| Fact Table | |
|---|---|
| Formula | C26H32F2O7 |
| License | FDA approved (Lidex ointment NDA 016909; first approved 1971; U.S. brand listed as discontinued, not for safety/effectiveness); Health Canada marketed as Lyderm Ointment 0.05% |
| Bioavailability | Not quantified for topical ointment; systemic percutaneous absorption is variable and increases with vehicle, impaired/inflamed skin, large surface area, prolonged use, and occlusive dressings |
| Legal status | Prescription only (Rx; Schedule: Prescription in Canada) |
| Chemical Name | Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6a,11ß,16a)- |
| Elimination half-life | Not established for topical fluocinonide; absorbed corticosteroids are metabolized mainly in the liver and excreted by the kidneys, with some biliary excretion |
| Dosage (Strength) | 0.05% topical ointment; 0.5 mg fluocinonide per gram; apply a thin film to affected area two to four times daily depending on severity |
| Pregnancy | Pregnancy Category C in older labeling; use only if potential benefit justifies fetal risk; avoid extensive use, large amounts, or prolonged treatment during pregnancy |
| Brands | Lidex; Lyderm (Canada); Vanos; Fluonex; generic fluocinonide topical cream/gel/ointment/solution |
| Protein binding | Specific percentage not established; systemically absorbed topical corticosteroids are bound to plasma proteins in varying degrees |
| PubChem CID | 9642 |
| MedlinePlus | a601054 |
| ChEBI | 5109 |
| ATC code | D07AC08; C05AA11; D07CC05 |
| DrugBank | DB01047 |
| KEGG | D00325 |
| Routes of administration | Topical cutaneous application; external skin use only, not ophthalmic use |
Lidex Ointment, also called Lyderm in Canada, contains fluocinonide 0.05%, a strong prescription steroid used on the skin. It helps reduce redness, swelling, itching, and irritation from skin problems such as eczema, psoriasis, contact dermatitis, and seborrheic dermatitis. Fluocinonide works by reducing inflammation in the skin. The ointment base helps hold in moisture, making it useful for dry, thick, or scaly patches.
Lidex Ointment is for use on the skin only. Apply a thin layer to the affected area 2 to 4 times per day or as directed by a healthcare provider. Rub it in gently, and wash your hands before and after use unless your hands are being treated. Do not cover, bandage, or tightly wrap the treated area unless instructed to by a healthcare provider, as doing so can cause your body to absorb more medicine. Avoid long-term use on the face, underarms, groin, or skin folds. Use the smallest amount needed for the shortest time needed to control symptoms.
The active ingredient in Lidex Ointment is fluocinonide. The inactive ingredients in the ointment base may include glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum, and white wax.
Before using this medication, you may want to consult a healthcare provider about the following:
Lidex Ointment is for external use on the skin only. Do not use it in the eyes, mouth, or vagina.
Using large amounts over wide areas of skin, applying it for long periods, or covering the treated skin with bandages or tight clothing can increase how much medicine the body absorbs. This can lead to adverse effects such as suppression of the body’s natural cortisol (HPA axis suppression) and high blood sugar. Use the smallest amount needed for the shortest time.
Long-term or repeated use can thin the skin and cause stretch marks, especially on the face, underarms, groin, or other skin folds where the skin is naturally thinner.
Do not use Lidex Ointment on skin that has an active untreated infection. If a skin infection (bacterial, fungal, or viral) is present, it should be treated with the right antimicrobial first.
Children may absorb more medicine through the skin compared to adults and are more sensitive to side effects, including slowed growth and adrenal suppression. Tight diapers or plastic pants should not be used on children being treated in the diaper area.
Stop using Lidex Ointment and tell your healthcare provider if local irritation, burning, blistering, or signs of infection develop on the treated skin.
Use it during pregnancy only if the potential benefit clearly outweighs the potential risk. Avoid using large amounts or treating wide areas during pregnancy. Talk with your healthcare provider if you are breastfeeding, since caution is advised when topical corticosteroids are used by nursing women.
Store at room temperature, around 68 to 77°F (20 to 25°C). Avoid temperatures above 30°C (86°F). Keep the tube tightly closed and out of reach of children.
Avoid taking or using this medication if you have a known allergy or hypersensitivity to fluocinonide, other corticosteroids, or any of the inactive ingredients in Lidex Ointment.
Common side effects of Lidex Ointment include:
Stop using Lidex Ointment and get medical help for signs of a serious allergic reaction such as widespread rash, swelling of the face, lips, tongue, or throat, or trouble breathing.
Other serious problems with long-term use can include thinning of the skin (skin atrophy), stretch marks (striae), a new or worsening skin infection, and systemic steroid effects such as Cushing-like symptoms (rounding of the face, weight gain in the trunk, easy bruising) and high blood sugar.
In children, long-term or excessive use may lead to slowed growth, delayed weight gain, and potentially increased pressure inside the skull.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.