LEDO OINTMENT 20G

Indications

Approved Uses

Topical local anesthesia and temporary relief of pain and pruritus from minor skin conditions (e.g., minor burns including sunburn, abrasions, insect bites) on intact skin.

Off-Label Uses

Off-label: symptomatic relief of hemorrhoids/anal fissure pain (external use), and premature ejaculation (topical penile application with precautions to avoid partner exposure).

Dosage & Administration

Initial Dose

Apply a thin layer (approximately 1-2g) to the affected area

Maintenance Dose

Apply to affected area 3-4 times daily as needed; do not exceed recommended application area

Children's Dosage

Maximum dose should not exceed 4.5 mg/kg. For children under 12 years, consult a doctor.

Dose Adjustment Notes

No formal dose adjustment is defined for topical use, but use the minimum effective amount and limit area/frequency in elderly/debilitated patients and in severe hepatic impairment; avoid excessive use especially on compromised skin.

How to Take

Clean and dry the affected area; apply a thin layer of LEDO (lidocaine HCl 5%) ointment to intact skin and gently rub in as needed; wash hands after use (unless treating hands); avoid contact with eyes and other mucous membranes; do not apply to large areas, broken/irritated skin, or under occlusive dressings unless directed by a clinician.

Side Effects

Common Side Effects

Application-site reactions such as mild burning/stinging, redness/erythema, irritation, swelling/edema, or blanching/pallor; rare allergic/contact dermatitis.

Side Effect Frequency

Common: local application-site reactions (burning/stinging, erythema, edema, pallor, altered sensation). Uncommon/rare: allergic/contact dermatitis or urticaria. Very rare but serious (usually with excessive absorption): CNS toxicity (dizziness, drowsiness, seizures), cardiovascular toxicity (bradycardia/arrhythmias), and anaphylaxis; methemoglobinemia is rare.

Safety & Warnings

Contraindications

Hypersensitivity to lidocaine, other amide-type local anesthetics, or any component of the ointment.

Warnings & Precautions

For topical use only; avoid eyes and mucous membranes unless directed; do not apply to large areas, broken/irritated skin, or under occlusive dressings; use the minimum effective amount and duration; increased toxicity risk in young children and in severe hepatic disease; monitor for methemoglobinemia in susceptible patients or with oxidant drugs; stop and seek care if systemic symptoms occur.

Age Restriction

No specific age cutoff in the verified SFDA data; avoid unsupervised use in infants/young children and use only under physician direction in pediatrics (especially <3 years) due to higher risk of systemic absorption/toxicity.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically relevant mainly if significant systemic absorption occurs: additive toxicity with other local anesthetics; additive cardiac effects with class I antiarrhythmics (e.g., mexiletine) and other antiarrhythmics; increased lidocaine exposure with CYP inhibitors such as cimetidine and some beta-blockers (e.g., propranolol); caution with methemoglobinemia-inducing drugs (e.g., dapsone, nitrates, sulfonamides).

Interaction Severity

Clinically significant interactions are mainly relevant only if substantial systemic absorption occurs: additive cardiac/CNS toxicity with class I antiarrhythmics (e.g., mexiletine) and other local anesthetics; increased lidocaine exposure with strong CYP inhibitors (e.g., cimetidine) and reduced clearance with some beta-blockers; caution with methemoglobinemia-inducing drugs is more relevant to agents like benzocaine/prilocaine than lidocaine alone.

Special Populations

Children

Maximum dose should not exceed 4.5 mg/kg. For children under 12 years, consult a doctor.

Elderly

Use minimum effective amount; elderly patients may have increased systemic absorption due to thinner skin; monitor for signs of systemic toxicity

Liver Impairment

No formal dose adjustment defined for topical use; in severe hepatic impairment use the minimum effective amount and avoid large areas/occlusion or frequent applications.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep tube tightly closed. Keep out of reach of children.

Stopping the Medicine

Safe to stop anytime.

Overdose

Systemic local-anesthetic toxicity may occur with excessive/large-area/occlusive use: perioral numbness, tinnitus, dizziness, confusion, tremor/seizures, respiratory depression, bradycardia/hypotension, arrhythmias/cardiac arrest; management is immediate removal/washing off, urgent medical care with airway/ventilation support and benzodiazepines for seizures (and lipid emulsion therapy if severe LAST per guidelines).

Patient Counseling

Apply a thin layer of lidocaine 5% ointment to intact skin only, using the smallest amount needed for effect; avoid eyes/mucosa and do not apply to large areas, broken/irritated/infected skin, or under occlusive/airtight dressings unless directed by a prescriber. Wash hands after application (unless treating hands) and stop/seek urgent care if symptoms of systemic local-anesthetic toxicity occur (e.g., dizziness, drowsiness, tinnitus, perioral numbness/metallic taste, confusion, seizures, or palpitations/irregular heartbeat). Keep out of reach of children and use only as prescribed (this product is prescription-only per SFDA).

Monitoring Requirements

No routine monitoring for standard localized topical use; counsel to monitor for local irritation and for systemic toxicity (e.g., dizziness, tinnitus, perioral numbness, confusion, seizures, arrhythmias) if used excessively, on large areas, under occlusion, or on broken skin.

Pharmacology

Onset of Action

Typically within 2-5 minutes after topical application (may be longer on thicker skin).

Duration of Effect

Approximately 30-60 minutes after topical application (variable by site, amount, and skin integrity).

Bioavailability

Systemic absorption from topical lidocaine is generally low on intact skin but is highly variable and increases with application to large areas, prolonged contact, inflamed/broken skin, and occlusive dressings.

Excretion

Primarily renal excretion, mainly as metabolites with only a small fraction excreted unchanged.

Product Information

Composition per Dose

Each gram of ointment contains 50 mg of Lidocaine Hydrochloride (5% w/w).

Generic Availability

Yes

OTC Alternatives

OTC alternatives for minor skin pain/itch include pramoxine-containing products and some lower-strength lidocaine products (commonly 4%) depending on local regulations; benzocaine products are also OTC in some markets but have higher methemoglobinemia risk.

Skin Condition

Local Anesthesia

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