АнвиМакс

General characteristics. Structure:

Active ingredients: paracetamol - 360 mg, ascorbic acid - 300 mg, gluconate calcium monohydrate - 100 mg, Rimantadinum a hydrochloride - 50 mg, rutoside trihydrate
(in terms of rutoside) - 20 mg, лоратадин - 3 mg; excipients: aspartame - 30 mg, a gipromelloza - 10 mg, silicon dioxide colloid - 20 mg, lactoses monohydrate - 4086 mg, fragrance food (a lemon or a lemon and honey, either raspberry, or blackcurrant) - 21 mg.

Description

Bag contents - mix of powder and granules from color, almost white to yellow with a greenish shade, with a characteristic smell (a lemon, a lemon with honey, raspberries, blackcurrant). Existence of single granules of pink color is allowed.

Solution after powder dissolution - colourless or with a yellowish shade slightly muddy solution with a characteristic smell (a lemon, a lemon with honey, raspberries, blackcurrant). Existence of not dissolved particles of yellow color is allowed.

Pharmacological properties:

Pharmacodynamics. The combined drug, possesses the antiviral, interferonogenny, febrifugal, anesthetizing, antihistaminic and angioprotektorny action.

Paracetamol possesses anesthetic and febrifugal action.

Ascorbic acid participates in regulation of oxidation-reduction processes, promotes normal permeability of capillaries, coagulability of blood, an angenesis, plays a positive role in development of immune responses of an organism, fills shortage of vitamin C.

Calcium the gluconate as a source of calcium ions, prevents development of a hyperpermeability and fragility of the vessels causing hemorrhagic processes at flu and the acute respiratory viral infection (ARVI), has antiallergenic effect (the mechanism is not clear).

Rimantadinum has antiviral activity concerning an influenza virus of A. Blokiruya of Sq.m channels of an influenza virus And, breaks its ability to get into cells and to release a ribonucleoprotein, inhibiting thereby the most important stage of replication of viruses. The alpha and scale induces development of interferon. At the flu caused by a virus B, Rimantadinum has anti-toxic effect.

Rutoside is a vasoprotective. Reduces permeability of capillaries, puffiness and an inflammation, strengthens a vascular wall. Slows down aggregation and increases extent of deformation of erythrocytes.

Loratadin - a blocker of H1-histamine receptors, warns edematization of fabrics, the histamine connected with release.

Pharmacokinetics. Paracetamol. Absorption - high. Communication with proteins of plasma - 15%. Gets through a blood-brain barrier. It is metabolized in a liver on three main ways: conjugation with glucuronides, conjugation with sulfates, oxidation by microsomal enzymes of a liver. In the latter case toxic intermediate metabolites which conjugate afterwards with glutathione, and then with cysteine and mercapturic acid are formed. The main isoenzymes of P450 cytochrome for this way of metabolism are CYP2E1 isoenzyme (preferential), CYP1A2 and CYP3A4 (supporting role). At deficit of glutathione these metabolites can cause damage and a necrosis of hepatocytes. Additional ways of metabolism are a hydroxylation to
3 hydroxyparacetamol and metoksilirovaniye to a 3-metoksiparatsetamol which conjugate afterwards with glucuronides or sulfates. At adults the glyukuronirovaniye prevails. The conjugated paracetamol metabolites (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. Only 3% in not changed look are removed by kidneys in the form of metabolites, preferential conjugates. At elderly patients the clearance of drug decreases and the elimination half-life increases.

By results of the conducted clinical researches the following pharmacokinetic parameters of paracetamol are set: the maximum concentration in a blood plasma is reached at use of powder in 0,7±0,39 h and makes 4,79±1,81 mkg/ml, the elimination half-life is equal to 2,73±0,76 h.

Ascorbic acid is absorbed in digestive tract (preferential in a jejunum). Communication with proteins of plasma - 25%. Digestive tract diseases (a peptic ulcer of a stomach and a 12-perstny gut, a lock or diarrhea, a helminthic invasion, a lambliasis), the use of fresh fruit and vegetable juice, alkaline drink reduce absorption of ascorbic acid in intestines. Concentration of ascorbic acid in plasma normal makes about 10-20 mkg/ml. Time of the maximum concentration in a blood plasma after intake - 4 h. Easily gets into leukocytes, thrombocytes, and then - into all fabrics; the greatest concentration is reached in ferruterous bodies, leukocytes, a liver and lens; gets through a placenta. Concentration of ascorbic acid in leukocytes and thrombocytes is higher, than in erythrocytes and in plasma. At scarce states concentration in leukocytes decreases later and more slowly and is considered as the best criterion for evaluation of deficit, than concentration in plasma. It is metabolized preferential in a liver in dezoksiaskorbinovy and further in oxalacetic acid and ascorbate-2-sulfate. It is removed by kidneys, through intestines, with then in not changed look and in the form of metabolites. Smoking and the use of ethanol accelerate destruction of ascorbic acid (transformation into inactive metabolites), sharply reducing stocks in an organism. It is removed at a hemodialysis.

Calcium gluconate. About 1/5-1/3 part of orally entered calcium of a gluconate are soaked up in a small bowel; this process depends on presence of ergocalciferol, pH, features of a diet and existence of the factors capable to connect calcium ions. Absorption of calcium ions increases at its deficit and use of a diet with the reduced maintenance of calcium ions. About 20% are removed by kidneys, other quantity (80%) - intestines.

Rimantadinum. After intake it is almost completely soaked up in intestines. Absorption - slow. Communication with proteins of plasma - about 40%. Distribution volume - 17-25 l/kg. Concentration in a nasal secret is 50% higher, than plasma. It is metabolized in a liver. More than 90% are removed by kidneys during 72 h, generally in the form of metabolites, 15% - in not changed look. At a chronic renal failure the elimination half-life increases twice. At persons with a renal failure and at elderly people can collect in toxic concentration if the dose is not adjusted in proportion to reduction of clearance of creatinine. The hemodialysis has insignificant effect on clearance of Rimantadinum.

By results of the conducted clinical researches the following pharmacokinetic parameters of Rimantadinum are set: the maximum concentration in a blood plasma is reached at use of powder in 5,28±2,54 h and makes 69,0±19,7 ng/ml, an elimination half-life of 33,26±12,76 h.

Rutoside. Time of the maximum concentration in a blood plasma after intake - 1-9 h. It is removed preferential with bile and to a lesser extent kidneys. An elimination half-life - 10-25 h.

Loratadin. It is quickly and completely soaked up in digestive tract. The maximum concentration at elderly people increases for 50%. Communication with proteins of plasma - 97%. It is metabolized in a liver with formation of an active metabolite of a deskarboetoksiloratadin with the participation of isoenzymes of CYP3A4 cytochrome and to a lesser extent CYP2D6. Does not get through a blood-brain barrier. It is removed by kidneys and with bile. At patients with a chronic renal failure and when carrying out a hemodialysis the pharmacokinetics practically does not change.

By results of the conducted clinical researches the following pharmacokinetic parameters of a loratadin are set: the maximum concentration in a blood plasma is reached in 3,28±1,25 h and makes 1,85±0,95 ng/ml, the elimination half-life is equal to 11,29±5,52 h.

Indications to use:

Etiotropic treatment of flu of A type, symptomatic treatment of the "catarrhal" diseases, flu and SARS which are followed by temperature increase, muscle pains, a headache, a fever at adults.

Route of administration and doses:

Inside.

To dissolve contents of one bag in half of glass of boiled warm water. To use right after dissolution. Before the use to stir solution.

Adult: to accept on 1 bag 2-3 times a day after food within 3-5 days (no more than 5 days) before disappearance of symptoms of a disease.

In the absence of improvement of health administration of drug it is necessary to stop and see a doctor.

Features of use:

Use duration - no more than 5 days.

Not to apply in the presence of the metastasizing tumors.

To the persons inclined to the ethanol use, it is necessary to consult drug prior to treatment with the doctor as paracetamol can have the damaging effect on a liver.

Influence on ability to manage the vehicles and other mechanisms demanding the increased concentration of attention

During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

According to the components which are a part.

From the central nervous system. Hypererethism, drowsiness, a tremor, a hyperkinesia, dizziness, a headache, "inflows" of blood to the person.

From the alimentary system. Damage of a mucous membrane of a stomach and duodenum, dyspepsia, dryness of a mucous membrane in a mouth, lack of appetite, abdominal distention (meteorism), diarrhea (diarrhea).

From an urinary system. Moderate pollakiuria.

From bodies of a hemopoiesis. Changes of indicators of blood. Control is necessary.

Others. Oppression of function of the insulyarny device of a pancreas (hyperglycemia, glucosuria).

Allergic reactions. Skin rash, itch, small tortoiseshell.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction immediately report about it to the doctor.

Interaction with other medicines:

Paracetamol reduces efficiency of uricosuric medicines. The accompanying use of paracetamol in high doses increases effect of anticoagulating medicines. Inductors of a microsomal oxidation in a liver (Phenytoinum, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and gepatotoksichny medicines increase products of hydroxylated active metabolites that causes a possibility of development of heavy intoxications even at small overdose. At simultaneous use with Metoclopramidum increase in speed of absorption of paracetamol is possible. Long use of barbiturates reduces efficiency of paracetamol. Inhibitors of a microsomal oxidation reduce risk of a hepatotoxic action.

Rimantadinum strengthens exciting effect of caffeine. Cimetidinum reduces clearance of Rimantadinum by 18%.

Ascorbic acid increases concentration in benzylpenicillin blood. Improves absorption in intestines of iron preparations (transfers trivalent iron to bivalent); can increase removal of iron at simultaneous use with Deferoxaminum. Increases risk of development of a crystalluria at treatment by salicylates and streptocides of short action, slows down removal by kidneys of acids, increases removal of the medicines having alkali reaction (including alkaloids). Reduces concentration in blood of oral contraceptives. Increases the general clearance of ethanol which in turn reduces concentration of ascorbic acid in an organism. At simultaneous use reduces chronotropic action of an izoprenalin. Barbiturates and Primidonum increase removal of ascorbic acid with urine. Reduces therapeutic effect of antipsychotic medicines (neuroleptics) - derivatives of a fenotiazin, a canalicular reabsorption of amphetamine and tricyclic antidepressants.

Loratadin. CYP3A4 and CYP2D6 inhibitors increase concentration of a loratadin in blood.

Contraindications:

Hypersensitivity to one or several components which are a part of drug; digestive tract erosive cankers in an aggravation phase; gastrointestinal bleedings; hemophilia; hemorrhagic diathesis; prothrombinopenia; portal hypertensia; avitaminosis To; renal failure; pregnancy, breastfeeding period; diseases of a thyroid gland, acute diseases of kidneys, liver (acute glomerulonephritis, acute pyelonephritis, acute hepatitis, or exacerbation of chronic diseases of data of bodies); alcoholism; a hypercalcemia, the expressed hypercalcuria, нефроуролитиаз, a sarcoidosis, a concomitant use of cardiac glycosides (risk of developing of arrhythmias); lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption; fenilketonuriya.

Children's age up to 18 years.

With care

Restriction of use at epilepsy, cerebral atherosclerosis, a diabetes mellitus, deficit glyukozo-6-fosfatdegidrogenazy, hemochromatosis, sideroblastny anemia, a thalassemia, a hyperoxaluria, a nephrolithiasis, dehydration, electrolytic disturbances (risk of development of a hypercalcemia), diarrhea, a sprue, a calcic nefrourolitiaz (in the anamnesis), hypercalcurias.

Elderly patients with arterial hypertension (the risk of development of a hemorrhagic stroke, at the expense of Rimantadinum drug which is a part increases).

Use at pregnancy and during breastfeeding

Use at pregnancy and during breastfeeding is contraindicated.

Overdose:

Symptoms: during the first 24 h after reception - pallor of integuments, nausea, diarrhea, vomiting, pain in epigastric area; glucose metabolism disturbance, a metabolic acidosis, tachycardia, arrhythmia, a headache, an exacerbation of the accompanying chronic diseases. Symptoms of an abnormal liver function can appear through
12-48 h after overdose. At heavy overdose - a liver failure with the progressing encephalopathy, a coma; an acute renal failure with a tubular necrosis (including in the absence of severe damage of a liver).

Treatment: introduction of donators of SH-group and predecessors of synthesis of glutathione - methionine during 8-9 h after overdose and Acetylcysteinum - during 8 h. Gastric lavage, symptomatic therapy. Need for holding additional therapeutic actions (further administration of methionine, Acetylcysteinum) is defined depending on concentration of paracetamol in blood, and also from time which passed after its reception.

Storage conditions:

In the dry place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

On 5 g of powder for preparation of solution for intake [lemon or lemon with honey, either crimson, or blackcurrant] in the bags thermowelded.

3, 6, 12 or 24 bags of the application instruction in a pack from a cardboard.