Anvimax powder for oral administration 5g sachet honey-lemon N6
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Active ingredients
Paracetamol + Rimantadine + Ascorbic Acid + Loratadine + Rutoside + Calcium Carbonate
Release form
Powder
Composition
Paracetamol 360 mg; ascorbic acid 300 mg; calcium gluconate monohydrate 100 mg; rimantadine hydrochloride 50 mg; rutoside (in the form of trihydrate) 20 mg; loratadine 3 mg; Excipients: aspartame - 30 mg, hypromellose - 10 mg, colloidal silicon dioxide - 20 mg, lactose monohydrate - 4086 mg, flavoring (lemon and honey) - 21 mg.
Pharmacological effect
Combined drug, has antiviral, interferonogenic, antipyretic, analgesic, antihistamine and angioprotective effect.; Paracetamol has analgesic and antipyretic effect.; Ascorbic acid is involved in the regulation of redox processes, it is a good pattern, and I have already been used as an asphiastrophystostomystricus. in the development of immune reactions of the body, compensates for the deficiency of vitamin C.; Calcium gluconate, as a source of calcium ions I, prevents the development of increased permeability and fragility of vessels that cause hemorrhagic processes in influenza and acute respiratory viral infections, has antiallergic effect (mechanism is unclear) .; Rimantadine has antiviral activity against influenza A virus. Blocking M2 channels of 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 anti-toxic 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 is a blocker of histamine H1 receptors, prevents the development of tissue edema associated with the release of histamine.
Pharmacokinetics
Paracetamol; Absorption and distribution; Absorption - high. According to the results of clinical studies, the following pharmacokinetic parameters of paracetamol were established: when using Cmax capsules of paracetamol in blood plasma, it is achieved in 1.20 ± 0.72 h and is 5.01 ± 1.70 mcg / ml, in the application of powder - in 0.7 ± 0.39 h and is 4.79 ± 1.81 mcg / ml.; Plasma protein binding - 15%.It penetrates the BBB.; Metabolism and elimination; 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% in unchanged form. According to the results of clinical trials, T1 / 2 paracetamol is 3.04 ± 1.01 h when taking the drug in capsules, 2.73 ± 0.76 h - when taking the drug in powder form; Pharmacokinetics in special clinical situations; In elderly patients, the clearance of the drug decreases and T1 increases / 2.; Ascorbic acid; Absorption and distribution; Absorbed from the gastrointestinal tract (mainly in the jejunum). Diseases of the gastrointestinal tract (gastric ulcer and duodenal ulcer, constipation or diarrhea, worm infestation, giardiasis), the use of fresh fruit and vegetable juices, alkaline drink reduces the absorption of ascorbic acid in the intestine. The plasma ascorbic acid concentration is normally around 10-20 μg / ml. The time to reach Cmax in blood plasma after oral administration is 4 hours; Binding to plasma proteins is 25%. 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 the placental barrier. 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 the best criterion for assessing deficiency than plasma concentration. ,through the intestine, with then unchanged and in the form of metabolites.; Pharmacokinetics in special clinical situations; Smoking and ethanol use accelerate the destruction of ascorbic acid (turning into inactive metabolites), drastically reducing reserves in the body. 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% excreted by the kidneys, the rest (80%) - intestines.; Rimantadine; Absorption and distribution; After ingestion is almost completely absorbed in the intestines. Absorption is slow. According to the results of clinical studies, the following pharmacokinetic parameters of rimantadine were established: when using Cmax capsules in blood plasma, it is reached in 4.53 ± 2.52 h and is 68.2 ± 26.6 ng / ml, when using the drug in powder form - in 5.28 ± 2.54 h and is 69 ± 19.7 ng / ml.; Binding to plasma proteins - about 40%. Vd - 17-25 l / kg. Concentration in nasal discharge is 50% higher than in plasma. Metabolism and excretion; Metabolized in the liver. More than 90% is excreted by the kidneys within 72 hours, mainly in the form of metabolites, 15% - unchanged. According to the results of clinical studies, T1 / 2 rimantadine is 30.51 ± 9.83 h when using the drug in the form of capsules, 33.26 ± 12.76 h - when using the drug in powder form.; Pharmacokinetics in special clinical cases; In chronic renal failure, T1 / 2 increases by 2 times. In patients with renal insufficiency and in elderly people, rimantadine can accumulate in toxic concentrations if the dose is not adjusted in proportion to the decrease in CC. Hemodialysis has an insignificant effect on the clearance of rimantadine.; Rutozid; The time to reach Cmax in the blood plasma after oral administration is 1–9 hours; It is mainly excreted in bile and to a lesser extent by the kidneys. T1 / 2 - 10-25 hours; Loratadine; Absorption and distribution; Quickly and completely absorbed from the gastrointestinal tract. According to the results of clinical studies, the following pharmacokinetic parameters of loratadine were established: when using the drug in the form of Cmax capsules in the blood plasma, it is reached in 2.92 ± 1.31 h and is 2.36 ± 1.53 ng / ml, when used in the form of a powder, in 3.28 ± 1.25 h 1.85 ± 0.95 ng / ml.; Plasma protein binding - 97%.Does not penetrate through the BBB.; Metabolism and excretion; Metabolized in the liver to form the active metabolite descarboethoxyloratadine with the participation of cytochrome CYP3A4 isoenzymes and to a lesser extent CYP2D6.; Excreted by the kidneys and with bile. According to the results of clinical studies, T1 / 2 loratadine when taking capsules is 12.36 ± 6.84 h, when using the drug in powder form - 11.29 ± 5.52 hours; Pharmacokinetics in special clinical situations; Cmax in the elderly increases by 50%; in patients with chronic renal failure, and during hemodialysis, the pharmacokinetics remain virtually unchanged.
Indications
Etiotropic treatment of influenza type A; symptomatic treatment of colds, 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; - avitaminosis K; - renal failure; - diseases of the thyroid gland; - acute diseases of the kidneys, liver (acute glomerulonephritis, acute pyelonephritis, acute hepatitis), or exacerbation of chronic diseases of these organs; - chronic alcoholism; - hypercalcemia, severe hypercalciuria; - Nephrourolithiasis; - sarcoidosis; - simultaneous reception of cardiac glycosides (risk of arrhythmias); - lactose intolerance, lactase deficiency, glucose-galactose malabsorption; - Phenylketonuria (for powder); - pregnancy; - breastfeeding period; - children's and teenage age up to 18 years.
Use during pregnancy and lactation
Use during pregnancy and during breastfeeding is contraindicated.
Dosage and administration
; The drug is taken orally after a meal. Capsules should be washed down with water. The powder (contents of 1 sachet) must be dissolved in 1/2 cup of warm boiled water and stirred. The resulting solution should be consumed immediately after preparation.; Adults should be prescribed 1 capsule P blue and 1 capsule P red (single dose) or 1 sachet of powder 2-3 times / day; The drug should be taken within 3-5 days ( no more than 5 days) until the symptoms of the disease disappear. In the absence of improvement in well-being, the patient should stop using the drug and consult a doctor.
Side effects
On the part of the nervous system: increased excitability, drowsiness, tremor, hyperkinesia, dizziness, headache, flushing of the blood to the face. , flatulence, diarrhea. From the urinary system: moderate pollakiuria. From the hematopoietic system: changes in blood parameters (control is necessary) .; From the endocrine system: inhibition of insular function Appar that pancreas (hyperglycemia, glycosuria) .; Allergic reactions:. rash, pruritus, urticaria; If any of the instructions indicated in the side effects are exacerbated or any other observed adverse effects, not defined in the instruction, the patient should immediately notify the doctor.
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: administration of donators of SH-groups and precursors of the synthesis of glutathione-methionine for 8–9 hours after overdose and acetylcysteine - for 8 hours stomach 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.ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications even with a slight overdose.; Simultaneous use with metoclopramide may increase the rate of absorption of paracetamol. .; Rimantadine enhances the stimulating effect of caffeine.; Cimetidine reduces to lirens rimantadine by 18%; Ascorbic acid increases the concentration of benzylpenicillin in the blood.; Improves intestinal absorption of iron preparations (converts ferric iron into bivalent); can 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 that have an alkaline reaction (including alkaloids); Decreases blood concentration oral contraceptives.; Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.; When used simultaneously, reduces the chronotropic effect . Isoprenaline; primidone Barbiturates and increase the excretion of ascorbic acid in urine; Decreases therapeutic action of antipsychotic drugs (neuroleptics) - phenothiazine derivatives;.. Decreases tubular reabsorption of amphetamine and tricyclic antidepressants; loratadine; Inhibitors of CYP3A4 and CYP2D6 loratadine increase the concentration in the blood..
special instructions
Duration of use - no more than 5 days.; Do not use the drug in the presence of metastatic tumors.; Patients who abuse alcohol, should consult a doctor before starting treatment with the drug, since paracetamol may have a damaging effect on the liver.; Effect on ability to drive motor vehicles and the management of mechanisms; During the period of treatment, care must be taken when driving vehicles and doing other potentially hazardous activities that require an increased concentration and attention and speed of psychomotor reactions.