Aspirin®-C (Aspirin®-C)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAcetylsalicylic acid + Ascorbic acidAcetylsalicylic acid + Ascorbic acid
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    • Dosage form: & nbsptablets, effervescent
    Composition:

    1 tablet contains

    Active substances: acetylsalicylic acid 400 mg, ascorbic acid (vitamin C) 240 mg.

    Excipients: sodium citrate dihydrate 1206 mg, sodium hydrogen carbonate 914 mg, citric acid anhydrous 240 mg, sodium carbonate anhydrous 200 mg.

    Description:Round, flat, oblique white tablets with an imprint in the form of a brand name ("Bayer's" cross) on one side, the other side is smooth.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID) + vitamin
    ATX: & nbsp

    N.02.B.A.51   Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:Acetylsalicylic acid belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, antipyretic, anti-inflammatory properties. The mechanism of action is based on the irreversible inhibition of cyclooxygenase enzymes that regulate the synthesis of prostaglandins.

    Acetylsalicylic acid, when taken orally at doses of 0.3 g to 1 g, is used to relieve pain and conditions associated with mild fever, such as colds and flu, to lower fever and relieve joint and muscle pain.

    Acetylsalicylic acid is also used in acute and chronic inflammatory diseases, such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

    Acetylsalicylic acid suppresses platelet aggregation by blocking the synthesis of thromboxane A2. Therefore, it is used for many vascular diseases in a dosage of 75-300 mg per day.

    Water-soluble vitamin ascorbic acid is part of the body's defense system against oxygen radicals and other oxidants of endogenous and exogenous origin, which also play an important role in the inflammatory process and the function of leukocytes.

    Research results in vitro and ex vivo showed that ascorbic acid has a positive effect on the leukocyte immune response in humans.

    Ascorbic acid makes a significant contribution to the synthesis of intracellular substances (mucopolysaccharides), which simultaneously with collagen fibers are responsible for the integrity of the walls of the capillaries.

    Addition of ascorbic acid to acetylsalicylic acid reduces gastrointestinal disturbances and oxidative stress. These benefits can lead to better tolerability of acetylsalicylic acid with ascorbic acid compared with acetylsalicylic acid alone.

    Pharmacokinetics:After oral administration acetylsalicylic acid quickly and completely absorbed from the gastrointestinal tract. During and after absorption, it becomes the main active metabolite, salicylic acid. The maximum concentration of acetylsalicylic acid in the blood plasma is reached in 10-20 minutes, salicylates - after 0.3-2 hours, respectively.

    Acetylsalicylic and salicylic acids completely bind to blood plasma proteins and are quickly distributed in the body. Salicylic acid penetrates into breast milk and penetrates the placenta.

    Salicylic acid undergoes metabolism, mainly in the liver. Metabolites of salicylic acid are salicylurea, salicylphenol glucuronide, salicylacyl glucuronide, gentisic acid and gentisynamic acid.

    The kinetics of elimination of salicylic acid depends on the dose, since the metabolism is limited by the activity of liver enzymes. The half-life period depends on the dose and ranges from 2-3 hours when low doses are used up to 15 hours - when high doses are used. Salicylic acid and its metabolites are excreted mainly by the kidneys.

    After oral administration ascorbic acid absorbed in the intestine Na+-dependent active transport system, most active - in the proximal part of the intestine. Absorption is not proportional to the dosage: with an increase in the daily oral dose of ascorbic acid, its concentration in the blood plasma and other body fluids does not increase proportionately, but tends to approach the upper limit.

    Ascorbic acid is filtered through the glomeruli and reabsorbed by the proximal tubules under the action of Na+dependent process. The main metabolites are excreted in the urine in the form of oxalates and diketogulonic acid.

    Indications:Symptomatic treatment of moderate or mild pain syndrome of various origins (headache, toothache, migraine, neuralgia,muscle pain, menstruation pains) in adults and febrile syndrome with colds and other infectious and inflammatory diseases in adults and children over 15 years of age.
    Contraindications:

    - Hypersensitivity to acetylsalicylic acid, other NSAIDs or any other components of the drug;

    - erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), gastrointestinal bleeding;

    - complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including in the anamnesis;

    - combined use of methotrexate in a dose of 15 mg per week or more;

    - expressed violations of the liver, kidneys (creatinine clearance less than 30 ml / min);

    - severe cardiac dysfunction (chronic heart failure III-IV functional class for NYHA);

    - hemorrhagic diathesis; hemophilia, thrombocytopenia;

    - deficiency of glucose-6-phosphate dehydrogenase;

    - deficiency of vitamin K;

    - cerebrovascular or other bleeding;

    - inflammatory bowel disease in the acute stage;

    - simultaneous reception of oral anticoagulants and acetylsalicylic acid in a dose exceeding 3 g per day;

    - pregnancy (I and III trimesters), the period of breastfeeding,

    - children's age (up to 15 years).

    Carefully:With concomitant therapy with anticoagulants, gout, peptic ulcer and / or duodenal ulcer (in anamnesis), erosive gastritis, and a tendency to gastrointestinal bleeding, violations of liver function, hypothrombinemia, hypovitaminosis K, anemia, conditions predisposing to fluid retention in the body ( including disorders of heart function, arterial hypertension), thyrotoxicosis, propensity to calcium-oxalate nephrolithiasis. The intake of oral anticoagulants and acetylsalicylic acid in a dose of less than 3 g per day, gastrointestinal bleeding (in the anamnesis), erosive gastritis outside of exacerbation, impaired renal function (creatinine clearance 30-60 ml / min), bronchial asthma, chronic obstructive pulmonary disease, polyposis of the nose, hay fever (pollinosis), drug allergy, chronic heart failure I-II functional class for NYHA, II trimester of pregnancy, simultaneous reception with methotrexate in a dose of less than 15 mg per week, urate nephrolithiasis, metrorrhagia, hypermenorrhoea.
    Pregnancy and lactation:In the I and III trimesters of pregnancy, the use of all drugs containing acetylsalicylic acid is contraindicated.

    In the second trimester of pregnancy, acetylsalicylic acid can be administered sporadically. As a long-term therapy is recommended not to use.

    Breastfeeding period

    Salicylates and their metabolites penetrate into breast milk in small amounts.

    When breastfeeding a child, the use of drugs containing acetylsalicylic acid is contraindicated.

    Dosing and Administration:

    Inside. Spill the effervescent tablet in a glass of water and drink after eating.

    In pain syndrome of mild and moderate intensity and febrile conditions, a single dose is 1 -2 effervescent tablets, the maximum single dose is 2 effervescent tablets, the maximum daily dose should not exceed 6 tablets. Intervals between doses of the drug should be at least 4 hours.

    The duration of treatment (without consulting a doctor) should not exceed 3-5 days.

    In order to reduce the risk of developing adverse reactions from the gastrointestinal tract, the minimum effective dose of the drug should be applied with the shortest course of treatment.

    Side effects:The incidence of adverse reactions is divided into frequent (≥ 1/100 and <1/10), infrequent (≥ 1/1000 and <1/100) and rare (≥ 1/10000 and <1/1000). For side reactions revealed during post-marketing observations and for which it is not possible to reliably estimate the frequency, "frequency is unknown" is indicated.

    Disorders from the gastrointestinal tract: often - a decrease in appetite; rarely diarrhea; frequency is unknown - dyspepsia, abdominal pain, nausea, vomiting, obvious (black stools, bloody vomiting) or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive-ulcerative lesions (including perforations) of the gastrointestinal tract.

    Impaired nervous system: infrequently - a headache; frequency unknown - dizziness, tinnitus (usually indicative of an overdose).

    Violations from the blood and lymphatic system: frequency unknown - hemorrhagic syndrome, thrombocytopenia.Bleeding can lead to acute or chronic anemia, iron deficiency anemia with appropriate laboratory and clinical manifestations (asthenia, pallor, hypoperfusion). In patients with deficiency of glucose-6-phosphate dehydrogenase, hemolysis and hemolytic anemia can be observed.

    Disorders from the kidneys and urinary tract: frequency is unknown - when used in high doses - hyperoxaluria and the formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

    Immune system disorders: frequency unknown - skin rash, rhinitis, anaphylactic reactions, bronchospasm, Quincke's edema, "aspirin triad" formation (bronchial asthma, polypous rhinosinusitis and intolerance to acetylsalicylic acid and pyrazolone drugs).

    Disorders from the liver and bile ducts: very rarely - Reye's syndrome (acute fatty liver dystrophy with developed acute liver failure and encephalopathy); rarely - violations of the liver (increased liver transaminases).

    When such symptoms appear, it is recommended to stop taking the drug and immediately consult a doctor.

    Overdose:In the initial stage of poisoning - excitation of the central nervous system, dizziness, severe headache, reduced hearing acuity, visual impairment, nausea, vomiting, increased breathing. Later there comes drowsiness, convulsions, anuria, depression of consciousness down to coma, respiratory insufficiency, disturbances of water-electrolyte metabolism.

    Treatment: if signs of poisoning should be caused by vomiting or rinsing of the stomach, appoint Activated carbon and laxative and seek medical attention. Treatment should be carried out in a specialized department of the hospital under careful control, if necessary, correction of acid-base balance, electrolyte balance, alkalinization of urine, hemodialysis, IVL.

    Interaction:Increases the toxicity of methotrexate, the effects of narcotic analgesics, other NSAIDs, oral hypoglycemic drugs, heparin, indirect anticoagulants, thrombolytic agents and platelet aggregation inhibitors, sulfonamides (including co-trimoxazole), triiodothyronine, reserpine; reduces the effects of uricosuric drugs (benzbromarone, sulfinpyrazone), antihypertensive drugs and diuretics (spironolactone, furosemide).

    Glucocorticosteroids, alcohol and alcohol-containing preparations increase the damaging effect on the gastrointestinal mucosa, increase the risk of developing gastrointestinal bleeding.

    Increases the concentration of digoxin, barbiturates and lithium preparations in blood plasma. Antatsida, containing magnesium and / or aluminum hydroxide, slow down and worsen the absorption of acetylsalicylic acid.

    Ascorbic acid improves the absorption of iron in the intestine. Selective serotonin reuptake inhibitors increase the risk of bleeding in the upper GI tract.

    Strengthens hypoglycemic action due to hypoglycemic action of acetylsalicylic acid and displacement of sulfonylurea derivatives from complexes with blood proteins.

    Reduces the effect of diuretics by reducing glomerular filtration against the background of oppression of prostaglandin production by the kidneys.

    Systemic glucocorticoids, in addition to hydrocortisone, increase the excretion of salicylates, which can lead to an overdose of salicylates after the abolition of glucocorticoid therapy.

    Increases the toxicity of valproic acid due to its displacement from complexes with blood proteins.

    The simultaneous use of deferoxamine with ascorbic acid can increase the toxicity of iron, especially in the heart, leading to cardiac decompensation.

    Special instructions:The drug is not prescribed as an antipyretic agent for children under 15 with acute respiratory infections caused by viral infections, because of the risk of developing Reye's syndrome (encephalopathy and acute fatty liver disease with acute development of liver failure).

    Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients.

    With prolonged use of the drug should periodically make a general blood test and analysis of feces for latent blood, monitor the functional state of the liver. Because the acetylsalicylic acid slows the clotting of the blood, the patient, if he is to undergo surgery, must warn the doctor in advance about taking the drug.

    During treatment should be abandoned the use of ethanol (increased risk of gastrointestinal bleeding).

    In the second trimester of pregnancy, one-time administration of the drug at recommended doses is possible only if the expected benefit for the mother will exceed the potential risk to the fetus.

    One dose of the drug contains 933 mg of sodium, which should be taken into account in patients receiving a salt-free diet.

    If you need to use the drug during lactation, breastfeeding should be discontinued.

    In order to reduce the risk of developing increased bleeding, the drug should be discontinued 4-8 days before the planned surgery and notified the doctor.

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

    Does not affect.

    Form release / dosage:Tablets effervescent 400 mg + 240 mg.
    Packaging:2 tablets per strip of paper, laminated with aluminum foil; 5 strips together with instructions for use in a pack of cardboard.
    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 the drug after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N013665 / 01
    Date of registration:09.11.2007 / 09.01.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Bayer Konsyumer Kare AGBayer Konsyumer Kare AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp19.10.2017
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