Godasal

General characteristics. Structure:

Active agent: acetylsalicylic acid of 100 mg; glycine of 50 mg

Excipients: starch corn; cellulose; fragrance lemon; sodium saccharinate.

Pharmacological properties:

Acetylsalicylic acid suppresses aggregation of thrombocytes by A2 thromboxane synthesis blocking. The mechanism of its action consists in an irreversible inactivation of TsOG-1 enzyme. The specified inhibiting effect is especially expressed for thrombocytes as they are not capable to resynthesis of the specified enzyme. It is defined also that acetylsalicylic acid renders also other inhibiting effects on thrombocytes. Thanks to the specified effects, it is applied at many cardiovascular diseases. Acetylsalicylic acid concerns to the NPVP group with analgetic, febrifugal and antiinflammatory properties.

Pharmacokinetics. Acetylsalicylic acid is soaked up in a GIT quickly and completely. In the course of absorption acetylsalicylic acid is metabolized before formation of the main metabolite — salicylic acid. Cmax in a blood plasma is defined in 10–20 min. after use for acetylsalicylic acid and by 0,3–2 h for salicylates. Removal kinetics dozozavisimy. T½ of acetylsalicylic acid — several minutes. T½ of salicylic acid is 2 h at reception of 0,5 g of acetylsalicylic acid, 4 h at reception of 1 g and 20 h at reception of 5 g. Linkng with blood proteins depends on concentration; 49–70% — for acetylsalicylic acid and 66–98% — for salicylic acid. After administration of acetylsalicylic acid salicylic acid is defined in SMZh and synovial fluid. Acetylsalicylic acid gets through a placental barrier and is emitted with breast milk. Acetylsalicylic acid and its metabolites are emitted from an organism preferential with kidneys.
Acetilsalicylic and salicylic acids completely contact proteins of a blood plasma and are quickly distributed in an organism. Salicylic acid gets through a placenta, and also into breast milk.
Salicylic acid is exposed to metabolism in a liver. Metabolites of salicylic acid are salitsilmochevy acid, салицилфенол a glucuronide, the glucuronide, gentisic acid and gentizinmochevy acid salitsilatsit.
Godasal contains excipient glycine which improves organoleptic properties of a tablet (pleasant taste and a smell), promotes improvement of portability of tablets, dissolution of acetylsalicylic acid and is the rn-buffer. Glycine is adsorbed on crystals of acetylsalicylic acid by the pellicle interfering sticking of acetylsalicylic acid to membranes of a mucous membrane promotes a bystry proglatyvaniye of a tablet, accelerates absorption, protects mucous membranes of a stomach and a duodenum at prolonged use of acetylsalicylic acid.

Indications to use:

for decrease in risk:
• death at patients with suspicion of an acute myocardial infarction;
• incidences and death at the patients who had a myocardial infarction;
• the tranzitorny ischemic attacks (TIA) and a stroke at patients with TIA;
• incidences and mortality at stable and unstable stenocardia;
• a myocardial infarction at patients with high risk of development of cardiovascular complications (a diabetes mellitus, controlled AG) and at persons with multifactorial risk of cardiovascular diseases (a lipidemia, obesity, smoking, advanced age, etc.).

For prevention:
• thromboses and an embolism after operations on vessels (transdermal translyuminarny catheter angioplasty (RTSA), endarterectomy of a carotid artery, aortocoronary shunting (CABG), arteriovenous shunting);
• a deep vein thrombosis and an embolism of lungs after a long immobilization (after surgeries).
For secondary prevention of a stroke.

Route of administration and doses:

Godasal appoint to adults and children 16 years are aged more senior. Drug is accepted inside to food without chewing, wash down with enough liquid. The tablet can be rassasyvat or chewed.
For decrease in risk of death at patients with suspicion of an acute myocardial infarction use drug in the recommended dose of 100-300 mg/days. Within 30 days after a heart attack continue to accept a maintenance dose of 100-300 mg/days. In 30 days it is necessary to consider a question of further prevention of a recurrence of a myocardial infarction.
To reach bystry absorption at use for this indication, the first tablet needs to be chewed!
At the patients who had a myocardial infarction apply 100–300 mg/days to decrease in risk of incidence and death.
For secondary prevention of a stroke use drug in a dose of 100-300 mg/days.
At patients with TIA apply 100–300 mg/days to decrease in risk of TIA and a stroke.
For decrease in risk of development of a disease and death at patients with stable and unstable stenocardia — 100–300 mg/days.
For prevention of a thromboembolism after operations on vessels (transdermal translyuminarny catheter angioplasty (RTSA), endarterectomy of a carotid artery, aortocoronary shunting (CABG), arteriovenous shunting) use drug in a dose of 100-200 mg/days daily or 300 mg every other day.
For prevention of a deep vein thrombosis and an embolism of a pulmonary artery after a long condition of an immobilization (after surgeries) — 100–200 mg/days or 300 mg every other day.
At patients with high risk of development of cardiovascular complications (a diabetes mellitus, controlled AG) and to persons with multifactorial risk of cardiovascular diseases (a lipidemia, obesity, smoking, advanced age, etc.) apply 100 or 300 mg to prevention of a myocardial infarction every other day.
Prevention. Children need to appoint drug taking into account information stated in the section SPECIAL INSTRUCTIONS.

Features of use:

It is necessary to swallow of tablets entirely, washing down with enough liquid, to rassosat or chew. Not to apply on an empty stomach.
At treatment of an acute myocardial infarction it is necessary to chew or get to the core of the first tablet.
At aortocoronary shunting treatment by drug needs to be begun in the first days after operation.
Drug is intended for prolonged treatment. Extension of term of treatment needs to be coordinated with the doctor.
Use of drug should not be combined with alcohol intake.
Godasal apply with care at:

• sensitivity to analgetic, anti-inflammatory, antirheumatic drugs, and also in the presence of an allergy to other substances;
• GIT ulcers, including chronic and recurrent ulcers or gastrointestinal bleedings in the anamnesis;
• simultaneous use of anticoagulants;
• disturbance of functions of a liver;
• a renal failure or cardiovascular system (for example pathology of vessels of a kidney, congestive heart failure, a hypovolemia, extensive operations, sepsis or heavy bleedings) as acetylsalicylic acid can increase risk of a renal failure and OPN also;
• heavy insufficiency glyukozo-6-fosfatdegidrogenazy as acetylsalicylic acid can cause hemolysis or hemolitic anemia, especially in the presence of factors which can increase risk of hemolysis, for example high doses of drug, fever or acute infectious process.
In case of prolonged use of drug before reception of an ibuprofen the patient has to consult with the doctor.
At patients with allergic complications, including with OH, allergic rhinitis, a small tortoiseshell, a skin itch, hypostasis of a mucous membrane and polipozy a nose, and also in combination with persistent infections of respiratory tracts and at patients with hypersensitivity to NPVP against the background of treatment with acetylsalicylic acid development of a bronchospasm or attack OH is possible.
At surgeries (including dental) use of the drugs containing acetylsalicylic acid can increase probability of strengthening of bleeding.
At use of low doses of acetylsalicylic acid decrease in removal of uric acid is possible. It can lead to developing of gout at patients with reduced removal of uric acid.
It is not necessary to use the drugs containing acetylsalicylic acid at children with a SARS which is followed or is not followed by fervescence, without consultation with the doctor. At some viral diseases, especially flu A, flu B and chicken pox, there is a risk of development of a syndrome of Ray which is very rare, but life-threatening disease that demands emergency medical service. The risk can be raised if acetylsalicylic acid is applied as the accompanying medicine, however relationship of cause and effect in this case is not proved. If the specified states are followed by long vomiting, it can be a sign of a syndrome of Ray.
Drug is not used as anesthetic.
At prolonged use for the purpose of prevention of side effects from the alimentary system it is desirable to accept with inhibitors of a proton pomp.
Use during pregnancy and feeding by a breast
Pregnancy. Women who presumably can be pregnant women or in I and II trimesters of pregnancy have to have a dose of the drugs containing acetylsalicylic acid as low as possible, and treatment duration — is shorter. At drug use the patient should report to the doctor about pregnancy approach. It is not necessary to use drug in I and II trimesters of pregnancy, except cases when the advantage of use exceeds risk.
Suppression of synthesis of prostaglandins can negatively influence pregnancy and/or embryonic/pre-natal development. The available data of epidemiological researches indicate possible risk of an abortion and malformations of a fruit after use of inhibitors of synthesis of prostaglandins at the beginning of pregnancy. The risk increases depending on increase in a dose and duration of therapy.
In the III trimester of pregnancy all inhibitors of prostaglandins can influence a fruit as follows:

• cardiopulmonary toxicity (with premature closing of an arterial channel and pulmonary AG);
• a renal failure with possible subsequent development of a renal failure with oligogidramniony;
on the woman and a fruit at the end of pregnancy as follows:

• increase in a bleeding time, antiagregantny effect which can arise even after use of very low doses;
• decrease in intensity and frequency of reductions of a uterus that can lead to a delay or lengthening of a duration of delivery.
Considering it, acetylsalicylic acid is contraindicated in the III trimester of pregnancy.
Feeding period breast. Salicylates and their metabolites get into breast milk in a small amount. If the dose exceeds 150 mg/days, breastfeeding should be stopped.
At prolonged use of drug or use of acetylsalicylic acid in high doses it is necessary to resolve an issue of the breastfeeding termination.
Children. According to indications (see INDICATIONS) drug Godasal is not used at children.
Use of acetylsalicylic acid for children aged up to 16 years can cause heavy side effects (including Ray's syndrome, one of signs of which is constant vomiting (see. Special INSTRUCTIONS)).

Side effects:

From the alimentary system: pain in a stomach, insignificant gastrointestinal bleedings (microhemorrhages), diarrhea, nausea, vomiting, dyspepsia symptoms, an abdominal pain, a GIT inflammation, GIT erosive cankers, gastrointestinal hemorrhages and perforation with the corresponding laboratory indicators and clinical manifestations. Noted such types of bleeding as perioperatsionny hemorrhages, hematomas, bleedings from bodies of urinogenital system. Hemorrhages can lead to acute and chronic posthemorrhagic anemia / an iron deficiency anemia (owing to the so-called latent microbleeding) with the corresponding laboratory manifestations and clinical symptoms, such as an adynamy, pallor of integuments, hypoperfusion.
At patients with severe forms of insufficiency glyukozo-6-fosfatdegidrogenazy revealed hemolysis or hemolitic anemia.
From immune system: hypersensitivity reactions with the corresponding laboratory and clinical manifestations include an asthmatic state, skin reactions of easy or average degree, and also from a respiratory path, a GIT and cardiovascular system, including such symptoms as rash, urticaria, hypostasis, an itch, rhinitis, a nose congestion, cardiorespiratory insufficiency and is very rare — heavy reactions, including development of a polymorphic erythema, anaphylactic reactions, a Quincke's disease, an acute anaphylaxis.
From kidneys and urinary tract: renal failure, hypoglycemia, development of OPN.
From a nervous system: the headache, dizziness, orientation disturbance, a hearing disorder or feeling of a ring in ears (tinit) which can also be overdose symptoms, especially at elderly people and children.
From vascular system: bleedings from a nose, gums or skin which proceed 4–8 h after administration of drug emergence of a serious hematencephalon, especially at patients with the high not stabilized ABP who at the same time receive medical treatment for anticoagulants is possible. In individual cases can be life-threatening.
From a liver and biliary tract: increase in level of separate laboratory indicators (insignificant or moderate increase in liver enzymes), tranzitorny liver failure.
Increase in expressiveness of inflammatory process in connection with system use of NPVP is in exceptional cases possible. It is necessary to report immediately to the doctor about emergence of infectious process or about increase in expressiveness of symptoms of an infectious disease at use of acetylsalicylic acid.
Even low doses of acetylsalicylic acid reduce removal of uric acid and, under certain conditions, with tendency to reduced excretion of uric acid can cause gout attacks in persons. At emergence of a chair of black color the patient needs to see a doctor immediately.

Interaction with other medicines:

Contraindications because of interaction. Use of a methotrexate in doses of 15 mg/week and increases hematologic toxicity of a methotrexate above (decrease in renal clearance of a methotrexate by antiinflammatory agents and replacement by methotrexate salicylates from communication with proteins of a blood plasma).
Combinations which should be applied with care. At use of a methotrexate in doses <15 mg/week hematologic toxicity of a methotrexate increases (decrease in renal clearance of a methotrexate by antiinflammatory agents and replacement by methotrexate salicylates from communication with proteins of a blood plasma).
Simultaneous use of an ibuprofen interferes with irreversible inhibition of thrombocytes acetylsalicylic acid. Treatment by an ibuprofen of patients with risk of cardiovascular diseases can limit cardiotyre-tread effect of acetylsalicylic acid.
At simultaneous use Godasal strengthens:

• effect of anticoagulants / тромболитиков / other inhibitors of aggregation of thrombocytes/hemostasis: the risk of bleeding increases;
• risk of gastrointestinal bleedings at simultaneous use from GKS (except for a hydrocortisone) applied to replacement therapy at Addison's disease; system GKS during treatment reduce the level of salicylates in blood and increase risk of overdose after the end of treatment;
• effect of alcohol: ethanol promotes injury of a mucous membrane of a GIT and prolongs a bleeding time owing to a synergism of acetylsalicylic acid and alcohol;
• effect of peroral antidiabetic drugs from group of derivatives of sulphonylurea or insulin strengthens hypoglycemic effect of the last due to hypoglycemic effect of acetylsalicylic acid and replacement of sulphonylurea, decrease in level of glucose of blood is possible;
• increases concentration of digoxin, barbiturates and salts of lithium in a blood plasma;
• action and side effects of NPVP and analgetics: at simultaneous use of high doses of salicylates with NPVP (thanks to the mutually strengthening effect) the risk of developing of ulcers and gastrointestinal bleedings increases;
• effect of the streptocides and such drugs used in combination with streptocides as sulfamethoxazole and Trimethoprimum;
• effect of triiodothyronine;
• action and toxicity of valproic acid: acetylsalicylic acid forces out it from communication with proteins of a blood plasma, increasing toxicity of the last.
Reduces clinical performance:

• antagonists of Aldosteronum (Spironolactonum, канреноат);
• diuretics (furosemide): diuretics in combination with high doses of acetylsalicylic acid reduce filtering of balls thanks to decrease in synthesis of prostaglandins in kidneys;
• anti-hypertensive means;
• APF in a combination with high doses of acetylsalicylic acid cause decrease in filtering in balls owing to inhibition of vazodilatatorny prostaglandins and decrease in anti-hypertensive effect;
• uricosuric drugs (пробенецид, бензобромарон): reduces effect of removal of uric acid (thanks to the competition of removal of uric acid renal tubules).
The patient should consult with the doctor before applying Godasal combined with the above-stated drugs.

Contraindications:

Hypersensitivity to acetylsalicylic acid, other salicylates or any component of drug; OH, caused by use of salicylates or NPVP in the anamnesis; acute round ulcer; hemorrhagic diathesis; heavy renal or liver failure; heavy heart failure.
Combination with a methotrexate in a dose of ≥15 mg/week (see INTERACTIONS).
III trimester of pregnancy.

Overdose:

Salicylates it is possible because of the chronic intoxication which arose owing to long therapy (use> of 100 mg/kg/days more than 2 days can cause toxic effects), and also acute intoxication which poses threat for life (overdose) and which reasons can be, for example, an accidental use by children or inadvertent overdose.
Symptoms. Dizziness, a ring in ears, deafness, the strengthened sweating, nausea and vomiting, a headache, confusion of consciousness. The specified symptoms can be controlled a dose decline. The ring in ears can be noted at concentration of salicylates in a blood plasma> 150–300 mkg/ml. Serious side reactions reveal at concentration of salicylates in a blood plasma> 300 mkg/ml. The expressed change of acid-base balance which can differ depending on age and weight of intoxication testifies to acute intoxication. Its frequent manifestation at children is the metabolic acidosis. Weight of a state cannot be estimated only on the basis of concentration of salicylates in a blood plasma. Absorption of acetylsalicylic acid can be slowed down in connection with a delay of gastric release, formation of concrements in a stomach or in case of administration of drug in the form of the tablets covered with an enterosoluble cover.
Treatment. Treatment of the acute intoxication caused by overdose of acetylsalicylic acid is defined by severity, clinical symptoms and is provided with standard methods which apply at poisoning. All taken measures have to be directed to acceleration of removal of drug from an organism and recovery of electrolytic and acid-base balance.

Manifestations and symptoms	Results of analyses	Therapeutic actions
Intoxication of easy or average degree		Gastric lavage, repeated administration of absorbent carbon, the forced alkaline diuresis
Tachypnea, hyperventilation, respiratory alkalosis	Alkalemiya, alkaluria	Recovery of electrolytic and acid-base balance
Hyperhidrosis (the strengthened sweating)
Nausea, vomiting
Intoxication of average or heavy degree		Gastric lavage, repeated administration of absorbent carbon, the forced alkaline diuresis, hemodialysis at serious conditions
Respiratory alkalosis with a compensatory metabolic acidosis	Acidemia, aciduria	Recovery of electrolytic and acid-base balance
Hyper pyrexia		Recovery of electrolytic and acid-base balance
Respiratory: hyperventilation, not cardiogenic fluid lungs, respiratory insufficiency, asphyxia
Cardiovascular: dizaritmiya, arterial hypotension, cardiovascular insufficiency	For example changes of the ABP, ECG
Loss of liquid and electrolytes: dehydration, oliguria, renal failure	For example hypopotassemia, hyponatremia, changes of function of kidneys	Recovery of electrolytic and acid-base balance
Glucose metabolism disturbance, ketoacidosis	Hyperglycemia, hypoglycemia (especially at children), the increased level of ketonic bodies
Ring in ears, deafness
Gastrointestinal: bleeding in a GIT
Hematologic: inhibition of thrombocytes, coagulopathy	For example prothrombinopenia
Neurologic: toxic encephalopathy and oppression of TsNS with such manifestations as a lethargy, confusion of consciousness, a lump and a spasm

Storage conditions:

In original packaging at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tab. of 100 mg, No. 20, No. 50, No. 100.