Xoomapar - instructions for use, dose, side effects, contraindications

Excipients: povidone K-30, sodium saccharinate anhydrous, sodium carbonate anhydrous, sodium hydrogen carbonate, citric acid anhydrous, sodium dihydrogen citrate anhydrous, flavoring lemon (Firmenich 502336 TP 05.51), aspartame, purified water *

(* consumed in the production process).

Description:

Almost white granules, which on contact with water form an effervescent suspension with a lemon flavor and odor.

Pharmacotherapeutic group:Analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:

Paracetamol has an analgesic and antipyretic effect.The drug blocks cyclooxygenase 1 and 2 mainly in the central nervous system (CNS), affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, what explains the almost complete absence of anti-inflammatory effect.

The drug does not adversely affect the water-salt exchange (sodium and water retention) and the mucous membrane of the gastrointestinal tract (GIT), due to the lack of influence on the synthesis of prostaglandins in peripheral tissues. The possibility of methaemoglobin formation is unlikely.

Pharmacokinetics:

Absorption is high. The time required to reach the maximum concentration (TCmax) is 0.5-2 h; the maximum concentration (Cmax) is 5-20 μg / ml. The connection with proteins is 15%. Penetrates through the blood-brain barrier.

The volume of distribution varies from 0.8 to 1.36 l / kg body weight. Breast milk penetrates less than 1% of the accepted dose of paracetamol. The therapeutically effective concentration of paracetamol in plasma is achieved when it is administered at a dose of 10-15 mg / kg. Metabolised in the liver (90-95%): 80% enters the conjugation reaction with glucuronic acidand sulfates with formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. In the metabolism of the drug is also involved isoenzyme CYP2E1. The half-life (T1 / 2) is 1.5-3 hours (the mean T1 / 2 is 2.3 hours). It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% - in unchanged form. In elderly patients, the clearance of the drug decreases and T1 / 2 increases.

Indications:

Applied as:

- antipyretic agents for infectious-inflammatory (bacterial, viral) diseases;

- anesthetic for pain in muscles and joints;

- anesthetic for mild to moderate pain syndrome (headache, toothache) of non-inflammatory origin; with neuralgia, algodismenore, with trauma.

Contraindications:

- Hypersensitivity to paracetamol or other components of the drug;

- children under 15;

- congenital insufficiency of glucose-6-phosphate dehydrogenase;

- expressed violations of the liver or kidney function (creatinine clearance (CK) less than 30 ml / min), viral hepatitis;

- phenylketonuria.

Carefully:

Renal and hepatic insufficiency, congenital Hyperbilirubinemia, alcoholic liver damage, elderly patients, pregnancy and lactation.

Pregnancy and lactation:Preclinical studies in animals have not revealed any adverse effect of paracetamol on pregnancy or fetal development. However, the risk can not be ruled out completely. During pregnancy, especially in the first trimester, and during lactation, the drug can be used only on the recommendation of a doctor, for a short period of time, preferably once.

Dosing and Administration:

Adults and children over 15 years of age: 1 sachet (1 g of paracetamol) dissolve in a glass of water, take 3-4 times a day.

Repeated reception of the drug is carried out with an interval of at least 4 hours.

Do not exceed the dose of 4 g (4 sachets) per day.

Do not exceed recommended daily doses.

In patients with impaired liver or kidney function, in elderly patients, the interval between doses should be at least 8 hours and the daily dose should be reduced.

Patients with alcoholic hepatosis should not take more than 2 sachets (2 g of paracetamol) per day.

Duration of admission (without consultation with a doctor) is no more than 5 days when prescribed as an anesthetic, and no more than 3 days - as a jargon-reducing remedy.

Further treatment with the drug is possible only after consulting a doctor.

Side effects:

Classification of the incidence of adverse events (WHO):

very often> 1/10

often from> 1/100 to <1/10

infrequently from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely from <1/10000, including individual messages.

When taking the drug in recommended doses, adverse reactions develop rarely and are poorly expressed.

From the digestive system: rarely - nausea; very rarely - vomiting, diarrhea, jaundice, pancreatitis and increased activity of "liver" enzymes.

Allergic reactions: rarely - skin rash, itchy skin, cr.apivniangioedema, Quincke's edema.

From the organs of hematopoiesis and lymphatic system: very rarely - leukopenia, thrombocytopenia.

Other: rarely - weakness.

Overdose:

Symptoms acute poisoning with paracetamol develop within 24 hours and are manifested: pallor of the skin, sweating, abdominal pain, anorexia, nausea, vomiting,hepatonecrosis (the severity of necrosis directly depends on the degree of overdose). Symptoms of liver dysfunction in adults are possible after 1-6 days after taking more than 10-15 g of paracetamol: increased activity of "liver" transaminases, an increase in prothrombin time. In rare cases, impaired liver function develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

Treatment: recommended discontinuation of the drug, gastric lavage, reception of enterosorbents (Activated carbon, polyphepan (hydrolysis lignin)). Further therapeutic measures should be carried out in the setting of a medical institution: the introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine for 8-9 hours after overdose and acetylcysteine-for 12 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as by the time passed after its reception.

Interaction:

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic action.

Reduces efficiency uricosuric drugs.

For prolonged and regular use paracetamol potentiates the action warfarin and other coumarin derivatives, increases the risk of bleeding.

Simultaneous reception colestyramine leads to a decrease in the absorption of paracetamol (and weakening effects of paracetamol).

Metoclopramide and domperidone increase the absorption of paracetamol.

Simultaneous application of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the terminal stage of renal failure.

Simultaneous application of paracetamol and chloramphenicol may be accompanied by an increase in T1 / 2 chloramphenicol up to 5 times.

Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which causes the possibility of developed severe intoxication even with small overdoses.

Salicylamide increases.T1 / 2 paracetamol, which leads to the accumulation of paracetamol and, accordingly, increased formation of its toxic metabolites.

Simultaneous application of paracetamol and ethanol can enhance hepatotoxicity of paracetamol, and also promote the development of acute pancreatitis.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Special instructions:

Do not use paracetamol simultaneously with other drugs containing paracetamol (risk of increased side effects).

Patients with congenital hyperbilirubility, the drug should be used in lower doses and with a longer interval between doses.

If there are signs of liver damage (skin itching, jaundice of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increasing the level of "liver" transaminases), stop taking the drug and consult a doctor.

With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, concomitantly with anticoagulants and drugs that affect the central nervous system.When taking metoclopramide, domperidone, or colestyramine, it is also necessary to consult a doctor.

Distorts the indicators of laboratory tests in quantitative determination of uric acid in the plasma.

To avoid toxic damage to the liver paracetamol should not be combined with the reception of alcoholic beverages, but also to people prone to chronic alcohol consumption. The risk of liver damage increases in patients with alcoholic hepatosis.

With continued use of the drug, it is necessary to monitor the parameters of peripheral blood and the functional state of the liver.

Patients who adhere to a strict diet for the sodium content should consider that 1 sachet of the drug contains 253.23 mg of sodium.

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

Xumapar does not affect the ability to drive a car and work with technical means.

Form release / dosage:

Granules for the preparation of a suspension for oral administration of 1000 mg.

Packaging:

2400 mg of granules are packed in a sachet of laminate consisting of paper, polyethylene, aluminum and rubber.

For 20 or 40 sachets, along with instructions for use in a cardboard box.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug with expired shelf life.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004524/10

Date of registration:21.05.2010 / 26.07.2010

Expiration Date:Unlimited

The owner of the registration certificate:Italfarmaco SpAItalfarmaco SpA Italy

Manufacturer: & nbsp

ITALFARMACO, S.p.A. Italy

Representation: & nbspITALFARMAKO SpA ITALFARMAKO SpA Italy

Information update date: & nbsp06.02.2018

Illustrated instructions

Instructions

Xoomapar (Xumapar)