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Cardiovascular Agents

Aspirin STADA® 81 mg

 

Pack size: 

Box of 2 blisters x 28 enteric-coated tablets.

 

Composition: 

Each enteric-coated tablet contains aspirin 81 mg.

 

Shelf-life:  

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from moisture. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Aspirin STADA 81® mg  is used in secondary prophylaxis following myocardial infarction and in patients with unstable angina or ischaemic stroke including cerebral transient attacks.
  • Administered orally. It should be swallowed whole with a full glass of water unless patient is fluid restrict, should not be crushed or chewed.
     
  • Adults and children over 16 years:
    The usual dosage for long-term :1-2 tablets once daily.
    In some circumstances a higher dose may be appropriate, especially in short-term, and up to 4 tablets a day may be used on the advice of a doctor.
  • Elderly:
    The risk/benefit ratios in the elderly have not been fully established.
  • Children:
    Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).


Or as prescribed by physicians.

 

  • Patients with known allergy to nonsteroidal anti-inflamatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma).
  • Children or teenagers for viral infections, with or without fever, because of the risk of Reye’s syndrome with concomitant use of aspirin in certain viral illnesses.
  • Patients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding.
  • Patients with severe renal failure (glomerular filtration rate less than 10 ml/minute), patient with severe hepatic insufficiency, patients with moderate and severe heart failure.

     

Common

  • Nausea, vomiting, dyspepsia, epigastric discomfort, hearburn, stomach pains, gastrointestinal ulceration.
  • Fatigue.
  • Rash, urticaria.
  •  Hemolytic anemia.
  • Weakness.
  • Dyspnea.
  • Anaphylactic shock.

Uncommon

  • Insomnia, nervousness, bile.
  • Iron deficiency.
  • Occult bleeding, prolongation of bleeding time, leukopenia, thrombocytopenia, anemia.
  • Hepatotoxicity.
  • Impaired renal function.
  • Bronchospasm.

Instructions about how to manage adverse reactions

  • The adverse effects on the CNS are completely reversible within 2 or 3 days after withdrawal of the drug. If dizziness, tinnitus, impaired hearing or hepatic injury occurs, the drug should be discontinued.
  • The elderly should be treated with the lowest effective dose for the shortest period possible.
  • The treatment of anaphylactic shock caused by acetylsalicylic acid does not differ from that ordinarily employed in acute anaphylactic reactions.
  • Adrenaline is the drug of choice, and usually controls angiodema and urticaria without difficulty.

     

  • Even low doses of aspirin can inhibit platelet function leading to an increase in bleeding time. This can adversely affect patients with inherited (hemophilia) or acquired (liver disease or vitamin K deficiency) bleeding disorders.
  • Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria, and prolonged bleeding time.
  • Patients with hypertension should be carefully monitored.
     
  • Pregnant women should only take aspirin if clearly needed. Although low-dose aspirin might be used in some pregnant patients, analgesic doses of aspirin should not be at term as they may be associated with delayed onset and prolongedation of labour and with maternal and neonatal bleeding.
  • Nursing mothers should avoid using aspirin because salicylate is excreted in breast milk.
     
  • Effects on ability to drive and use machines: Unfound data.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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