Hydrocortisone 1% ointment

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Hydrocortisone

Tillgänglig från:

Strides Pharma UK Ltd

ATC-kod:

D07AA02

INN (International namn):

Hydrocortisone

Dos:

10mg/1gram

Läkemedelsform:

Cutaneous ointment

Administreringssätt:

Cutaneous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 13040000; GTIN: 5031676004677 5031676000785

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydrocortisone Ointment 1 %
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ointment containing 1% micronised hydrocortisone
Excipient(s) with known effect
Wool fat
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
Smooth off white translucent ointment
4.1
THERAPEUTIC INDICATIONS
Hydrocortisone has topical anti-inflammatory activity of value in the
treatment
of a wide variety of dermatological conditions, including the
following:
•
eczema – atopic, infantile, discoid, stasis
•
dermatitis - primary irritant, contact allergic, photo or seborrheic
•
prurigo nodularis
•
neurodermatoses
•
otitis externa
•
intertrigo
•
insect bite reactions
•
napkin rash, where concurrent infection is excluded or being
addressed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly:_ Apply, once to four times daily gradually
increasing the intervals
between applications as the condition improves. Treatment may then be
reduced to
two to three times a week or when symptoms recur. Gentle massage
assists
penetration. The same dose is used for adults and the elderly, as
clinical evidence
would indicate that no special dosage regimen is necessary in the
elderly.
_Children and infants:_ Gently apply a thin layer of ointment to the
affected
area(s) two or three times a day. Long term therapy should be avoided
and
where possible limited to five to seven days.
Method of administration
For cutaneous use only.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
•
Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or
dermatophyte) or viral (e.g. herpes simplex) infections of the skin,
infected
lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid
use. If a
patient presents with symp