Source: Registered Drug Product Database (NG) Revision Year: 2025 Publisher: Manufacturer: Huazhong Pharmaceutical Co., Ltd. Site of Manufacture: No.118, Xianshan Road, Xiangyang City, Hubei Province, China
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Dexamethasone crosses the placenta. During pregnancy, especially in the first trimester, the drug should only be administered after careful benefit-risk assessment.
In long-term treatment with glucocorticoids during pregnancy, foetal growth disorders cannot be excluded. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. See also section 5.3 of the SmPC. If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the foetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced.
Dexamethasone is excreted in breast milk. There are no known cases of harm to the infant. Nevertheless, the drug should be strongly indicated during lactation. If the disease requires higher doses, breast-feeding should be discontinued.
Dexamethasone decreases testosterone biosynthesis and endogenous ACTH secretion which has an effect on the spermatogenesis and the ovarian cycle.
There have been no studies on the effects on the ability to drive and use machines.
Not applicable.
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