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

Excipients: starch, silicon dioxide colloidal, povidone, sodium, benzoate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium lauryl sulfate, microcrystalline cellulose, talc, magnesium stearate, sodium carboxymethyl starch.

Description:

Round flat tablets white or white with a light yellow shade of color with a facet and an engraving NP against the background of a tree on both sides.

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:Paracetamol (non-narcotic analgesic) blocks cyclooxygenase I and II mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains the almost complete absence of anti-inflammatory effect. The absence of blocking effect on the synthesis of prostaglandins in peripheral tissues determines the absence of a negative influence on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration is 0.5-2 h; the maximum concentration is 5-20 μg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Less than 1% of the dose of paracetamol taken by the lactating mother penetrates into breast milk.

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 glucuronic or sulfuric acids; and then with 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-methoxyparacetamol, which are subsequently conjugated to glucuronides or sulfates. In adults, glucuronation predominates, in newborns (including premature infants) and small children, sulfation. Conjugated metabolites of paracetamol (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. The period, half-life is 1-4 hours. It is excreted by the kidneys in the form of metabolites,predominantly conjugates, only 3% unchanged. In elderly patients, clearance of paracetamol decreases and the half-life increases.

Indications:

Moderately or mildly expressed pain syndrome (headache, dental, migraine pain, neuralgia, myalgia).

Elevated body temperature for colds and other infectious and inflammatory diseases

Contraindications:

- Hypersensitivity to paracetamol.

- Children under 2 years.

Carefully:

Renal and hepatic insufficiency, benign hyperbilirubinemia (including Gilbert's syndrome, viral hepatitis, alcoholic liver damage), alcoholism, pregnancy, lactation, elderly age, deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Inside, with a lot of liquid, 1-2 hours after eating (taking immediately after a meal leads to a delay in the onset of action). 1-2 tablets 2-3 times a day at intervals of not less than 4 hours. The maximum single dose for adults and children over 12 years is 2 tablets (1000 mg), daily - 8 tablets (4000 mg).

In patients with impaired liver and kidney function, with Gilbert's syndrome and in elderly patients, the interval between doses should be at least 8 hours and the daily dose should be reduced. Duration of admission is no more than 5 days with the appointment as an anesthetic and 3 days as an antipyretic.

Side effects:

Nausea, vomiting, epigastric pain, allergic reactions (skin rash, itching, urticaria, Quincke's edema), nephrotoxicity (renal colic, pyuria, interstitial nephritis, papillary necrosis).Rarely, anemia, leukopenia, thrombocytopenia, agranulocytosis. With prolonged use in large doses - hepatotoxic action, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Overdose:Symptoms: during the first 24 hours after administration - pallor of the skin, anorexia, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose). The toxic effect of the drug in adults is possible after taking more than 10-15 g of paracetamol: an increase in the activity of "liver" transaminases, an increase in prothrombin time, an extensive clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver function abnormalities develop with lightning speed and can be complicated by renal failure (tubular necrosis).

Treatment: stop taking the drug, do a lavage, take Activated carbon. Further therapeutic measures should be carried out in the setting of a medical institution: the introduction of donors SH-grypp and the precursors of the synthesis of glutathione-methionine for 8-9 h after an overdose and acetylcysteine for 8 hours.The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication with small overdoses.

Ethanol promotes the development of acute pancreatitis.

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

Reduces the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.

Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, along with other anti-inflammatory and analgesic agents, as well as 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.

When the drug is used for a long time, it is necessary to monitor the pattern of peripheral blood and the functional state of the liver.

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

The drug has no sedative effect and can be recommended to people of any profession, including those whose activities require increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 500 mg.

Packaging:

For 4, 10, 20 tablets in a PVC / Al blister, 2, 4, 6, 8, 10, 12, 14, 20 tablets in a strip Al/ Al or 30, 60 tablets in a glass or plastic bottle.

For 1 plastic or glass bottle, 1, 2, 3, 4, 5, 10, 15 blisters or strips in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N009512

Date of registration:31.05.2010

The owner of the registration certificate:Natur Product Europe BVNatur Product Europe BV Netherlands

Manufacturer: & nbsp

NATUR PRODUKT EUROPE, B.V. Netherlands

Representation: & nbspNatur Product International Inc.Natur Product International Inc.Russia

Information update date: & nbsp02.03.2017

Illustrated instructions

Instructions

Strimol (Strimol)