authorization known as pediatric-use marketing authorization or PUMA
be granted for medicines which are already authorized, and have been
specifically developed for children; they should also no longer be
under protection. The pediatric-specific formulation of hydrocortisone
is named Alkindi.
in Primary Adrenal InsufficiencyHydrocortisone,
a glucocorticoid has been used to treat primary adrenal insufficiency both in
adults and children as a replacement therapy for the naturally occurring
cortisol in the body.
The aim of the treatment is
to reduce the symptoms of hormone deficiency without leading to increased
‘Primary adrenal insufficiency can now be treated with a hydrocortisone formulation that is specific for children suffering from primary adrenal insufficiency and one that results in a better therapeutic effect.’
The tablet form
of hydrocortisone, while easy for an adult to consume maybe difficult to be
swallowed by children who are nor old enough. Hence these tablets are crushed
and given to them based on their requirements. The powder or the crushed
tablets of hydrocortisone are really bitter to taste and children usually
refuse to take such unpleasant medications.
compounding there is also a possibility of medication error leading to the
child ingesting either an excess or a reduced amount of the medication that can
result in inappropriate pharmacological therapy.
formulation of hydrocortisone as oral granules for immediate release will
greatly reduce such risks of medication errors and also deliver more accurate
doses to children
. The granules also help in
masking the bitter taste and result in proper medication adherence finally
leading to better treatment outcomes.
is a steroid hormone known for its crucial role in regulating and maintaining
According to the WHO's list of essential
medicines, hydrocortisone is considered to be one of the most effective and
safe medications required in the healthcare system.
is an anti-inflammatory and immunosuppressive drug which is considered to be
the pharmaceutical form of cortisol available for topical application, oral
administration, and intravenous injection. It is found to be the drug of choice
for treating adrenocortical insufficiency.
was found effective in various disease conditions such as rheumatoid arthritis,
chronic obstructive pulmonary disease, asthma, thyroiditis, dermatitis,
androgenital syndrome, and hypercalcemia. It is necessary to taper the dose
slowly because the abrupt stopping of the drug results in withdrawal symptoms.
Primary Adrenal Insufficiency?Primary
adrenal insufficiency is a long-term hormonal disorder that occurs due to the
impairment of the adrenal glands resulting in inadequate secretion of certain
hormones by the adrenal
gland. It is commonly termed as Addison's disease
and usually occurs when the adrenal glands are damaged and as a result
cannot secrete an adequate quantity of the adrenal hormone called cortisol.
insufficiency, if left untreated leads to severely low blood pressure,
depression, weight loss, fluctuations in mood and personality, vomiting, muscle
weakness or fatigue, abdominal pain, electrolyte imbalance, and kidney damage.
Adrenal crisis is also reported in some cases due to the repeated exposure to
stress such as infection, injury, surgery or accidents. As a result, death
could also follow.
It is estimated
that nearly 110 to 144 of every 1 million people living in developed countries
suffer from primary adrenal insufficiency.
primary adrenal insufficiency are
- Autoimmune disease
- Tumor of the adrenal gland or
congenital adrenal hyperplasia
- Disease caused by unknown origin
- Adrenal Insufficiency & Addison's Disease - (https://www.niddk.nih.gov/health-information/endocrine-diseases/adrenal-insufficiency-addisons-disease)
- Predicting Cortisol Exposure from Paediatric Hydrocortisone Formulation Using a Semi-Mechanistic Pharmacokinetic Model Established in Healthy Adults - (https://www.ncbi.nlm.nih.gov/pubmed/28762136)
- Hydrocortisone - (https://www.pituitary.org.uk/information/treating-a-pituitary-condition/hydrocortisone/)