Aclobet-N30 gm

Aclobet-N is a topical triple-combination preparation used for short-term treatment of inflamed skin conditions where infection with susceptible bacteria and/or Candida is present, confirmed, or strongly suspected.

• Established uses: Recalcitrant/severe eczema and localized psoriasis (excluding widespread plaque psoriasis) that has not responded to less potent corticosteroids, when secondary bacterial and/or candidal infection is present.
• Guideline/label-supported use: Neurodermatitis (lichen simplex chronicus) and other steroid-responsive dermatoses complicated by infection.
• Adjunct use: As short-term adjunct therapy in intertriginous or inflamed dermatoses with mixed bacterial-fungal colonization; not a substitute for systemic therapy in extensive infection.

Because Aclobet-N combines a very potent corticosteroid with two anti-infectives, it is intended only for short, physician-directed courses, not for long-term or maintenance use.

Each gram of Clobetasol Propionate + Neomycin Sulphate + Nystatin cream/ointment typically contains Clobetasol Propionate BP 0.05% w/w, Neomycin Sulphate BP (equivalent to neomycin base) 0.5% w/w, and Nystatin BP 100,000 IU, in a cream or ointment base.

Aclobet-N is a fixed-dose triple-combination topical preparation containing clobetasol propionate, a super-high-potency (Class I) synthetic corticosteroid; neomycin sulphate, an aminoglycoside antibacterial; and nystatin, a polyene antifungal active mainly against Candida species. It is formulated as a cream or ointment for short-term application to inflamed skin lesions with associated or suspected bacterial and fungal infection.

Topical corticosteroid (super-high/Class I potency) combined with a topical aminoglycoside antibiotic and a topical polyene antifungal — Aclobet-N is a corticosteroid-antibacterial-antifungal combination for dermatological use.

Clobetasol Propionate + Neomycin Sulphate + Nystatin combines three complementary actions:

• Clobetasol propionate is a highly potent topical corticosteroid that binds intracellular glucocorticoid receptors, inducing anti-inflammatory, antipruritic, and vasoconstrictive effects via inhibition of phospholipase A2 and downstream inflammatory mediators.
• Neomycin sulphate is an aminoglycoside that binds the bacterial 30S ribosomal subunit, causing misreading of mRNA and inhibiting bacterial protein synthesis, giving activity against many Gram-positive and some Gram-negative skin pathogens.
• Nystatin binds ergosterol in the fungal cell membrane, creating pores that increase membrane permeability and cause leakage of intracellular contents, leading to fungal cell death; it is active primarily against Candida albicans and other Candida species.

Wash and dry hands before and after use. Apply a thin layer of Aclobet-N only to the affected skin, gently rubbing in. Do not apply to the face, groin, axillae, or under occlusive dressings or diapers/nappies unless specifically directed by a physician, since absorption is increased at these sites. Avoid contact with the eyes and mucous membranes. Do not cover the treated area with an airtight dressing unless instructed.

Significant systemic drug interactions are unlikely with correct topical use of Aclobet-N, but the following should be noted:

• Neuromuscular blocking agents: if substantial neomycin absorption occurs (e.g., use on large or broken skin areas), it may potentiate neuromuscular blockade.
• Other aminoglycosides or ototoxic/nephrotoxic drugs: concurrent systemic use combined with significant neomycin absorption may increase the risk of ototoxicity or nephrotoxicity.
• Other topical or systemic corticosteroids: concurrent use over the same or broad skin areas increases the risk of systemic corticosteroid side effects.

Local side effects are most common with topical use of Aclobet-N:

• Common: burning, stinging, or itching at the application site; skin atrophy; telangiectasia (visible small blood vessels).
• Uncommon: striae (stretch marks), skin dryness, folliculitis, hypopigmentation.
• Rare/with prolonged or extensive use: allergic contact dermatitis (particularly to neomycin), secondary infection or overgrowth of non-susceptible organisms, hypertrichosis, HPA-axis suppression and Cushingoid features, and (rarely) glaucoma or cataract if used near the eyes.

Stop use and consult a physician if a rash, worsening irritation, or signs of allergic reaction develop.

The safety of Aclobet-N in pregnancy has not been well established, and topical corticosteroids can be absorbed systemically. It should be used during pregnancy only if clearly needed, at the lowest effective dose and for the shortest possible duration, and only if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

It is not known whether topically applied Aclobet-N components are excreted in significant amounts in breast milk. Use during breastfeeding is not generally recommended unless a physician determines it is necessary; if used, avoid application to the breast area and consult a physician.

Aclobet-N contains a super-high-potency corticosteroid and should be used with caution:

• Duration and extent limits: Do not use for more than 7 days without medical review, and do not exceed 2 weeks of continuous use (maximum about 4 weeks under close supervision) or the maximum body surface area/weekly quantity advised, to reduce the risk of HPA-axis suppression, Cushingoid features, and skin atrophy.
• Site restrictions: Avoid use on the face, groin, axillae, and under occlusive dressings or diapers unless specifically directed, due to increased absorption at these sites.
• Neomycin sensitization: Neomycin is a common cause of allergic contact sensitization; discontinue if a rash or worsening irritation develops.
• Infection type: Not intended for primary viral infections (herpes, chickenpox) or extensive/deep fungal infections, which may require concurrent systemic antifungal or antiviral therapy.
• Eye contact: Avoid contact with the eyes; prolonged periocular use can increase the risk of glaucoma and cataract.
• Abrupt discontinuation: After prolonged use, stopping suddenly may cause a rebound flare (topical steroid withdrawal); taper as directed by a physician.
• Stewardship: Because this product contains an antibiotic (neomycin), take/apply Aclobet-N exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice, to reduce the risk of antibiotic resistance and skin sensitization.

Topical overuse or accidental ingestion of Aclobet-N is unlikely to cause acute life-threatening toxicity, but excessive or prolonged application can lead to systemic corticosteroid effects (hypercortisolism/Cushingoid features) and, rarely, effects related to neomycin absorption. If overuse, accidental ingestion, or signs of systemic effects occur, seek immediate medical attention or contact a poison control center; do not attempt specific home treatment.

Store below 25°C, in a dry place away from direct light and moisture. Do not freeze. Keep out of reach of children.

Elderly: No specific dose adjustment established; use the lowest effective amount for the shortest duration, as skin is often thinner and more susceptible to atrophy.

Renal/hepatic impairment: No formal dose adjustment established for topical use of Aclobet-N; however, caution is advised if significant systemic neomycin absorption is expected (e.g., use over large or denuded areas), given the risk of nephrotoxicity.

Pediatric: See Pediatric Uses.

Pregnancy/lactation: See Pregnancy and Lactation.

Treatment with Aclobet-N should be as short as possible. Most patients should not use it for more than 7 days without medical reassessment. Continuous use should not exceed 2 weeks, and should not exceed a total of about 4 weeks even under close physician supervision, after which alternative therapy should be considered. It is not intended for long-term or maintenance treatment.

Clobetasol Propionate + Neomycin Sulphate + Nystatin belongs to the following drug classes: Topical corticosteroid (super-high potency, Class I) + Aminoglycoside antibacterial (topical) + Polyene antifungal (topical).

Clobetasol Propionate + Neomycin Sulphate + Nystatin acts through three mechanisms: clobetasol propionate suppresses inflammation by activating glucocorticoid receptors and reducing inflammatory mediator release and vascular permeability; neomycin sulphate binds bacterial ribosomes to block protein synthesis, killing susceptible bacteria; and nystatin binds fungal membrane ergosterol to disrupt membrane integrity and kill susceptible Candida organisms.

Use of Aclobet-N in children under 2 years is not recommended; safety and efficacy have not been established in this age group. In children 2 years and older, it may be used under close medical supervision for short courses (generally up to 5 days), avoiding occlusive dressings and the diaper area, because children have a higher skin-surface-to-body-weight ratio and are more susceptible to systemic corticosteroid absorption and HPA-axis suppression.