Dexamethasone 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone

Available from:

Waymade Healthcare Plc

ATC code:

H02AB02

INN (International Name):

Dexamethasone

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

Package leaflet: Important information for the patient
DEXAMETHASONE 2MG TABLETS
The name of your medicine is Dexamethasone 2mg tablets but it will be
referred to as Dexamethasone throughout this
leaflet.

DEXAMETHASONE IS A STEROID MEDICINE, PRESCRIBED FOR MANY DIFFERENT
CONDITIONS INCLUDING SERIOUS ILLNESSES

YOU NEED TO TAKE IT REGULARLY TO GET THE MAXIMUM BENEFIT

DON’T STOP TAKING THIS MEDICINE WITHOUT TALKING TO YOUR DOCTOR-YOU
MAY NEED TO REDUCE THE DOSE GRADUALLY

DEXAMETHASONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(READ SECTION 4: POSSIBLE SIDE EFFECTS). SOME PROBLEMS SUCH AS MOOD
CHANGES (FEELING DEPRESSED, OR
‘HIGH’), OR STOMACH PROBLEMS CAN HAPPEN STRAIGHT AWAY. IF YOU FEEL
UNWELL, IN ANY WAY, KEEP TAKING YOUR
MEDICINE, BUT SEE YOUR DOCTOR STRAIGHT AWAY

SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS.
THESE INCLUDE WEAKNESS OF ARMS AND LEGS, OR DEVELOPING A ROUNDER FACE
(READ SECTION 4 FOR MORE
INFORMATION)

IF YOU TAKE IT FOR MORE THAN 3 WEEKS, IN THE UK, YOU WILL GET A BLUE
‘STEROID CARD’: ALWAYS KEEP IT WITH YOU AND
SHOW IT TO ANY DOCTOR OR NURSE TREATING YOU

KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR SHINGLES, IF YOU HAVE
NEVER HAD THEM. THEY COULD AFFECT
YOU SEVERELY. IF YOU DO COME INTO CONTACT WITH CHICKEN POX OR
SHINGLES, SEE YOUR DOCTOR STRAIGHT AWAY
NOW READ THE REST OF THIS LEAFLET
IT INCLUDES OTHER IMPORTANT INFORMATION ON THE SAFE AND EFFECTIVE USE
OF THIS MEDICINE THAT MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of
illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.

Summary of Product characteristics

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.
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.
_1._
_ _
_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, 1mg 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
2mg
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.
2.
_Children_
0.01-0.1mg/kg of body weight daily
Dosage of glucocorticoids should be adjusted on the basis of the
individual
patient's response.
4.3
CONTRAINDICATIONS
•
Systemic infection unless specific antimicrobial therapy given.
•
Avoid live virus vaccines in those receiving immunosuppressive doses
as the serum antibod