Formulary Chapter 2: Cardiovascular system - Full Chapter
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Chapter Links... |
Academic Health Science Network (North East and North Cumbria) - Atrial Fibrilation |
County Durham and Darlington DVT Pathway Information |
County Durham and Tees Valley Prescribing Guideline for the Use of Anticoagulants in Non-Valvular Atrial Fibrillation |
NICE NG148: Acute kidney injury: prevention, detection and management |
NICE NG191: COVID-19 rapid guideline: managing COVID-19 |
North Cumbria - Cardiovascular workplan 2022 |
South Tees Hospitals Cardiology drug prescribing guidelines & formulary |
Details... |
02.01 |
Positive inotropic drugs |
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02.01.01 |
Cardiac glycosides |
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Digoxin
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Formulary
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- 62.5, 125 & 250 microgram tablets .
- 50 microgram per ml elixir .
- 500 microgram in 2ml injection .
- 100 microgram in 1ml injection unlicensed .
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02.01.01 |
Digoxin-specific antibody |
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Digoxin specific antibody fragments (Digifab®)
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Formulary
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For the treatment of life threatening digoxin toxicity only, requests must be cleared by an appropriate clinician.
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02.01.02 |
Phosphodiesterase type-3 inhibitors |
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Enoximone
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Formulary
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- As per licensed indication
- Injection given orally. Approved for the treatment of severe heart failure in adults and children to wean from IV milrinone as a bridge to transplant and to reduce the need for ventricular assist devices (VADs) unlicensed
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Milrinone
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Formulary
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02.02 |
Diuretics |
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02.02.01 |
Thiazides and related diuretics |
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Indapamide 2.5mg tablets
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First Choice
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- First choice for new patients
- Modified release (MR) indapamide tablets are NON FORMULARY.
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Bendroflumethiazide 2.5mg tablets
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Alternatives
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- Current patients should continue on bendroflumethiazide
- Bendroflumethiazide 5mg tablets are available but not recommended for general use.
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Metolazone (Xaqua®)
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Alternatives
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MHRA Drug Safety Update (Jan 2023): Xaqua (metolazone) 5mg tablets: exercise caution when switching patients between metolazone preparations
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Chlorothiazide 250mg in 5ml suspension
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Unlicensed
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- Treatment should only be on advice from paediatric cardiology or nephrology specialists
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Furosemide
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First Choice
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Bumetanide
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Alternatives
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Torasemide
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Alternatives
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02.02.03 |
Potassium-sparing diuretics and aldosterone antagonists |
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Amiloride Hydrochloride
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First Choice
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Finerenone (Kerendia®)
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Formulary
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- Approved as an option for treating stage 3 and 4 chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults - in line with NICE TA877:
- add-on to optimised standard care; this should include, unless they are unsuitable, the highest tolerated licensed doses of:
- angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) and
- sodium–glucose cotransporter‑2 (SGLT2) inhibitors and
- the person has an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 or more.
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NENC - Finerenone for treating chronic kidney disease in people with type 2 diabetes
NICE TA877: Finerenone for treating chronic kidney disease in type 2 diabetes
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02.02.03 |
Aldosterone antagonists |
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Spironolactone
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Formulary
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- Resistant Hypertension - Step 4 NICE NG 136 - consider seeking expert advice
- Post-acute myocardial infarction patients and patients with heart failure treatment should be initiated on instructions from a cardiologist or GP with a specialist interest in cardiology. Spironolactone is first choice (ahead of eplerenone) for severe heart failure.
- Spironolactone 10mg and 50mg in 5ml suspension is also approved unlicensed.
- 50mg/5ml - Recommended strength in children as per NPPG/RCPCH Position Statement: Using Standardised Strengths of Unlicensed Liquid Medicines in Children.
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MHRA Drug Safety Update (Dec 2016): Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia—clarification, December 2016
MHRA Drug Safety Update (Feb 2016): Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia.
RCPCH Position Statement: Using Standardised Concentrations of Liquid Medicines in Children
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Eplerenone
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Formulary
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- For use in post-acute myocardial infarction patients with left ventricular dysfunction and heart failure. Only to be used in patients who are unable to tolerate the estrogenic side effects of spironolactone. Treatment should only be on advice from a cardiologist.
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NICE NG106: Chronic heart failure in adults: diagnosis and management
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02.02.04 |
Potassium-sparing diuretics with other diuretics |
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Spironolactone and chlorothiazide capsules
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Unlicensed
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- For use in paediatric cardiology.
- Capsules are manufactured to have 1:10 ratio of spironolactone to chlorothiazide - formulations available include:
- 1mg/10mg
- 2mg/20mg
- 3mg/30mg
- 5mg/50mg
- 10mg/100mg
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02.02.05 |
Osmotic diuretics |
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Mannitol
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Formulary
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02.02.06 |
Mercurial diuretics |
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02.02.07 |
Carbonic anhydrase inhibitors |
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02.02.08 |
Diuretics with potassium |
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02.03 |
Anti-arrhythmic drugs |
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Magnesium Sulphate Injection
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Formulary
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MHRA Drug Safety Update (May 2019): Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy
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02.03.01 |
Management of arrhythmias |
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02.03.02 |
Drugs for arrhythmias |
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02.03.02 |
Supraventricular arrhythmias |
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Adenosine
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Formulary
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- 6mg in 2ml injection
- 25mg in 5ml injection unlicensed
- 30mg in 10ml injection for infusion - NHCT only
- 130mg in 130ml IV infusion unlicensed
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Regadenoson
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Formulary
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- For radionuclide myocardial perfusion imaging in patients who are unable to undergo adequate exercise stress (e.g. COPD and asthma patients where dobutamine is indicated, and obese patients who require several vials of adenosine).
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02.03.02 |
Supraventricular and ventricular arrhythmias |
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Amiodarone
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Formulary
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- 100mg & 200mg tablets
- 50mg in 5ml suspension is also approved unlicensed
- 150mg/3ml & 300mg/10ml injection
NHS England (June 2019) advises that prescribers should not initiate amiodarone in primary care for any new patient.
in exceptional circumstances, where there is a clinical need for amiodarone to be prescribed, this should be undertaken in a cooperation arrangement with a multi-disciplinary team and/or other healthcare professional. Amiodarone has an important place in the treatment of severe cardiac rhythm disorders where other treatments either cannot be used or have failed. It has potential major toxicity and its use requires monitoring both clinically and via laboratory testing.
MHRA Drug Safety Update (Mar 2022): Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision
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NENC Shared Care Protocol - Amiodarone for patients in adult services
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Atenolol
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Formulary
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Flecainide
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Formulary
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- 50mg & 100mg tablets
- 5mg in 1ml liquid unlicensed.
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Propafenone
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Formulary
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Disopyramide
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Formulary
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Dronedarone
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Formulary
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- Approved for patients who are unsuitable for or not tolerant of amiodarone. Treatment should be initiated by a cardiologist.
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NENC Shared Care Protocol - dronedarone for patients in adult services
NICE TA197 (Atrial fibrillation - dronedarone)
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Flecainide Injection
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Formulary
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Mexiletine
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Formulary
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- unlicensed
- ECG monitoring is required to be carried out by as part of the initiation process of mexiletine.
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Sotalol
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Formulary
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Ajmaline
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Unlicensed
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- For use as a diagnostic test of Brugada syndrome.
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02.03.02 |
Ventricular arrhythmias |
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Lidocaine
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Formulary
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- 100mg injection, pre-filled syringes
- 1mg/ml (0.1%) & 2mg/ml (0.2%) IV infusions 500ml
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02.04 |
Beta-adrenoceptor blocking drugs |
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Atenolol (Cardioselective)
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First Choice
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Propranolol (non-cardioselective)
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First Choice
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Atenolol Injection
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Formulary
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Labetalol Injection
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Formulary
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Metoprolol Injection
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Formulary
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Propranolol Injection
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Formulary
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Bisoprolol
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Alternatives
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- 5mg & 10mg tablets.
- 1.25mg, 2.5mg, 3.75mg & 7.5mg tablets - for use in the treatment of heart failure only. The 5mg and 10mg tablets should be used where possible - cheaper than other strengths.
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Carvedilol
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Alternatives
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- For use in the treatment of heart failure only.
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Esmolol
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Alternatives
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Labetalol
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Alternatives
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- Tablets: 50mg, 100mg, 200mg, 400mg
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Metoprolol
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Alternatives
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- Tablets: 50mg, 100mg
- SR Tablets: 200mg
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Sotalol
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Alternatives
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- Treatment should only be intiated on the advice of a cardiologist.
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Celiprolol Hydrochloride
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Restricted
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- For specialist use in the treatment of patients who cannot tolerate other beta-blockers. Treatment should only be intiated on the advice of a cardiologist.
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Nadolol
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Restricted
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- Limited to use by cardiologists in patients with long QT syndrome/idiopathic ventricular fibrillation.
- Liquid formulations (unlicensed) can be obtained for use in children if necessary. Treatment should only be on the advice of a cardiologist.
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Nebivolol
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Restricted
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- For specialist use in the treatment of patients who cannot tolerate other beta-blockers. Treatment should only be on the advice of a cardiologist.
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02.05 |
Drugs affecting the renin-angiotensin system and some other antihypertensive drugs |
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02.05.01 |
Vasodilator antihypertensive drugs |
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Hydralazine
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Formulary
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Minoxidil
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Formulary
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- Treatment should only be on the advice of a cardiologist/nephrologist.
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Diazoxide
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Formulary
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Sodium nitroprusside
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Formulary
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- unlicensed import
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Ambrisentan
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Formulary
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
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Bosentan
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Formulary
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
- Approved for systemic sclerosis with ongoing digital ulcer disease (to reduce number of new digital ulcers) - in accordance with NHS England Commissioning policy.
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Sildenafil and Bosentan for the Treatment of Digital Ulceration in Systemic Sclerosis
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Epoprostenol
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Formulary
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
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Hydralazine Injection
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Formulary
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Iloprost
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Formulary
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
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Macitentan
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Formulary
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
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Riociguat
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Formulary
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- Approved for Chronic Thromboembolic Pulmonary Hypertension - in accordance with NHS England Commissioning policy.
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Tadalafil
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Formulary
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- Approved for pulmonary hypertension in adults for whom treatment with sildenafil is not tolerated or effective (in accordance with NHS England Commissioning policy).
- Approved for systemic sclerosis with ongoing digital ulcer disease (to reduce number of new digital ulcers) - in accordance with NHS England Commissioning policy.
- Approved for secondary Raynaud's.
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Treprostinil
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Unlicensed
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- Approved for pulmonary hypertension - in accordance with NHS England Commissioning policy.
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02.05.02 |
Centrally acting antihypertensive drugs |
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Clonidine 100 microgram tablets
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Formulary
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- Treatment should be on the advice of a cardiologist/nephrologist.
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Clonidine 150 microgram in 1ml injection
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Formulary
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- For use in paediatric cardiac ITU and in adult ITU patients with delerium and agitation, often around extubation unlicensed.
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Methyldopa
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Formulary
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Moxonidine
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Formulary
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02.05.03 |
Adrenergic neurone blocking drugs |
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02.05.04 |
Alpha-adrenoceptor blocking drugs |
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Doxazosin
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Formulary
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02.05.04 |
Phaeochromocytoma |
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Phenoxybenzamine
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Formulary
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Phentolamine
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Formulary
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02.05.05 |
Drugs affecting the renin-angiotensin system |
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02.05.05.01 |
Angiotensin-converting enzyme inhibitors (ACE inhibitors) |
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Lisinopril
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First Choice
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Ramipril
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First Choice
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- Most cost effective formulation to be prescribed
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Enalapril
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Alternatives
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- For use in breastfeeding mothers only. Breastfeeding mothers should be converted to ramipril when they are no longer breastfeeding.
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Perindopril erbumine
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Alternatives
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- Perindopril is third line for all indications including prevention of stroke.
- Note: Perindopril arginine is Non-Formulary.
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Items not to be routinely prescribed in primary care
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Captopril
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Alternatives
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- Treatment should only be on the advice of a hospital paediatrician.
- 5mg in 5ml suspension are also approved for use.
- 2mg capsules are also approved for use unlicensed.
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02.05.05.02 |
Angiotensin-II receptor antagonists |
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Losartan
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First Choice
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- To be used as first line treatment in all new patients.
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Candesartan
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Alternatives
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Irbesartan
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Alternatives
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- Only to be used in the treatment of exisiting patients.
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Valsartan
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Alternatives
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- Only to be used in the treatment of existing patients.
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Sacubitril & valsartan (Entresto®)
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Alternatives
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- Only approved for use in accordance with NICE guidance.
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NICE TA388: Sacubitril valsartan for heart failure (updated 16/7/16 to include adoption resources)
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02.05.05.03 |
Renin inhibitors |
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02.06 |
Nitrates, calcium-channel blockers, and potassium-channel activators |
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02.06.01 |
Nitrates |
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Glyceryl Trinitrate
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Formulary
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- 400 microgram/metered dose spray .
5mg & 10mg/day patches - for use in cardiothoracic critical care unit..
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Glyceryl Trinitrate Injection
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Formulary
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- 5mg in 5ml , 50mg in 10ml & 50mg in 50ml injections
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Isosorbide Dinitrate 10mg in 10ml injection
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Formulary
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Isosorbide Mononitrate 10mg, 20mg and 40mg tablets, and 60mg MR tablets
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Formulary
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- 10mg, 20mg and 40mg tablets
- 60mg MR tablets - should only be used in patients when the non-modified release tablets are unsuitable .
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02.06.02 |
Calcium-channel blockers |
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Amlodipine
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First Choice
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- Preferred calcium channel blocker for treating hypertension.
- If a 10mg dose is not tolerated e.g. due to leg/ankle
oedema, consider reducing dose before changing to an alternative such as lercanidipine.
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MHRA Drug Safety Update (Dec 2014): Simvastatin: dose limitations with concomitant amlodipine or diltiazem
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Diltiazem
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First Choice
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- Preferred calcium channel blocker for angina.
- Zemtard® is the formulary brand of choice for starting new patients on long acting diltiazem.
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MHRA Drug Safety Update (Dec 2014): Simvastatin: dose limitations with concomitant amlodipine or diltiazem
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Felodipine
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Formulary
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- M/R tablets: 2.5mg, 5mg, 10mg
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Nimodipine Injection
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Formulary
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- 10mg in 50ml for IV infusion
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Verapamil Injection
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Formulary
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- Injection: 5mg/2ml (2.5mg/1ml)
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Lercanidipine
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Alternatives
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- For use as a second line calcium channel blocker where amlodipine is not tolerated.
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Nifedipine
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Alternatives
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- Once daily formualtions are preferred
- 20mg controlled release tablets (Adalat LA), 30mg & 60mg m/r capsules (Coracten XL)
- 5mg & 10mg capsules
- 10mg & 20mg retard tablets
- 20mg in 1ml (1mg/drop) nifedipine oral solution is also approved for use unlicensed.
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Verapamil
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Alternatives
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- Tablets - 40mg, 80mg, 120mg, 160mg
- MR Tablets - 240mg
- Oral Solution - 40mg/5ml
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Nimodipine
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Alternatives
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- 30mg tablets - treatment should be on the advice of the stroke team or a cardiologist.
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Nicardipine 1mg in 1ml injection
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Alternatives
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- Approved as a second line agent for the treatment of aortic dissection and pre-eclampsia.
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02.06.03 |
Other anitanginal drugs |
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Nicorandil
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Formulary
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MHRA Drug Safety Update (Jan 2016): Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications
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Ivabradine
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Formulary
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- Angina - for intiation on advice from a consultant cariologist in patients with contra-indications to or intolerance of beta-blockers.
- Heart failure - approved for use in accordance with NICE guidelines.
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NICE CG126: Guidance on Stable Angina (2011)
MHRA Drug Safety Update (Dec 2014): Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects
NICE TA267: Ivabradine for treating chronic heart failure
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Ranolazine
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Formulary
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- For use in the treatment of angina in those patients for whom other treatments have been unsuccesful.
- Initial prescribing should be by a consultant cardiologist only.
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NICE CG126: Guidance on Stable Angina (2011)
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02.06.04 |
Peripheral vasodilators and related drugs |
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Naftidrofuryl
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Formulary
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- Approved for the treatment of intermittent claudication in people with peripheral arterial disease.
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NICE CG147: Lower limb peripheral arterial disease management
NICE TA223: Intermittent claudication drugs
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02.06.04 |
Other preparations used in peripheral vascular disease |
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02.07 |
Sympathomimetics |
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02.07.01 |
Inotropic sympathomimetics |
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Dobutamine
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Formulary
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Dopamine
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Formulary
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Isoprenaline
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Unlicensed
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Levosimendan
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Unlicensed
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- Approved for use in weaning paediatric and adult patients off extracorporeal membrane oxygenation (ECMO).
- Approved for use in paediatrics and adults where additional intravenous inotropic support is considered appropriate.
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02.07.02 |
Vasoconstrictor sympathomimetics |
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Noradrenaline / Norepinephrine
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Formulary
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Ephedrine
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Formulary
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- 30mg in 1ml injection
- 30mg in 10ml syringe unlicensed.
- 15mg tablets.
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Metaraminol
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Formulary
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Midodrine
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Formulary
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- For specialist initiation in treating symptomatic hypotension that has not responsed to conventional therapies.
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Phenylephrine
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Formulary
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02.07.03 |
Cardiopulmonary resuscitation |
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Adrenaline (epinephrine)
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Formulary
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- 1 in 1,000 injections in 1ml syringes and 1ml & 10ml ampoules.
- 1 in 10,000 injections in 1ml & 10ml ampoules & syringes.
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02.08 |
Anticoagulants and protamine |
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Defibrotide
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Formulary
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- Approved for use in severe veno-occlusive disease following stem cell transplant - in accordance with NHS England commissioning policy.
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Use of defibrotide in severe venoocclusive disease following stem cell transplant
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Idarucizumab
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Formulary
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- Approved for use as a rapid reversal agent for dabigatran.
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02.08.01 |
Parenteral anticoagulants |
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Argatroban
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Formulary
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- For use on advice of haematologists in patients with heparin induced thrombocytopenia.
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Heparin
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Formulary
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02.08.01 |
Low molecular weight heparins |
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Enoxaparin (Inhixa®)
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Formulary
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- Use during pregnancy and for pre-operative bridging therapy .
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Venous thromboembolic diseases: diagnosis, management and thrombophilia testing
Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism
Shared Care Guideline (CUMBRIA ONLY) - Low Molecular Weight Heparin (LMWH) - Enoxaparin
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Tinzaparin
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Formulary
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- Use during pregnancy and for pre-operative bridging therapy .
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Venous thromboembolic diseases: diagnosis, management and thrombophilia testing
Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism
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Danaparoid
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Formulary
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- For use on advice from haematologists in patients who develop thrombocytopenia with heparins - cross reactivity with heparin antibodies is thiought to be <10%.
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Bivalirudin
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Formulary
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- Approved for preventing thrombosis in patients undergoing percutaneous coronary artery interventions.
- For use instead of abciximab in some low risk patients.
- Approved in combination with aspirin and clopidogrel for the treatment of adults with ST segment elevation MI undergoing percutaneous coronary intervention, in accordance with NICE guidance.
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NICE NG185: Acute coronary syndromes
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02.08.01 |
Heparin flushes |
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Heparin (Flush)
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Formulary
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- 50 units in 5ml & 200 units in 2ml – for flushing cannulae
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TauroHep® (Taurolidine and citrate catheter lock solution with heparin)
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Formulary
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- Approved for use in the prevention of central intravenous line infections
in; haemodialysis patients, adult parenteral nutrition patients, patients with recurrent line infections, and immune deficiency unit patients.
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TauroLock® (Taurolidone and citrate catheter lock solution)
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Formulary
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- Approved for use in the prevention of central intravenous line infections in; haemodialysis patients, adult parenteral nutrition patients, patients with recurrent line infections, and immune deficiency unit patients.
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Epoprostenol
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Formulary
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- For pulmonary hypertension see section 2.5.1
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Iloprost
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Formulary
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- Mainly for use in treating pulmonary hypertension - see secton 2.5.1
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Fondaparinux
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Formulary
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- Approved for high risk orthopaedic surgery pateints and as an alternative to enoxaparin in accordance with NICE guidance.
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Venous thromboembolic diseases: diagnosis, management and thrombophilia testing
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02.08.02 |
Oral anticoagulants |
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Warfarin
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Formulary
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- 500 microgram, 1mg, 3mg & 5mg tablets .
- 1mg/1ml oral suspension - - for use in paediatric patients on mechanical support using ventricular assistance devices, and for patients with mechanical heart valves or irregular heart rythms who have not been weaned .
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MHRA Drug Safety Update (July 2016): Warfarin: reports of calciphylaxis
MHRA Drug Safety Update (Oct 2020): Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic
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Phenindione
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Formulary
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Acenocoumarol (Sinthrome®)
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Formulary
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Andexanet alfa (Ondexxya®)
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Formulary
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- 200mg powder for solution for infusion
- Approved for reversing anticoagulation from apixaban and rivaroxaban in adults with life-threatening or uncontrolled bleeding in line with NICE
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NICE TA697: Andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban
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Apixaban
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA245: Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults
NICE TA275: Apixaban for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation
NICE TA341: Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
MHRA Drug Safety Update June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
|
Dabigatran
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
|
MHRA Drug Safety Update Dec 2014: Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment
MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
MHRA Drug Safety Update June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
NICE TA157: Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults
NICE TA249: Dabigatran for Stroke prevention in AF
NICE TA327: Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
|
Edoxaban
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
|
MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
NICE TA354: Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism
NICE TA355:Edoxaban for preventing stroke/systemic embolism in non‑valvular atrial fibrillation
|
Rivaroxaban
|
Formulary
|
- 2.5mg, 10mg, 15mg & 20mg tablets
- 1mg/1ml granules for oral suspension
- approved for the treatment of VTE in children
- Only approved for use in accordance with NICE guidance.
|
MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
MHRA Drug Safety Update July 2019: Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
MHRA Drug Safety Update June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
MHRA Drug Safety Update Oct 2018: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
NICE TA170: Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults
NICE TA256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation
NICE TA261: Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism
NICE TA287: Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism
NICE TA335: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome
|
Rivaroxaban (For CAD/PAD)
|
Formulary
|
- Rivaroxaban co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
- Approved for use in accordance with NICE TA607
|
MHRA Drug Safety Alert June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
MHRA Drug Safety Update July 2019: Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
MHRA Drug Safety Update Oct 2018: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
NICE TA607: Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease
|
|
|
|
02.08.02 |
Stroke prevention in AF |
|
|
02.08.02 |
VTE treatment |
|
|
02.08.02 |
VTE prophylaxis in hip/knee surgery |
|
|
|
02.08.03 |
Protamine sulphate |
|
|
Protamine Sulphate
|
Formulary
|
|
|
|
Aspirin
|
Formulary
|
- 75mg dispersible tablets
- Note: 75mg e/c tablets – no longer recommended for use.
|
|
Cangrelor (Kengrexal®)
|
Formulary
|
- 50mg powder for concentrate for solution for injection/infusion
- Approved for bridging therapy in patients who have recently had a coronary stent but require urgent elective surgery
|
|
Clopidogrel
|
Alternatives
|
- Approved for use in cardiac patients being fitted with stents/acute coronary syndromes and where aspirin is contraindicated/not tolerated, despite its use in combination with acid suppressants e.g. omeprazole.
- Approved ischaemic stroke; in peripheral arterial/multivascular disease; or after MI only if aspirin not suitable in line with NICE.
- The North of Tyne APC recommends the use of generic 75mg clopidogrel tablets in all the approved indications for clopidogrel.
- Care should be taken to ensure that the brand supplied is suitable if it is to be packed into monitored dosage systems.
|
MHRA Drug Safety Update (December 2013): Clopidogrel - risk of acquired haemophilia with clopidogrel
NICE TA210: Clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events
|
Dipyridamole
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
- 50mg in 5ml sugar free suspension alos avialable unlicensed.
|
NICE TA210: Clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events
|
Prasugrel
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
|
MHRA Drug Safety Update (January 2014): Prasugrel (Efient): increased risk of bleeding – advice around timing of loading dose for prasugrel
NICE TA317 (replaces TA182): Acute coronary syndrome - prasugrel
|
Ticagrelor
|
Alternatives
|
- Only approved for use in accordance with NICE guidance.
|
NICE TA236: Ticagrelor for the treatment of acute coronary syndromes
NICE TA420: Ticagrelor for preventing atherothrombotic events after myocardial infarction
|
Tirofiban
|
Alternatives
|
|
|
Abciximab
|
Alternatives
|
|
|
Aspirin 500mg in 5ml injection
|
Unlicensed
|
- For specialist use in the endovascular treatment of cerebral
aneurysms
|
|
Clopidogrel 75mg in 5ml suspension
|
Unlicensed
|
- Approved for use in paediatric patients with Berlin Heart devices.
|
|
|
|
|
|
|
02.10 |
Stable angina, acute coronary syndromes, and fibrinolysis |
|
|
|
02.10.01 |
Management of stable angina and acute coronary syndromes |
|
|
02.10.02 |
Fibrinolytic drugs |
|
|
|
Primary Percutaneous Coronary Intervention (PCI) is now preferred to thrombolysis in patients with myocardial infarction with ST segment elevation (STEMI). |
|
Streptokinase
|
First Choice
|
|
|
Alteplase
|
Formulary
|
- 10mg, 20mg, and 50mg injections.
- Also approved for stoke in accordance with NICE guidance.
- 2mg in 2ml injection - approved for unblocking intravenous lines, mainly in paediatric dialysis patients.
|
NICE NG128: Stroke and transient ischaemic attack in over 16s: diagnosis and initial management
NICE TA264: Ischaemic stroke (acute) - alteplase
|
Tenecteplase (Metalyse®)
|
Formulary
|
- 5,000 units (25mg) powder and solvent for solution for injection
- 10,000 units (50mg) powder and solvent for solution for injection
- Approved or treating acute ischaemic stroke in adults in line with NICE
|
NICE TA990: Tenecteplase for treating acute ischaemic stroke
|
Urokinase
|
Formulary
|
|
|
|
|
02.11 |
Antifibrinolytic drugs and haemostatics |
|
|
Tranexamic Acid
|
Formulary
|
- Also available as a 500mg in 5ml syrup unlicensed.
|
|
Tranexamic Acid Injection
|
Formulary
|
- 100mg/ml Solution for Injection
|
|
Aminocaproic acid
|
Unlicensed
|
- Approved for the use in paediatric patients undergoing extracorporeal membrane oxygenation (ECMO).
|
|
Aprotinin
|
Unlicensed
|
- For limited use in cardiothoracic surgery.
|
|
02.11 |
Blood-related products |
|
|
|
A range of blood factors including factors VII & VIII are stocked at the RVI for use in the treatment of haemophilia etc. |
|
Antithrombin III (Kybernin®)
|
Formulary
|
|
|
Beriplex - P/N® (Dried Prothrombin Complex)
|
Formulary
|
- Approved for reversing the effects of oral anticoagulants in patients with life or limb threatening bleeding in accordance with a regional protocol.
|
|
Factor IX (Fraction, Dried)
|
Formulary
|
|
|
Factor VIIa (Recombinant)
|
Formulary
|
|
|
Factor VIII (Fraction, Dried)
|
Formulary
|
|
|
Factor VIII (Inhibitor Bypassing Fraction)
|
Formulary
|
|
|
Factor XIII (Fraction, Dried)
|
Formulary
|
|
|
Fibrinogen
|
Formulary
|
|
|
Octanate
|
Formulary
|
- Approved for patients with severe Haemophilia A and an inhibitor and in whom there is agreement to undertake immune tolerance induction with a plasma derived product.
|
|
Octaplas and Octaplas LG
|
Formulary
|
- Solution for infusion containing 45-75mg/ml human plasma proteins.
|
|
Protein C Concentrate (Ceprotin®)
|
Formulary
|
|
|
Prothrombin Complex Concentrate (Octaplex®)
|
Formulary
|
|
|
02.12 |
Lipid-regulating drugs |
|
|
Alirocumab
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
|
NICE TA393: Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
|
Evolocumab
|
Formulary
|
- Approved for use in accordance with NICE guidance for treating primary hypercholesterolaemia.
- Approved for the treatment of homozygous familial hypercholesterolaemia in line with NHS England Commissioning policy.
|
NICE TA394: Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
|
Icosapent ethyl (Vazkepa®)
|
Formulary
|
- 998mg capsules
- Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:
- established cardiovascular disease (secondary prevention), defined as a history of any of the following:
- acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
- coronary or other arterial revascularisation procedures
- coronary heart disease
- ischaemic stroke
- peripheral arterial disease, and
- low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre
|
NICE TA805: Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides
|
Inclisiran (Leqvio®)
|
Formulary
|
- 284mg/1.5ml solution for injection pre-filled syringes
- Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults in line with NICE.
|
NICE TA 733 - Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia
|
|
|
|
|
02.12 |
Bile acid sequestrants |
|
|
Colestyramine
|
Formulary
|
- For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments.
- Also approved for the treatment of leflunomide toxicity .
|
|
Colesevelam
|
Formulary
|
- For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments.
|
|
|
Bempedoic acid (Nilemdo®)
|
Formulary
|
- 180mg tablets
- Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults in line with NICE and following the statin intensification pathway outlined in NEELI
|
NICE TA694 - Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia
|
Bempedoic acid with ezetimibe (Nustendi®)
|
Formulary
|
- Bempedoic acid 180mg & ezetimibe 10mg tablets
- Approved for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults in line with NICE and following the statin intensification pathway outlined in NEELI
|
NICE TA694 - Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia
|
Ezetimibe
|
Formulary
|
- Only approved for use in accordance with NICE guidance.
- For further information refer to NEELI.
|
NICE TA385: Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia
|
|
|
For initiation in lipid clinic only in patients with familial hypercholesterolaemia and/or those with substantial cardiovascular risk and who are unable to tolerate existing treatments. |
|
Fenofibrate
|
First Choice
|
For initiation in lipid clinic only in patients with combined hyperlipidaemias and severe hypertriglycerideamia.
|
MHRA Drug Safety Update (Dec 2010): Fibrates: first-line treatment not recommended
|
Bezafibrate
|
Formulary
|
|
MHRA Drug Safety Update (Dec 2010): Fibrates: first-line treatment not recommended
|
|
Atorvastatin
|
First Choice
|
- 10mg, 20mg, 40mg & 80mg tablets
|
|
Rosuvastatin
|
Formulary
|
- 5mg, 10mg, 20mg & 40mg tablets
- May be used as an alternative to atorvastatin for primary or secondary prevention in line with NEELI guidance
|
|
Simvastatin
|
Alternatives
|
- 10mg, 20mg. 40mg & 80mg tablets
|
MHRA Drug Safety Update (Dec 2014): Simvastatin: dose limitations with concomitant amlodipine or diltiazem
|
Atorvastatin Chewable
|
Alternatives
|
- 10mg and 20mg chewable tablets
- Note: atorvastatin 10mg and 20mg chewable tablets should be used instead of simvastatin suspension where solid dosage forms cannot be used.
|
|
Pravastatin
|
Alternatives
|
- 10mg, 20mg & 40mg tablets
|
|
02.12 |
Nicotinic acid group |
|
|
02.12 |
Omega-3 fatty acid compounds |
|
|
|
02.12 |
Other lipid modifying agents |
|
|
|
Ethanolamine Oleate
|
Formulary
|
|
|
Sodium Tetradecyl Sulphate
|
Formulary
|
|
|
02.14 |
Drugs affecting the ductus arteriosus |
|
|
Indometacin 1mg injection
|
First Choice
|
unlicensed
|
|
Ibuprofen 10mg injection (Pedea®)
|
Formulary
|
- Approved only for use when there is a supply problem with indometacin.
|
|
|
Dapafliflozin (Forxiga®)
|
Formulary
|
- 5mg and 10mg tablets
- Approved for treating chronic heart failure with reduced ejection fraction in line with NICE
- Approved for treating chronic heart failure with preserved or mildly reduced ejection fraction in adults in line with NICE
|
NICE TA679: Dapagliflozin for treating chronic heart failure with reduced ejection fraction
NICE TA902: Dapagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction
|
Empagliflozin (Jardiance®)
|
Formulary
|
- 10mg and 25mg tablets
- Approved for the treatment of chronic heart failure with reduced ejection fraction in adults in line with NICE
- Approved for the treatment of chronic heart failure with preserved or mildly reduced ejection fraction in line with NICE
|
NICE TA773: Empagliflozin for treating chronic heart failure with reduced ejection fraction
NICE TA929: Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction
|
|
|
Mavacamten (Camzyos®)
|
Formulary
|
- Approved as an option for treating symptomatic obstructive hypertrophic cardiomyopathy in adults who have a New York Heart Association class of 2 to 3 in line with NICE and NHSE Specialised Commissioning guidance.
- It is recommended only if:
- it is an add‑on to individually optimised standard care that includes beta‑blockers, non-dihydropyridine calcium-channel blockers or disopyramide, unless these are contraindicated.
The following providers are commissioned to provide this service:
- North Cumbria Integrated Care NHS Foundation Trust
- South Tees Hospitals NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
|
NICE TA913: Mavacamten for treating symptomatic obstructive hypertrophic cardiomyopathy
|
.... |
Non Formulary Items |
Aliskiren
|
Non Formulary
|
- Note: not to be prescribed in new patients (July 2019).
- Existing patients should be reviewed to evaluate ongoing care plans
|
Items not to be routinely prescribed in primary care
|
|
Key |
|
|
Cytotoxic Drug
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
NHS England |
|
Homecare |
|
CCG |
|
Traffic Light Status Information
Status |
Description |
|
Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
|
Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
|
Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
|
Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
|
NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
|
UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
|
NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
|
|
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