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Prescribing Information

Acitrom® Tablets [0.5/1/2/3/4 mg]

Composition: Nicoumalone I.P [0.5/1/2/3/4 mg]

Therapeutic Indications: Nicoumalone is indicated for the prevention and treatment of thrombosis and its extension, the treatment of atrial fibrillation with embolization, the prophylaxis and treatment of pulmonary embolism, and as an adjunct in the treatment of coronary occlusion.

Dosage and administration: Therapy with Nicoumalone, should always be controlled by periodic prothrombin time determinations conducted by a skilled technician. In general, the prothrombin time should be maintained at 2 1/2 to 3 times the control value. In the majority of patients, an initial loading dose to 16-26 mg is usually considered desirable. Induction is completed on the second day by administration of 8-16 mg. Thereafter, the patient is usually well maintained on a daily dosage of 2-10 mg. The dose needs to be individualized. There is a wide variation in maintenance dosage requirements from patient to patient. However, once established for an individual patient, the maintenance dosage tends to remain constant. Hence, in long-term therapy, adequate control may frequently be maintained by weekly prothrombin determinations.

Combined treatment with Heparin: Because of the relatively short induction period with Nicoumalone, supplement administration of heparin is seldom required. However, heparin may be given at the start of treatment, if considered necessary.

Required Frequency of Prothrombin Time Determination: In general, it takes 7-10 days to stabilize the patient on regular maintenance dosage of Nicoumalone. Throughout this period, daily prothrombin time determinations are recommended. Once the patient is satisfactorily stabilized, determinations may be required only at weekly intervals.

Contraindications: Nicoumalone, is contraindicated in patients who have active bleeding or subacute endocarditis. Relative contraindications are uncooperative patient and lack of adequate facilities to carry out prothrombin time studies.

Prolong prothrombin time: Phenylbutazone, Metronidazole, Sulfinpyrazone, Trimethoprim, Sulphamethoxazole, Cimetidine, Omeprazole, Amiodarone, Cephalosporin, Clofibrate, Heparin, Thyroxine, Anabolic steroids. Reduce Prothrombin time: Cholestyramine, Barbiturates, Rifampin, Griseofulvin, Carbamazepine, Penicillins large doses, Aspirin, NSAIDs and Moxalactam. Care in patient selection is desirable to ensure cooperation, particularly from alcoholic, emotionally unstable or psychotic or senile patients. Bleeding during oral anticoagulant therapy may not always correlate with the prothrombin time.

Pregnancy & Nursing Mothers: In pregnancy, both mother and fetus are subject to the risks of anticoagulant therapy; fetal hemorrhage and intrauterine death have occurred. Pregnant women who are candidates for anticoagulant therapy should be carefully evaluated and the indications critically reviewed. The risk of withholding the drug should be weighed against the possible dangers entailed in administering it. Since the drug appears in the mother's milk, the nursing infant should be observed for evidence of unexpected bleeding.

Warnings and precautions: Keep out of reach of Children. Nicoumalone, is a potent drug and caution should be used when it is administered in any condition where added risk of hemorrhage is present. At the earliest sign of bleeding, the drug should be withdrawn. It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter. Dosage can be controlled only by periodic determination of prothrombin time. Determinations of clotting and bleeding times are not effective measures for control of therapy. It is important to bear in mind that sodium heparin prolongs the one-stage prothrombin time. Accordingly when sodium heparin is given with Nicoumalone, a period from 4 to 5 hours after the last intravenous dose, and 12 to 24 hours after the last subcutaneous dose of sodium heparin, should elapse before blood is drawn, if a valid prothrombin time is to be obtained. Several factors may alter the activity of Nicoumalone, such as: a change in the intake of vitamin K, fat, or leafy green vegetables; vitamin K deficiency of the newborn; fever; alcoholism; vitamin C deficiency; x-ray therapy; and diarrhea causing increased loss in the stool and/or decreased absorption from the Gut. Many drugs can increase or decrease the effect of Nicoumalone, on the prothrombin time. No other drug should be administered with Nicoumalone, without a full appreciation of its potentialities of interacting with an oral anticoagulant. If a drug is added to or withdrawn from a patient's therapeutic regimen, it is essential that his prothrombin time be carefully monitored. Fatalities have been reported from interactions affecting the metabolism of coumarin anticoagulants or their binding to plasma proteins.

Adverse reactions: Note: Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, such as leukopenia, agranulocytosis, mouth ulcers, nephropathy, and red-orange urine, the pharmacological similarities among the oral anticoagulant drugs require that each of the reactions be considered when Nicoumalone is administered. The occurrence of significant gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Mucosal and intramural hemorrhage resulting in paralytic ileus and intestinal obstruction have been reported. Non-hemorrhagic adverse reactions have also been reported, including hypersensitivity primarily related to individual reactivity, dermatitis urticaria, alopecia, fever, nausea, vomiting, cramps and diarrhoea, leukopenia, agranulocytosis, mouth ulcers, nephropathy, and red-orange urine. Local skin necrosis has occurred on very rare occasions, at times even when the prothrombin time was within apparently safe limits.

Storage: Store in a cool, dry place, protect from light.

Pack: Acitrom® 1/2/3/4 mg supplied in strip of 30 tablets and 0.5 mg supplied in strips of 10 tablets.

Please refer to full prescribing information before usage. Additional information available on request with Medical Services Division, Abbott Health Care Limited, D Mart Bldg; Goregaon Mulund Link Road; Mulund West Mumbai-400080.