Wockhardt UK Ltd

Section 4.3: text added –

Because of the special hazard of post-operative haemorrhage heparin is contra-indicated during surgery of the brain, spinal cord and eye, in procedures at sites where there is a risk of bleeding, in patients that have had recent surgery, and in patients undergoing lumbar puncture or regional anaesthetic block.

Section 4.4: text amended:

The risk of bleeding is increased with severe renal impairment and in the elderly (particularly elderly women) over 60 years of age.

Section 4.5 – text amended

Interaction with other medicinal products and other forms of interactions

            Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and other NSAIDs, dextran solutions, dipyridamole, or any other drug which may interfere with coagulation, should be used with care.  Increased risk of haemorrhage with ketorolac (avoid concomitant use even with low-dose heparin).

            Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase, dipyridamole, dextran solutions, or. Aany other drug which may interfere with coagulation.

Cephalosporins:  Some cephalosporins, e.g. cefaclor, cefixime and ceftriaxone, can affect the coagulation process and may therefore increase the risk of haemorrhage when used concurrently with heparin.

ACE inhibitors:  Hyperkalaemia may occur

 with concomitant use ACE inhibitors. 

 Nitrates:  Reduced activity of heparin has been reported with simultaneous intravenous glyceryl trinitrate infusion.

Probenecid: May increase the anticoagulant effects of heparin.

 Tobacco smoke:  Nicotine may partially  counteract the anticoagulant effect of heparin.  Increased heparin dosage may be required in  smokers.

            Interference with diagnostic tests may be  associated with pseudo-hypocalcaemia (in

            haemodialysis patients), artefactual increases in total thyroxine and triiodothyronine,

             simulated metabolic acidosis and inhibition of the chromogenic lysate assay for

            endotoxin.  Heparin may interfere with the determination of aminoglycosides by   immunoassays.     

Section 4.8 – text added:

Adrenal insufficiency secondary to adrenal haemorrhage has been associated with heparin (rarely).

Section 6.2 – text added:

The following drugs are incompatible with heparin;

                        Alteplase, amikacin sulphate,   amiodarone hydrochloride, ampicillin sodium, aprotinin, benzylpenicillin  potassium or sodium, cefalotin sodium,   chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium  besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin sodium, methotrimeprazine, netilmicin sulphate, nicardipine hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride, polymyxin B sulphate,

                         promethazine hydrochloride, streptomycin sulphate, tobramycin sulphate, triflupromazine hydrochloride, vancomycin hydrochloride and vinblastine

                         sulphate.