paediatrics Flashcards
What is an unlicensed medicines?
They do not have a marketing authorisation or product license in the UK (issued by either the MHRA or EMA)
Examples include imported medicines, extemporaneous preparations, manufactured specials or products manipulated in a ways that is not stipulated in the SPC e.g. opening capsules.
What is an off-label medicine?
They do have a marketing authorisation or product licence but are used outside of their recommendations listed in the SPC e.g. differ doses age group, indiction or route.
Do we need consent from parents to use unlicensed or off label medicines ?
Yes
Topical preparations in neonates
Thin skin - can cause toxicity
IV administration
Small veins - can cause irritation
new purchase contracts
- displacement values may need to be recalculated
- new stability work - QC
What are the problems with some preservatives we have in children’s medicines?
Parabens (preservative) - Hypersensitivity reported from oral formulations (pruritus, respiratory depression and rash) avoid neonates with liver problems due to risk of jaundice (as it can effect bilirubin binding)
- benzyl alcohol, benzoates, benzoic acid - fatal reactions have accord in pre-term babies and neonates due to accumulation of benzoic acid.limit to 5mg/kg/day and avoid in pre-term very low weight newborn babies.
- propylene glycol (solvent, preservative) ADR’s include seizures, CNS toxicity, ototoxicity, hyperosmolity and lactic acidosis. Children < 4 years old have a limited metablock pathway resulting in accumulation of propylene glycol. There are large amounts in some injections
Ethanol - some oral preparations contain up to 30% ethanol. adverse reactions CNS, cardiovascular system, respiration, drug absorption, metabolism and interactions.Long term effects in chronic dosing are unknown. Ethanol blood conc max 25mg/100ml.
Colouring (to aid compliance) - FD and C yellow no5 cause hives and hyperactivity.
Excipients that paediatrics cannot tolerate
Parabens (preservatives)
benzoic acid, benzyl alcohol, benzoate’s (preservatives)|
Propylene glycol (solvent/preservative)
Ethanol (solvent/preservative)
Colourings
Do specials require a license to be produced?
yes
- can provide a certificate of conformity (dissolution tests particle size control, homogeneity tests to ensure dose reproducibility)
Children should be referred for investigations if any of the following are present
unexplained feeding difficulties distressed behaviour faltering growth chronic cough/hoarsness single episode of pneumonia
GORD symptoms
0-23 months - regurgitation, crying, feeding difficulties
2-11 years - regurgitation, heartburn, chronic cough
12-17 : regurgitation heart burn
options to combat GORD
- smaller more frequent feeds (maintaining the same daily amount 150ml/kg/day)
- thickener added (which is weaned on improvement)
- alginate therapy (gaviscon). If trial of this is successful continue untill weaning on solid foods.
if symptoms still persist: (<12)
1) ranitidine - 4 week trial
2) PPI - 4 week trial
> 12 - 4 week trial of PPI
alginates should not be used in children….
- at risk of dehydration
- at risk of obstruction
- pre-term infants
- renal impairment
- congestive heart failure (sodium content)
risks of long term PPI’s
C.diff increased bone fractures acute interstitial fracture CAP low magnesium B12 deficiency rebound acid hyper-secretion
Why may breast fed infants not like ‘gaviscon infant’
it has a salty taste when mixed with water
ranitidine concerns
doses <15mg can only be given with a 1 ml syringe which most community pharmacies probably don’t stock. IT should not be diluted.
It also contains sorbitol, salt and 8% ethanol
ethanol safety levels
1-5.9mg/kg/day of ethanol is safe in children up to 6 years old.
6-75mg/kg/day ethanol is safe in 6-12 years old
PPI concerns
There are minimum weights on the products
- 1.7kg om omeprazole 10mg MUPS
- 3.3kg for omeprazole 10mg capsules
- 7.5kg for lansoprazole 15mf orodispersible tableys
- 10kg for esomeprazole 10mg granules
Domperidone
Metoclopramise side effects
Cardiac
Neurological
Alienate therapy in infants
- should not be used with thick and easy formula together
- should not be used in pre-term infants
- initial trial should be 1-2 weeks
constipation diagnosis
1) less than 3 complete stools per week
2) hard large stool
3) rabbit droppings
Patient gets two or more points in the chart in regards to pattern, symptoms associated with defection and the history.
idiopathic constipation is diagnosed when….
- timing of onset of constipation with potential precipitating factors (change in diet, potty training, arrival of new siblings, starting nursery)
- normal passage of meconium as birth
- generally well with weight and heigh within normal limits
- no symptoms in legs normal locomotor development
- changes in infant formila, weaning, insufficiency fluid intake
If recurrent children may be tested for coeliac disease and hypothyroidism
Should we advised unprocessed bran in children?
no it can cause bloating, flatulance and reduced absorption of micronutrients.
dietary recommendations - fruit, veg, high fibre bread, baked beans, wholegrain breakfast cereals.
Constipation treatment - maintenance therapy
- macrogol
- stimulant laxative
- macrogol not tolerated substitute with stimulant in addition or with another osmotic laxative.
Inform families that disimpaction treatment can cause soiling and abode pain.
Enemas should only be trials after all oral meds have been exhausted. Micro lax are not licensed in <3 years however they are used.
impaction should always try to be removed prior to maintenance
Always discontinue gradually depending ons school frequency and consistency
