Indications

– Secondary prevention of myocardial infarction and stroke in patients with a history of transient ischemic attacks.
– Relief of mild to moderate pains.

Present

Bottle of 100 enteric– coated tablets. Box of 1 bottle.

Composition

Aspirin starch equivalent to acetylsalicylic acid…………………………..81mg
Excipients s.q. for.….………..…….……………..……………………1 tablet
(Sodium starch glycolate, stearic acid, colloidal silicon dioxide, lactose, methacrylic acid copolymer, talc, polyethylene glycol 4000, titanium dioxide, diethyl phthalate, sunset yellow, tartrazine, isopropyl alcohol, acetone).

Actions

Acetylsalicylic acid (aspirin) has analgesic, antipyretic and anti– inflammatory properties and it also inhibits platelet aggregation.

Contra-Indications

– Hypersensitivity to any ingredient of the medicine.
– Patients with history of sensitivity reactions to aspirin or other NSAIDs, in whom attacks of asthma, rhinitis or urticaria have been precipitated by such drugs.
– Patients with history of asthma.
– Patients with hemophilia, thrombocytopenia, active gastric or duodenal ulcer, moderate and severe heart failure, liver failure, kidney failure.

Side effect

– Common: nausea, vomiting, dyspepsia, epigastric discomfort, heartburn, stomach pain, gastro– intestinal ulcers, fatigue, rash, urticaria, hemolytic anemia, muscle weakness, dyspnea, anaphylaxis.
– Uncommon: insomnia, restlessness, irritability, lack of iron, occult blood loss, prolonged bleeding time, leukopenia, thrombocytopenia, anemia, hepatotoxicity, renal dysfunction, bronchospasm.
– Inform your doctor about side– effects when using this medicine.

Interaction

– Reduce concentration of indomethacin, naproxen and fenoprofen.
– Increase risk of bleeding by warfarin.
– Increase serum concentrations of methotrexate, sulphonylurea antidiabetics, phenytoin, valproic acid and their toxicity.
– Decrease effects of uricosurics such as probenecid and sulphinpyrazone.
OVERDOSAGE & MANAGEMENT: The management includes:
– Gastric emptying by induced emesis, care should be exercised to avoid aspiration of vomiting, or gastric lavage, activated charcoal administration. Intensive symptomatic and supportive treatment should be instituted. Fever reduction, correction of fluid, electrolyte and
acid– base disturbances, treatment of ketosis development, maintenance of adequate plasma glucose level should be carried out as required.
– Monitoring serum salicylate concentration until nontoxic serum salicylate level is attained. Because absorption and distribution of salicylate may continue, if massive doses were ingested, the monitoring should be continued accordingly.
– Forced alkaline diuresis to increase salicylate elimination. Sodium bicarbonate should not be given orally because it might increase absorption of salicylate. If acetazolamide is used, it should be used only in adults with respiratory alkalosis and only under the supervision of clinicians experienced in the use of the drug in salicylate overdosage since it may precipitate metabolic acidosis and lead to severe complications.
– Exchange transfusion, hemodialysis, peritoneal dialysis may be employed in severe overdosage.
– Signs of pulmonary edema and convulsion should be monitored and adequate treatment should be employed as necessary.
– Blood transfusion or administration of vitamin K may be necessary if hemorrhagic complications occur.
– Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

24 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

– Tablet should not be chewed or crushed, and should be swallowed whole with water.
– As prescribed by the physicians.
– Recommended dosage:
+ Secondary prevention of myocardial infarction and stroke: 1 – 2 tablets daily.
+ Relief of pains: Adults and children over 12 years: 4 – 6 tablets, 4 – 6 times daily. Do not exceed 3g daily.
Children: 50mg/kg body weight daily, divided into 4 – 6 doses, but it is restricted because of the risk of Reye’s syndrome.