Dermicolon Ointment 0.1/1 %w/w

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Triamcinolone Acetonide

Available from:

Macleods Pharmaceuticals Limited, INDIA

ATC code:

Corticosteroids for systemic use/ plain

INN (International Name):

Triamcinolone Acetonide

Dosage:

0.1/1 %w/w

Pharmaceutical form:

Ointment

Manufactured by:

Macleods Pharmaceuticals Limited, INDIA

Product summary:

Physical description: Translucent ointment; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DERMICOLON 0.1 % (TRIAMCINOLONE ACETONIDE OINTMENT USP 0.1% W/W)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gm of Ointment contains:
Triamcinolone Acetonide USP ........ 1 mg
FOR EXCIPIENTS SEE POINT 6.1
3.
PHARMACEUTICAL FORM
Topical Ointment
PHYSICAL DESCRIPTION: Translucent Ointment
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Topical corticosteroids are indicated for the relief of the
inflammatory
and
pruritic manifestations of corticosteroid-responsive dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as
a thin film
from two to four times daily depending on the severity of the
condition.
Occlusive dressing may be used for the management of psoriasis or
recalcitrant
conditions. If an infection develops, the use of occlusive dressing
should be
discontinued and appropriate antimicrobial therapy instituted.
SPECIAL POPULATIONS
Paediatric population
Administration of topical corticosteroids to children should be
limited to the
least
amount
compatible
with
an
effective
therapeutic
regimen.
Chronic
corticosteroid
therapy
may
interfere
with
the
growth
and
development
of
children. 4.3 CONTRAINDICATIONS
Hypersensitivity reactions to any component of the drug or
cephalosporins,
penicillins and other beta-lactam antibiotics. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General Systemic absorption of topical corticosteroids has produced
reversible
hypothalamic-pituitary-adrenal
(HPA)
axis
suppression,
manifestations
of
Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application
of the
more potent steroids, use over large surface areas, prolonged use, and
the addition
of occlusive dressings. Therefore, patients receiving a large dose of
a potent topical
steroid applied to a large surface area or under an occlusive dressing
should be
evaluated periodically for evidence of HPA axis suppression by