Abbreviated Prescribing Information
Nicoumalone Tablets IP
Acitrom Tablets [0.5/1/2/3/4 mg]
Each uncoated tablet contains:
Nicoumalone I.P [0.5/1/2/3/4 mg]
For the prevention and treatment of thromboembolic diseases such as venous thrombosis, atrial fibrillation with embolization, pulmonary embolism and as an adjunct in the treatment of coronary occlusion.
DOSAGE AND ADMINISTRATION
Adult: 4-12 mg on the 1st day and 4-8 mg on the 2nd day.
Maintenance: 1-8 mg daily given in a single dose at the same time every day.
• Known hypersensitivity to Acenocoumarol and related coumarin derivatives or to excipients
• Severe hypertension
• In patients unable to cooperate and who are unsupervised (e.g. Unsupervised senile patients, alcoholics and patients with psychiatric disorders)
• Active haemorrhage or risk of serious haemorrhage
It is also contraindicated in conditions where the risk of haemorrhage is greater than the possible clinical benefit, e.g.:
• Haemorrhagic blood dyscrasia or Haemorrhagic diathesis.
• Shortly before or after surgical intervention on the central nervous system, as well as eye operations and traumatizing surgery involving extensive exposure of tissues.
• Peptic ulcers or haemorrhage in the urogenital tract, gastrointestinal tract, or respiratory system, as well as acute pericarditis, cerebrovascular haemorrhages and pericardial effusion, and infective endocarditis.
• Severe hypertension, severe renal or hepatic disease.
• Increased fibrinolytic activity as encountered after operations on the prostate, lung, uterus, etc.
WARNINGS AND PRECAUTIONS
• Strict medical supervision is recommended in conditions or diseases that may reduce the protein binding of Nicoumalone/Acenocoumarol.
• In patients with hepatic dysfunction particular care should be taken, as synthesis of coagulation factors may also be impaired or there may be an underlying platelet dysfunction.
• The anticoagulant effect of Nicoumalone/Acenocoumarol may be altered by disorders affecting gastrointestinal absorption.
• A careful dosage schedule must be adopted in cases of severe heart failure, since activation or gamma -carboxylation of the coagulation factors may be reduced in the presence of hepatic congestion. However, it may be necessary to raise the dosage, with the reversal of hepatic congestion.
• In patients with known or suspected (e.g. abnormal bleeding after injury) protein C or protein S deficiency, caution should be exercised.
• Anticoagulant medication should be monitored with special care, in elderly patients.
• Intramuscular injections may cause haematomas and should be avoided during treatment with anticoagulants. Subcutaneous and intravenous injections, on the other hand, lead to no such complications.
• Care should be taken where it is necessary to shorten the PT/INR for diagnostic or therapeutic interventions (e.g. angiography, minor surgery, lumbar puncture, tooth extractions, etc.).
• Nicoumalone/Acenocoumarol tablets contain lactose and therefore are not recommended in patients with rare hereditary problems of galactose intolerance, of lactase deficiency or of glucose-galactose malabsorption.
PREGNANCY AND LACTATION
Haemorrhage, Vasculitis, allergic reactions, urticaria, rash
Issued On: 30th July 2018
Source: Prepared based on full prescribing information, Version 2.0, dated 30th July 2018
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For full prescribing information, please contact:
Abbott Healthcare Pvt. Ltd., Medical Services Division, Floor 18, Godrej BKC, Plot No.: C-68, Near MCA Club, BKC, Bandra (E), Mumbai-400051