HYDROCORTISONE 10 MG TABLETS

Active substance: HYDROCORTISONE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 10 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg hydrocortisone.
Excipient(s) with known effect: lactose monohydrate (199.94 mg per tablet).
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Tablet.
A white, round, biconvex tablet.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
Hydrocortisone Tablets are indicated for replacement therapy in congenital
adrenal hyperplasia in children.
Hydrocortisone Tablets are also used for the emergency treatment of severe
bronchial asthma, drug hypersensitivity reactions, serum sickness,
angioneurotic oedema and anaphylaxis in adults and children.

4.2.

Posology and method of administration
For oral administration.
Replacement therapy
Children: 10-30 mg in divided doses is the normal daily requirement (see also section
4.4, Special Warnings and Precautions for Use).

In patients requiring replacement therapy, the daily dose should be given when
practicable, in two doses. The first dose in the morning should be larger than the
second dose in the evening, thus simulating the normal diurnal rhythm of cortisol
secretion.
Acute emergencies
60-80 mg every 4-6 hours for 24 hours then gradually reduce the dose over several
days.
Steroids should be used cautiously in the elderly, since adverse effects are enhanced
in old age (see section 4.4, Special Warnings and Precautions for Use).
When long term treatment is to be discontinued, the dose should be gradually reduced
over a period of weeks or months, depending on dosage and duration of therapy (see
section 4.4, Special Warnings and Precautions for Use).
Undesirable effects may be minimised by using the lowest effective dose for the
minimum period, and by administering the daily requirement as a single morning
dose, or whenever possible, as a single morning dose on alternative days. Frequent
patient review is required to titrate the dose against disease activity.

4.3

Contraindications
Hydrocortisone Tablets are contraindicated in patients with known
hypersensitivity to any of the ingredients. They are also contraindicated in
patients with systemic infections (unless specific anti-infective therapy is
employed) and in patients vaccinated with live vaccines.

4.4

Special warnings and precautions for use
A patient information leaflet should be supplied with this product.
Adrenal suppression
Adrenal cortical atrophy develops during prolonged therapy and may persist
for years after stopping treatment. Withdrawal of corticosteroids after
prolonged therapy must therefore always be gradual to avoid acute adrenal
insufficiency, being tapered off over weeks or months according to the dose
and duration of treatment. During prolonged therapy, any intercurrent illness,
trauma or surgical procedure will require a temporary increase in dosage. If
corticosteroids have been stopped following prolonged therapy, they may need
to be temporarily re-introduced.
Patients should carry ‘Steroid Treatment’ cards which give clear guidance on
the precautions to be taken to minimise risk and which provide details of the
prescriber, drug, dosage and the duration of treatment.
Anti-inflammatory / immunosuppressive effects and infection

Suppression of inflammatory response and immune function increases the
susceptibility to infections and their severity. The clinical presentation can
often be atypical and serious infections such as septicaemia and tuberculosis
may be masked and may reach an advanced stage before being recognised.
New infections may appear during their use.
Chickenpox is of particular concern since this normally minor illness may be
fatal in immunosuppressed patients. Patients (or parents of children) without a
definite history of chickenpox should be advised to avoid close personal
contact with chickenpox or herpes zoster and if exposed they should seek
urgent medical attention. Passive immunisation with varicella / zoster
immunoglobulin (VZIG) is needed by exposed, non-immune patients who are
receiving systemic corticosteroids or who have used them the previous 3
months; should this be confirmed, the illness warrants specialist care and
urgent treatment. Corticosteroids should not be stopped and the dose may need
to be increased.
Patients should be advised to take particular care to avoid exposure to measles
and to seek immediate medical advice if exposure occurs. Prophylaxis with
intramuscular normal immunoglobulin may be needed.
Live vaccines should not be given to individuals with impaired immune
responsiveness caused by high doses of corticosteroids. Killed vaccines or
toxoids may be given though their effects may be attenuated.
Particular care is required when prescribing systemic corticosteroids in
patients with the following conditions and frequent patient monitoring is
necessary:
a)
osteoporosis (postmenopausal females are particularly at risk);
b)

hypertension or congestive heart failure;

c)

existing or previous history of severe affective disorders (especially
previous history of steroid psychosis);

d)

diabetes mellitus (or a family history of diabetes);

e)

previous history of tuberculosis or characteristic appearance on a chest
x-ray. The emergence of active tuberculosis can, however, be prevented
by the prophylactic use of anti-tuberculous therapy;

f)

glaucoma (or family history or glaucoma);

g)

previous corticosteroid-induced myopathy;

h)

liver failure;

i)

renal insufficiency;

j)

epilepsy;

k)

peptic ulceration;

l)

recent myocardial infarction.

During treatment, the patient should be observed for psychotic reactions,
muscular weakness, electrocardiographic changes, hypertension and untoward
hormonal effects.
Corticosteroids should be used with caution in patients with hypothyroidism.
Use in children:
Corticosteroids cause growth retardation in infancy, childhood and
adolescence; this may be irreversible. Treatment should be limited to the
minimum dosage for the shortest possible time, retardation (see section 4.2,
Posology and Method of Administration).
Use in the elderly:
The common adverse effects of systemic corticosteroids may be associated
with more serious consequences in old age, especially osteoporosis,
hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning
of the skin. Close clinical supervision is required to avoid life threatening
reactions (see section 4.2, Posology and Method of Administration).
Withdrawal symptoms:
In patients who have received more than physiological doses of systemic
corticosteroids (approximately 40 mg cortisone or equivalent) for greater than
3 weeks, withdrawal should not be abrupt. How dose reduction should be
carried out depends largely on whether the disease is likely to relapse as the
dose of systemic corticosteroids is reduced. Clinical assessment of disease
activity may be needed during withdrawal. If the disease is unlikely to relapse
on withdrawal of systemic corticosteroids but there is uncertainty about HPAaxis suppression, the dose of systemic corticosteroid may be reduced rapidly to
physiological doses. Once a daily dose equivalent to 40 mg cortisone is
reached, dose reduction should be slower to allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued
up to 3 weeks, is appropriate if it is considered that the disease is unlikely to
relapse. Abrupt withdrawal of doses of up to 200 mg daily of cortisone, or
equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis
suppression, in the majority of patients. In the following patient groups,
gradual withdrawal of systemic corticosteroid therapy should be considered
even after courses lasting 3 weeks or less:
• patients who have had repeated courses of systemic corticosteroids,
particularly if taken for greater than 3 weeks;


when a short course has been prescribed within one year of cessation of
long term therapy (months or years);



patients receiving doses of systemic corticosteroid greater than 200 mg
daily of cortisone (or equivalent);



patients repeatedly taking doses in the evening.

Patients/and or carers should be warned that potentially severe psychiatric
adverse reactions may occur with systemic steroids (see Section 4.8

Undesirable effects). Symptoms typically emerge within a few days or weeks
of starting the treatment. Risks may be higher with high doses/systemic
exposure (see also Section 4.5 Interaction with other medicinal products and
other forms of interaction), although dose levels do not allow prediction of the
onset, type, severity or duration of reactions. Most adverse reactions resolve
after either dose reduction or withdrawal of the medicine, although specific
treatment may be necessary. Patients/carers should be encouraged to seek
medical advice if worrying psychological symptoms develop, especially if
depressed mood or suicidal ideation is suspected. Patients/carers should also
be alert to possible psychiatric disturbances that may occur either during or
immediately after dose tapering/withdrawal of systemic steroids, although
such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids
in patients with existing or a previous history of severe affective disorders in
themselves or in their first degree relatives. These would include depressive or
manic-depressive illness and previous steroid psychosis.
Patients with rare hereditary problems of galactose intolerance, the Lapp
lactase deficiency or glucose-galactose malabsorption should not take this
medicine.

4.5

Interaction with other medicinal products and other forms of interaction
The metabolism of corticosteroids may be enhanced and the therapeutic effects
reduced by certain barbiturates (e.g. phenobarbital) and by phenytoin,
rifampicin, rifabutin, primidone, carbamazepine and aminoglutethimide.
Mifepristone may reduce the effect of corticosteroids for 3-4 days.
Erythromycin and ketoconazole may inhibit the metabolism of corticosteroids.
Ritonavir may increase the plasma concentration of hydrocortisone.
Oestrogens and other oral contraceptives increase the plasma concentration of
corticosteroids, and dosage adjustments may be required if oral contraceptives
are added to or withdrawn from a stable dosage regimen.
The growth promoting effect of somatropin may be inhibited by the
concomitant use of corticosteroids.
The desired actions of hypoglycaemic drugs (including
antihypertensives and diuretics are antagonised by corticosteroids.

insulin),

The effectiveness of coumarin anticoagulants may be affected by concurrent
corticosteroid therapy and close monitoring of the INR or prothrombin time is
required to avoid spontaneous bleeding.

Serum levels of salicylates, such as aspirin and benorilate, may increase
considerably if corticosteroid therapy is withdrawn, possibly causing
intoxication. Concomitant use of salicylates or of non-steroidal antiinflammatory drugs (NSAIDs) with corticosteroids increases the risk of
gastrointestinal bleeding and ulceration.
The potassium-depleting effects of acetazolamide, loop diuretics, thiazide
diuretics and carbenoxolone are enhanced by corticosteroids and signs of
hypokalaemia should be looked for during their concurrent use. The risk of
hypokalaemia is increased with theophylline and amphotericin. Corticosteroids
should not be given concomitantly with amphotericin, unless required to
control reactions.
The risk of hypokalaemia also increases if high doses of corticosteroids are
given with high doses of sympathomimetics e.g. bambuterol, fenoterol,
formoterol, ritodrine, salbutamol, salmeterol and terbutaline. The toxicity of
cardiac glycosides, e.g. digoxin, is increased if hypokalaemia occurs.
Concomitant use with methotrexate may increase the risk of haematological
toxicity.
High doses of corticosteroids impair the immune response and so live vaccines
should be avoided (see also section 4.4, Special Warnings and Precautions for
Use).

4.6

Fertility, Pregnancy and lactation
Pregnancy
The ability of corticosteroids to cross the placenta varies between individual
drugs; however, cortisone readily crosses the placenta.
Administration of corticosteroids to pregnant animals can cause abnormalities
of foetal development including cleft palate, intra-uterine growth retardation
and affects on brain growth and development. There is no evidence that
corticosteroids result in an increased incidence of congenital abnormalities,
such as cleft palate / lip in man. However, when administered for prolonged
periods or repeatedly during pregnancy, corticosteroids may increase the risk
of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in
the neonate following prenatal exposure to corticosteroids but it is usually
resolved spontaneously following birth and is rarely clinically important. As
with all drugs, corticosteroids should only be prescribed when the benefits to
the mother and child outweigh the risks. When corticosteroids are essential
however, patients with normal pregnancies may be treated as though they were
in the non-gravid states.
Lactation
Corticosteroids are excreted in breast milk, although no data are available for
cortisone. Doses of up to 200 mg daily of cortisone are unlikely to cause
systemic effects in the infant. Infants of others taking higher doses than this

may have a degree of adrenal suppression but the benefits of breast feeding are
likely to outweigh any theoretical risk.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
The incidence of predictable undesirable effects, including hypothalamicpituitary-adrenal suppression correlates with the relative potency of the drug,
dosage, timing of administration and the duration of treatment (see section 4.4,
Special Warnings and Precautions for Use).
The following side effects may be associated with the long-term systemic use
of corticosteroids.
Anti-inflammatory and immunosuppressive effects:
Increased susceptibility and severity of infections with suppression of clinical
symptoms and signs, opportunistic infections, and recurrence of dormant
tuberculosis treatment (see section 4.4, Special Warnings and Precautions for
Use).
Gastrointestinal:
Dyspepsia, peptic ulceration with perforation and haemorrhage, abnormal
distension, oesophageal ulceration, candidiasis, acute pancreatitis.
Musculoskeletal:
Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular
osteonecrosis, tendon rupture.
Fluid and electrolyte disturbance:
Sodium and water retention, hypertension, potassium loss, hypokalaemic
alkalosis.
Dermatological:
Impaired healing, skin atrophy, bruising, striae, acne, telangiectasia.
Endocrine / metabolic:
Suppression of the hypothalamo-pituitary-adrenal axis, growth suppression in
infancy, childhood and adolescence, menstrual irregularity and amenorrhoea.
Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance
with increased requirement for antidiabetic therapy, negative protein and
calcium balance, and increased appetite.
Neuropsychiatric:

Euphoria, psychological dependence, depression, insomnia and aggravation of
schizophrenia. Increased intracranial pressure with papilloedema in children
(pseudotumour cerebri), usually after treatment withdrawal. Aggravation of
epilepsy.
Ophthalmic:
Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular
cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or
fungal diseases.
Cardiovascular:
Myocardial rupture following recent myocardial infarction.
General:
Hypersensitivity, including anaphylaxis has been reported. Nausea, malaise,
leucocytosis, thromboembolism.
Withdrawal symptoms:
Too rapid a reduction of corticosteroid dosage following prolonged treatment
can lead to acute renal insufficiency, hypotension and death (see section 4.4
Special warnings and precautions for use). A withdrawal syndrome may also
occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy
skin modules and weight loss.
A wide range of psychiatric reactions including affective disorders (such as
irritable, euphoric, depressed and labile mood, and suicidal thoughts),
psychotic reactions (including mania, delusions, hallucinations, and
aggravation of schizophrenia), behavioural disturbances, irritability, anxiety,
sleep disturbances, and cognitive dysfunction including confusion and amnesia
have been reported. Reactions are common and may occur in both adults and
children. In adults, the frequency of severe reactions has been estimated to be
5-6%. Psychological effects have been reported on withdrawal of
corticosteroids; the frequency is unknown.

4.9

Overdose
Overdosage may cause nausea and vomiting, sodium and water retention,
hyperglycaemia and occasional gastrointestinal bleeding. Treatment need only
be symptomatic although cimetidine (200-400 mg by slow intravenous
injection every 6 hours) or ranitidine (50 mg by slow intravenous injection
every 6 hours) may be administered to prevent gastrointestinal bleeding.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC code: H02A B09.
Hydrocortisone is an adrenal corticosteroid having glucocorticoid and some
mineralocorticoid properties.

5.2

Pharmacokinetic properties
Hydrocortisone given by mouth is readily absorbed from the gastrointestinal
tract. Hydrocortisone is extensively bound to plasma proteins and has a
biological half-life of about 100 minutes. Hydrocortisone is metabolised in the
liver and most body tissues to hydrogenated and degraded forms, such as
tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine,
mainly conjugated as glucuronides, together with a very small proportion of
unchanged hydrocortisone.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose monohydrate
Pregelatinised starch
Calcium stearate.

6.2

Incompatibilities
None stated.

6.3

Shelf life
Amber glass bottle: 24 months.
PVC/aluminium foil blister pack: 18 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
Amber glass bottle with HDPE/polypropylene cap containing 100 tablets.
PVC/aluminium foil blister packs containing 30 tablets.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Amdipharm PLC
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 20072/0238

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/09/2012

10

DATE OF REVISION OF THE TEXT
10/09/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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