Cliomet1%+0.02%

Cliomet is a topical/otic combination of an anti-infective (iodoquinoline) and a corticosteroid, used for short-term treatment of inflammatory skin and ear conditions that are infected or likely to be infected.

Established/labelled uses

• Acute and chronic otitis externa (inflammation of the external ear canal) with bacterial and/or fungal infection, where reduction of inflammation together with anti-infective cover is required.
• Infected inflammatory dermatoses such as infected eczema, infected contact dermatitis, and infected seborrhoeic dermatitis of the skin, where a mixed or presumed bacterial/fungal infection accompanies the inflammation.

Notes on evidence strength

Cliomet is intended only for short courses in conditions where both an anti-infective and an anti-inflammatory effect are wanted at the same time; it is not intended as first-line therapy for infection or inflammation alone. It should not be used to treat primary fungal or viral infections without concurrent appropriate antimicrobial cover, and it is not a substitute for systemic therapy in severe or spreading infection.

Each mL/g of Clioquinol + Flumetasone Pivalate topical (ear/skin) drops typically contains:

• Clioquinol (Iodochlorhydroxyquin) 1% w/v
• Flumetasone Pivalate 0.02% w/v

Exact strengths and formulation (drops, cream, or lotion) may vary by brand; refer to the specific product label for the marketed strength.

Cliomet is a fixed-dose topical/otic combination product. Clioquinol is a halogenated 8-hydroxyquinoline derivative with antibacterial and antifungal activity, while flumetasone pivalate is a synthetic, fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.

The combination is formulated as ear drops and/or a topical skin preparation intended for short-term use in inflamed, infected or potentially infected skin and ear conditions, combining anti-infective cover with control of inflammation and itching.

Cliomet belongs to the class of topical corticosteroid and anti-infective combinations, used dermatologically and otologically.

Clioquinol (Iodochlorhydroxyquin)

Clioquinol is a halogenated hydroxyquinoline with broad-spectrum antibacterial and antifungal activity against common skin and ear pathogens, including Staphylococcus aureus, Candida species, and dermatophytes. Its exact mechanism is not completely defined but is thought to involve chelation of essential metal ions required by microorganisms.

Flumetasone Pivalate

Flumetasone pivalate is a synthetic corticosteroid that binds intracellular glucocorticoid receptors, inducing anti-inflammatory proteins and suppressing pro-inflammatory mediators. This reduces local oedema, erythema, itching, and inflammatory cell infiltration in the skin and ear canal.

When applied topically as directed, systemic absorption of both components is generally low; however, absorption increases with use on broken or extensively inflamed skin, under occlusion, on mucous membranes, or for prolonged periods, particularly in infants and young children.

• For ear use: clean and dry the outer ear canal gently before use. Warm the bottle slightly in the hand (avoid hot water) to reduce dizziness from cold drops. Tilt the head to the side, instil the prescribed number of drops, and keep the head tilted (or gently press the tragus) for a minute to allow the drops to reach the canal.
• For skin use: apply a thin film to clean, dry affected skin only; avoid application to the eyes, mouth, or open wounds unless directed.
• Wash hands before and after application. Do not use with an occlusive dressing unless specifically instructed by a physician.
• Do not use Cliomet for longer than the prescribed duration.

Because Cliomet is applied topically/locally and systemic absorption is normally low, clinically significant drug-drug interactions are uncommon with correct use.

• Iodine-containing preparations / thyroid function tests: Clioquinol contains iodine and can interfere with thyroid function tests (e.g., protein-bound iodine, radioactive iodine uptake) for several weeks after use; inform the laboratory/physician of recent use before such tests.
• Other topical or systemic corticosteroids: Concurrent use of multiple corticosteroid-containing products may increase the risk of local and, rarely, systemic corticosteroid effects; avoid combining unless advised by a physician.
• Live vaccines: Extensive or prolonged use leading to systemic corticosteroid absorption may theoretically reduce immune response to live vaccines; clinically relevant mainly with extensive/prolonged use.

Most side effects of Cliomet are local and related to the site of application:

• Local burning, stinging, itching, or irritation at the application site
• Allergic contact dermatitis or hypersensitivity reactions
• Yellow-brown staining of skin, hair, nails, and clothing (a characteristic effect of clioquinol)
• With prolonged or extensive use: skin thinning, striae, telangiectasia, or other signs of local corticosteroid overuse; delayed wound healing
• With use in a perforated eardrum: ototoxicity (hearing disturbance) - see Contraindications
• Rarely, secondary fungal or bacterial overgrowth with prolonged use

Patients should stop use and consult a physician if irritation, sensitisation, or worsening of the condition occurs.

Data on the use of Cliomet in pregnancy and lactation are limited. As with other topical corticosteroid/anti-infective combinations, Cliomet should be used in pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus, and treatment should be limited to the smallest effective amount for the shortest possible time, avoiding use over large areas.

It is not known whether topically applied clioquinol or flumetasone pivalate are excreted in human milk in clinically significant amounts. As a precaution, breastfeeding women should avoid applying Cliomet to the breast/nipple area and should consult a physician before use during breastfeeding.

• Cliomet is intended for short-term use only; prolonged or extensive application increases the risk of systemic corticosteroid absorption (with potential HPA-axis suppression) and of iodine absorption (with potential effects on thyroid function), especially in infants, young children, and when used under occlusion or on broken/extensive skin.
• Avoid contact with the eyes; if accidental eye contact occurs, rinse thoroughly with water.
• Use with caution in patients with known or suspected thyroid disorders or iodine sensitivity because of the iodine content of clioquinol.
• Cliomet may stain skin, hair, and fabric yellow-brown; warn patients of this before starting treatment.
• If used in the ear, the eardrum should be examined (where feasible) before starting treatment to exclude perforation; discontinue and seek medical advice if ear pain, discharge, or hearing changes occur.
• Discontinue if signs of hypersensitivity, worsening infection, or skin atrophy appear, and consult a physician.
• Not for ophthalmic use.

Significant systemic toxicity from topical overdose of Cliomet is unlikely under normal use, but excessive or prolonged application over large areas, especially in children, may increase the risk of corticosteroid- and iodine-related systemic effects. If accidental ingestion occurs, or if signs of systemic toxicity (e.g., unusual drowsiness, thyroid disturbance symptoms) develop after extensive topical use, seek immediate medical attention or contact a poison control centre; do not attempt home treatment beyond removing residual product from the skin/ear and seeking prompt medical advice.

Store at room temperature (below 30°C), protected from light and moisture. Keep the container tightly closed and out of the reach of children.

Pediatric use

Cliomet should be used with caution in infants and young children because their higher skin-surface-to-body-weight ratio increases the risk of systemic absorption of both the corticosteroid and clioquinol. Use the smallest effective amount for the shortest necessary duration, and avoid prolonged or extensive use, occlusive dressings, and use on broken skin in this age group. Safety and efficacy in neonates and very young infants have not been well established; use only under medical supervision.

Elderly

Elderly patients often have thinner skin, which may increase local absorption and the risk of skin atrophy; use the lowest effective amount for the shortest duration.

Hepatic/renal impairment

No specific dose adjustment is established for topical/otic use, as systemic absorption is normally minimal; however, caution is advised with extensive or prolonged application in patients with significant hepatic or renal impairment.

Cliomet is intended for short-term use only. For ear conditions, treatment is generally limited to about 7-10 days; for skin conditions, courses are generally limited to about 2-4 weeks, and continuous use beyond this should be reassessed by a physician. If there is no improvement within the first week, or if the condition worsens, medical advice should be sought rather than continuing or increasing use.

Clioquinol + Flumetasone Pivalate combines two drug classes:

• Clioquinol - a halogenated hydroxyquinoline (iodoquinoline) topical anti-infective (antibacterial/antifungal)
• Flumetasone Pivalate - a synthetic, fluorinated topical corticosteroid (glucocorticoid)

In Clioquinol + Flumetasone Pivalate, clioquinol provides local antibacterial and antifungal activity against common skin and ear pathogens, likely via chelation of metal ions essential to microbial metabolism, while flumetasone pivalate acts on glucocorticoid receptors in skin/mucosal cells to reduce inflammation, oedema, and itching. The combined effect is designed to control infection and inflammation together in short-term topical/otic therapy.

Cliomet may be used in children under medical supervision for short courses in otitis externa or infected inflammatory skin conditions, but should be used cautiously because of the larger skin-surface-to-body-weight ratio in children, which raises the risk of systemic absorption of the corticosteroid and iodine-containing components. Prolonged use, use under occlusion, and use on broken or extensively inflamed skin should be avoided in children. Safety and efficacy in neonates and infants have not been well established; use only as directed by a pediatrician.