Mechanism of effect
anti-inflammatory, antipruritic and vasoconstrictive
Pharmacodynamic
NOLIX ™ Cream is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of the anti-inflammatory effect of the topical corticosteroids is not completely understood. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation.
Pharmacokinetics
Pharmacokinetics - The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
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. They are metabolized primarily in the liver and then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Drug indications
NOLIX ™ Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage
For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day
Drug contraindications
Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of components of the preparation
Side effects
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
The following may occur more frequently with occlusive dressings:
Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria
Interactions
Acarbose , insulin , Glimepiride , Insulin glargine , Insulin isophane , Insulin aspart , Albiglutide , Semaglutide , Miglitol , Dapagliflozin , Empagliflozin , Troglitazone , Exenatide , Ertugliflozin , dulaglutide , chlorpropamide , Linagliptin , Canagliflozin , Alogliptin , Saxagliptin , Acetohexamide , Sitagliptin , Pioglitazone , Glipizide , Tolbutamide , Tolazamide , Rosiglitazoneacarbose
acetohexamide
albiglutide
alogliptin
canagliflozin
chlorpropamide
dapagliflozin
dulaglutide
empagliflozin
ertugliflozin
exenatide
glimepiride
glipizide
glyburide
insulin
insulin aspart
insulin aspart protamine
insulin degludec
insulin detemir
insulin glargine
insulin glulisine
insulin inhalation, rapid acting
insulin isophane
insulin lispro
insulin lispro protamine
insulin regular
insulin zinc
insulin zinc extended
linagliptin
liraglutide
lixisenatide
metformin
miglitol
nateglinide
pioglitazone
pramlintide
repaglinide
rosiglitazone
saxagliptin
semaglutide
sitagliptin
tolazamide
tolbutamide
troglitazone
Alerts
General - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
Conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using 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. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.
Pediatric patients may absorb proportionally larger amounts of topicalcorticosteroids and thus be more susceptible to systemic toxicity (See Pediatric Use under PRECAUTIONS).
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, NOLIX ™ Cream should be discontinued until the infection has been adequately controlled.
Points of recommendation
(flurandrenolide USP, 0.05%) should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.
Pregnancy level
This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
US FDA pregnancy category: C
Breast feeding warning
Flurandrenolide has not been studied during breastfeeding. Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short-term application of topical corticosteroids would pose a risk to the breastfed infant by passage into breastmilk. However, it would be prudent to use the least potent drug on the smallest area of skin possible. It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only the lower potency corticosteroids should be used on the nipple or areola where the infant could directly ingest the drugs from the skin. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[1] Any topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
Related drugs
Betamethasone , Triamcinolone , Flucinolone , PrednisolonePrednisolone
Triamcinolone
Betamethasone
Flucinolone
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