Dexamethasone (base) 3.3mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

base) 3.3mg/1ml solution for injection ampoules (Wockhardt UK Ltd

ATC code:

H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

3.3mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intrabursal; Intramuscular; Intraarticular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5012727912479

Patient Information leaflet

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION OF 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
pg1/2
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 medic

Summary of Product characteristics

OBJECT 1
DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION
OR INFUSION
Summary of Product Characteristics Updated 25-May-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Dexamethasone 3.3 mg/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