Noxipak
Noxipak Uses, Dosage, Side Effects, Food Interaction and all others data.
Fluocinolone acetonide is a corticosteroid primarily used in dermatology to reduce skin inflammation and relieve itching. It is a synthetic hydrocortisone derivative. Fluocinolone acetonide was also found to strongly potentiate TGF-β-associated chondrogenesis of bone marrow mesenchymal stem/progenitor cells, by increasing the levels of collagen type II by more than 100 fold compared to the widely used dexamethasone.
Fluocinolone acetonide is a synthetic anti-inflammatory corticosteroid and thus, the effect of its interaction with the body produces vasoconstriction and suppression of membrane permeability, mitotic activity, immune response and release of inflammatory mediators.
For its ophthalmic indications, fluocinolone acetonide is administered as intravitreal micro-insert. This preparation was observed in clinical trials to reduce the recurrence of uveitis flares by 2 fold when compared with the non treated patients even after six months after initial administration. As well the intraocular pressure seemed to increase slightly with the presence of the fluocinolone implant but it is important to monitor intraocular pressure.
Urea is an osmotic diuretic similar to mannitol but more irritant. It induces diuresis by increasing osmotic pressure of the glomerular filtrate and increasing excretion of sodium, potassium and chloride ions. Its osmotic effect also draws water from cells e.g. brain, CSF and anterior chamber of the eye, thereby decreasing intracranial or intraocular pressure. Unlike mannitol, urea penetrates the eye and causes a rebound increase in intraocular pressure if the plasma concentration of the drug is less than that in the vitreous humour. Applied topically, urea promotes hydration of keratin and mild keratolysis in dry skin. It increases water uptake by the stratum corneum and has an antipruritic effect.
As a humectant, urea draws water into the striatum corneum.
| Trade Name | Noxipak |
| Generic | Fluocinolone acetonide + urea |
| Type | Kit |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
This Cream and Ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin.
This is particularly suitable for topical application in:
- Eczema and dermatitis: Atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
- Prurigo, Psoriasis, lichen planus.
- Discoid lupus erythematosus.
Urea 25% cream is used for the treatment of dry, cracked skin and hyperkeratosis on the soles of the feet including the heels. Suitable for general and diabetic foot care.
Noxipak is also used to associated treatment for these conditions: Acute Otitis Media, Allergy Skin, Anal Fissures, Atopic Dermatitis (AD), Blisters, Chronic Disease of Skin, Dermatosis, Diabetic Macular Edema (DME), External Hemorrhoid, Friction and Pressure Injuries, Hemorrhoids, Internal, Non-infectious Posterior Uveitis Chronic Uveitis, Otitis Externa, Perianal erythema, Pruritus, Psoriasis of the scalp, Purulent Wounds, Scab, Seborrheic dermatitis of the scalp, Skin Infections, Bacterial, Skin Inflammation caused by Bacterial Infections, Skin Inflammation of the ear, Uveitis, Wound Infections, Anal eczema, Chronic eczematous otitis externa, Corticosteroid-responsive dermatoses, Postoperative Care, Perioperative management therapy, Postoperative treatmentDermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dry Eyes, Dry Skin, Dry Skin; Eczema, Eczema, Dyshidrotic, Eye pruritus, Helicobacter Pylori Infection, Insect Bites, Lichen Planus (LP), Neurodermatitis, Nummular Dermatitis, Psoriasis, Seborrheic Dermatitis, Sunburn, Allergic skin manifestations, Anal eczema, Calluses, Moisturizing
How Noxipak works
Fluocinolone acetonide is a corticosteroid and thus, it can be inferred that it acts by inhibiting the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation.
Some reports have indicated that fluocinolone acetonide presents a high binding affinity for the glucocorticoid receptor. After binding the receptor, the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements in the promoter region of the target genes. This effect promotes the induction of phospholipase A2 inhibitory proteins (lipocortins). Through this mechanism of action, it is thought that fluocinolone induces mainly one of the lipocortins, annexin 1, which will later mediate the synthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of arachidonic acid which is the precursor of all these inflammatory mediators. Hence, the induction of these proteins will prevent the release of arachidonic acid by phospholipase A2.
Dosage
Noxipak dosage
A small quantity of Fluocinolone Acetonide is applied lightly up to 2 or 3 times a day, and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly.
Apply a small amount twice daily to the skin after washing or bathing.
In extreme cases, before bed you may choose to cover the feet with plastic wrap and then put socks over the plastic wrap to increase the hydration rate.
Recommended for use on adults and children over 12 years.
After use, wear sandals or slippers to avoid staining carpets.
Side Effects
Side-effects are extremely rare, but as with all topical corticosteroids, patient may show hypersensitivity reaction.
May irritate inflamed skin or exudative lesions. Transient stinging may occur in deep cracks. Discontinue use if local irritation or rash occurs during use.
Toxicity
Studies to determine the carcinogenic and its effect in fertility have not been performed. It is important to consider that several corticosteroids have been shown to present genotoxic potential but fluocinolone acetonide was shown to not be genotoxic in the Ames test and mouse lymphoma TK assay.
Precaution
Appropriate anti-infective cover should be given if there is an associated infection. Long term continuous topical steroid therapy can produce atrophic skin changes. Do not apply to the face for prolonged periods. Prolonged use or treatment of extensive areas can produce adrenal suppression, especially in infants and children.
Volume of Distribution
This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal.
Elimination Route
When administered as an eye implant, fluocinolone acetonide presents a sustained delivery for even 12 months in which there can be observed a sustained release. The concentration of fluocinolone acetonide are generally higher in the vitreous and retina with a little dispersion to the aqueous humor.
There are reports indicating that topical administration of fluocinolone acetonide produces a percutaneous absorption which is determined by the vehicle, integrity of the epidermal barrier and the use of occlusive dressing.
Independently of the route of administration, the systemic absorption of fluocinolone acetonide is below 0.1 ng/ml which indicates that the systemic distribution is very minimal and the effect of fluocinolone is mainly local.
Half Life
The reported half-life of fluocinolone acetonide ranges between 1.3-1.7 hours.
Clearance
This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal and the concentration in urine is lower than the minimum quantitation limit.
Elimination Route
Fluocinolone acetonide is mainly excreted by the kidneys. It is important to mention that the systemically absorbed dose is very minimal.
Pregnancy & Breastfeeding use
Pregnancy: Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate intrauterine growth retardation. There may be a small risk of such effects on the human fetus.
Lactation: When topical steroid treatment is necessary, minimize amount and length of treatment.
Urea cream can be used during pregnancy and lactation.
Contraindication
Primary infections of the skin and in rosacea, acne, perioral dermatitis, anogenital pruritis and napkin eruption. Also known hypersensitivity to neomycin
For use only on the soles of the feet and heels unless otherwise directed by the prescriber. Pregnant women should consult their Healthcare Professional before use. For External Use Only. Avoid contact with eyes. Keep out of reach of children. Always replace cap after use. Do not use if tube seal is broken or appears tampered with.
Storage Condition
Store at temperature below 30° C.
Store between 10° – 30° C in a dry place. Keep lid tightly closed.
Innovators Monograph
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