How it works
Salibet is a corticosteroid drug, sometimes called a steroid. Steroids reduce the amount of inflammatory chemicals your body makes. They also reduce your body’s natural immune response, which helps to control inflammation.
Salibet injectable suspension doesn’t cause drowsiness, but it can cause other side effects.
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What are the side effects of Salibet dipropionate?
The most common side effects of Salibet are:
- burning at the area of application,
- irritation, and
Salibet is classed as a potent topical corticosteroid. Topical corticosteroids are also referred to as topical steroids. Topical steroids are used in addition to moisturisers (emollients) for treating inflammatory skin conditions such as eczema and dermatitis. A topical steroid is used when patches of eczema or dermatitis flare up. Salibet relieves the symptoms of a flare-up by reducing inflammation, itching and redness. It is not a cure for the condition, but it will help to relieve the symptoms. Short courses of Salibet may also be prescribed for the treatment of psoriasis for small areas such as the scalp, soles of the feet, or palms of the hands.
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Oral steroids like Salibet are used to treat a wide variety of conditions. Some examples include autoimmune diseases (for example, systemic lupus erythematosus, autoimmune hepatitis, sarcoidosis); joint and muscle diseases (for example, rheumatoid arthritis); and allergies and asthma. They are also used in the treatment of some cancers. Salibet works by interfering with the release of certain chemicals in the body which cause inflammation.
Salibet is also prescribed as a replacement treatment for people who are not producing enough natural corticosteroid in their bodies due to an adrenal gland disorder called congenital adrenal hyperplasia (CAH).
Salibet and Alcohol
Both alcohol and Salibet topical can dry the skin, and the combination may dry the skin even more.
You should avoid or limit drinking alcohol while taking Salibet topical.
Effects of Prematurely Increased Exposure to Glucocortico > Administration of synthetic glucocortico >Salibet or dexamethasone, to pregnant women at risk for preterm delivery clearly has been shown to provide a broad range of benefits to infants born prematurely. 106 However, antenatal exposure to synthetic glucocorticoids can increase placental 11βHSD2 expression and alter postnatal HPA function. 49,106-110 In addition, a large RCT comparing one course of prenatal steroids to repeated exposures at 2-week intervals found that repeated steroids did not result in any further reduction in a composite measure of morbidity, but did result in significantly lower birth weight and shorter gestation. 111
Premature exposure to increased concentrations of endogenous cortisol may also have adverse short and long-term effects. Cortisol concentrations in extremely preterm infants in the first postnatal weeks are far higher than normal fetal concentrations 104,112 and extremely preterm infants have been shown to also have higher cortisol concentrations at 8 and 18 months. 113 In turn, elevated cortisol concentrations in children and adults have been correlated with elevated blood pressure and increased insulin resistance, suggesting a long-term effect of HPA axis programming. 114
The extent of percutaneous absorption of topical corticostero >DOSAGE AND ADMINISTRATION ).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Twenty-five pediatric patients ages 6 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study. Salibet Dipropionate Lotion, USP 0.05% w/w was applied twice daily for 2 to 3 weeks over a mean body surface area of 45% (range 35% to 72%). In 11 of 15 (73%) evaluable patients, adrenal suppression was indicated by either a ≤ 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤ 18 mcg/dL and an increase of DOSAGE AND ADMINISTRATION )
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 15 evaluable patients, of the 11 subjects who showed evidence of suppression, 6 subjects were tested 2 weeks after discontinuation of Salibet Dipropionate Lotion, USP 0.05% w/w, and 4 of the 6 (67%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticostero >PRECAUTIONS - Pediatric Use .)
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
What are the uses for Salibet dipropionate?
Salibet is used for the relief of itching and inflammation associated with a wide variety of skin conditions in patients 13 years of age or older. Examples include allergic dermatitis, atopic dermatitis, contact dermatitis, and plaque psoriasis.
Pregnancy and Salibet
Salibet is a FDA Pregnancy Category C drug, because steroids are known to cause birth defects in animals but the effects in pregnant humans haven't been studied adequately.
You should tell your doctor if you are pregnant or plan to become pregnant before taking this medication in any of its forms.
Salibet, like most steroids, is found in breast milk and may stunt your baby's growth.
You should tell your doctor if you are breastfeeding or planning to breastfeed before using Salibet in any form.
Is Salibet dipropionate safe to take if I'm pregnant or breastfeeding?
Use of Salibet in pregnant women has not been studied. When corticosteroids are given systemically (orally, intramuscularly or intravenously) to pregnant animals fetal abnormalities occur.
It is not known if Salibet is secreted in breast milk. Corticosteroids absorbed into the body may appear in breast milk and may cause harmful effects in breast fed infants.