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Dosage form: & nbsppowder for solution for oral administration [cranberry]
Composition:

The contents of one sachet:

Active substances: 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, silicon dioxide colloid 20 mg, lactose monohydrate 4,086 mg, flavor (cranberry or lemon, or lemon and honey, or crimson or blackcurrant) 21 mg.

Description:

The contents of the sachet - a mixture of powder and granules from almost white to yellow with a greenish tint of color with a characteristic smell (cranberries or lemon, or lemon with honey, or raspberries or black currants). The presence of single granules of pink color is allowed.

The solution after dissolving the powder - colorless or with a yellowish hue a slightly cloudy solution with a characteristic odor (cranberry or lemon, or lemon with honey, or raspberry, or black currant). Presence of undissolved yellow particles is allowed.

Pharmacotherapeutic group:ORZ and "colds" of symptoms remedy
ATX: & nbsp
  • Other combined drugs used for catarrhal diseases
  • Pharmacodynamics:

    The combined preparation has antiviral, interferonogenic, antipyretic, analgesic, antihistamine and angioprotective action.

    Paracetamol has an analgesic and antipyretic effect.

    Ascorbic acid participates in the regulation of oxidation-reduction processes, promotes normal permeability of capillaries, blood coagulability, tissue regeneration, plays a positive role in the development of immune responses of the body, replenishes vitamin C deficiency.

    Calcium gluconate, as a source of calcium ions, prevents the development of increased permeability and fragility of the vessels that cause hemorrhagic processes in influenza and acute respiratory viral infection (ARVI), has an antiallergic effect (the mechanism is unclear).

    Rimantadine has antiviral activity against influenza A virus. M2-channels of the influenza A virus, violates its ability to penetrate cells and release the ribonucleoprotein, thereby inhibiting the most important stage of viral replication. It induces the production of interferons alpha and gamma. With influenza caused by virus B, rimantadine has an antitoxic effect.

    Rutozid is an angioprotector. Reduces the permeability of capillaries, swelling and inflammation, strengthens the vascular wall.It inhibits aggregation and increases the degree of erythrocyte deformation.

    Loratadin - blocker H1-gistaminovyh receptors, prevents the development of edema of the tissues associated with the release of histamine.

    Pharmacokinetics:

    Paracetamol. Absorption is high. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Metabolised in the liver in three main ways: conjugation with glucuronides, conjugation with sulfates, oxidation with microsomal enzymes of the liver. In the latter case, toxic intermediate metabolites are formed, which are subsequently conjugated to glutathione, and then to cysteine ​​and mercapturic acid. The main isoenzymes of cytochrome P450 for this pathway of metabolism are isoenzyme CYP2E1 (predominantly), CYP1A2 and CYP3A4 (a secondary role). With a deficiency of glutathione, these metabolites can cause damage and necrosis of hepatocytes. Additional metabolic pathways include hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxy and paracetamol, which are subsequently conjugated to glucuronides or sulfates. In adults, glucuronation predominates.Conjugated metabolites of paracetamol (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and the half-life increases.

    Based on the results of clinical studies, the following pharmacokinetic parameters of paracetamol are established: the maximum concentration in blood plasma is reached when the powder is used after 0.7 ± 0.39 hours and is 4.79 ± 1.81 μg / ml, the elimination half-life is 2.73 ± 0 , 76 hours

    Ascorbic acid absorbed in the gastrointestinal tract (mainly in the jejunum). Connection with plasma proteins - 25%. Diseases of the gastrointestinal tract (peptic ulcer of stomach and duodenum, constipation or diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices, alkaline drink reduce the absorption of ascorbic acid in the intestine. The concentration of ascorbic acid in the plasma is normally around 10-20 μg / ml. The time of maximum concentration in the blood plasma after ingestion is 4 hours.Easily penetrates into leukocytes, platelets, and then into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye; penetrates the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in plasma. With deficient states, the concentration in leukocytes decreases later and more slowly and is considered as the best criterion for assessing the deficit than the concentration in the plasma. Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic acid and ascorbate-2-sulfate. It is excreted by the kidneys, through the intestine, with sweat in unchanged form and in the form of metabolites. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (conversion into inactive metabolites), sharply reducing the reserves in the body. It is in hemodialysis.

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

    Rimantadine. After oral administration, it is almost completely absorbed in the intestine. Absorption is slow. The connection with plasma proteins is about 40%. The volume of distribution is 17-25 l / kg. Concentration in nasal secretion is - 50% higher than plasma concentration. Metabolised in the liver. More than 90% is excreted by the kidneys within 72 hours, mainly in the form of metabolites, 15% - in unchanged form. In chronic renal failure, the elimination half-life is 2-fold. In individuals with kidney failure 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 an insignificant effect on the clearance of rimantadine.

    According to the results of clinical studies, the following pharmacokinetic parameters of rimantadine were established: the maximum concentration in blood plasma is achieved when using the powder after 5.28 ± 2.54 hours and is 69.0 ± 19.7 ng / ml, the half-life is 33.26 ± 12, 76 hours

    Rutozid. The time of maximum concentration in the blood plasma after ingestion is 1-9 hours. It is excreted mainly with bile and, to a lesser extent, kidneys. The half-life is 10-25 hours.

    Loratadin. Quickly and completely absorbed in the gastrointestinal tract. The maximum concentration in the elderly is increased by 50%. The connection with plasma proteins is 97%. Metabolized in the liver with the formation of an active metabolite of descabroxetoxyloratadine with the participation of cytochrome CYP3A4 isoenzymes and to a lesser extent CYP2D6. Does not penetrate the blood-brain barrier. It is excreted by the kidneys and with bile. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

    According to the results of clinical studies, the following pharmacokinetic parameters of loratadine are established: the maximum concentration in blood plasma is achieved through 3.28 ± 1.25 h and is 1.85 ± 0.95 ng / ml, the half-life is 11.29 ± 5.52 h .

    Indications:

    Etiotropic treatment of influenza type A, symptomatic treatment of "colds", flu and ARVI, accompanied by fever, muscle pain, headache, chills in adults.

    Contraindications:

    Hypersensitivity to one or more of the components that make up the drug; erosive-ulcerative lesions of the gastrointestinal tract in the phaseexacerbations; gastrointestinal bleeding; hemophilia; hemorrhagic diathesis; hypoprothrombinemia; portal hypertension; avitaminosis K; kidney failure; pregnancy, the period of breastfeeding; diseases of the thyroid gland, acute kidney disease, liver (acute glomerulonephritis, acute pyelonephritis, acute hepatitis, or exacerbation of chronic diseases of these organs); chronic alcoholism; hypercalcemia, expressed hypercalciuria, nephrourolythiasis, sarcoidosis, simultaneous reception of cardiac glycosides (risk of arrhythmias); lactose intolerance, lactase deficiency, glucose-galactose malabsorption; phenylketonuria.

    Children under 18 years.

    Carefully:

    Limitation of use in epilepsy, cerebral arteriosclerosis, diabetes, deficiency of glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, kidney stones, dehydration, electrolyte disturbances (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nefrourolitiaze (in history ), hypercalciuria.

    Elderly patients with hypertension (increased risk of hemorrhagic stroke, due to the included in the preparation rimantadine).

    Pregnancy and lactation:

    Application during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    Inside.

    Dissolve the contents of one sachet in half a glass of boiled warm water. Use immediately after dissolving. Stir the solution before use.

    Adults: Take 1 packet 2-3 times a day after meals for 3-5 days (not more than 5 days) until the symptoms disappear.

    If there is no improvement in the state of health, stop taking the medication and consult a doctor.

    Side effects:

    In accordance with the constituent components.

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

    From the digestive system. Lesion of the mucous membrane of the stomach and duodenum, dyspepsia, dryness of the mucous membrane in the mouth, lack of appetite, bloating (flatulence), diarrhea (diarrhea).

    From the urinary system. Moderate pollakiuria.

    On the part of the organs of hematopoiesis. Changes in blood counts. Control is needed. Other. Oppression of the insular pancreas function (hyperglycemia, glucosuria).

    Allergic reactions. Skin rashes, itching, hives.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor immediately.

    Overdose:

    Symptoms: within the first 24 hours after administration - pallor of the skin, nausea, diarrhea, vomiting, pain in the epigastric region; disturbance of glucose metabolism, metabolic acidosis, tachycardia, arrhythmia, headache, exacerbation of concomitant chronic diseases. Symptoms of liver dysfunction 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: introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine for 8-9 hours after an overdose and acetylcysteine-for 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 on the time elapsed after its administration.

    Interaction:

    Paracetamol reduces the effectiveness of uricosuric medicines. 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 slight overdose. With simultaneous application with metoclopramide, an increase in the rate of absorption of paracetamol is possible. Long-term use of barbiturates reduces the effectiveness of paracetamol. Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.

    Rimantadine enhances the caffeine's exciting effect. Cimetidine reduces the clearance of rimantadine by 18%.

    Ascorbic acid increases the concentration of benzylpenicillin in the blood. Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous use with deferoxamine. Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids). Reduces the concentration in the blood of oral contraceptives. Increases the total 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 primidon 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.

    Loratadin. 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 if there are metastatic tumors.

    Persons prone to ethanol use should consult a doctor before starting treatment with the drug, since paracetamol can have a damaging effect on the liver.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:Powder for solution for oral administration [blackcurrant].
    Packaging:

    For 5 g of powder for the preparation of a solution for ingestion [cranberry or lemon, or lemon with honey, or raspberry, or black currant] in heat-sealable bags.

    3, 6, 12 or 24 bags with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    30 months.

    Do not use the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001747
    Date of registration:02.07.2012 / 06.05.2014
    Date of cancellation:2017-07-02
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp08.02.2016
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