Hc45 Hydrocortisone Acetate 1% w/w Cream

As hydrocortisone acetate is a weak corticosteroid, topical preparations are usually well tolerated, especially under recommended use, where treatment exposure and duration is restricted (see section 4.2).

Undesirable effects from topical corticosteroids are more commonly associated with potent corticosteroids compared with weak agents like hydrocortisone acetate. Adverse effects are very uncommon and typically linked with prolonged therapy or misuse (see section 4.9). 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. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); 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.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie. 

4.2  Overdose

No special antidotes are likely to be required.

Acute overdose is highly unlikely. 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.

5.2  Pharmacodynamic Properties

Pharmacotherapeutic Group: Corticosteroids, dermatological preparations; corticosteroids, weak (group I); ATC Code: D07AA02

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

5.3  Pharmacokinetic Properties

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.

5.4  Preclinical Safety Data

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.

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layers and can be increased by inflammation or diseases of the epidermal barrier.

Hydrocortisone is absorbed to a greater degree from scrotum, axilla, eyelid, face and scalp than from the forearm, knee, palm and sole.

10        DATE OF (PARTIAL) REVISION OF THE TEXT

 July 2015

As hydrocortisone acetate is a weak corticosteroid, topical preparations are usually well tolerated, especially under recommended use, where treatment exposure and duration is restricted (see section 4.2).

Undesirable effects from topical corticosteroids are more commonly associated with potent corticosteroids compared with weak agents like hydrocortisone acetate. Adverse effects are very uncommon and typically linked with prolonged therapy or misuse (see section 4.9). 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. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); 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.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie. 

4.2  Overdose

No special antidotes are likely to be required.

Acute overdose is highly unlikely. 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.

5.2  Pharmacodynamic Properties

Pharmacotherapeutic Group: Corticosteroids, dermatological preparations; corticosteroids, weak (group I); ATC Code: D07AA02

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

5.3  Pharmacokinetic Properties

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.

5.4  Preclinical Safety Data

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.

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layers and can be increased by inflammation or diseases of the epidermal barrier.

Hydrocortisone is absorbed to a greater degree from scrotum, axilla, eyelid, face and scalp than from the forearm, knee, palm and sole.

10        DATE OF (PARTIAL) REVISION OF THE TEXT

 July 2015