You are using an outdated browser. For a faster, safer browsing experience, upgrade for free today.
  • API
For the Use of a Registered Medical Practitioner or a Hospital or a Laboratory Only

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.


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

• Pregnancy

• 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.


• 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.



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

™/ * Trademark of the Abbott Group of Companies.

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