Dexamethasone 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone

Available from:

A A H Pharmaceuticals Ltd

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; GTIN: 5025903006527 5025903007630 5025903090113

Patient Information leaflet

TEMPLATE
DEXAMETHASONE 0.5 MG AND 2 MG TABLETS
PATIENT INFORMATION LEAFLET
THIS LEAFLET CONTAINS IMPORTANT INFORMATION ABOUT DEXAMETHASONE
TABLETS. READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
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.
•
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 ‘Possible
Side Effects’ section below). 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
‘Possible Side Effects’ section below)
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID
CARD’: always keep it with you and show 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.
IN THIS LEAFLET
1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW

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