MHRA warnings Flashcards
all the MHRA warnings in the BNF baybee
polyethylene glycols
do not mix with starch based thickeners = thin watery suspension that may cause aspiration
stimulant laxative (bisocodyl)
remember diet and lifestyle is first line - this should only be used if lifestyle & bulk-forming and osmotic laxatives have been tried
should not be given if under 12 or 12-17 unless under a doctors request
Senna, sodium picosulfate
try diet and lifestyle measures first & other laxatives
over 12s only
Loperamide
serious cardiovascular events (QT prolongation; torsade de pointes; heart attack) including fatalities have been reported and associated with large overdoses
naloxone- antidote (may need repeated doses) & monitor 48 h for CNS depression
DO NOT EXCEED DOSE
PPIs
SCLE can occur weeks/ months after exposure
lesions (esp in areas that get a lot of sunlight) + arthralgia = avoid sunlight in that area & probably withdraw med
Hyoscine butylbromide injection
tachycardia, hypotension, anaphylaxis- more likely in those with underlying coronary heart disease
C/Ied in cardiac tachycardia, caution in CHD
ensure resus is available
Obeticholic acid
serious liver injuries and deaths
ensure dose is adjusted or liver impairment
Naltrexone with bupropion
dizziness, somnolence, loss of consciousness, seizure
may affect ability to drive esp in early treatment
corticosteroids
-central serious chorioretinopathy
- steroid emergency card bc adrenal suppression
- rebound flares if topical - dermatitis w intense redness, stinging, burning which may spread further than initial area-> use lowest strength, shortest duration
amiodarone
avoid with sofosbuvir- bradycardia / heart block
serious adverse effects- eyes, heart, lung, liver, thyroid, skin, PNS- may continue a month or longer after discontinuation- ensure regular review & LFTs, TFTs checked
seek advice if worsening symptoms of pulmonary toxicity/ serious adverse events
sotalol
qt interval prolongation-> life threatening ventricular arrhythmia
avoid hypokalaemia (correct hypoK/ Mg before starting)
reduce dose/ stop if qt interval if over 550msecs
andexanet alfa
dont use anti factor Xa assay - these may cause an underestimate of reversal of apixaban - use clinical parameters
avoid before use of heparin as reverses effect
apixaban, rivaroxaban, dabigatran (5)
1) new contraindications- lesions and conditions that carry sig risk of major bleed; use of other anticoagulants alongside; consider renal function
2) Larger risk compared to warfarin on of repeat thrombotic events with patients with antiphospholipid syndrome
3) remain vigilant for bleeds & adjust dose for renal impairment
4) may interact with some antibacterials and antivirals
5) if switching from warfarin, ensure that warfarin is stopped before DOAC started
specific to rivaroxaban
take 15/ 20mg tabes WITH FOOD
Vitamin K antagonist
1) for those on direct acting antivirals for hep C, changes in the liver function necessitate close INR monitoring
2) acute illness may exaggerate effect of warfarin and require dose reduction- INR needed more often
3) notify health care provider if unwell/ loss of appetite/ vom/ diarrhoea
change in diet/ smoking status/ alcohol consumption/ new meds/ supplements/ cannot make it to INR appt
warfarin specifically
calciphylaxis- calcium accumulates in skin= painful rash (common in end-stage renal disease)
hydrochlorothiazide
prolonged use- dose cumulative increase in risk of non-melonoma skin cancer- advise them to check regularly and report any changes
use sun protection, limit direct sunlight
reconsider choice if they have had skin cancers in past
Riociguat
increased mortality and severe adverse effects in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias- contraindicated in this group
noradrenaline/ norepinephrine
solution for infusion (0.08 and 0.16mg/ml) should not be diluted prior to use, and only be used for those established on noradrenaline therapy, where there dose is clinically proven to be escalating
adrenaline (3)
1) IV route should be used with extreme care by specialists only
2) give 2 autoinjectors- should be carried at all times- train on specific device, check expiration date regularly (can sign up for expiration alert services)
3) emerade 150s are discontinued
Use as soon as suspected allergic reaction occurs and call 999
tiotropium inhalers
braltus
ensure that capsules are stored in the screw bottle, not in the device itself, and check that the mouthpiece is clear before inhaling, never place the capsule in the mouthpiece- to avoid aspiration of capsule
salmeterol inhalers
LABAs should only be added if regular ICS are not controlling asthma sufficiently
should not be introduced if asthma is rapidly deteriorating
start low go slow
step back down to ICS when they have good long-term control
Inhaled corticosteroids
Central serious chorioretinopathy - report blurred vision/ other visual symptoms
steroid emergency card/ paediatric steroid emergency card
Beclometasone inhalers
prescribe by brand- Qvar (extra fine particles) is twice as potent as clenil modulite
Beclometasone with formoterol (trimbow)
fostair (extra fine particles) more potent than trimbow- dose may need to be adjusted when switching
Montelukast
be alert for neuropsychiatric reactions- esp speech impairment/ OCD symptoms in young people and adolescents -check risk/benefit if this occurs
Chlorphenamine maleate
Children under 6 should not be given cough/ cold mixtures containing this drug OTC
Hydroxyzine
small risk of QT interval prolongation& torsade de pointes
-> contraindicated if long QT or high risk of QT prolongation
-> max dose elderly= 50mg
-> max dose children < 40kg is 2mg/kg
use lowest effective dose
Promethazine
Children under 6 should not be given cough/ cold mixtures containing this drug OTC
Desensitising vaccines (e.g. bee venom/ grass pollen/ dust mite extract etc)
Should only be used by specialists for licensed indications - take particular care if they have asthma
Ivacaftor
risk of serious liver injury/ failure in those with cirrhosis or portal hypertension especially if taking kaftan with ivacaftor
-> check bilirubin, ALT and AST before treatment and every 3 mo during 1st year of tx, then annually (more often if they have liver disease) - caution
-> discontinue if significant changes in levels [ transaminases 5xULN/ transaminases are 3x ULN AND bilirubin is 2xULN] / live injury
Pholcodine
do not supply OTC to children under 6
if 6-12 can give after principles of best care have been tried - restricted to 5 days use