Maxidex 0.1% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone

Available from:

Dowelhurst Ltd

ATC code:

S01BA01

INN (International Name):

Dexamethasone

Dosage:

1mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040100

Patient Information leaflet

PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXIDEX
® 0.1%W/V, EYE DROPS, SUSPENSION
(dexamethasone)
1. WHAT MAXIDEX IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE MAXIDEX
3. HOW TO USE MAXIDEX
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MAXIDEX
6. FURTHER INFORMATION
MAXIDEX belongs to a group of medicines known as corticosteroids.
IT IS USED TO TREAT inflammation of the eye surface and the front
portion
inside the eye (anterior segment) and to prevent or treat inflammation
following surgery to the eye.
It helps to relieve the symptoms of inflammation such as redness,
soreness and swelling.
DO NOT USE MAXIDEX...

If you think that you have ANY TYPE OF INFECTION, including viral,
fungal, untreated parasitic eye infections and tuberculosis of the
eye.

If you are ALLERGIC to dexamethasone or any of the other
ingredients listed in section 6.
If any of these apply, ask your doctor for advice.
TAKE SPECIAL CARE...

Only use Maxidex in your eye(s).
Maxidex should be used WITH CAUTION IN CHILDREN UNDER 2 YEARS
of age.

Maxidex should not be used for more than one week, unless
advised by your doctor. Use of Maxidex for long periods of time,
may cause:
o
Increased pressure in your eye(s). If you already have high
pressure in your eye(s) or an eye disease such as glaucoma.
You should have your eye pressure checked regularly while
using Maxidex.. Ask your doctor for advice. This is especially
important in paediatric patients, as the risk of corticosteroid-
induced increased pressure in the eye may be greater in
children and may occur earlier than in adults. The risk of
increase in eye pressure and/or cataract formation is higher in
susceptible patients(e.g. patients with diabetes) using steroids.
o
The development of Cataracts. You should see your doctor
regularly if using on a long term basis.

Use of steroids MAY MAKE EYE INFECTIONS WORSE and DELAY
HEALING of an eye wound. If you have an infection, your doctor will
prescribe another medicine to treat it. Topical NSAIDs (Non-
Steroidal Anti Inflammatory Drugs-Me

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MAXIDEX 0.1% w/v, eye drops, suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 0.1% w/v
Excipient with known effect in suspension:
Benzalkonium Chloride 0.01% w/v.
For the full list excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for treatment of steroid responsive inflammatory conditions
of the
conjunctiva, cornea and anterior segment of the eye such as: anterior
uveitis,
iritis,
cyclitis,
allergic
and
vernal
conjunctivitis,
herpes
zoster
keratitis,
superficial punctate keratitis and non-specific superficial keratitis.
Also indicated for the treatment of corneal injury from chemical,
radiation or
thermal burns or following penetration by foreign bodies. Indicated
for post-
operative use to reduce inflammatory reactions and suppress graft
reaction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents, and children (2 years of age and above)
The
frequency
of
instillation
of
drops
and
the
duration
of
treatment
will
vary
depending upon the severity of the underlying condition and the
response to treatment.
Severe inflammations require one to two drops instilled into the eye
every thirty to
sixty minutes until a satisfactory response occurs.
Subconjunctival or systemic steroid therapy should be considered if
there is no
response. When a favourable response has been observed reduce the
dosage towards
one drop every four hours.
Method of Administration
For ocular use only.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using
product.
Do not let the tip of the dropper touch the eye.
Nasolacrimal
occlusion
or
gently
closing
the
eyelid
after
administration
is
recommended.
This
may
reduce
the
systemic
absorption
of
medicinal
products
administered via the ocular route and result in a decrease in systemic
adverse reactions.
Paediatric patients
The safety and efficacy of this product has