ACRETIN 0.05% CREAM 30G

Indications

Approved Uses

Acne vulgaris (topical).

Off-Label Uses

Off-label (dermatology-directed): melasma and post-inflammatory hyperpigmentation (often in combination regimens), photoaging, and some disorders of keratinization (e.g., ichthyosis/keratosis pilaris); evidence for warts/molluscum/striae is variable and not routine.

Dosage & Administration

Dosing by Condition

Acne vulgaris: apply a thin layer to the entire affected/acne-prone area once daily at bedtime; consider starting every other night and increase to nightly as tolerated.

Initial Dose

Apply a pea-sized amount to affected area once daily at bedtime; every-other-night application recommended initially to assess tolerability

Maintenance Dose

Apply a thin layer to the affected area once daily at bedtime. Frequency may be reduced for maintenance once acne is controlled.

Maximum Dose

Apply a thin film once daily at night (some patients start every other night and titrate); no systemic maximum dose is defined for topical use.

Children's Dosage

Not approved for children under 12 years; adolescents 12 years and older: same as adult dosing

Dose Adjustment Notes

If irritation occurs, reduce frequency (e.g., every other night or 2-3 times weekly) and/or use moisturizer; temporarily stop if severe, then restart at a lower frequency and titrate to nightly as tolerated.

How to Take

Cleanse gently and pat dry; wait 20-30 minutes until skin is completely dry; apply a pea-sized amount as a thin film to the entire acne-prone/affected area once daily at bedtime; avoid eyes, lips, nostrils and other mucous membranes; wash hands after application; use moisturizer as needed and apply daily sunscreen.

Side Effects

Common Side Effects

Dryness (xerosis), peeling/desquamation, erythema, burning/stinging, pruritus/irritation; increased photosensitivity; possible transient pigmentary changes (hyper- or hypopigmentation) especially in darker skin or with irritation.

Side Effect Frequency

Very common (≥10%): erythema/redness, dryness, peeling/desquamation, burning/stinging/irritation; itching/pruritus may occur. Less common: photosensitivity, temporary hyper/hypopigmentation, dermatitis; rare: blistering/crusting or severe irritation requiring discontinuation.

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to tretinoin or any component; avoid use in pregnancy unless clearly needed (generally avoided).

Warnings & Precautions

Avoid eyes, lips, mucous membranes and angles of nose; do not apply to sunburned/windburned/irritated or eczematous skin; minimize UV exposure and use sunscreen/protective clothing; expect early irritation/peeling and possible initial acne flare; avoid concurrent harsh/abrasive products and waxing on treated areas.

Age Restriction

Safety and efficacy not established in children <12 years; use only if clinician judges benefit outweighs risk.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Primarily additive local irritation with other topical irritants/keratolytics (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol), abrasive cleansers/astringents, and other topical retinoids; increased photosensitivity risk with concurrent photosensitizing drugs (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides).

Interaction Severity

MODERATE: concomitant topical irritants/keratolytics (e.g., benzoyl peroxide, salicylic acid, sulfur/resorcinol, astringents, alcohol-based products) increase irritation; benzoyl peroxide may oxidize tretinoin-separate application times (e.g., BPO AM, tretinoin PM). MINOR-MODERATE: other photosensitizing drugs may increase sunburn risk-reinforce photoprotection rather than avoid combination outright.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Children

Not approved for children under 12 years; adolescents 12 years and older: same as adult dosing

Elderly

Standard adult dosing; elderly patients may have more sensitive skin and should start with every-other-night application

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Can be stopped at any time; acne may gradually recur over weeks to months after discontinuation.

Overdose

Excess topical application may cause marked erythema, peeling, burning/discomfort-stop temporarily and wash off if needed; accidental ingestion warrants poison center/urgent medical advice and supportive care.

Patient Counseling

Apply a thin layer (about a pea-sized amount for the whole face) once daily at bedtime to clean, completely dry skin; start every other night if sensitive and increase as tolerated. Avoid eyes, eyelids, lips, corners of nose/mouth, and broken/sunburned skin. Expect dryness, redness, peeling, burning/stinging and possible initial acne flare in the first 2-4 weeks; use a gentle cleanser and non-comedogenic moisturizer. Minimize sun/UV exposure and use daily broad‑spectrum sunscreen (SPF ≥30) and protective clothing. Avoid harsh scrubs, astringents, alcohol-based products, and other irritating acne treatments unless advised. If severe irritation occurs, reduce frequency or stop and seek advice. Avoid use during pregnancy (and if planning pregnancy) unless specifically directed by a clinician; results typically require consistent use for ~8-12 weeks.

Monitoring Requirements

No routine laboratory monitoring; monitor clinically for local irritation/dermatitis, photosensitivity, and adherence/tolerability.

Pharmacology

Mechanism of Action

Binds nuclear retinoic acid receptors (RARs) in keratinocytes, altering gene transcription to normalize follicular epithelial differentiation, reduce cohesiveness of keratinocytes, increase turnover/comedolysis, and provide anti-inflammatory effects.

Onset of Action

Acne: irritation and/or apparent flare can occur in the first 1-2 weeks; initial improvement typically in ~2-4 weeks, with more meaningful benefit by 8-12 weeks of consistent use.

Duration of Effect

Benefits persist only with continued use; acne commonly relapses after discontinuation.

Bioavailability

Minimal systemic bioavailability; percutaneous absorption is typically <2% with normal topical use.

Excretion

For any systemically absorbed fraction: excreted via both urine and feces (biliary), predominantly as metabolites.

Product Information

Available Dosage Forms

Cream, Gel, Solution

Composition per Dose

Each gram of cream: 0.5 mg tretinoin (0.05%) in a cream base

Generic Availability

Yes

OTC Alternatives

No OTC equivalent to tretinoin; OTC options for acne include adapalene 0.1% (where available), benzoyl peroxide, and salicylic acid.

Skin Condition

Acne

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