SURECURE 0.1% GEL 30GM

Indications

Approved Uses

Topical treatment of acne vulgaris.

Dosage & Administration

Dosing by Condition

Acne vulgaris: apply a thin film to the entire affected area once daily in the evening/at bedtime after washing and drying the skin.

Initial Dose

Apply a thin film to the affected area once daily in the evening.

Maintenance Dose

Apply a thin film to the affected area once daily in the evening.

Maximum Dose

Apply a thin film once daily (usually at night) to affected areas; no defined systemic maximum dose for topical use.

Children's Dosage

Not approved for children under 12 years of age; for patients 12 years and older, same adult dosing applies

Dose Adjustment Notes

No systemic dose adjustment is needed; if significant irritation occurs, use a moisturizer and reduce frequency (e.g., every other night) or temporarily stop until tolerated, then resume once daily as tolerated.

How to Take

Cleanse with a mild cleanser and dry the skin; apply a thin film to the entire affected area (not spot treatment) once daily in the evening/at bedtime; avoid eyes, lips, and mucous membranes; wash hands after application.

Side Effects

Common Side Effects

Application-site irritation including erythema, dryness, scaling/peeling, burning/stinging, pruritus; photosensitivity/sunburn can occur.

Side Effect Frequency

Very common (>10%): Dryness, scaling, burning/stinging, erythema. Common (1-10%): Skin discomfort, pruritus, sunburn. Uncommon (<1%): Acne flare, contact dermatitis, eyelid edema, conjunctivitis, skin discoloration, rash, eczema.

Safety & Warnings

Contraindications

Hypersensitivity to adapalene or to any excipients in the gel.

Warnings & Precautions

Avoid contact with eyes, lips, and mucous membranes; do not apply to cuts/abrasions, eczematous, or sunburned skin; minimize UV exposure (sun/sunlamps) and use sunscreen/protective clothing; expect possible irritation and early acne flare; use caution with weather extremes (wind/cold) and with concomitant irritating topical products.

Age Restriction

Not approved under 12 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Primarily additive local irritation with concomitant topical irritants/drying agents (e.g., abrasive/medicated cleansers, alcohol/astringents, spices/lime), and with keratolytics such as salicylic acid, sulfur, resorcinol; avoid using other topical retinoids concurrently unless specifically directed; benzoyl peroxide can be used with adapalene but may increase irritation (often separated by time of day).

Interaction Severity

MODERATE: Concomitant use with other irritating topical agents (e.g., benzoyl peroxide, salicylic acid, sulfur/resorcinol, astringents, abrasive cleansers, alcohol-based products) or other topical retinoids can increase irritation; if combined (e.g., with benzoyl peroxide), consider separating application times and monitor tolerability.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Not approved for children under 12 years of age; for patients 12 years and older, same adult dosing applies

Elderly

Standard adult dosing; no specific adjustments required, though elderly patients may have more sensitive skin

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Overdose

Topical overuse may cause marked local irritation (erythema, peeling, burning/stinging); manage by stopping temporarily or reducing frequency and using supportive skin care. If accidentally ingested, seek medical attention; symptoms are expected to be low but may resemble retinoid/Vitamin A-type toxicity with significant ingestion.

Patient Counseling

Apply once nightly to clean, completely dry skin in a thin layer over the whole affected area; avoid eyes/lips/mucosa and broken or sunburned skin; expect dryness/irritation and consider moisturizer and reduced frequency if needed; use daily sunscreen/limit sun exposure; improvement usually takes 8-12 weeks and early worsening may occur; wash hands after use.

Monitoring Requirements

No routine monitoring; monitor for excessive local irritation or allergic contact dermatitis

Pharmacology

Mechanism of Action

A retinoid that selectively binds retinoic acid receptors (primarily RAR-β and RAR-γ), normalizing follicular epithelial differentiation and reducing microcomedone formation, with anti-inflammatory effects.

Onset of Action

Improvement is typically seen after about 8-12 weeks; an initial flare/worsening can occur in the first few weeks.

Duration of Effect

Effect is maintained only with continued use; acne typically relapses gradually after discontinuation.

Half-Life

Unknown/not clinically meaningful after topical use due to minimal systemic absorption.

Bioavailability

Systemic absorption is very low/negligible after topical application; plasma levels are generally not quantifiable (when measurable, exposure is <0.25 ng/mL).

Metabolism

If absorbed, adapalene undergoes hepatic metabolism (oxidation such as O-demethylation/hydroxylation) followed by conjugation; overall systemic metabolism is limited because absorption is minimal.

Excretion

Primarily biliary excretion with elimination mainly in feces for any absorbed fraction.

Protein Binding

High plasma protein binding (>99%) for any systemically absorbed fraction.

Product Information

Available Dosage Forms

For this product: topical gel.

Composition per Dose

Each gram of gel: adapalene 1 mg (0.1%)

Generic Availability

Yes

Skin Condition

Acne

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