By Pharmaceutical Press
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Extra resources for British National Formulary (BNF) 68
Special care is needed in the neonatal period (first 28 days of life) and doses should always be calculated with care. At this age, the risk of toxicity is increased by reduced drug clearance and differing target organ sensitivity. Whenever possible, intramuscular injections should be avoided in children because they are painful. Where possible, medicines for children should be prescribed within the terms of the marketing authorisation (product licence). However, many children may require medicines not specifically licensed for paediatric use.
This is because experience in children may still be limited. The identification and reporting of adverse reactions to drugs in children and neonates is particularly important because: . the action of the drug and its pharmacokinetics in children (especially in the very young) may be different from that in adults; . drugs are not extensively tested in children; . many drugs are not specifically licensed for use in children and are used ‘off-label’ or as unlicensed products; Many children are able to swallow tablets or capsules and may prefer a solid dose form; involving the child and parents in choosing the formulation is helpful.
Other problems need to be considered. For example, Prescribing for children Although medicines cannot be promoted outside the limits of the licence, the Human Medicines Regulations 2012 does not prohibit the use of unlicensed medicines. It is recognised that the informed use of unlicensed medicines or of licensed medicines for unlicensed applications (‘off-label’ use) is often necessary in paediatric practice. It is particularly important to state the strengths of capsules or tablets. Although liquid preparations are particularly suitable for children, they may contain sugar which encourages dental decay.
British National Formulary (BNF) 68 by Pharmaceutical Press