Locoid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrocortisone butyrate 0.1%;  

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Hydrocortisone butyrate 0.1%

Dosage:

0.1 %

Pharmaceutical form:

Topical ointment

Composition:

Active: Hydrocortisone butyrate 0.1%   Excipient: Liq. paraf. gel with 5% poyethylene oleogel to 100%.

Units in package:

Tube, aluminium, 1x15g, 15 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

NewChem SpA

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, 1x15g - 15 g - 60 months from date of manufacture stored at or below 25°C - Tube, aluminium, 1x30g - 30 g - 60 months from date of manufacture stored at or below 25°C - Tube, aluminium, 1x100g - 100 g - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1974-10-10

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION
LOCOID

0.1% HYDROCORTISONE BUTYRATE
FORMULATIONS
LIPOCREAM
OINTMENT
TOPICAL EMULSION (LOCOID CRELO
®
)
SCALP LOTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Locoid
®
. It does not contain all the available
information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this
medicine against the expected benefits.
Use Locoid
®
as instructed. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT LOCOID
® IS USED FOR
Locoid
®
is used on the skin in adults and children to relieve the redness,
swelling, itching and
discomfort of skin inflammation such as:
•
Psoriasis (a skin disorder with raised, rough, reddened areas covered
with dry, fine
silvery scales)
•
Eczema (a skin condition with itching, redness and a burning feeling.
In some forms of
eczema there may be oozing sores that become hard and scaly)
•
Other types of dermatitis (itching skin diseases)
Hydrocortisone butyrate belongs to a group of medicines called
corticosteroids.
Your doctor may have prescribed Locoid
®
for another reason. Ask your doctor why this medicine
has been prescribed for you.
This medicine is available only with a doctor’s prescription.
BEFORE YOU USE LOCOID
®
_WHEN YOU MUST NOT USE LOCOID_
_®_
DO NOT USE THIS MEDICINE IF YOU HAVE:
1.
AN ALLERGY TO:
•
any medicine containing hydrocortisone butyrate
2
•
any of the ingredients listed at the end of this leaflet (see Product
Description).
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the
skin.
2.
SKIN LESIONS CAUSED BY:
•
ANY BACTERIAL INFECTION (SUCH AS IMPETIGO, TUBERCULOSIS)
•
ANY VIRAL INFECTION (SUCH AS COLD SORES, SHINGLES, CHICKEN POX, COMMON
WARTS, FLAT
WARTS,

Summary of Product characteristics

Page
1
of
5
NEW ZEALAND DATA SHEET
1
LOCOID
®
Lipocream
Ointment
Topical Emulsion (Locoid Crelo
®
)
Scalp Lotion
hydrocortisone butyrate
2
QUALITATIVE AND QUANTITATIVE COMPOSTION
Each formulation contains active ingredient 0.1% hydrocortisone
butyrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
LIPOCREAM:
white or nearly white cream
OINTMENT:
white ointment
TOPICAL EMULSION (LOCOID CRELO
®
):
a practically white emulsion
SCALP LOTION:
clear, colourless solution
4
CLINICAL PARTICULARS
4.1 INDICATIONS
Corticosteroid for topical application in adults and children. The
products are recommended for
clinical use in the treatment of conditions responsive to topical
corticosteroids, e.g. eczema, dermatitis
and psoriasis.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
For adults and children, to be applied to the affected parts one to
four times a day, or as directed by
the physician.
In a controlled trial, once daily administration was associated with a
slower rate of skin clearance and
may, therefore, be especially recommended in cases where
considerations of convenience and/or
compliance arise.
Where necessary, application may be made under an occlusive dressing.
4.3 CONTRAINDICATIONS
•
Skin lesions caused by:
−
bacterial infections (e.g. pyodermias, luetic and tuberculous
processes)
−
viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares, verrucae
planae, condylomata, mollusca contagiosa)
−
mycotic and yeast infections
−
parasitic infections (e.g. scabies)
•
Ulcerous skin lesions, wounds
•
Adverse reactions induced by corticosteroids (e.g. dermatitis
perioralis, striae atrophicae)
•
Ichthyosis, juvenile dermatosis plantaris, acne vulgaris, acne
rosacea, fragility of the skin vessels,
skin atrophy
Page
2
of
5
•
Allergic hypersensitivity to components of the vehicle or to
corticosteroids (the latter rarely
occurs).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In pregnant animals, administration of corticosteroids can cause
abnormalities of foetal d