Paracetamol Extra Chewable Tablets with Vitamins C N10 obl
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Active ingredients
Paracetamol + Ascorbic Acid
Release form
Non-chewable pills
Composition
1 tablet contains: paracetamol 500 mg, ascorbic acid 150 mg. Auxiliary substances: hydroxypropylmethylcellulose (hypromellose), polyethylene glycol 6000 (macrogol 6000), corn starch, stearic acid.
Pharmacological effect
Combined drug. Paracetamol has an analgesic and antipyretic effect. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood coagulation, tissue regeneration, in the synthesis of steroid hormones; increases the body's resistance to infections, reduces vascular permeability. Lengthens the effect of paracetamol (slowing its excretion).
Pharmacokinetics
Paracetamol Absorption - High. Tmax - 0.5-2 h; Cmax - 5-20 mcg / ml. Plasma protein binding - 15%. Penetrates the BBB. Vd ranges from 0.8 to 1.36 l / kg body weight. Less than 1% of the paracetamol dose taken by the nursing mother passes into breast milk. A therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg. 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, in newborns (including prematurely born babies) and young children - sulfation. Conjugated paracetamol metabolites (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. The half-life (T1 / 2) is 1-4 hours.Excreted by the kidneys as metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of the drug decreases and T1 / 2 ascorbic acid increases. Plasma protein binding is 25%. The normal concentration of ascorbic acid in plasma is approximately 10-20 mcg / ml. 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. Under conditions of deficiency, the concentration in leukocytes decreases later and more slowly and is considered as the best criterion for assessing deficiency than plasma concentration. Metabolized mainly in the liver to deoxyascorbine and then to oxaloacetic acid and ascorbate-2-sulfate. breast milk in unchanged form and in the form of metabolites. When administered in high doses, the rate of excretion sharply increases. Smoking and ethanol use accelerate the destruction of ascorbic acid (turning into inactive metabolites), drastically reducing reserves in the body. It is derived during hemodialysis.
Indications
Febrile syndrome on the background of colds, pain (mild and moderate severity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea; pain with injuries, burns.
Contraindications
Hypersensitivity, gastrointestinal bleeding, portal hypertension, renal failure, pregnancy (I and III trimesters), lactation, deficiency of glucose-6-phosphate dehydrogenase. (syndromes of Gilbert, cudgel-Johnson and Rotor), alcoholism.
Use during pregnancy and lactation
Contraindications: pregnancy (I and III trimesters); lactation period.
Dosage and administration
Inside Single dose for adults and children (weighing more than 50 kg) - 1 tab. or 10-15 mg / kg (in terms of paracetamol), the maximum daily dose - 4 tab .; children 6-12 years old - 1/2 tab., the maximum daily dose is 2 pills. The treatment course is not more than 10 days. Before use, the tablet is dissolved in 100-200 ml of boiled water. In case of liver failure, the daily dose is reduced by reducing the single dose and / or multiplicity of admission.
Side effects
Allergic reactions (skin rash, itching, urticaria, angioedema), nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis. With prolonged use in large doses - hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (renal colic, glycosuria, interstitial nephritis, papillary necrosis).
Overdose
Symptoms (caused by paracetamol): pale skin, loss of appetite, nausea, vomiting; hepatonecrosis (severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effects in adults are possible after taking more than 10-15 g of paracetamol: increased activity of hepatic transaminases, an increase in prothrombin time (12-48 hours after administration); A detailed clinical picture of liver damage occurs after 1-6 days. Rarely, liver failure develops at lightning speed and may be complicated by renal failure (tubular necrosis). Treatment: the introduction of donators of SH-groups and precursors of the synthesis of glutathione - methionine - 8–9 hours after overdose and N-acetylcysteine - after 12 hours. The need for additional therapeutic measures (further introduction of methionine, in / in the introduction of N-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
Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxications with small overdose. acute pancreatitis. Reduces the effectiveness of urikozuricheskikh drugs. When reducing the speed of emptied Stomach (propanthelin) slows down the effect of the drug, while accelerating (metoclopramide) begins to act faster. Increases the toxicity of chloramphenicol. May enhance the effect of indirect anticoagulants.
special instructions
When hyperthermia lasts more than 3 days and pain syndrome lasts more than 5 days, consultation with a physician is required. Displays the results of laboratory tests assessing the concentration of glucose and uric acid in plasma. Do not use other drugs containing paracetamol, as well as other non-narcotic analgesics, NSAIDs (for example, metamizol, acetylsalicylic acid, ibuprofen), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol. Simultaneous use of other drugs dstvami must be in accord with vrachom.Bolnym diabetes should take into account that 1 sachet formulation contained about 3.8 g saharozy.Litsam prone to the use of ethanol, it should be before the start of drug treatment consult with a physician, since paracetamol could have a damaging effect on the liver.