Dexamethasone 2mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Dexamethasone

Disponível em:

Teva UK Ltd

Código ATC:

H02AB02

DCI (Denominação Comum Internacional):

Dexamethasone

Dosagem:

2mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06030200; GTIN: 5060032240640 5060032240657 5060032240664

Folheto informativo - Bula

148 x 420 mm Zonder Laetuscode.indd 1
08-05-13 15:18
DEXAMETHASONE 2 MG TABLETS
•
calcium supplements
•
medicines for pain and inflammation called
NSAIDs such as ibuprofen, diclofenac or naproxen
•
a medicine for urea cycle disorder called sodium
phenylbutyrate (usually started by a specialist
doctor or consultant)
•
medicines for diabetes
•
medicines for heartburn, indigestion or stomach
ulcers, called antacids
•
medicines used to treat a condition called
myasthenia gravis
•
medicine for glaucoma such as acetazolamide.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist BEFORE taking
Dexamethasone.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Dexamethasone can reach your baby and may slow
its growth. Small amounts of dexamethasone may get
into breast milk; tell your doctor if you are
breast-feeding.
DRIVING AND USING MACHINES
Steroids may cause a feeling of movement, even
while you are still and this can cause you to feel dizzy
(vertigo). Changes in your eyesight or muscle
weakness may also happen. If you are affected you
should not drive or operate machinery.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF DEXAMETHASONE
This medicine contains lactose monohydrate. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg)
per tablet, that is to say essentially ‘sodium-free’.
REMEMBER ALWAYS TO CARRY A STEROID TREATMENT
CARD. MAKE SURE YOUR DOCTOR OR PHARMACIST GIVES
YOU THIS AND HAS FILLED OUT THE DETAILS INCLUDING
THE DOSE AND HOW LONG YOU WILL HAVE TREATMENT.
If you have surgery, an accident or become unwell
while taking this medicine, tell whoever is treating you
that you are taking Dexamethasone tablets.
Always take this medicine exactly as your doctor or
pharmacist has told you.

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dexamethasone 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0 mg dexamethasone.
Contains lactose monohydrate (68.8mg per tablet); for a full list of
excipients,
see section 6.1.
3
PHARMACEUTICAL FORM
Round white tablet, one side marked DX
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated in a wide variety of disorders amenable to glucocorticoid
therapy, as well as
an adjunct in the control of cerebral oedema.
Dexamethasone is indicated in the treatment of coronavirus disease
2019 (COVID-19)
in adult and adolescent patients (aged 12 years and older with body
weight at least 40
kg) who require supplemental oxygen therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In general, glucocorticoid dosage depends on the severity of the
condition and
response of the patient. Under certain circumstances, for instance in
stress and
changed clinical picture, extra dosage adjustments may be necessary.
If no favourable
response is noted within a couple of days, glucocorticoid therapy
should be
discontinued.
_Adults _
Usually, daily oral dosages of 0.5 - 10 mg are sufficient. In some
patients higher
dosages may be temporarily required to control the disease. Once the
disease is under
control, the dosage should be reduced or tapered off to the lowest
suitable level under
continuous monitoring and observation of the patient (See Section
4.4).
For a short dexamethasone suppression test, 1 mg dexamethasone is
given at
11 pm and plasma cortisol measured the next morning. Patients who do
not show a
decrease in cortisol can be exposed to a longer test: 500 micrograms
dexamethasone is
given at 6 hourly intervals for 48 hours followed by 2 mg every 6
hours for a further
48 hours. Twenty-four hour urine collections are made before, during
and at the end
of the test for determination of 17-hydroxycorticosteroids.
_Children_
0.01-0.1 mg/kg of body weight daily.
Dosage of glucocorticoids should be adjusted on the basis of the
individ