OLFEN 1% GEL 50G

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in musculoskeletal conditions amenable to topical NSAID therapy (e.g., acute soft-tissue injuries such as sprains/strains/contusions and localized rheumatic/degenerative conditions such as osteoarthritis of peripheral joints).

Off-Label Uses

Common off-label uses include localized tendinopathy/tennis elbow, bursitis, and other minor localized sports/overuse injuries where topical NSAIDs are used for symptomatic relief.

Dosage & Administration

Dosing by Condition

Apply a thin layer to the affected area 3-4 times daily; typical amounts are about 2-4 g per application depending on the size of the area/joint, with duration guided by response and need for medical review if not improving.

Initial Dose

Apply 2-4 g (approximately 5-10 cm strip) to the affected area 3-4 times daily

Maintenance Dose

2-4 g applied 3-4 times daily to the affected area

Maximum Dose

Do not exceed 32 g/day total across all sites; typical per-site maximum is 16 g/day

Children's Dosage

Not recommended for children under 14 years

Dose Adjustment Notes

No routine dose adjustment is required for topical use; use the lowest effective amount for the shortest duration and use caution/avoid extensive application in patients with significant renal, hepatic, cardiovascular disease or when using other NSAIDs.

How to Take

Apply a thin layer to clean, dry, intact skin over the affected area and gently rub in; wash hands after application (unless treating the hands). Avoid contact with eyes/mucosa and do not apply to broken/irritated skin or under occlusive dressings; allow the gel to dry before covering with clothing.

Side Effects

Common Side Effects

Common: local application-site reactions such as rash, pruritus/itching, erythema/redness, burning/stinging, dry skin/scaling; contact dermatitis can occur.

Side Effect Frequency

Most common adverse effects are local application-site reactions (e.g., pruritus, erythema, rash/dermatitis, dryness, burning); photosensitivity is uncommon; systemic allergic reactions are rare.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/excipients; history of NSAID/aspirin-induced asthma/urticaria or other allergic-type reactions; application to non-intact skin (open wounds, mucosa, eyes); use in the third trimester of pregnancy

Warnings & Precautions

External use only; avoid eyes/mucosa and non-intact skin; do not use under occlusion or with heat; minimize sun/UV exposure on treated area; stop if rash occurs; caution in asthma/NSAID allergy history; use the smallest amount for the shortest duration to limit systemic NSAID risks

Age Restriction

Not recommended for children under 14 years unless directed by a clinician

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically relevant interactions are uncommon with topical use; caution with concurrent systemic NSAIDs/aspirin and anticoagulants/antiplatelets if large areas/prolonged use; avoid layering other topical products on the same site

Interaction Severity

Clinically relevant interactions are generally LOW to MODERATE for topical use, but increase with large-area/prolonged use: additive risk with other NSAIDs/aspirin; caution with anticoagulants/antiplatelets (bleeding risk), and with ACEi/ARB/diuretics, lithium, and methotrexate mainly if systemic exposure is significant.

Food Interaction

No restriction

Special Populations

Pregnancy

Category B (first and second trimesters); contraindicated in third trimester

Children

Not recommended for children under 14 years

Elderly

Standard adult dosing; use minimum effective amount and duration due to increased risk of skin reactions

Kidney Impairment

No specific dose adjustment for topical use; use with caution/avoid prolonged or extensive use in advanced renal impairment

Liver Impairment

No specific dose adjustment for topical use; use with caution in severe hepatic impairment

Storage & Patient Advice

Storage Conditions

Do not store above 30°C. Keep tube tightly closed. Keep out of reach of children.

Missed Dose

Apply when remembered; if it is close to the next scheduled application, skip the missed dose and resume the regular schedule-do not apply extra to make up for a missed dose.

Stopping the Medicine

Safe to stop anytime if pain resolves. Consult a healthcare provider if used for more than 21 days.

Overdose

Topical overdose is unlikely; if ingested, manage as NSAID overdose with supportive care and urgent medical evaluation (GI upset/bleeding possible)

Patient Counseling

Apply a thin layer to clean, dry, intact skin only; avoid eyes/mouth/nose and wash hands after use (unless treating hands); do not use occlusive/tight bandages or apply external heat to the area; avoid excessive sunlight/UV exposure on treated skin; stop and seek advice if significant irritation/rash occurs or if symptoms persist beyond ~7-14 days; seek urgent care for signs of systemic NSAID adverse effects or allergy (e.g., swelling, wheeze, black stools).

Monitoring Requirements

No routine laboratory monitoring is required for short-term, limited-area topical use; monitor clinically for skin reactions and, in higher-risk patients or prolonged/large-area use, consider monitoring for NSAID systemic effects (e.g., blood pressure, edema, GI bleeding symptoms, renal function if clinically indicated).

Pharmacology

Mechanism of Action

Inhibits COX-1 and COX-2, reducing prostaglandin synthesis at the site of application, leading to decreased local inflammation, pain, and swelling.

Onset of Action

Typically within about 30-60 minutes, with continued improvement over several days of regular use.

Duration of Effect

Approximately 4-6 hours of symptomatic relief per application (variable by site and condition).

Half-Life

Approximately 1-2 hours (systemic diclofenac terminal half-life; topical use does not materially change the intrinsic elimination half-life of the absorbed fraction).

Bioavailability

Low systemic absorption, typically about ~6% of systemic exposure compared with oral diclofenac (often cited range ~5-10% depending on formulation and area treated).

Metabolism

Minimal systemic absorption for topical use; any absorbed diclofenac undergoes hepatic metabolism primarily via CYP2C9 with minor CYP3A4 contribution, followed by hydroxylation to 4'-hydroxydiclofenac and conjugation.

Excretion

Excreted mainly as metabolites in urine (~65%) with the remainder via bile/feces (~35%).

Protein Binding

>99% plasma protein bound (mainly to albumin).

Product Information

Available Dosage Forms

For this SFDA-registered product: topical gel (diclofenac sodium 1%) in a 50 g tube.

Composition per Dose

Each 1 gram of gel contains: 10mg Diclofenac Sodium

Generic Availability

Yes

OTC Alternatives

Topical NSAID analgesics (e.g., ibuprofen gel, ketoprofen gel, piroxicam gel) and other OTC local analgesics (e.g., capsaicin cream/gel, trolamine salicylate) are reasonable alternatives; oral paracetamol or oral ibuprofen are OTC systemic alternatives when topical therapy is insufficient or unsuitable.

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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