NEO-MEDROL CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

Available from:

PFIZER CANADA ULC

ATC code:

D07CA02

INN (International Name):

METHYLPREDNISOLONE AND ANTIBIOTICS

Dosage:

2.5MG; 5MG

Pharmaceutical form:

CREAM

Composition:

METHYLPREDNISOLONE ACETATE 2.5MG; NEOMYCIN SULFATE 5MG

Administration route:

TOPICAL

Units in package:

25G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0205670001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2006-08-02

Summary of Product characteristics

PRESCRIBING INFORMATION
NEO-MEDROL*
(Methylprednisolone Acetate-Neomycin Sulfate)
25 g Topical Cream
GLUCOCORTICOID - ANTIBIOTIC
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
October 17, 2003
Kirkland, Quebec H9J 2M5
Control No. 087360
* TM Pharmacia Enterprises S.A.
Pfizer Canada Inc, Licensee
© Pfizer Canada Inc 2003
2
INDICATIONS
An adjunct in the treatment of contact, atopic and seborrheic
dermatitis, pruritus ani and
vulvae, and neurodermatitis when complicated by infection caused by
organisms
sensitive to neomycin.
CONTRAINDICATIONS
Tuberculosis of the skin, chickenpox, herpes simplex, vaccinia,
superficial fungus or
yeast infections. Not for use in the eye. Known hypersensitivity to
any of the
components.
PRECAUTIONS
Although untoward effects associated with the use of topical
corticosteroids are
uncommon and not to be expected from ordinary use, sensitization,
irritation and failure
of therapeutic response have been noted in rare instances. Application
to extensive areas,
too frequent application, or application under occlusive dressings may
result in systemic
absorption with symptoms of adrenal suppression, localized atrophy and
striae. If
secondary bacterial infection exists or supervenes, concomitant
antimicrobial therapy is
indicated.
3
Articles in current medical literature indicate an increase in the
incidence of patients
allergic to neomycin. The possibility of such a reaction should be
borne in mind.
Ototoxicity and nephrotoxicity have been reported following absorption
of topically
applied neomycin.
Convulsions have been reported with concurrent use of
methylprednisolone and
cyclosporine. Since concurrent administration of these agents results
in a mutual
inhibition of metabolism, it is possible that convulsions and other
adverse events
associated with the individual use of either drug may be more apt to
occur.
_Pregnancy:_
The safety of the use of topical corticosteroid preparations during
pregnancy
has not been fully established. Therefore corticosteroids should not
be use