Aspirin c effervescent pills №10

Trade name of the drug

Aspirin-C

Grouping name

Acetylsalicylic acid + [Ascorbic acid].

Dosage Form

Effervescent tablets.

Composition

1 pill contains

Active ingredients: Acetylsalicylic acid 400 mg, Ascorbic acid (vitamin C) 240 mg.

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

Description

Round, flat, beveled to the edge of the pill in white with a stamp in the form of a trademark ("Bayer" cross) on the one hand, the other side is smooth.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory drug (NSAIDs) + vitamin.

Pharmacological properties

Pharmacodynamics

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

Acetylsalicylic acid, when taken orally in dosages of 0.3 g to 1 g, is used to relieve pain and mild fever, such as the common cold and flu, to reduce fever and relieve pain in the joints and muscles.

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. It is therefore used in many vascular diseases at 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 (flour-polysaccharides), which simultaneously with the collagen fibers are responsible for the integrity of the walls of capillaries.

Adding 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 is rapidly and completely absorbed from the gastrointestinal tract. During and after absorption, it turns into the main active metabolite, salicylic acid.The maximum concentration of acetylsalicylic acid in plasma is reached in 10–20 minutes, salicylates - in 0.3–2 hours, respectively.

Acetylsalicylic and salicylic acids are completely bound to plasma proteins and are rapidly distributed in the body. Salicylic acid penetrates into breast milk and passes through the placenta.

Salicylic acid is metabolized, mainly in the liver. Salicylic acid metabolites are salicylic uric acid, salicylphenol glucuronide, salicylacyl glucuronide, gentisic acid and gentisin uric acid.

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

After oral administration, ascorbic acid is absorbed in the intestine by the Na + -dependent active transport system, most actively 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 proportionally, but tends to approach the upper limit.

Ascorbic acid is filtered through the glomeruli and reabsorbed by proximal channels under the action of the Na + -dependent process.The major metabolites are excreted in the urine as oxalates and diketogulonic acid.

Indications for use

Symptomatic treatment of moderate or mild pain syndrome of various origins (headache, toothache, migraine, neuralgia, muscle pain, pain during menstruation) in adults and febrile syndrome in 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 acute phase), Gastrointestinal bleeding;
• complete or incomplete combination of asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, including a history;
• combined use of Methotrexate at a dose of 15 mg per week or more;
• severe impaired liver function, kidney (creatinine clearance less than 30 ml / min);
• severe cardiac dysfunction (chronic heart failure of the III-IV functional class according to NYHA);
• hemorrhagic diathesis; hemophilia, thrombocytopenia;
• glucose-6-phosphate dehydrogenase deficiency;
• vitamin K deficiency;
• cerebrovascular or other bleeding;
• inflammatory bowel disease in the acute stage;
• simultaneous administration of oral anticoagulants and acetylsalicylic acid in a dose exceeding 3 g per day;
• pregnancy (I and III trimesters), breastfeeding period;
• children's age (up to 15 years).

Carefully

With concomitant therapy with anticoagulants, gout, gastric ulcer and / or duodenal ulcer (in history), erosive gastritis, and a tendency to gastrointestinal bleeding, impaired liver function, hypothrombinemia, hypovitaminosis K, anemia, predisposed disorders. body (including dysfunction of the heart, arterial hypertension), thyrotoxicosis, tendency to calcium-oxalate nephrolithiasis. Acceptance of oral anticoagulants and acetylsalicylic acid at a dose of less than 3 g per day, gastrointestinal bleeding (history), erosive ha street without exacerbation, impaired renal function (creatinine clearance 30-60 ml / min), bronchial asthma, chronic obstructive pulmonary disease, nasal polyposis, hay fever (pollinosis), drug allergy, NYHA functional class I-II functional heart failure, II trimester of pregnancy, simultaneous use with methotrexate at a dose of less than 15 mg per week, urate nephrolithiasis, meter agia, hypermenorrhea.

Use during pregnancy and during breastfeeding

In the I and III trimesters of pregnancy, the use of all drugs containing acetylsalicylic acid is contraindicated.

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

Breastfeeding period

Salicylates and their metabolites in small quantities pass into breast milk.

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

Dosage and administration

Inside Dissolve the effervescent pill in a glass of water and drink after a meal.

With pain syndrome of weak and medium intensity and feverish 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. The 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 adverse reactions from the gastrointestinal tract, the minimum effective dose of the drug should be applied by the shortest course of treatment.

Side effect

According to the frequency of occurrence, adverse reactions are divided into frequent (> 1/100 and <1/10), non-frequent (> 1/1000 and <1/100) and rare (> 1/10000 and <1/1000). For adverse reactions identified in the process of post-marketing observations and for which the frequency cannot be reliably estimated, “frequency unknown” is indicated.

Violations of the gastrointestinal tract:

often - loss of appetite; rarely diarrhea; frequency unknown - dyspepsia, abdominal pain, nausea, vomiting, overt (black stool, bloody vomiting) or hidden signs of gastrointestinal bleeding,which can lead to iron deficiency anemia, erosive-ulcerative lesions (including perforation) of the gastrointestinal tract.

Nervous system disorders:

infrequently - headache;

frequency is unknown - dizziness, tinnitus (usually are signs of overdose).

Violations of the blood and lymphatic system:

frequency is unknown - hemorrhagic syndrome, thrombocytopenia. Bleeding can lead to acute or chronic anemia, iron deficiency anemia with appropriate laboratory and clinical manifestations (asthenia, pallor, hypoperfusion). Hemolysis and hemolytic anemia may be observed in patients with deficiency of glucose-6-phosphate dehydrogenase.

Kidney and urinary tract disorders:

the frequency is unknown - when used in high doses - hyperoxaluria and the formation of urine stones from Calcium oxalate, damage to the glomerular apparatus of the kidneys.

Immune system disorders:

frequency is not known - skin rash, rhinitis, Anaphylactic reactions, bronchospasm, Queen's edema, the formation of an “aspirin triad” (bronchial asthma, polypous rhinosinusitis and non-tolerance of acetylsalicylic acid and pyrazolone preparations).

Disorders of the liver and biliary tract:

very rarely - Reye's syndrome (acute fatty degeneration of the liver with developed acute liver failure and encephalopathy);

rarely, abnormal liver function (increased liver transaminases).

When these symptoms appear, it is recommended to stop taking the drug and immediately contact your doctor.

Overdose

In the initial stage of poisoning - excitation of the central nervous system, dizziness, severe headache, reduced hearing acuity, blurred vision, nausea, vomiting, increased breathing. Later, drowsiness, convulsions, anuria, depression of consciousness up to coma, respiratory failure, impaired water and electrolyte metabolism.

Treatment: for signs of poisoning, induce vomiting or gastric lavage, administer activated charcoal and laxative, and consult a doctor. Treatment should be carried out in a specialized hospital department under close supervision, if necessary, correction of acid-base balance, electrolyte balance, urine alkalization, hemodialysis, mechanical ventilation.

Interaction with other drugs

It enhances the toxicity of methotrexate, narcotic analgesics and other NSAIDs, pe-roralnyh hypoglycemic drugs, Heparin, anticoagulants, tromboliti-ing and platelet aggregation inhibitors, sulfonamides (including co-trimoxazole), triiodo-thyronine, reserpine; reduces the effects of uricosuric drugs (benzbromarone, sulfin-pyrazone), antihypertensive drugs and diuretics (spironolactone, furosemide).

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

Increases the concentration of Digoxin, barbiturates and lithium preparations in the blood plasma. Antacids containing Magnesium and / or aluminum hydroxide slow down and impair the absorption of acetylsalicylic acid.

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

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

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

Systemic glucocorticoids, except Hydrocortisone, increase the excretion of salicylates, which can lead to an overdose of salicylates after discontinuation of glucocorticoid therapy.

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

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

special instructions

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