage conditions

In a dry place at a temperature not higher than 25 ° C.

Keep out of reach of children.