FENISTIL GEL 30G

Indications

Approved Uses

Symptomatic relief of itching (pruritus) associated with minor skin irritations such as insect bites/stings, urticaria, eczema/dermatoses, and minor burns/sunburn.

Dosage & Administration

Initial Dose

Apply a thin layer to the affected area 2 to 4 times daily.

Maintenance Dose

Apply a thin layer to the affected area 2 to 4 times daily as needed.

Children's Dosage

Children ≥1 month: apply a thin layer to affected area 2-4 times daily. Avoid use in premature infants and neonates on large skin areas

Side Effects

Side Effect Frequency

Uncommon (≥0.1% to <1%): application-site reactions such as burning/stinging and dry skin. Very rare (<0.01%): hypersensitivity/allergic skin reactions.

Safety & Warnings

Warnings & Precautions

Avoid contact with eyes and mucous membranes; do not apply to open wounds or large/extensively inflamed or broken skin; use sparingly on small areas in infants/young children (avoid extensive use in premature infants/neonates); avoid excessive sun/UV exposure of treated areas; seek medical advice if symptoms worsen or persist beyond ~7 days.

Age Restriction

Adults and children: can be used from 1 month of age; in infants/young children (especially <2 years) use only on small areas and preferably with medical advice; avoid use on extensive areas in premature infants/neonates.

Drug Interactions

Interaction Severity

No clinically significant drug interactions are expected with topical use as directed; caution only if used excessively or with other sedating antihistamines due to potential additive effects if systemic absorption occurs.

Food Interaction

Not applicable (no food interactions expected with topical use).

Special Populations

Children

Children ≥1 month: apply a thin layer to affected area 2-4 times daily. Avoid use in premature infants and neonates on large skin areas

Storage & Patient Advice

Storage Conditions

Store below 30°C.

Stopping the Medicine

Safe to stop anytime.

Overdose

Topical overdose is unlikely; accidental ingestion can cause systemic antihistamine toxicity-adults may have CNS depression/sedation, children may have CNS excitation (agitation, ataxia, hallucinations) plus anticholinergic effects (dry mouth, fever, tachycardia, urinary retention); management is supportive and urgent medical evaluation is required.

Patient Counseling

Apply a thin layer to affected skin 2-4 times daily; for external use only; avoid eyes/mouth/mucous membranes; do not apply to large areas or broken/oozing/infected skin; wash hands after use; avoid prolonged sun exposure on treated areas; seek medical advice if symptoms worsen or do not improve within ~7 days; store below 30°C.

Pharmacology

Mechanism of Action

Competitive histamine H1-receptor antagonist that reduces histamine-mediated vasodilation and capillary permeability, thereby relieving pruritus; may also have mild local anesthetic/antipruritic effects.

Onset of Action

Rapid onset-typically within minutes (about 5-15 minutes) after application.

Duration of Effect

Typically provides itch relief for several hours (about 4-6 hours), with reapplication up to 2-4 times daily as needed.

Half-Life

Approximately 6 hours (systemic half-life reported after oral/systemic exposure); not well-defined for topical use due to minimal absorption.

Bioavailability

Topical (gel): low systemic bioavailability/absorption, typically around 10% or less when used as directed; oral bioavailability is not applicable to this topical gel product.

Excretion

Excreted via urine and bile/feces (renal and biliary/fecal elimination).

Product Information

Available Dosage Forms

Gel (topical); oral drops also exist in some markets, but tablets are not a standard Fenistil formulation in many jurisdictions and are not supported by the provided verified API data for this product.

Composition per Dose

Each gram of gel: 1 mg dimethindene maleate (0.1% w/w)

Generic Availability

Yes

Skin Condition

General (pruritus/urticaria/insect bites)

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