Hydrocortisone butyrate

There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity of hydrocortisone 17-butyrate. Although, animal studies have shown the more potent corticosteroids to be teratogenic after dermal application, the clinical relevance in humans has not been established.

Therefore, during pregnancy hydrocortisone butyrate should only be used when the potential benefit justifies the potential risk.

It is unknown whether hydrocortisone 17-butyrate/metabolites are present in maternal milk following topical application.

The use of hydrocortisone butyrate during breastfeeding is not expected to affect breastfed infants since the systemic absorption of topically applied hydrocortisone 17-butyrate is low.

Hydrocortisone butyrate can be used during breastfeeding, but it is recommended to avoid applying hydrocortisone butyrate directly on the breast.

In a 2-year dermal rat carcinogenicity study with hydrocortisone butyrate lotion, hydrocortisone butyrate was administered to Sprague-Dawley rats at topical doses of 0.05, 0.15, and 0.3 mg/kg/day in males and 0.1, 0.25, and 0.5 mg/kg/day in females (0.1% lotion). No drug-related tumors were noted in this study up to the highest doses evaluated in this study of 0.3 mg/kg/day in males (0.1X MTHD) and 0.5 mg/kg/day in females (0.2X MTHD).

Hydrocortisone butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitrogenotoxicity tests (Ames test and L5178Y/TK^+/- mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay).

No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and I ncluding 1.8 mg/kg/day (0.7X MTHD). Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥0.6 mg/kg/day (0.2X MTHD).

None known.

In clinical studies, cases of skin irritation and hypersensitivity were reported.

The most frequently reported adverse reactions post-marketing are hypersensitivity and skin reactions such as erythema, pruritus and skin infection.

Adverse reactions are listed by MedDRA System Organ Class.

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

^* often irreversible, with thinning of the epidermis
^** Dermatitis and eczema, including contact dermatitis