Fluocinolone Acetonide + Clioquinol

Uses

This cream is used for inflammatory skin conditions such as eczema, dermatitis or psoriasis that are infected or likely to become infected.

Fluocinolone Acetonide + Clioquinol is also used to associated treatment for these conditions: Acne, Atopic Dermatitis (AD), Dermatitis, Contact, Dermatosis, Eczema impetiginous, Eczema of the nuchal nape of the neck, Folliculitis, Fungal ear infection caused by Aspergillus niger, Infantile Eczema, Inflammation, Intertrigo, Lichen simplex chronicus, Moniliasis, Nummular Dermatitis, Otitis Externa, Pruritis of the scroti, Pruritus Ani, Pruritus Vulvae, Pyoderma, Stasis dermatitis, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Bacterial dermatoses, Chronic otitis externa, Corticosteroid-responsive dermatoses, Disseminated Neurodermatitis, Localized NeurodermatitisAcute 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 treatment

How Fluocinolone Acetonide + Clioquinol works

Clioquinol is bacteriostatic, however, the precise mechanism of its action is unknown.

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

Fluocinolone Acetonide + Clioquinol dosage

This medicine is for external use on the skin only. The cream or ointment should be applied thinly and evenly to the affected area(s). Avoid getting the medicine in the eyes, or in contact with the inside of the mouth or nose. Rinse with cold water if accidental contact occurs. Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated. If your doctor has advised you to use dressings with this medicine, the skin should be cleansed before applying the cream/ointment under a fresh dressing.

Side Effects

Medicines and their possible side effects can affect individual people in different ways. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. The following side effects are known to be associated with this medicine.

• Skin irritation at site of application, such as burning, itching and redness.
• Allergic inflammation of the skin (contact dermatitis).
• Thinning of the skin.
• Changes in skin pigmentation.
• Stretch marks (striae).
• Groupings of fine blood vessels becoming prominent under the skin (telangiectasia).

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.

Interaction

This medicine is not known to affect other medicines. However, as with all medicines, it is important to tell your doctor or pharmacist what medicines you are already using, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before using any new medicines while using this one, to make sure that the combination is safe.

If you are using other medicines on the same area of skin it is recommended that you leave several minutes between applying each product. This is to allow each product time to be absorbed and avoid them mixing on the skin.

If you apply moisturisers shortly before or after applying this medicine these can dilute the corticosteroid and potentially make it less effective. Try to apply your moisturisers at a different time of day, or at least 30 minutes before or after this one.

Volume of Distribution

This pharmacokinetic parameter is not relevant as the systemic absorption of fluocinolone acetonide is very minimal.

Elimination Route

Topical absorption is rapid and extensive, especially when the skin is covered with an occlusive dressing or if the medication is applied to extensive or eroded areas of the skin. Clioquinol is absorbed through the skin in sufficient amounts to affect thyroid function tests.

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

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings, or for prolonged periods of time. Consult your doctor for further information.

This medicine should not be used during breastfeeding unless considered essential by your doctor. If it is prescribed by your doctor it should not be used on large areas of skin, underneath airtight dressings or for prolonged periods of time. If it is applied to the breasts it should be washed off carefully before breastfeeding and then reapplied afterwards.

Contraindication

This cream should not be used in

• Children under one year of age.
• Allergy to iodine.
• Primary bacterial skin infections, such as impetigo.
• Primary fungal skin infections such as thrush, ringworm, athlete's foot.
• Viral skin infections, such as chickenpox, shingles, cold sores or herpes simplex.
• Acne.
• Chronic inflammatory disorder of the facial skin (acne rosacea).
• Inflammatory rash around the mouth (perioral dermatitis).
• Itching around the back passage and genitals.
• Nappy rash.
• Widespread plaque psoriasis.

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Innovators Monograph

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