DAKTACORT CREAM

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROCORTISONE; MICONAZOLE NITRATE

Available from:

JOHNSON & JOHNSON PTE. LTD.

ATC code:

D01AC52

Dosage:

1% w/w

Pharmaceutical form:

CREAM

Composition:

HYDROCORTISONE 1% w/w; MICONAZOLE NITRATE 2% w/w

Administration route:

TOPICAL

Prescription type:

Pharmacy Only

Manufactured by:

JANSSEN PHARMACEUTICA NV

Authorization status:

ACTIVE

Authorization date:

1988-06-23

Patient Information leaflet

PRODUCT NAME 

DAKTACORT
TM
 cream 

DOSAGE FORMS AND STRENGTHS

Each gram contains 20 mg miconazole nitrate and 10
mg hydrocortisone. 
White, homogenous, odourless cream for topical application to
the skin. 
For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 
INDICATIONS 
Infections of the skin by dermatophytes or Candida spp., in which
inflammatory symptoms are 
prominent.  

Thus DAKTACORT is particularly indicated for the initial stages
of treatment. Once the 
inflammatory symptoms have disappeared, treatment
may be continued with miconazole nitrate 20 
mg/g topical cream, if preferred. In view
of DAKTACORT’S antibacterial effect on gram-positive 
bacteria, the product may also be used for mycotic infections with
bacterial superinfection. 

DOSAGE AND ADMINISTRATION 
DAKTACORT
TM
 cream should be applied topically to the lesion once to
twice daily. 
DAKTACORT
TM
 cream should be rubbed in gently until it has been
completely penetrated into the 
skin. This dosage applies to both adults and
children. The treatment of DAKTACORT
TM
 cream (or 
subsequently miconazole nitrate 20 mg/g topical cream) should
be continued without interruption 
until the lesion has completely disappeared (usually after 2 to 5
weeks).  

SPECIAL POPULATIONS 
_USE IN INFANTS _
In infants, long term continuous topical corticosteroid
therapy should be avoided. (see _Warnings and _
_Precautions_) 

_USE IN ELDERLY _
Natural thinning of the skin occurs in
the elderly; hence corticosteroids should be used sparingly and 
for short periods of time.  

If after 7 days of treatment no improvement has occurred, cultural isolation of the infecting organism 
should be followed by appropriate local or systemic antimicrobial
therapy 

CONTRAINDICATIONS 
Known hypersensitivity to miconazole or other imidazole
derivatives, hydrocortisone or another 
ingredient of DAK

Summary of Product characteristics

PRODUCT NAME
DAKTACORT
TM
cream
DOSAGE FORMS AND STRENGTHS
Each gram contains 20 mg miconazole nitrate and 10 mg hydrocortisone.
White, homogenous, odourless cream for topical application to the
skin.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
Infections of the skin by dermatophytes or Candida spp., in which
inflammatory symptoms are
prominent.
Thus DAKTACORT is particularly indicated for the initial stages of
treatment. Once the
inflammatory symptoms have disappeared, treatment may be continued
with miconazole nitrate 20
mg/g topical cream, if preferred. In view of DAKTACORT’s
antibacterial effect on gram-positive
bacteria, the product may also be used for mycotic infections with
bacterial superinfection.
DOSAGE AND ADMINISTRATION
DAKTACORT
TM
cream should be applied topically to the lesion once to twice daily.
DAKTACORT
TM
cream should be rubbed in gently until it has been completely
penetrated into the
skin. This dosage applies to both adults and children. The treatment
of DAKTACORT
TM
cream (or
subsequently miconazole nitrate 20 mg/g topical cream) should be
continued without interruption
until the lesion has completely disappeared (usually after 2 to 5
weeks).
SPECIAL POPULATIONS
_USE IN INFANTS _
In infants, long term continuous topical corticosteroid therapy should
be avoided (see
_Warnings and _
_Precautions_
).
_USE IN ELDERLY _
Natural thinning of the skin occurs in the elderly; hence
corticosteroids should be used sparingly and
for short periods of time.
If after 7 days of treatment no improvement has occurred, cultural
isolation of the infecting organism
should be followed by appropriate local or systemic antimicrobial
therapy
CONTRAINDICATIONS
Known hypersensitivity to miconazole or other imidazole derivatives,
hydrocortisone or another
ingredient of DAKTACORT
TM
cream. Tuberculous skin infections, herpes simplex, vaccinia and all
forms of varicella. DAKTACORT
TM
is not indicated for infections caused by gram negative bacteria.
WARNINGS AND PRECAUTIONS
If a reaction