Indications & Uses
Heparon is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Administer Heparin Sodium Injection by Intermittent IV Injection, IV Infusion, Or Deep Subcutaneous Injection. Heparin Sodium Injection is not intended for Intramuscular (IM) use.Heparin sodium is not effective by oral administration and should not be given orally.Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Use of a final filter is recommended during administration of all parenteral solutions, where possible.Therapeutic Anticoagulant Effect with Full-Dose Heparin- Deep Subcutaneous (Intrafat) Injection Initial Dose 333 units/kg subcutaneously Use a different site for each injection Every 12 hours 250 units/kg subcutaneously Intermittent Intravenous Injection Initial Dose 10,000 units Intermittent Intravenous Injection Every 4 to 6 hours 5,000 to 10,000 units Continuous Intravenous Infusion Initial Dose 5,000 units by intravenous injection Continuous Intravenous Infusion Continuous 20,000 to 40,000 units/24 hours *Based on 150 lb. (68 kg) patient Surgery of the Heart and Blood Vessel- Intravascular via Total Body Perfusion Initial Dose ≥ 150 units/kg; adjust for longer procedures Use in Extracorporeal TherapyThe concentration of 2 units/mL will suffice to prevent clotting on initiation of extracorporeal therapy by priming the devices with this solution. NOTE: A proper and effective heparinisation schedule must be initiated in the patient before and maintained throughout the procedures to prevent subsequent clotting and blood path obstruction. The particular manufacturer's directions for use of the dialyser or other extracorporeal apparatus must be referred to. The direction sheets for the use of therapeutic dosage forms of heparin must equally be referred to and adjusted to a given patient’s condition and response to achieve sustained, effective anticoagulation within clinically safe parameters. Both intermittent and continuous infusion of 5000, 10000 or 20000 units are employed for this purpose and are unrelated to the low dose heparin in this preparation that is directed at preparing the apparatus for initial use.Maintenance of Catheter PatencyAlthough the rate for infusion of the 2 units/mL formulation is dependent upon age, weight, clinical condition of the patient and theprocedure being employed, an infusion rate of 3 mL/hour has been found to be satisfactory.Periodic platelet counts; hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.Because dosages of this drug are titrated to response, no additives should be made to heparin sodium injection.
Side Effects
Haemorrhage: Haemorrhage is the chief complication that may result from heparin therapy. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug. Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site, but certain specific haemorrhage complications may be difficult to detect. Adrenal haemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Such treatment should therefore be discontinued in patients who develop signs and symptoms of acute adrenal haemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient's death. Ovarian (corpus luteum) haemorrhage has developed in a number of women of reproductive age receiving short or long-term anticoagulant therapy. This complication, if unrecognised, may be fatal. Retroperitoneal haemorrhage has also been reported. Local Irritation: Local irritation, erythema, mild pain, haematoma or ulceration may follow deep subcutaneous (intrafat) injection of Multiparin. These complications are much more common after intramuscular use, and such use is not recommended. Hypersensitivity: General hypersensitivity reactions have been reported, with chills, fever and urticaria as the most usual manifestations. Asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occur more rarely. Itching and burning, especially on the plantar surface of the feet, may occur. Thrombocytopenia has been reported in patients receiving heparin, with a reported incidence of 0 to 30%. While often mild and of no obvious clinical significance, such thrombocytopenia can be accompanied by severe thromboembolic complications such as skin necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke and possible death. Certain episodes of painful, ischaemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions. Whether these are in fact identical to the thrombocytopenia-associated complications remains to be determined. Miscellaneous: Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipidaemia on discontinuation of Multiparin have also been reported. Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALTI]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.
Cautions & Contraindications
Warnings & Precautions
General. White Clot Syndrome: Patients on heparin have been reported to develop new thrombus formation together with thrombocytopenia caused by irreversible aggregation of platelets induced by heparin, the so-called "white clot syndrome". This process may lead to severe thromboembolic complications such as skin necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke and possible death. Heparin administration should therefore be promptly discontinued if a patient develops new thrombosis in association with thrombocytopenia. Spinal/Epidural Haematomas: When neuraxial anaesthesia (epidural/spinal anaesthesia) or spinal puncture is employed, patients who are anticoagulated or scheduled to be anticoagulated with unfractionated heparin or low molecular weight heparins/heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma, which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting haemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. The physician should weigh the potential benefit against the risk before neuraxial intervention in patients who are anticoagulated or are to be anticoagulated for thromboprophylaxis. Multiparin Resistance Haemorrhage: Haemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in haematocrit, a fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a haemorrhagic event. Multiparin should be used with extreme caution in disease states in which there is an increased danger of haemorrhage. Some of the conditions in which an increased danger of haemorrhage exists are: Cardiovascular: subacute bacterial endocarditis and severe hypertension. Surgical: during and immediately following (a) spinal tap or spinal anaesthesia or (b) major surgery, especially involving the brain, spinal cord or eye. Haematologic: conditions associated with increased bleeding tendencies, such as haemophilia, thrombocytopenia, and some vascular purpuras. Gastrointestinal: ulcerative lesions and continuous tube drainage of the stomach or small intestine. Other: menstruation and liver disease with impaired haemostasis. Coagulation Testing: When Multiparin is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests. If the coagulation test is unduly prolonged or if haemorrhage occurs, Multiparin should be discontinued promptly. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving heparin, with a reported incidence of 0 to 30%. Mild thrombocytopenia (count greater than 100,000/mm3) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, the heparin product should be discontinued. If continued heparin therapy is essential, administration of heparin from a different organ source can be reinstituted with caution. Solutions containing sodium ions should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which oedema with sodium retention exists. The intravenous administration of solutions can cause fluid and/or solute overloading, resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema. The risk of dilutional states is inversely proportional to the electrolyte concentrations and volume of the infusion. The risk of solute overload causing congested states with peripheral and pulmonary oedema is directly proportional to the electrolyte concentrations and volume of the infusion. Excessive administration of potassium-free solutions may result in significant hypokalaemia. In patients with diminished renal function, administration may result in sodium retention. Multiparin-induced Thrombocytopenia (HIT) and Multiparin-induced Thromocytopenia and Thrombosis (HITT): Multiparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as Multiparin-induced Thrombocytopenia and Thrombosis (HITT). Thrombotic events may also be the initial presentation of HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischaemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and an alternative anticoagulant considered if the patient requires continued anticoagulation. Delayed Onset of HIT and HITT: Multiparin-induced Thrombocytopenia and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT. Laboratory Tests: Periodic platelet counts, haematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration (see Dosage and Administration). Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of heparin. Likewise, no reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.
Contraindications
Heparin sodium should not be used in the following patients: those with severe thrombocytopenia; those in whom suitable blood coagulation tests, such as the whole-blood clotting time and partial thromboplastin time, cannot be performed at appropriate intervals (this contraindication applies to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin); and those with an uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation.