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 Formulary Chapter 2: Cardiovascular system - Full Chapter
02.01  Expand sub section  Positive inotropic drugs
02.01.01  Expand sub section  Cardiac glycosides
 note 
  • Digoxin controls the ventricular rate in patients with persistent or permanent atrial fibrillation, especially when it occurs with heart failure. It is also used in the treatment of supraventricular tachycardias and atrial flutter but not ventricular arrhythmias.
  • Digoxin should only be considered as monotherapy for permanent AF in predominantly sedentary patients who need treatment for rate control.
  • A loading dose may be given on initiation of therapy to achieve a rapid therapeutic effect; otherwise it will take about a week to obtain maximal effect. An oral loading dose is often satisfactory but for a more rapid onset it can be given by intravenous infusion. Even with intravenous administration, response may take many hours; persistence of tachycardia is therefore not an indication for exceeding the recommended dose.
  • In patients with heart failure who are in sinus rhythm a loading dose is not required, and a satisfactory plasma-digoxin concentration can be achieved over a period of about a week.
  • Intramuscular injection should be avoided as it is painful and absorption is variable.
  • Age and renal function are key determinants of the dosing regimen.
Digoxin
View adult BNF View SPC online  Track Changes
First Choice
Green
 
02.02  Expand sub section  Diuretics
 note 

  • Diuretics help to reduce fluid overload in heart failure. Loop diuretics are preferred for acute exacerbations.  Thiazide-like diuretics are now recommended by NICE for the treatment of hypertension in newly diagnosed patients.  
  • Thiazide-like diuretics are fully effective only when renal function is normal or only minimally impaired and are contraindicated in severe impairment. Loop diuretics may be required in hypertensive patients with severe renal impairment.
  • Do not prescribe diuretics routinely later than early afternoon.
  • Thiazide-like and loop diuretics can cause serum-potassium levels to fall in some patients, particularly during the first few weeks of treatment. Hypokalaemia should be treated appropriately if it occurs. A potassium-sparing diuretic is generally more effective and convenient than potassium chloride supplements.  
  • Regular review of diuretic use is desirable to confirm continued need and to monitor adverse effects such as dehydration, which may cause renal impairment particularly in the elderly. Use of potassium supplements or potassium-sparing diuretics should be re-assessed regularly by measuring serum-potassium levels.
02.02.01  Expand sub section  Thiazides and related diuretics
 note  See section 2.2
  • The action of indapamide is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy.
  • Indapamide is claimed to lower blood pressure with less metabolic disturbance than other diuretics particularly less aggravation of diabetes mellitus.
  • Metolazone and loop diuretics appear to have a synergistic effect when combined. Profound diuresis can occur so monitor patient carefully. Use intermittently based on achievement of a target weight. Reduce dose or stop treatment until target weight exceeded again.
  • Indapamide 2.5mg
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    If a diuretic is to be initiated or changed. Existing patients should remain on bendroflumethiazide.
    NB Indapamide MR is not recommended as limited evidence of additional benefits and higher cost.

     
    Metolazone
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    Restricted Drug Restricted
    Amber Simple
    Oedema resistant to large doses of loop diuretics alone.
    This product has been discontinued by the manufacturers but imported sources are now available. Local specialist opinion is to use bendroflumethiazide as an alternative in line with the recommendations of the British Society for Heart Failure. 
    Link  British Society for Heart Failure statement: Metolazone withdrawal
       
    02.02.02  Expand sub section  Loop diuretics to top
     note 
    • Furosemide (40-60mg) has a similar effect to bumetanide (1mg) for most clinical uses. Diuresis is complete within 6 hours of oral administration with both drugs therefore if necessary they can be given twice in one day without disturbing sleep.
    • Bioavailability of oral bumetanide is sometimes better than furosemide particularly in patients with right-sided congestive heart failure associated with liver/ splanchnic congestion.
    • The therapeutic effect of loop diuretics can be measured by monitoring the patient’s weight on a daily basis.
    • In acute heart failure, small doses of parenteral loop diuretics are valuable (onset of action approximately 5 minutes after IV injection).
    • Large doses of loop diuretics may be required in renal failure.
    Furosemide
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    IV Guide available through 'Injectable Medicines Guide' link on front page of INsite. 
    Bumetanide
    View adult BNF View SPC online  Track Changes
    Second Choice
    Green
     
       
    Torasemide
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    For consultant cardiologist signature only 
    Link  Leicestershire Evaluation: Torasemide in Resistant Heart Failure
       
    02.02.03  Expand sub section  Potassium-sparing diuretics and aldosterone antagonists
     note 
    • Amiloride and spironolactone are weak diuretics if given alone, but their diuretic and antihypertensive effects are additive with those of loop and thiazide diuretics. They should be used in preference to potassium supplements if hypokalaemia is a problem with loop or thiazide diuretics alone.
    • Combinations should not be used unnecessarily and in practice are often not justified when treating hypertension, as the risk of hyponatraemia is greater than with one agent alone.
    • Amiloride and spironolactone may take 2-3 days to become fully effective.
    • Potassium-sparing diuretics are contra-indicated in renal failure; the elderly may insidiously develop hyperkalaemia due to deterioration in renal function.
    • Close monitoring required if prescribed together with other agents that raise serum potassium. These include potassium supplements, ACE inhibitors and angiotensin-II antagonists. Non-steroidal anti-inflammatory drugs (NSAIDs) and ciclosporin may also increase the risk of hyperkalaemia. Serum potassium should be monitored 3 monthly and within 7-14 days after a dose change.
    Amiloride
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
     
    02.02.03  Expand sub section  Aldosterone antagonists
    Spironolactone
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    Restricted Drug Restricted
    Green
    NICE recommends in patients with heart failure due to left ventricular systolic dysfunction who remain moderately to severely symptomatic despite optimal therapy of ACE inhibitors and β blocker. Specialist advice should be sought as monitoring required.
    Can also be used when an aldosterone antagonist is clearly indicated (e.g. primary hyperaldosteronism or treatment of oedema and/or ascites in hepatic cirrhosis). 
    Link  MHRA Advice: Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia
       
    Eplerenone
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    Evidence supports the use in patients admitted to CCU following an MI with proven left ventricular failure in addition to other treatment. Second line as an alternative to spironolactone in patients who have chronic heart failure or hypertension and suffer from gynaecomastia.
     
       
    02.02.04  Expand sub section  Potassium-sparing diuretics with other diuretics
     note  Combined loop or thiazide diuretic with a potassium-sparing agent should not be used indiscriminately. They are more expensive than diuretic alone and are more likely to cause hyponatraemia or other adverse reactions than a single agent.
    Co-amilofruse 5/40
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    Formulary
    Green
    Amiloride 5mg with furosemide 40mg
    Proprietary brands are more costly
     
       
    Co-amilozide 5/50
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    Formulary
    Green
    Amiloride 5mg with hydrochlorothiazide 50mg; (Moduretic) 
    Link  MHRA advice: Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use
       
    02.02.08  Expand sub section  Diuretics with potassium
     note 

    Products that combine a diuretic with potassium chloride are not recommended because they often contain insufficient potassium (8-12mmol per tablet) to correct hypokalaemia.

    02.03  Expand sub section  Anti-arrhythmic drugs to top
     note 
    • Management of arrhythmias other than atrial fibrillation should be under the care of a specialist. Advice can be found in the Cardiology Handbook.
    • For management of atrial fibrillation see the relevant sections on beta-blockers, digoxin and calcium channel blockers.
    • Restricted drugs should only be initiated on the advice of an appropriate hospital specialist.
    • Before starting anti-arrhythmic drugs, ensure accurate diagnosis, assessment of the severity of symptoms, the patient's general condition, co-morbidities and consideration of the prognosis.
    • As a rule of thumb anti-arrhythmic drugs have the potential to be pro-arrhythmic!
    • Combinations of anti-arrhythmic agents are more likely to produce significant negative inotropic effects. Review periodically to determine whether treatment should be continued.
    02.03.01  Expand sub section  Management of arrhythmias
    02.04  Expand sub section  Beta-adrenoceptor blocking drugs
     note 

    • NICE recommends beta-blockers as first line treatment in angina, rate control in persistent and permanent AF and also heart failure (alongside an ACE inhibitor). Beta blockers are also recommended post MI in clinically stable patients.
    • Beta blockers are now only recommended for the treatment of resistant hypertension.
    • Bisoprolol and carvedilol are beta blockers licensed for use in heart failure. They may also be preferred in post MI patients with LVSD.
    • Existing co-morbidities need to be taken into account when prescribing beta blockers especially in patients with poorly controlled diabetes, reversible airways disease and unstable heart failure. Cardio-selective beta blockers such as atenolol and bisoprolol may be preferable when there are no other alternatives.
    • Introduce beta blockers slowly. Gradually reduce the dose if beta-blockers are to be stopped as sudden withdrawal may cause an exacerbation of angina and rebound worsening of myocardial ischaemia.
    • For specialist use of beta-blockers to treat arrhythmias see section 2.3
    Bisoprolol Fumarate
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    First Choice
    Green
     
    Carvedilol
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    Restricted Drug Restricted
    Green Conditional
    For use in heart failure only. Initiation and titration should be by a health care professional with experience in managing heart failure. 
       
    Atenolol
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    Intravenous and liquid preparations available

    Existing patients can continue receiving tablets
    UHL also use in post natal patients if not breast feeding  
       
    Propranolol Hydrochloride
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    Less cardioselective and shorter acting than atenolol. Drug of choice for thyrotoxic crisis and portal hypertension. Dose requirements may differ considerably between individuals because of variable first-pass hepatic metabolism. 
       
    02.05  Expand sub section  Drugs affecting the renin-angiotensin system and some other antihypertensive drugs
    02.05.01  Expand sub section  Vasodilator antihypertensive drugs
     note 
    • Seek specialist advice on the management of hypertensive emergencies
    • In treatment of hypertensive urgencies, diastolic pressure should ideally be lowered to 100-110mmHg over the first 24 hours of treatment with oral BP-lowering treatment. Avoid a sudden dramatic fall in blood pressure, particularly in chronic hypertensives and the elderly as it can result in reduced cerebral perfusion, deterioration in renal function and myocardial ischaemia.  Aim to lower blood pressure over several days with oral drugs and close monitoring.
    • Hypertensive encephalopathy and left ventricular failure are hypertensive emergencies and as such require more rapid reduction in blood pressure with intravenous BP-lowering treatment.

    Sodium Nitroprusside
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    Restricted Drug Restricted
    Red
    Recommended choice for hypertensive crisis
    Starts to act within a few minutes. Blood pressure can be readily controlled by adjusting the infusion rate. It can be used in dissecting aortic aneurysm in combination with a beta-blocker to prevent an increase in heart rate.
     
       
    Labetalol
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    Restricted Drug Restricted
    Red
    After bolus injection, the maximum effect usually occurs within five minutes and the effective duration of action is usually about six hours but may be as long as eighteen hours.
    Alternative choice to sodium nitroprusside for hypertensive crisis.
    Labetalol can also be used during pregnancy (3rd trimester) for management of severe pre-eclampsia/ eclampsia. 
       
    Hydralazine Hydrochloride
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    Useful for hypertensive emergencies in pregnancy. Second line choice after labetalol for pre-eclampsia /eclampsia. Acts about 20 minutes after IV injection (slightly longer if given IM). 
       
    02.05.02  Expand sub section  Centrally acting antihypertensive drugs to top
    Moxonidine
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    Restricted Drug Restricted
    Amber Simple
    For initiation by hypertension clinic only. 
       
    02.05.03  Expand sub section  Adrenergic neurone blocking drugs
    02.05.04  Expand sub section  Alpha-adrenoceptor blocking drugs
     note 
    • Lower blood pressure by arteriolar and venous dilatation.
    • Not recommended by NICE in the treatment of hypertension until step 4.
    • May improve urine flow in men with benign prostatic hyperplasia and therefore may be an additional benefit in such patients.
    • Alpha-blockers can cause postural hypotension. Gradual upward titration of the dose will minimise the risk of syncope when therapy is initiated.

    Doxazosin
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    First Choice
    Green
    Standard release preparation.
    Modified release preparations are more expensive and offer no clinical advantage over standard release preparations. 
    02.05.05  Expand sub section  Drugs affecting the renin-angiotensin system
    02.05.05.01  Expand sub section  Angiotensin-converting enzyme inhibitors (ACE inhibitors)
     note 

    (ACE) inhibitors are recommended by NICE for the following:

    • Step 1 for the treatment of hypertension in patients under 55 years  (other than black patients of African or Caribbean family origin of any age).
    • ACE inhibitors are recommended at step 2 for treatment of hypertension for those over 55 years. Losartan should be used in preference to an ACE inhibitor in black patients of African or Caribbean family origin of any age at step 2.
    • All patients with heart failure due to LVSD should be considered for treatment with an ACE inhibitor. The dose should be titrated to the recommended "target" or maximum tolerated.
    • Type 2 diabetic patients with renal nephropathy.
    • Secondary prevention after acute myocardial infarction.
    • ARBs are useful alternatives in patients in whom ACE inhibitors are contraindicated or not tolerated.
    Lisinopril
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    First Choice
    Green
    Hypertension and heart failure.
    In heart failure, target dose is 20mg daily.  
    Ramipril
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    Second Choice
    Green
    Hypertension and heart failure.
    In heart failure, target dose is 10mg daily.
     
       
    Perindopril erbumine
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    Restricted Drug Restricted
    Green
    Initiation restricted on the advice of a senior cardiologist to patients where
    hypotension is a significant issue with 1st line choices or in hypotensive patients as a first line choice.

     
       
    Lisinopril + Hydrochlorothiazide  (Zestoretic®)
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    On advice of the hypertension clinic only 
    Link  MHRA advice: Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use
       
    02.05.05.02  Expand sub section  Angiotensin-II receptor antagonists to top
     note 
    • Do not routinely prescribe ARBs except as an alternative to an ACE inhibitor where there is a contraindication, intolerance or allergy.
    • NICE Guidelines for Hypertension recommend losartan at step 2, in preference to an ACE inhibitor in black patients of African or Caribbean family origin of any age.
    • All local organisations are monitored to ensure that this happens using the National "Better Care Value Indicators"
    Losartan Potasium
    View adult BNF View SPC online  Track Changes
    First Choice
    Green

    First choice ARB in hypertension.
    Also licensed for diabetic nephropathy in type 2 diabetes.

     
    Candesartan
    View adult BNF View SPC online  Track Changes
    First Choice
    Green

    First choice ARB in heart failure for new initiations. Existing patients to remain on current therapy

     
    Valsartan
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    May be used for post-MI heart failure if intolerant of an ACE inhibitor. Use is not recommended for other indications as it is more expensive than recommended choices. 
       
    Sacubitril Valsartan (Entresto® )
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber SCA
    For use by Heart Failure Clinic in line with NICE TA 388 only. If initiated by Heart Failure Clinic, GPs may continue prescribing under shared care 
    Link  NICE TA 388: Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction
    Link  SCA for sacubitril/valsartan (Entresto®) in the treatment of Heart Failure
       
    02.05.05.03  Expand sub section  Renin inhibitors
    Aliskiren
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber SCA
    Aliskiren is available for treatment of hypertension if initiated by appropriate specialists at UHL. GPs may continue prescribing under shared care.

     
    Link  MHRA advice: Aliskiren (Rasilez▼): risk of cardiovascular and renal adverse reactions—new contraindications and warnings
    Link  SCA: Aliskiren in the treatment of hypertension
       
    02.06  Expand sub section  Nitrates, calcium-channel blockers, and potassium-channel activators
    02.06.01  Expand sub section  Nitrates
     note 
    • Nitrates are the mainstay of treatment for acute angina. They can also be used prophylactically if necessary e.g. before exertion. 
    • NICE recommends that nitrates are offered as a 3rd line option for prophylaxis of stable angina.   

     

    Glyceryl Trinitrate Spray (GTN)
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    For acute angina.
    Spray acts within about 2 minutes and is effective for up to 30 minutes. 
    Isosorbide Mononitrate
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    Prophylaxis of angina.
    Give the standard-release version twice a day with the last dose of the day in the early afternoon to allow an adequate nitrate-free period and prevent development of tolerance. Modified release forms should not be used routinely as they are more expensive and tolerance is more likely to develop.
     
    02.06.02  Expand sub section  Calcium-channel blockers
     note 
    • Dihydropyridine calcium-channel blockers are recommended by NICE as first line treatment of hypertension in black patients of African or Caribbean origin of any age and for all other patients aged 55 or older. 
    • Recommended by NICE as a first line treatment option of stable angina (diltiazem).
    • Rate controlling calcium channel blockers are recommended by NICE as a first line option for rate control in persistent and permanent AF.
    • Calcium-channel blockers do not reduce the risk of myocardial infarction in unstable angina.
    • The pharmacological action of calcium-channel blockers differ significantly. Co-morbidities and other medication need to be taken into account when prescribing.
    • Sudden withdrawal may exacerbate angina.
    Amlodipine
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    Greater effect on vascular smooth muscle than in the heart and tend not to cause clinical deterioration in heart failure. 
    Diltiazem Hydrochloride
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    Avoid in heart failure because it may further depress cardiac function and cause clinically significant deterioration. Monitor heart rate if co-prescribed with a β-blocker. Prescribe longer acting formulations by brand. Use Angitil SR for twice daily dosing and Viazem XL for once daily. 
    Lacidipine
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    Occasionally used by the hypertension clinic. 
       
    Nifedipine
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted Once or twice daily preparations
    For use in Obstetrics, Nephrology, Raynauld’s syndrome. Also available for emergency treatment of hypertension in acute medical and cardiology settings 
       
    02.06.03  Expand sub section  Other anitanginal drugs to top
    Ivabradine
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    For patients with angina who cannot tolerate beta blockers, calcium channel blockers or nitrates.
    Amber traffic light status for chronic heart failure in line with NICE TA267

    Date of entry of decision to Formulary: February 2013
     
    Link  MHRA Advice: Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects—new advice to minimise risk
    Link  NICE TA 267: Ivabradine in chronic heart failure
    Link  Simple Amber: Ivabradine
       
    Nicorandil
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    A potassium channel activator used for the prophylaxis of angina where calcium channel blockers, beta blockers or nitrates are either contraindicated, not tolerated or if symptoms are not adequately controlled. 
    Link  MHRA Advice: Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications
       
    Ranolazine
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    For use in line with NICE CG 126. Ranolazine may be initiated in primary care but use should be audited. Second appointment recommended to assess effect and titrate dose if necessary one month after initiation.  
       
    02.06.04  Expand sub section  Peripheral vasodilators and related drugs
     note  Most peripheral vasodilators are considered less suitable for prescribing by the BNF and are not recommended for prescribing in the Leicestershire community.  NICE TA223 recommends naftidrofuryl as an option for treatment.  This is not routinely stocked at UHL but is available on request.
    02.07  Expand sub section  Sympathomimetics
    02.07.01  Expand sub section  Inotropic sympathomimetics
     note 
    • For prescribing in hospital only.
    • Inotropic sympathomimetics increase cardiac contractility, but they are haemodynamically different. In addition, the main effects of dopamine depend on the dose administered. In low doses, cardiac stimulation and renal vascular dilation occur and in larger doses vasoconstriction occurs. See Cardiology Handbook 2015 for further information.
    • Increased heart rate and arrhythmias may occur but dobutamine may be slightly less chronotropic and arrhythmogenic than dopamine used at a higher dose.
    Dobutamine
    View adult BNF View SPC online  Track Changes
    First Choice
    Red
    Caution in severe hypotension.
    IV Guide available through 'Injectable Medicines Guide' link on front page of INsite. 
    Dopamine Hydrochloride
    View adult BNF View SPC online  Track Changes
    Second Choice
    Red
    Contra-indicated in patients with tachyarrhythmias or phaeochromocytoma. IV Guide available through 'Injectable Medicines Guide' link on front page of INsite.
     
       
    02.08  Expand sub section  Anticoagulants and protamine
    02.08.01  Expand sub section  Parenteral anticoagulants to top
     note 
    • Unfractionated heparin (UFH) is also known as standard heparin. It is useful for the treatment of very short term anticoagulation or in patients where there is a high risk of bleeding and in renal impairment as it has a short duration of action and can also be fully reversed by protamine.
    • Subcutaneous low molecular weight heparins LMWH such as dalteparin are preferred for routine use.
    • Flushing intravenous catheters: Sodium chloride 0.9% is recommended to maintain the patency of standard IV lines although heparinised solutions are used for indwelling central lines.
    Heparin Sodium
    View adult BNF View SPC online  Track Changes
    First Choice
    Red
    IV full anticoagulation. Prophylaxis 
    Heparin Sodium
    View adult BNF View SPC online View childrens BNF  Track Changes
    First Choice
    Green
    For flushing of lines  
    Argatroban
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    Specialist renal use only.
    For treatment of HIT or suspected HIT in patients with renal impairment (CrCl <20 ml/min) For CrCl 20-50 ml/min, discuss with an haemostasis and thrombosis clinician
     
    Link  Leicestershire Evaluation: Argatroban in HIT
       
    02.08.01  Expand sub section  Low molecular weight heparins
     note 
    • Low molecular weight heparins (LMWH) are the usual first choice for anticoagulation as they are easier to administer than unfractionated heparin (UFH) and do not require APTT monitoring.
    • For prevention of VTE, all in-patients and day case surgery patients should be risk assessed using the appropriate risk assessment tool and prescribed dalteparin 5000units daily if indicated and if there are no contraindications. In patients with creatinine clearance<30ml/min reduce the dose to 2,500units daily.
    • Therapeutic doses should be calculated according to patient weight and renal function. The prescriber should document the weight of the patient on the prescription.
    Dalteparin Sodium (Fragmin®)
    View adult BNF View SPC online  Track Changes
    First Choice
    Green

    Thromboprophylaxis and Treatment of DVT and when used in line with primary care warfarin guidance for low INR

     

     

     
    Enoxaparin Sodium
    View adult BNF View SPC online  Track Changes
    Second Choice

    Red For acute coronary syndromes.

     

     
       
    02.08.02  Expand sub section  Oral anticoagulants
     note 
    • Warfarin is a competitive antagonist of vitamin K (phytomenadione), involved in the production of clotting factors. Its anticoagulant effect takes 36-48 hours to develop fully and is monitored using the international normalised ratio (INR). For treatment of VTE, heparin should continue for at least 5 days following warfarin initiation and not stopped until the INR has been in the therapeutic range for two consecutive tests.
    • Guidance on indications and target INRs are listed in the UHL Guidelines on Initiation of Oral Anticoagulation
    • The Anticoagulation (Warfarin) Induction Pack should be used for all new patients starting therapy with warfarin.
    • The Anticoagulation Initiation Pack for Oral Direct Factor Xa Inhibitors and Thrombin Inhibitors should be used for all new patients starting on either rivaroxaban, apixaban or dabigatran. 
    • The recommended inpatient dosing time for warfarin is 2pm and the INR should be measured between 8-10am the following morning.
    • Both vitamin K (phytomenadione) and prothrombin complex concentrate product are used for the emergency reversal of warfarin. Administration must not be delayed.
    • There is currently no product available for the emergency reversal of apixaban, dabigatran or rivaroxaban
    • All patients discharged from hospital on anticoagulants should be referred to the UHL anticoagulant clinic for counselling.
    • Please be aware of the MHRA warning concerning DOACs and antiphospholipid syndrome
    • Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome is available for use by consultant cardiologists on request. Use only in line with NICE TA 335.  Decision added June 16. Traffic light status is red for this indication.
    Warfarin
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
    Within UHL give 1mg tablets to all patients initiated on warfarin.
    Patients already established on warfarin should receive the strengths of tablets they are used to. 
    Link  MHRA Advice: Topical miconazole, including oral gel - reminder of potential for serious interactions with warfarin
    Link  MHRA Advice: Warfarin: reports of calciphylaxis
       
    Edoxaban
    View adult BNF View SPC online  Track Changes
    Formulary
    Green

    For Atrial Fibrillation (AF) use inline with the Leicestershire Algorithms.

    For patients with non-valvular AF, edoxaban is the preferred choice based on lower drug acquisition cost unless there is a specific clinical reason not to do so.

    Date of entry of decision to formulary: November 2015

     
    Link  Leicestershire Guidance: DOAC for Non-Valvular AF
    Link  NICE TA 355: Edoxaban in AF
       
    Rivaroxaban
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
    For Atrial Fibrillation (AF) use in line with the Leicestershire Algorithms.

    Date of entry of decision to Formulary: August 2012
     
    Link  Leicestershire Guidance:Direct Oral Anti-Coagulants for Non-Valvular Atrial Fibrillation
    Link  MHRA Advice: Rivaroxaban : reminder that 15 mg and 20 mg tablets should be taken with food
    Link  UHL Prescriber Checklist
       
    Apixaban
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
    For Atrial Fibrillation (AF) use inline with the Leicestershire Algorithms.

    Date of entry of decision to Formulary: May 2013
     
    Link  Leicestershire Guidance: DOAC for Non-Valvular AF
    Link  UHL Prescriber Checklist
       
    Dabigatran etexilate
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
    For Atrial Fibrillation (AF) use inline with the Leicestershire Algorithms. 
    Link  Leicestershire Guidance: DOAC for Non-Valvular AF
    Link  UHL Prescriber Checklist
       
    Rivaroxaban
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    For DVT and PE use. Patients should be referred to the anticoagulant clinic for counselling.

    Date of entry of decision to Formulary:
    PE - September 2013
    DVT - October 2012 
    Link  MHRA Advice: Rivaroxaban : reminder that 15 mg and 20 mg tablets should be taken with food
       
    Apixaban
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    For DVT and /or PE use in line with NICE TA 341 only


    Date of entry of decision to formulary: September 2015 
    Link  NICE TA 341: Apixaban for DVT / PE
       
    Dabigatran etexilate
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber SCA
    Available DVT and PE in line with SCA.
    Use in line with NICE TA 327

    Date decision added to Formulary: February 2015 
    Link  NICE TA 327: Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
       
    Edoxaban
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber SCA
    Available on request for treating and preventing DVT and PE in line with NICE: TA 354

    Date of entry of decision to formulary: October 2015 
    Link  NICE TA 354: Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism
    Link  SCA: Dabigatran and Edoxaban – DVT and PE
       
    Rivaroxaban (2.5mg strength tablet only) (Xarelto®)
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red

    Atherothrombotic events in coronary artery disease in conjunction with acetylsalicylic acid as per NICE TA 335 only

     
    Link  NICE TA 335: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome
       
    Acenocoumarol
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    Red traffic light status for new patients but existing patients can continue to be supplied by primary care 
       
    Fondaparinux Sodium
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    For HIT 
    Link  Leicestershire Evaluation: Fondaparinux in HIT
       
    02.08.02  Expand sub section  Stroke prevention in AF
    02.08.02  Expand sub section  Atrial Fibrillation
    02.08.02  Expand sub section  VTE treatment to top
    02.08.03  Expand sub section  Protamine sulphate
     note  Protamine injection can be given to reverse the effect of heparin if an immediate effect is required.
    Protamine sulphate
    View adult BNF View SPC online  Track Changes
    Formulary
    Red
    IV Monograph available through 'Injectable Medicines Guide' link on front page of INsite. 
       
    02.09  Expand sub section  Antiplatelet drugs
     note 
    • Use of low dose aspirin for the primary prevention of heart attacks and strokes in people without cardiovascular disease including diabetic patients is no longer recommended as the increased risk of bleeding outweighs any vascular benefits.
    • Prescribing of antiplatelets for secondary prevention should be line with appropriate UHL or LMSG Guidelines.
    • Patients with mild to moderate dyspeptic symptoms taking aspirin should be prescribed a PPI or H2 antagonist before switching to clopidogrel (which may also cause gastro-intestinal adverse effects).
    • The MHRA has updated its advice on the interaction between PPI's and clopidogrel. It now recommends that use of either omeprazole or esomeprazole with clopidogrel should be discouraged. This does not include lansoprazole.
    Aspirin
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
     
       
    Clopidogrel
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
    In line with guidance from the Royal College of Physicians’, LMSG recommends that clopidogrel at a dose of 75mg daily (following initial 300mg loading dose) is used for stroke and TIA patients in sinus rhythm. See link below

     
    Link  National clinical guideline for stroke
    Link  MHRA Advice: Clopidogrel: risk of acquired haemophilia
       
    Dipyridamole
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
     
       
    Prasugrel
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    For ACS In line with Shared Care Agreement (SCA)and UHL guidance

    Date decision added to Formulary: September 2014 
    Link  MHRA Advice: Prasugrel (Efient): increased risk of bleeding—information on timing of loading dose
    Link  NICE TA 317: Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes
    Link  Simple Amber Medicines
    Link  UHL oral antiplatelet guidance
       
    Ticagrelor
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    For treatment ACS In line with NICE TA236 and UHL guidance.
    For prevention of atherothrombotic events in line with NICE TA420.
    On consultant cardiologist authorisation only. 
    Link  NICE TA 236: Ticagrelor for the treatment of acute coronary syndromes
    Link  NICE TA 420: Ticagrelor for preventing atherothrombotic events after myocardial infarction
    Link  Simple Amber Medicines
    Link  UHL oral antiplatelet guidance
       
    02.10  Expand sub section  Myocardial infarction and fibrinolysis
    02.10.01  Expand sub section  Management of myocardial infarction
     note 
    • Percutaneous Coronary Intervention (PCCI) is first line treatment of ST-segment elevation myocardial infarction (STEMI). Thrombolysis is now rarely used at UHL.
    • Further information on the management of STEMI can be found in the UHL Cardiology Handbook and UHL- ED Management of STEMI Guidelines
    02.10.02  Expand sub section  Fibrinolytic drugs to top
     note 
    • Rapid treatment with thrombolytics is essential and need to be administered within time frames specified in local and national guidelines.
    • Laboratory monitoring is necessary, initially to exclude coagulation defects and subsequently to ensure that fibrinolysis is occurring.
    • Tranexamic acid should be available to use as an antidote if necessary.
    Tenecteplase
    View adult BNF View SPC online  Track Changes
    First Choice
    Red
    Replaces Reteplase which has been discontinued

    Treatment of STEMI
     
    Alteplase
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    For use in selected specialist situations including stroke and massive PE.

    Date of entry of decision to Formulary: September 2012
     
    Link  NICE TA 264: Alteplase
       
    02.11  Expand sub section  Antifibrinolytic drugs and haemostatics
    Tranexamic Acid
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    Inhibits activation of plasminogen. Used to prevent bleeding or treat bleeding associated with excessive fibrinolysis. Intravenous use as an antidote to thrombolytics is restricted to hospital use. 
    Fibrinogen  (Riastap®)
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red

    Treatment of severe bleeding in acquired hypofibrinogenemia resulting from operative interventions, in particular after cardiac surgery.

     
       
    02.11  Expand sub section  Blood-related products
     note  Blood products are supplied by blood bank and NOT pharmacy.

    High cost products excluded to tariff are commissioned by NHSE in line with BCSH guidelines
    NovoSeven®
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Available only with the agreement of the Haematology Specialist Registrar or Haematology Consultant. 
    Link  Statement on unlicensed use within UHL
       
    Prothrombin Complex Concentrate
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    Available only with the agreement of the Haematology Specialist Registrar or Haematology Consultant. 
    Link  UHL Guidelines: Prothrombin Complex Concentrate Clinician pack
       
    Antithrombin III (Kybemin®)
    View adult BNF View SPC online View childrens BNF  Track Changes
    Restricted Drug Restricted
    Red
    Available only with the agreement of the Haematology Specialist Registrar or Haematology Consultant.

     
       
    Idarucizumab  (Praxbind)
    View adult BNF View SPC online View childrens BNF  Track Changes
    Restricted Drug Restricted
    Red
    For reversal of dabigatran related bleeding only. Not suitable for other DOAC related bleeds.

    Idarucizumab is available in ED 
    Link  Leicestershire Evaluation: Idarucizumab for Reversal of Dabigatran Related Bleeding
    Link  UHL Guidance: Management of bleeding in patients taking a DOAC
       
    02.12  Expand sub section  Lipid-regulating drugs
     note 

    Simvastatin 40mg daily is the usual first line choice for lipid lowering for the majority of patients for primary and secondary prevention except in ACS, renal transplant patients and patients on concurrent medications where there is a significant interaction and a lower dose of simvastatin or atorvastain is appropriate. 

    • Leicestershire Lipid Modification Guidance summarises the recommendations of NICE CG 66 and 67.
    • Review statin choice after six months in patients treated for ACS and follow secondary prevention pathway.
    • For patients aged 75 or older the decision to treat should be made on an individual basis.
    • Refer all patients with total serum cholesterol >10.0mmol/L or fasting serum triglycerides >10 to an appropriate specialist clinic.
    • Treatment of familial hypercholesterolaemia should be in line with NICE CG 71.
      For further advice contact: 
      Lipid Clinic on (0116) 287 1471 ext. 3029
      Chemical Pathology on (0116) 258 6550
    Evolocumab  (Repatha®)
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    High Cost Medicine
    For use by the lipid clinic only.
    Approved in line with NICE TA 394 (added September 2016) for treating primary non-familial hypercholesterolaemia and mixed dyslipidaemia and primary heterozygous familial hypercholesterolaemia

    Use for homozygous familial hypercholesterolaemia is commissioned by NHS England only through established apheresis centres. UHL is not one of these so any request for treatment in this circumstance would need to be referred to one of the following: Central Manchester University Hospitals NHS Foundation Trust; Queen Elizabeth Hospital Birmingham; Royal Brompton and Harefield NHS Foundation Trust; Imperial College NHS Trust and University Hospitals Bristol NHS Foundation Trust.

     
    Link  NICE TA 394: Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
       
    Alirocumab  (Praluent®)
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Red
    For use by the lipid clinic only.
    Approved in line with NICE TA 393 (added September 2016)for treating primary non-familial hypercholesterolaemia and mixed dyslipidaemia and primary heterozygous familial hypercholesterolaemia
     
    Link  NICE TA 393: Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
       
    Lomitapide (Lojuxta)
    View adult BNF View SPC online View childrens BNF  Track Changes
    Restricted Drug Restricted
    Red
    NHS England

    To be prescribed in line with NHSE SSC 1679 only

     
       
    02.12  Expand sub section  Bile acid sequestrants
     note  Colestyramine / Colestid are cholesterol binding resins which bind bile acids in the gut as well as ingested cholesterol to reduce LDL cholesterol. Other drugs should be taken at least 1 hour before or 4–6 hours after colestyramine to reduce possible interference with absorption.
    02.12  Expand sub section  Ezetimibe to top
     note  Ezetimibe inhibits the intestinal absorption of dietary and biliary cholesterol.  It has a limited place in therapy and should be prescribed only in line with Leicestershire Lipid Modification Guidance and NICE TA 385
    02.12  Expand sub section  Fibrates
     note  Fibrates reduce very low density lipoprotein (VLDL), LDL cholesterol and triglycerides in addition to raising HDL. The MHRA has advised “Fibrates should only be used as first-line therapy in patients with isolated severe hypertriglyceridaemia (specialist use). In patients with mixed hyperlipidaemia, fibrates may be used only when a statin or other effective treatments are contraindicated or not tolerated.” The combination of statin with fibrate increases the risk of side effects and toxicity including serious muscle toxicity; therefore use with caution and monitor closely.
    Fenofibrate
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    200mg od dose preferred over other standard regimens as similar efficacy but lower acquisition cost. 
       
    Bezafibrate
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    More expensive than fenofibrate. 
       
    02.12  Expand sub section  Statins
     note 
  • All statins act by inhibiting an enzyme involved in cholesterol synthesis. They reduce LDL with little effect on high density lipoprotein (HDL) cholesterol or triglycerides.
  • Simvastatin (alternative pravastatin) is the first line choice for lipid lowering for the majority of patients.
  • In practice, simvastatin 80mg and atorvastatin 80mg are less well tolerated compared to a 40mg dose and give minimal additional cholesterol-lowering efficacy.
  • Atorvastatin
    View adult BNF View SPC online  Track Changes
    First Choice
    Green
    20mg once daily 1st choice in line with LMSG guidance 
    Simvastatin
    View adult BNF View SPC online  Track Changes
    Formulary
    Green
     
    Link  MHRA Advice: Simvastatin: increased risk of myopathy at high dose (80 mg)
       
    Fluvastatin
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    For use in renal transplant patients only. 
       
    Pravastatin Sodium
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    Low intensity statin with alternative metabolic pathway for use in patients who do not tolerate simvastatin.
    Also suitable for patients in allogeneic stem cell transplants due to lower level of interactions. 
       
    Rosuvastatin
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Green
    High intensity statin with alternative metabolic pathway for use in patients with ACS who do not tolerate atorvastatin. 
       
    02.12  Expand sub section  Nicotinic acid group
     note  Nicotinic acid reduces very low density lipoprotein (VLDL) and triglycerides and increases HDL. It is now only available as a combined product Tredaptive (nicotinic acid and laropiprant). Laropiprant suppresses the flushing associated with administration of nicotinic acid.
    02.12  Expand sub section  Omega-3 fatty acid compounds
    Omacor
    View adult BNF View SPC online  Track Changes
    Restricted Drug Restricted
    Amber Simple
    Omacor is classified as Simple AMBER on the Leicestershire traffic light system for use in hypertriglyceridemia. Initiation is limited to the lipid clinic at UHL but may then be continued in primary care. It is classified as BLACK for other uses 
    Link  Leicestershire Evaluation: Omacor in Hypertriglyceridaemia
    Link  Leicestershire Evaluation: Omacor in Post MI
       
     ....
     Non Formulary Items
    Amlodipine & valsartan  (Exforge®)

    View adult BNF View SPC online View childrens BNF Track Changes
    Non Formulary
    Black
     
    Aspirin EC

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Burosumab  (Crysvita®)

    View adult BNF View SPC online Track Changes
    Non Formulary
    Black

    Not yet reviewed

     
    Captopril

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Co-triamterzide

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Emicizumab  (Hemlibra®)

    View adult BNF View SPC online Track Changes
    Non Formulary
    Black

    For prophylaxis of bleeding episodes.

     
    Enoxaparin BECAT prefilled syringes

    View adult BNF View SPC online Track Changes
    Non Formulary
    Black
     
    Etamsylate

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Felodipine

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Indapamide SR  (Natrilix-SR®)

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Irbesartan

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Lercanidipine Hydrochloride  (Zanidip®)

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Nonacog Beta Pegol  (Refixia®)

    View adult BNF View SPC online Track Changes
    Non Formulary
    Black

    Not yet reviewed.

     
    Olmesartan

    View adult BNF View SPC online Track Changes
    Non Formulary
    Link  Leicestershire Evaluation: Olmesartan in Hypertension
     
    Olmesartan, amlodipine & hydrochlorothiazide  (Sevikar HCT®)

    View adult BNF View SPC online View childrens BNF Track Changes
    Non Formulary
    Black
     
    Simvastatin and Ezetimibe  (Inegy®)

    View adult BNF View SPC online Track Changes
    Non Formulary
     
    Telmisartan

    View adult BNF View SPC online Track Changes
    Non Formulary
    Link  Leicestershire Evaluation: Telmisartan in Hypertension
     
    Tredaptive® (nicotinic acid and laropiprant)

    View adult BNF View SPC online Track Changes
    Non Formulary This product has now been withdrawn in line with MHRA advice below.
    Link  MHRA Advice: Tredaptive (combined niacin-laropiprant): no longer for prescribing as preliminary HPS2-THRIVE trial failed to show benefit outweighs risks.
     
    Ubiquinone (Co-Enzyme Q10)

    View adult BNF View SPC online Track Changes
    Non Formulary
    Black
    Statin Myopathy
    Link  Leicestershire Evaluation: CO-Enzyme Q10 Ubiquinone Statin in Myopathy
     
    Urokinase

    View adult BNF View SPC online Track Changes
    Non Formulary Urokinase is no longer used within UHL apart from unblocking occluded catheters.
     
      
    Key
    note Notes
    Section Title Section Title (top level)
    Section Title Section Title (sub level)
    First Choice Item First Choice item
    Non Formulary Item Non Formulary section
    Restricted Drug
    Restricted Drug
    Unlicensed Drug
    Unlicensed
    Track Changes
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to children's BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Black

    Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

    Red

    Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

    Amber SCA

    Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

    Amber Simple

    Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.  

    Green Conditional

    Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.   

    Green

    Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

    netFormulary