Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
02-06-2017
Summary of Product characteristics
(SPC)
05-12-2020
Active ingredient:
Dexamethasone sodium phosphate
Available from:
Wockhardt UK Limited
ATC code:
H02AB; H02AB02
INN (International Name):
Dexamethasone sodium phosphate
Dosage:
4 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection/infusion
Administration route:
Intramuscular injection
Units in package:
1ml glass ampoules in packs of 5 or 10; 2ml glass ampoules in packs of 5
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
CP Pharmaceuticals Ltd
Therapeutic group:
Glucocorticoids
Therapeutic area:
Glucocorticoids; dexamethasone
Therapeutic indications:
It e can be used for all forms of general and local glucocorticoid injection therapy and all acute conditions in which intravenous glucocorticoids may be life-saving.
Authorization status:
Not marketed
Authorization date:
2015-01-09
Patient Information leaflet
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE PHOSPHATE 4MG/ML SOLUTION FOR INJECTION OR INFUSION
IMPORTANT INFORMATION ABOUT THIS MEDICINE
• 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 BE GIVEN
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
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dexamethasone is and what it is used for
2. What you need to know before you are given Dexamethasone
3. How you are given Dexamethasone
4. Possible side effects
5. How to store Dexamethasone
6. Contents of the pack and other information
1. WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR
The name of your medicine i
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 December 2020
CRN009FHJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3.3 mg dexamethasone (as sodium
phosphate) which is equivalent to 4 mg dexamethasone
phosphate or 4.37 mg dexamethasone sodium phosphate.
Each 2 ml contains 6.6 mg dexamethasone (as sodium phosphate) which is
equivalent to 8 mg dexamethasone phosphate or
8.74 mg dexamethasone sodium phosphate.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless to slightly yellowish solution, having pH ranging
from 7.0 to 8.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone can be used for all forms of general and local
glucocorticoid injection therapy and all acute conditions in
which intravenous glucocorticoids may be life-saving.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
N.B. FOR THIS SECTION OF DOCUMENT ALL DOSES ARE EXPRESSED AS MG
DEXAMETHASONE
In general, glucocorticoid dosage depends on the severity of the
condition and response of the patient. Under certain
circumstances, for instance in stress, extra dosage adjustments may be
necessary. If no favourable response is noted within a
couple of days, glucocorticoid therapy should be discontinued.
_Adults and Elderly_
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 acute life-threatening situations (e.g. anaphylaxis, acute severe
asthma) substantially higher dosages may be needed.
Cerebral oedema (adults): initial dose 8-16 mg iv followed by 5 mg iv
or im every 6 hours, until a satisfactory result has been
obtained. In brain surgery these dosages may be necessary until
several days after the operation. Thereafter, the dosage has to
be tapered off gradually. Increase of intr
Read the complete document
