Topicort is indicated for the treatment of: Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, and mild to moderate eczema.

Posology

Once or twice a day, for a maximum of 7 days. If the condition is not improved, consult your doctor.

Elderly population

Dosage adjustments are not considered necessary in the elderly.

Paediatric population

Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.

 

Method of administration:

For topical administration.

Apply accurately and sparingly to a small area. Massage gently into the skin.

Topicort cream is contraindicated: In patients with hypersensitivity to hydrocortisone acetate or to any of the excipients listed in section 6.1 below. The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne athlete's foot, or infected bites and stings. In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Not for use with an occlusive dressing or on large areas of the body.

 

The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).

If the condition does not improve consult your doctor. Prolonged use of the product is not recommended (see section4.2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation.

Contains: propylene glycol which may cause skin irritation, methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed), and butylated hydroxytoluene which may cause local skin reactions (e.g. contact dermatitis, or irritation to the eyes and mucous membranes).

1.1  Interactions with other medicinal products and other forms of interaction

 None known

 

Pregnancy

This product should not be used in pregnancy without medical advice. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

 

Breast-feeding

This product should not be used whilst breast-feeding unless recommended by a health care professional.

Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.

 

Fertility

No known effects.

None known

If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued.

Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency.

System Organ Class	Frequency	Adverse Events
Skin and Subcutaneous Tissue Disorders	Not known	Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis
Musculoskeletal and Connective Tissue Disorders	Not known	Collagen disorder

Frequencies are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

 

Acute overdose is highly unlikely. No special precautions or antidotes are likely to be needed. Chronic overdose or misuse may increase the risk of topical or systemic steroid-related adverse effects, including hypothalamic pituitary adrenal (HPA) axis suppression and Cushing's syndrome.

Management of overdose with topical corticosteroids includes gradual discontinuation under medical supervision.

Pharmacotherapeutic group: corticosteroids, dermatological preparations; corticosteroids, weak (group I), ATC code: D07AA02.

Hydrocortisone acetate is a well characterised corticosteroid which has anti-inflammatory activity resulting, at least in part, from binding with a steroid receptor. Hydrocortisone acetate reduces inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.  

Not applicable

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

Whilst there is inadequate evidence on safety in human pregnancy, animal studies have demonstrated a possible association between topical corticosteroids and foetal abnormalities, including cleft palate and intra-uterine growth retardation

Stearic acid

Cetyl alcohol

Isopropyl myristate

Polyoxyl-40-stearate

Propylene glycol

Methyl parahydroxybenzoate

Triethanolamine

Citric acid

Butylated hydroxytoluene

Disodium edetate

Purified water

non known

24 months

Store below 30^◦

1.1   

Aluminum tubes containing 30 gm of the cream with plastic cap.

No special requirements