Release form, composition and packaging
Tablets effervescent round, flat, beveled to the edge, white color, with an engraved unique (bierowski cross) from one side.
Auxiliary substances: sodium citrate anhydrous, sodium carbonate odnosemjannyj, citric acid anhydrous, sodium carbonate anhydrous.2 PCs. – strips of paper are laminated (12) – packs of cardboard.
2 PCs. – strips of laminated paper (6) – packs cardboard.Clinico-pharmacological group: NSAIDs used during migraine attacks
tab. effervescent 500 mg: 12 or 24 PCs – P No. 016188/01, 08.12.06
The description of the drug based on approved application instructions and approved by the manufacturer for издания2006 G. Pharmacological, dastans. Has analgesic, antipyretic and anti-inflammatory effect. The mechanism of action is the irreversible inhibition of the enzyme cyclo-oxygenase regulating the synthesis of prostaglandins E2, I2 and thromboxane A2.One of the basic mechanisms of headache the migraine attack is aseptic neurogenic inflammation of the blood vessels and the Dura mater. Acetylsalicylic acid inhibits the formation of prostaglandins, which are mediators of inflammation, reduces irritation of pain receptors of the trigeminal nerve. On the other hand, acetylsalicylic acid inhibits the synthesis of vascular endothelial nitric oxide, which is involved in the initiation and maintenance of headache migraine.Pharmacokineticstudies ingestion, acetylsalicylic acid is rapidly and completely absorbed from the gastrointestinal tract. In the period of absorption and immediately after the acetylsalicylic acid is converted into the main active metabolic salicylic acid. Cmax of acetylsalicylic acid in the blood plasma is reached in 10-20 min, Cmax of salicylic acid in 0.3-2 h. Distribution and metabolizmom 80% of acetylsalicylic and salicylic acid binds to plasma proteins and are rapidly distributed in the tissues. Salicylic acid is excreted in breast milk and crosses the placental barrier.Salicylic acid is metabolized in the liver with the formation of metabolites salicylate, salecalifornia glucuronide, salicylanilide glucuronide, gentisic and gentisuric acids.Videnablyudenie of salicylic acid is dose-dependent.T1/2 while taking the drug in low doses is 2-3 h when taking the drug in high doses – 15 h Salicylic acid and its metabolites are excreted mainly by the kidneys.Indications— symptomatic treatment of headaches with migraines.Mode datirovannom the drug is prescribed a single dose of 1 g (2 tablets). If necessary, the drug can be repeated after 4-8 hours the Maximum daily dose of 3 g (6 tablets), which should not be exceeded.The patient should be informed not to take the drug for more than 3 days without consulting a doctor. If migraine attacks are frequent, and their frequency increases or long-term symptoms remain, consult a doctor if necessary, can be assigned to an alternative treatment.Use of Aspirin 1000 in children is not recommended because studies in these patients have not been conducted.Effervescent tablets should be taken inside after eating, before taking to dissolve in a glass of water.Side deystviya the digestive system: abdominal pain, nausea, vomiting, heartburn, gastrointestinal bleeding (including hidden, leading to the development of iron deficiency anemia), gastric ulcer and duodenal ulcer (including perforated), increase in liver transaminases.CNS: dizziness, tinnitus, impaired hearing, headache (usually are signs of an overdose)From the hematopoietic system: prolongation of bleeding time, bleeding of different localization (Novoe, from the gums, hemorrhagic purpura).Allergic reactions: anaphylactic reactions, asthma, angioedema, urticaria, allergic skin reactions.Contraindications erosivno-azwenne defeat of the gastrointestinal tract, hemorrhagic diathesis, bronchial asthma induced by ingestion of salicylates and NSAIDs, — combined use with methotrexate dose 15 mg per week, — renal insufficiency — hepatic insufficiency — severe heart failure in the decompensation stage, I and III trimenon of pregnancy, lactation (breastfeeding), — hypersensitivity to acetylsalicylic acid, other salicylates or to any components of the drug.The drug is not prescribed to children under 15 years with acute respiratory diseases caused by viral infections, because of the risk of Reye’s syndrome (encephalopathy and acute fatty degeneration of the liver with acute hepatic insufficiency).With caution should designate product for gout, hyperuricemia, patients with a history of indications ulcerative lesions of the gastrointestinal tract (including ulcers disease stomach and duodenal ulcers) or jeludochno-intestinal bleeding, impaired renal function and liver, bronchial asthma, chronic respiratory diseases, hay fever, polyposis of the nasal mucosa, allergic reactions to drugs (including NSAIDs), in the II trimester of pregnancy.Application at pregnancy and feeding grudyu I and III trimester of pregnancy the use of all drugs containing acetylsalicylic acid is contraindicated.In the II trimester of pregnancy, acetylsalicylic acid can be assigned occasionally. As long-term therapy do not use.When applied in III trimester of pregnancy, acetylsalicylic acid at a dose of ?500 mg/day, as well as other inhibitors of prostaglandins, can cause in the fetus premature closure of the ductus arteriosus and pulmonary hypertension, renal dysfunction until the development of renal failure with malovodie, the prolonged bleeding time in mother and fetus late in pregnancy (this effect can be observed even with the use of acetylsalicylic acid in low doses).Salicylates and their metabolites in small amounts of infiltrating breast milk.When breastfeeding, the use of drugs containing acetylsalicylic acid is contraindicated.Used in the dysfunction pecription of liver failure. With caution should appoint at violations of function of liver.Used in the dysfunction occpational in renal failure. With caution should designate product in violation of kidney function.Special ukazaniya use in children with acute viral infections of acetylsalicylic acid increases the risk of Reye’s syndrome. Because the purpose of the Aspirin 1000 in this category of patients is contraindicated.The use of acetylsalicylic acid can cause bronchospasm in patients with bronchial asthma, hay fever, polyposis in the nasal mucosa, chronic respiratory diseases, allergic reactions to other drugs (in the form of skin reactions, itching, urticaria).The drug can cause bleeding of varying severity during and after surgical interventions.The ability of acetylsalicylic acid to inhibit platelet aggregation may lead to increased bleeding during and after surgery (including minor surgical interventions, for example, extraction of the tooth). The risk of bleeding increases with the use of acetylsalicylic acid in high dose. Hemorrhagic effect lasts for 4-8 days after discontinuation of acetylsalicylic acid.Acetylsalicylic acid in low doses can trigger the development of gout in predisposed patients (with decreased excretion of uric acid from the body).Long-term use of analgesics can lead to the formation of the headache of addiction, which occurs in the period of their abolition.Frequent use of analgesics (particularly combinations of different analgesics) can lead to the development of severe renal disease analgesic nephropathy.When used on the background of the drug alcohol payaetsya the risk of damage to the mucosa of the gastrointestinal tract and lengthening the bleeding time.Be aware that 1 dose (2 tab.) contains 1086 mg sodium, you need to consider in applying the drug in patients on a diet that requires limiting the use of salt.Perepozitsionirovan particularly dangerous for elderly patients and young children (up to the development of fatal outcome).Symptoms: overdose of moderate severity – tinnitus, hearing loss, headache, dizziness, lethargy, overdose, severe – fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular shock, respiratory failure, hypoglycemia, severe.Treatment: an overdose of moderate severity – decrease dose with severe shown urgent hospitalization in a specialist unit for emergency treatment (gastric lavage, the appointment of activated carbon, determination of acid-base balance, alkaline diuresis to obtain the values of the urine pH within 7.5-8, conduct of forced alkaline diuresis at a concentration of salicylates in the blood of more than 500 mg/l (3.6 mmol/l) in adults and 300 mg/l (2.2 mmol/l) in children, compensation for loss of fluid, symptomatic treatment). In severe poisoning, a kidney dialysis possible. Drug vzaimodeistviyami Aspirin 1000 with methotrexate in a dose of 15 mg / week is contraindicated.With simultaneous use of Aspirin 1000 with methotrexate at a dose less than 15 mg per week, increased haematological toxicity of methotrexate due to the fact that NSAIDs reduce the renal clearance of methotrexate, and salicylates, in particular, displace it from plasma proteins.At simultaneous reception of Aspirin and 1000 indirect anticoagulants (coumarin, heparin) increases the risk of bleeding by inhibition of platelet function, damage of the gastric mucosa and duodenal ulcers and displacement of oral anticoagulants from their plasma proteins.With simultaneous use of other NSAIDs with salicylates at high doses (3 g/day or more) due to synergistic action increases the risk obrazovniya ulcers of the mucous membrane of the gastrointestinal tract and bleeding.While the use of Aspirin 1000 reduces the therapeutic effect of uricosuric drugs (benzbromarone, probenecid) due to the competitive tubular elimination of uric acid.With simultaneous use of Aspirin 1000 and digoxin increases the concentration of the latter in plasma by reducing its excretion.Aspirin 1000 enhances the effect of hypoglycemic agents (insulin and sulfonylurea derivatives) due to the hypoglycemic effect of acetylsalicylic acid and displacement of sulfonylureas from plasma proteins the blood.Aspirin 1000 in the combined use enhances the effect of thrombolytic and antiplatelet drugs (including ticlopidine).While the use of diuretics in combination with acetylsalicylic acid at a dose of 3 g/day or more reduced glomerular filtration due to decrease of prostaglandin synthesis in the kidneys.While the use of systemic corticosteroids (except for hydrocortisone) Aspirin 1000 concentration of salicylates in the blood is reduced, because corticosteroids increase the excretion of the latter.While the use of ACE inhibitors and Aspirin 1000 in a dose of 3 g/day and boee marked decrease in the hypotensive effect of ACE inhibitors due to the reduction of glomerular filtration.Acetylsalicylic acid breaks the bond of valproic acid to plasma proteins, thereby increasing its toxicity.With the combination of ethanol with acetylsalicylic acid enhanced damaging effect on the gastrointestinal mucosa and prolonged bleeding time.Terms and conditions grannyplanet should be stored in inaccessible to children at temperature not exceeding 25°C. shelf Life – 3 years.