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LOWSPIRIN


 

Composition:
Active substance: Acetylsalicylic acid; 
1 coated tablet contains Acetylsalicylic acid 75 mg.
Additional ingredients: Microcrystalline cellulose, Pre-gelled Starch, Colloidal silicon dioxide anhydrous, Stearic acid, Opadry Y-1-7000 White coating, Acryl-Eze 93018359 White coating.

Medicine form: Enteric coated tablets.

Pharmacotherapeutic group: Anti-thrombotic agents. АТС code B01A C06.

Clinical characteristics:
Indications:
Primary prophylaxis of myocardial infarction in patients with stenocardia; secondary prophylaxis of myocardial infarction; thrombosis and embolism prophylaxis, including increased risk of their appearance (after surgical interventions on vessels and coronary artery bypass grafting); prophylaxis of disturbance of cerebral blood flow by ischemic type.

Contraindications:

Hypersensitivity to Acetyisallicylic acid and other salicylates. Ulcerations of gastrointestinal tract in acute phase; hemorrhagic diathesis, thrombocytopenia, hemophilia; liver insufficiency and oxaluria; bronchial asthma; concurrent anticoagulants treatment; glucose-6-phoshpate dehydrase deficit. Pregnancy, lactation. Children age less than 18 years old.

Administration and Dosage:
LowspirinÔ preparation is used per oral after meal with enough water. 
For primary prophylaxis of myocardial infarction patients with stenocardia; secondary prophylaxis of myocardial infarction it is necessary to use 75–150 mg of the preparation per day.
For thrombosis and embolism prophylaxis, including increased risk of their appearance (after surgical interventions on vessels and coronary artery bypass grafting); prophylaxis of disturbance of cerebral blood flow by ischemic type the preparation is administered in dose 75–300 mg per day.
The tablet should be swallowed as whole and without chewing, with a small portion of water. It is not recommended to break tablets.

Adverse reactions:
In general LowspirinÔ is well tolerated due to low content of Acetylsalicylic acid
Side effects are observed in isolated cases: 
Allergic reactions: bronchospasm, skin rash; in patients of risk group – asthmatic attack provocation.
Gastrointestinal tract: nausea, vomiting, diarrhea; during long-term usage it is possible erosion, stomach and duodenal ulcers and gastrointestinal hemorrhages. 
Hematological system: thrombocytopenia, asiderotic anemia (associated with gastrointestinal hemorrhages).
Genital system: lengthening of the menstrual duration.

Overdosage:
Overdosage is more possible in elderly patients. 
Symptoms: nausea, vomiting, tinnitus, hearing acuity decrease, dizziness, mental confusion, fever, hyperventilation, ketoacidosis, respiratory alkalosis, coma, cardiovascular and breathing insufficiency, severe hypoglycemia, haemorrhages.
Treatment: hospitalization, activated carbon, gastric lavage, determination of acid-base balance, infusion therapy, forced diuresis indicated in salicylates concentration in blood plasma more than 500 mg/l (intravenous infusion of hydrocarbonate sodium 88 mequ in 1 l of 5% glucose solution with a rate of 10–15 ml/kg/h), hemodialisis. The treatment is symptomatic.

Pregnancy and Lactation:
The preparation is contraindicated during Ist and IInd trimester of pregnancy; if it is necessary the preparation should be used when the expected benefit for mother exceeds the risk for fetus. 
If the preparation treatment is necessary lactation should be stopped.

Children:
The preparation is contraindicated because of possible risk of Rhey syndrome appearance.

Special Precautions:
Simultaneous usage of Acetylsalicylic acid and alcohol increases the risk of gastrointestinal tract mucous coat lesion and prolongation of haemorrhage time.

Pecularities in Usage.
The drug is carefully administered in podagra and hyperiricosuria because Acetylsalicylic acid reduces uric acid excretion that can provoke acute podagra attack in patients with disorders of urinary acid metabolism. 
The drug is also carefully administered in gastrointestinal pathology, kidney and liver function disorders, bronchial asthma, chronic airways diseases, pollinosis, Schneiderian membrane polyposis, drugs allergic reactions, deficit of vitamin K and glucose-6-phosphatdehydrogenase. 
The preparation can cause haemorrhages of different severe degrees during and after surgical interventions. Therefore it is necessary to stop the preparation use 5–7 days before the elective surgery or teeth extraction. 
The preparation usage in high doses cause hypoglycemic effect and this must be taken into consideration in its administration in pancreatic diabetes patients. 
In case of long-term administration of the preparation in high doses a regular haemotological control (hemoglobin level and blood coagulation system indexes) is necessary.

Influence on ability to drive a car and to operate any other machines.
There are no data indicating negative influence of Acetylsalicylic acid on reactions velocity while driving a car and operating other machines.

Drug interactions and other types of interactions.
In concurrent usage with antacids Acetylsalicylic acid absorption from gastrointestinal tract is decreased. 
In combination with glucocorticosteroids salicylates excretion and risk of gastrointestinal haemorrhages increases; it should not be used with any of the nonsteroidal anti-inflammatory drugs. 
Actions of heparin and indirect anticoagulants are enhanced in concurrent usage with Acetylsalicylic acid because of platelets dysfunction and indirect anticoagulants extrusion from binding with blood proteins. The preparation also enhances actions of thrombolytic and anti-thrombotic agents (including Ticlopidine).
Acetylsalicylic acid reduces action of hypotensive drugs, increases digoxyn concentration in blood plasma and enhances its effect by delaying its excretion. 
Acetylsalicylic acid enhances action of hypoglycemic agents (insulin and sulfonylurea derivatives) due to Acetylsalicylic acid's hypoglycomizing effect and sulfonylurea derivatives extrusion from binding with blood proteins. 
In concurrent usage with uricozuric agents (benzbromarone), furocemide, spironolactone Acetylsalicylic acid reduces their actions. 
The preparation should not be concurrently used with Methotrexate because Acetylsalicylic acid enhances its action due to kidney clearance decrease and its extrusion from binding with blood proteins.

Pharmacological properties:
Pharmacodynamics: Acetylsalicylic acid has analgetic, antipyretic, anti-inflammatory and antiaggregatory action.
It inhibits cyclooxygenase and depresses arachidonic acid metabolism via cyclooxygenase path, blocks thromboxane synthesis. Decrease of thromboxane А2 number in thrombocytes causes irreversible inhibition of aggregation, provides minor vasodilatory action. Acetylsalicylic acid increases fibrinolytic activity of plasma and increases vitamin K-dependent factors of coagulability (II, VII, IX, X).
It decreases lethality and risk of myocardial infarction development in unstable angina. It is effective in primary prophylaxis of cardiovascular disease, especially in myocardial infarction in men above 40 years old, and in secondary prophylaxis of myocardial infarction. In daily dose of 900 mg and more it decreases ischemic stroke rate and death rate, recurrence rate of cerebral circulation disorders in patients who have had a stroke.
It decreases blood coagulation due to decreases in thrombocyte aggregation  as a result of thromboxane А2 synthesis inhibition in them. 
Usage of enteric coated tablets decreases incidents of gastric side effects.
Pharmacokinetics: After per oral intake it is almost completely absorbed in gastrointestinal tract. 
During absorption it can be pre-systemically eliminated in intestine wall and in liver (it is deacetylated). 
Resorbed part is very quickly hydrolyzed by special exterase, thus the half-excretion time is not more than 15–20 min. Anion of Acetylsalicylic acid is circulated and distributed in organism (it binds with albumin up to 75–90%). Maximal concentration in blood plasma is reached in 2 hours. Serum level of salicylates is variable. It practically does not bind with plasma proteins. Salicylate biotransformation is mainly in liver with formation of four principal metabolites, which are determined in many tissues and urine. Salicylates excreted mainly by active secretion in renal tubule in unchanged form (60%) and in form of metabolites. Excretion of unchanged salicylate depends on urine pH (during urine alkalizing salicylate ionization is increased, its reabsorption is impaired and excretion is increased). Excretion rate depends on dose – in high doses the half-excretion time is 2–3 hours, and in case of dose increase it can be increased up to 15–30 hours.

Pharmaceutical characteristiscs
General physic-chemical properties: white, circular, biconvex enteric coated tablets.

Shelf-life:
3 years.

Storage conditions:
Store in dry, protected from sun light place at the temperature not more than 25°С.
Keep it out of reach of children.

Packing:
10 tablets are in a strip, there are 3 strips in a carton box.

Conditions of supply:
By prescription.

Manufacturer:
Kusum Healthcare Pvt. Ltd.

Address:
SP 289 (A), RIICO INDL. AREA, CHOPANKI, BHIWADI (Raj.), India.