Excedrin tablets, # 20

Pain syndrome of moderate and mild intensity of various origins:

• headache,

• migraine,

• toothache,

• neuralgia,

• arthralgia and myalgia (pain in muscles and joints),

• algodismenorrhea (pain during menstruation).

Inside, during or after meals.

Adults and adolescents from 15 years old: 1 table. every 4-6 hours

At the first signs of migraine, take 2 tables.

The average daily dose is 3-4 tablets. per day, the maximum daily dose is 6 tablets. in a day.

After taking 2 tablets. relief of headache and other types of pain usually comes quickly - after 15 minutes, with migraines, relief usually occurs after 30 minutes.

In case of pain syndrome, the drug should not be taken for more than 5 days without consulting a doctor; for migraines, the drug should not be taken for more than 3 days without consulting a doctor.

Active substances:

paracetamol 250 mg, acetylsalicylic acid 250 mg, caffeine 65 mg
Excipients: hyprolose - 5 mg, microcrystalline cellulose - 100 mg, stearic acid - 2.5 mg.
The composition of the film shell: carnauba wax - 0.08 mg, white film material - 4.48 mg (hypromellose, titanium dioxide, propylene glycol, povidone, sorbitan laurate, polysorbate 20, mineral oil, benzoic acid, simethicone emulsion, brilliant blue dye). '

• Hypersensitivity to any of the components in the drug;

• erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;

• gastrointestinal bleeding;

• complete or incomplete combination of bronchial asthma, recurrent polypnosis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);

• surgical interventions accompanied by bleeding;

• hemophilia;

• hemorrhagic diathesis;

• hypoprothrombinemia;

• severe arterial hypertension;

• portal hypertension;

• severe course of ischemic heart disease;

• glaucoma;

• vitamin deficiency K;

• renal failure;

• the simultaneous use of other drugs containing paracetamol, acetylsalicylic acid or other NSAIDs;

• deficiency of glucose-6-phosphate dehydrogenase;

• increased excitability;

• sleep disorders;

• pregnancy;

• lactation;

• children under 15 years of age (the risk of developing Reye's syndrome in children with hyperthermia against the background of viral diseases).

Precautions: gout or arthritis; liver disease; headaches associated with head trauma; taking anticoagulants, hypoglycemic agents, as well as the simultaneous administration of drugs containing acetylsalicylic acid or other analgesic and antipyretic components.

pharmachologic effect

ExcedrinЃ is a combined preparation containing paracetamol, acetylsalicylic acid and caffeine.

Paracetamol has an analgesic, antipyretic and extremely weak anti-inflammatory effect, which is associated with its effect on the center of thermoregulation in the hypothalamus and a weakly expressed ability to inhibit the synthesis of prostaglandins in peripheral tissues.

Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory effects. Quickly relieves pain, especially caused by the inflammatory process, and also moderately inhibits platelet aggregation and slows down the process of thrombus formation, improving microcirculation in the focus of inflammation.

Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, dilates the blood vessels of skeletal muscles, brain, heart, kidneys, and reduces platelet aggregation. Reduces drowsiness, fatigue, increases mental and physical performance. In this combination, a small dose of caffeine practically does not have a stimulating effect on the central nervous system, but it helps to normalize the tone of the cerebral vessels and accelerate blood flow in it.

Pharmacokinetics

Paracetamol is easily absorbed in the gastrointestinal tract, Cmax in blood plasma are found in the interval from 30 minutes to 2 hours after administration. Paracetamol is metabolized in the liver and excreted by the kidneys, mainly in the form of glucuronides and sulfate conjugates. Less than 5% of paracetamol is excreted unchanged. The duration of T1 / 2 varies from 1 to 4 hours. The connection with plasma proteins is negligible at usual therapeutic doses, however, it increases with increasing dose. A hydroxylated metabolite, which is formed in small amounts in the liver under the influence of mixed oxidases and is usually rendered harmless by binding with glutathione, can accumulate in case of an overdose of paracetamol and cause liver damage.

Acetylsalicylic acid is rapidly and completely absorbed, undergoes rapid hydrolysis in the gastrointestinal tract, liver and blood to the formation of salicylates, which undergo further metabolism, mainly in the liver.

Caffeine is completely and quickly absorbed. The maximum concentrations are observed in the interval from 5 to 90 minutes after taking on an empty stomach. In adults, excretion occurs almost entirely through hepatic metabolism. There is a pronounced variability in the individual values ??of elimination in adults. Average T1 / 2 from blood plasma is 4.9 hours in the range 1.9-12.2 hours. Caffeine is distributed in all body fluids. The connection of caffeine with plasma proteins is 35%. Caffeine is almost completely metabolized by oxidation, demethylation and acetylation and excreted by the kidneys. Major metabolites: 1-methylxanthine, 7-methylxanthine, 1.7-dimethylxanthine.

Side effect

Gastralgia, nausea, vomiting, hepatotoxicity, nephrotoxicity, erosive ulcerative lesions of the gastrointestinal tract, allergic reactions, tachycardia, increased blood pressure, bronchospasm.

With prolonged use - dizziness, headache, visual disturbances, tinnitus, decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (nosebleeds, bleeding gums, purpura, etc.), kidney damage with papillary necrosis, deafness, malignant exudative erythema (syndrome Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), Reye's syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, liver dysfunction).

Application during pregnancy and lactation

Despite the fact that acetylsalicylic acid can be used in the II trimester of pregnancy, the safety of this combination in pregnant and breastfeeding women has not been studied, therefore the drug is contraindicated in pregnant women (in all trimesters) and breastfeeding.

Application for impaired renal function

The use of the drug for renal failure is prohibited.

Application in children

The use of the drug for children under 15 years of age is prohibited (the risk of developing Reye's syndrome in children with hyperthermia against the background of viral diseases).

special instructions

If, after taking the drug, symptoms persist, worsen, or new symptoms develop, consult a doctor immediately. When taking the drug in the recommended dose, the body receives the same amount of caffeine as is contained in one cup of coffee, so you should reduce the consumption of caffeine-containing products during treatment with this drug in order to avoid the development of nervous excitement, irritability, insomnia and heart palpitations against the background of an overdose of caffeine. If you suspect an overdose, you should immediately seek medical attention, even if there are no symptoms. You should refrain from drinking alcohol while taking the drug due to an increased risk of liver damage and gastrointestinal bleeding. Since acetylsalicylic acid slows down blood clotting, the patient,who is to undergo surgery, must warn the doctor in advance about taking the drug. Acetylsalicylic acid in low doses reduces the excretion of uric acid, and therefore, in patients with a predisposition, the drug can provoke an attack of gout. With prolonged use of the drug, it is necessary to monitor the peripheral blood and the functional state of the liver.

Influence on the ability to drive vehicles and work with mechanisms

The effect of the drug on the ability to drive and operate machinery was not reported.

Overdose

Symptoms due to the presence of paracetamol (when taken in doses of more than 10-15 g / day): during the first 24 hours, pallor of the skin, nausea, vomiting, anorexia, abdominal pain, impaired glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose, hepatic failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. The hepatotoxic effect in adults is manifested when taking 10 g or more.

Symptoms due to the presence of acetylsalicylic acid (when taken in doses of more than 150 mg / kg): with mild intoxication - nausea, vomiting, tinnitus, blurred vision, dizziness, severe headache. In severe poisoning - hyperventilation of the lungs of central origin (shortness of breath, choking, cyanosis, cold clammy sweat, respiratory paralysis), respiratory acidosis. The greatest risk of developing chronic intoxication is observed in children and the elderly when taken for several days more than 100 mg / kg / day. In case of moderate and severe poisoning, hospitalization is necessary.

Symptoms due to the presence of caffeine (when taken in doses greater than 300 mg / day): gastralgia, agitation, anxiety, agitation, motor restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremors, or muscle twitching; nausea and vomiting, sometimes with blood; ringing in the ears, epileptic seizures (in acute overdose - tonic-clonic). Treatment: monitoring the acid-base state and electrolyte balance. Depending on the state of metabolism - the introduction of sodium bicarbonate, sodium citrate or sodium lactate. Increasing alkalinity enhances the excretion of acetylsalicylic acid by alkalizing urine. Gastric lavage in the first 4 hours, provocation of vomiting, intake of activated carbon,laxative drugs, the introduction of SH-group donors and precursors of the synthesis of glutathione methionine within 8-9 hours after an overdose and acetylcysteine ??- within 8 hours.

Drug interactions

The drug can enhance the effect of heparin, indirect coagulants, reserpine, steroid hormones and hypoglycemic drugs.

Concomitant use with other NSAIDs, methotrexate increases the risk of side effects. Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, as well as anti-gout drugs that promote the excretion of uric acid. Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other inducers of microsomal liver enzymes contribute to the formation of toxic metabolites of paracetamol, which affect liver function. Metoclopramide accelerates the absorption of paracetamol. Under the influence of paracetamol, the half-life of chloramphenicol is increased by 5 times. When taken again, paracetamol can enhance the effect of anticoagulants (coumarin derivatives).

Concomitant use of paracetamol, acetylsalicylic acid and alcoholic beverages increases the risk of developing hepatotoxic effects. Caffeine accelerates the absorption of ergotamine.