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HEPARIN MUCOUS is a brand name for Heparin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of thrombo-embolic disorders such as deep vein thrombosis, acute arterial embolism or thrombosis, thrombophlebitis, pulmonary embolism and fat embolism. For prophylaxis against deep vein thrombosis and thrombo-embolic events in susceptible patients. For the prevention of clotting in the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For the treatment or prevention of thrombo-embolic disorders:
Treatment Dosage: Intravenous administration 5,000-10,000 IU every 4 hours or 500 IU/kg bodyweight daily as a continuous infusion in sodium chloride injection or dextrose injection. Doses should be individually adjusted according to coagulation tests.
Subcutaneous administration The initial dose is 250 IU/kg bodyweight. Further doses should be given every 12 hours and individually adjusted according to coagulation tests. 5 to 2 times that of control on blood withdrawn 4 - 6 hours after the first injection or commencement of infusion and at similar intervals until the patient is stabilised.
Prophylactic Dosage:
Administration is by subcutaneous injection. Patients undergoing major elective surgery: 5,000 IU should be given 2 hours pre-operatively and then every 8 - 12 hours post-operatively for 10 - 14 days or until the patient is ambulant, whichever is the longer.
Following myocardial infarction: 5,000 IU should be given twice daily for 10 days or until the patient is mobile. Other patients: 5,000 IU should be given every 8-12 hours. These standard prophylactic regimens do not require routine control.
Dosage in Children Treatment Dosage:
Standard treatment dosages should be given initially. Subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.
Dosage in the Elderly Treatment Dosage:
Lower treatment dosages may be required. However, standard treatment dosages should be given initially and then subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.
Prophylactic Dosage:
Dosage alterations are unnecessary for prophylaxis in the elderly. Pregnancy This heparin formulation contains the preservative benzyl alcohol. As benzyl alcohol may cross the placenta the use of this formulation should be avoided in pregnancy.
The estimation of the frequency of undesirable effects is based on a pooled analysis: pooling data together from clinical studies and also a review of data from spontaneous reporting. The most frequently reported adverse reactions are haemorrhage and erythema.
4). Complications may occur particularly when high doses are administered. Although major haemorrhages are uncommon, death or permanent disability have been reported in some cases. Immune-mediated heparin-induced thrombocytopenia (type II) is an uncommon but well-known adverse reaction in connection with heparin therapy.
Immune-mediated heparin-induced thrombocytopenia (type II) largely manifests within 5 to 14 days of receiving the first dose. Furthermore, a rapid-onset form has been described in patients previously exposed to heparin. Immune-mediated heparin-induced thrombocytopenia (type II) may be associated with arterial and venous thrombosis.
4). In rare cases, heparin may cause hyperkalaemia due to hypoaldosteronism. 4). Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Blood and lymphatic system disorders Uncommon: (≥1/1,000 and <1/100) Thrombocytopenia, including non-immune heparin associated thrombocytopenia (type I) Immune system disorders Uncommon: (≥1/1,000 and <1/100) Anaphylactic reaction Heparin-induced thrombocytopenia (type II) Hypersensitivity Metabolism and nutrition disorders Uncommon: (≥1/1,000 and <1/100) Hyperkalaemia Vascular disorders Common: (≥1/100 and <1/10) Haemorrhage Haematoma Skin and subcutaneous tissue disorders Common: (≥1/100 and <1/10) Erythema Uncommon: (≥1/1,000 and <1/100) Skin necrosis Rash* Urticaria Pruritus *Various types of rashes such as erythematous, generalised, macular, maculo-papular, papular and pruritic have been reported Musculoskeletal and connective tissue disorders Uncommon: (≥1/1,000 and <1/100) Osteoporosis (in connection with long-term treatment) Reproductive system and breast disorders Uncommon: (≥1/1,000 and <1/100) Priapism General disorders and administration site conditions Uncommon: (≥1/1,000 and <1/100) Injection site reaction Investigations Common: (≥1/100 and <1/10) Transaminases increased Uncommon: (≥1/1,000 and <1/100) Activated partial thromboplastin time prolonged beyond therapeutic range Paediatric population The observed safety profile is similar in children and adults.
3). Heparin should be used with caution in patients with hypersensitivity to low molecular weight heparin. Care should be taken when heparin is administered to patients with increased risk of bleeding complications, hypertension, renal or hepatic insufficiency.
This list is not exhaustive. 5). In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.
The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.
In decision making on the interval between the last administration of heparin at prophylactic doses (≤15,000 IU/day) and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account.
Placement or removal of a peridural or spinal catheter should not be allowed until 4-6 hours after the last heparin administration and subsequent dose should not take place before at least 1 hour post procedure. For treatment doses (>15,000 IU/day), placement or removal of a peridural or spinal catheter should not be allowed until 4-6 hours after last intravenous heparin administration or 8-12 hours after last subcutaneous heparin administration.
Re-administration should be delayed until the surgical procedure is completed or at least 1 hour post procedure. Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction.
1. 4) Active major haemorrhage and risk factors for major haemorrhage. Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, intracranial haemorrhage or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.
This list is not exhaustive. Septic endocarditis. In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contraindicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.
Furthermore, in patients receiving treatment doses of heparin, insertion of epidural catheter is contraindicated. 6). Heparin contains 10 mg/ml of the preservative benzyl alcohol. This must not be given to premature babies or neonates due to the risk of gasping syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If use is considered essential, the dosage recommendations given in this section should be followed.
Treatment Dosage:
Standard treatment dosages should be given initially by continuous intravenous infusion, or every 12 hours by subcutaneous injection. Intermittent intravenous injections are not advised. Subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.
4 IU/ml as determined by specific anti-Xa assay. A suggested dosage is 5,000 IU every 12 hours in early pregnancy increasing to 10,000 IU every 12 hours in the last trimester. The dosage should be reduced during labour and the standard prophylactic dosage is suitable in the puerperium.
For the prevention of clotting during haemodialysis:
An initial bolus dose should be given, followed by a continuous intravenous infusion.
Adults:
Initially: 1,000 - 5,000 IU. Maintenance: 1,000 - 2,000 IU per hour, adjusted to maintain clotting time > 40 minutes. Method of administration For intravenous or subcutaneous injection.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these. If signs or symptoms of epidural or spinal haematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.
Heparin should not be administered by intramuscular injection due to the risk of haematoma. Due to the risk of haematoma, concomitant intramuscular injections should also be avoided. Because of the risk of immune-mediated heparin-induced thrombocytopenia (type II), platelet count should be measured before the start of treatment and periodically thereafter.
8). Platelet counts will usually normalise within 2 to 4 weeks after withdrawal. Low molecular weight heparin should not be used as an alternative to heparin in case of heparin-induced thrombocytopenia (type II). Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT. 8). 5). In patients at risk, potassium levels should be measured before starting heparin and monitored regularly thereafter, particularly if treatment is prolonged beyond about 7 days.
g. decreasing potassium intake, discontinuing other drugs that may affect potassium balance). Excipients Heparin contains benzyl alcohol, methyl- and propyl parahydroxybenzoate and sodium as excipients. Methyl- and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
Benzyl alcohol may cause allergic reactions. 3). It is not known at which amount benzyl alcohol is toxic. Due to risk of accumulation of benzyl alcohol, this medicine should not be used for more than one week in children up to 3 years old.
Extra caution is advised if high doses of benzyl alcohol are used, especially in patients with reduced liver- and kidney function due to risk of accumulation and toxicity (metabolic acidosis). High doses may only be administered if necessary.
1 mg sodium/ml which is less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’ for doses up to 5 ml (corresponding to 5,000 IU heparin sodium). Heparin contains 41 mg sodium per 10 ml vial. 1 % of the WHO recommended maximum daily intake of 2 g for an adult.