OLFEN PATCH 140/MG 5PATCHES

Indications

Approved Uses

Local symptomatic treatment of pain and inflammation due to minor acute soft-tissue injuries such as strains, sprains, and contusions (localized musculoskeletal pain).

Off-Label Uses

Localized osteoarthritis pain (knee), tendinopathy, bursitis

Dosage & Administration

Dosing by Condition

Acute minor strains/sprains/contusions (localized pain): apply 1 patch to the affected area twice daily (about every 12 hours) for short-term use (commonly up to 7 days unless directed otherwise).

Initial Dose

1 patch applied to the affected area every 12 hours

Maintenance Dose

1 patch every 12 hours (up to 2 patches per day)

Maximum Dose

Maximum: 2 patches in 24 hours (per labeled directions); do not exceed recommended duration without medical advice (commonly short-term use).

Children's Dosage

Approved for use in children 6 years of age and older.

How to Take

Apply to clean, dry, intact skin over the painful area. Remove from pouch, peel off liner, and press firmly (especially edges). Wash hands after application/removal. Do not cut the patch. Avoid applying to broken/irritated skin and avoid occlusive dressings; remove before bathing/showering/swimming if it will not adhere well. Replace per labeled schedule (commonly every ~12 hours if used twice daily).

Side Effects

Common Side Effects

Application-site reactions: redness/erythema, itching/pruritus, rash, irritation/burning, dermatitis, dry skin.

Side Effect Frequency

Most common: local application-site reactions (e.g., pruritus, erythema, dermatitis, burning/irritation, dry skin); systemic NSAID adverse effects (GI upset, headache) are uncommon/rare with topical use but possible.

Safety & Warnings

Contraindications

Hypersensitivity to diclofenac/other NSAIDs (including aspirin) or history of NSAID-induced asthma/urticaria; use in the setting of CABG surgery; third trimester of pregnancy; do not apply to broken/diseased skin at the application site (e.g., open wounds, eczema/dermatitis).

Warnings & Precautions

External use only; avoid eyes/mucosa; do not apply to broken, infected, or eczematous skin; avoid occlusive dressings/heat sources over the patch; use the lowest effective dose for the shortest duration and avoid combining with other NSAIDs; caution in patients with CV disease risk, prior GI ulcer/bleed, renal/hepatic impairment, asthma/NSAID sensitivity; stop if rash or hypersensitivity occurs; remove before MRI if product contains metal (per product instructions).

Age Restriction

Not approved for children under 6 years.

Driving Warning

Safe

Drug Interactions

Interaction Severity

MAJOR: None specific to the patch at recommended use, but avoid concurrent systemic NSAIDs unless advised (additive NSAID toxicity). MODERATE: Anticoagulants/antiplatelets (e.g., warfarin), methotrexate, lithium, digoxin-risk is lower than oral but possible with systemic absorption, especially with prolonged/large-area use. MINOR: Other topical NSAIDs/irritants (additive local skin irritation).

Food Interaction

No clinically relevant food interaction (not applicable for transdermal use).

Special Populations

Children

Approved for use in children 6 years of age and older.

Elderly

Use with caution; elderly patients are at higher risk of adverse skin reactions and systemic NSAID effects. Use the lowest effective dose for the shortest duration.

Kidney Impairment

No routine dose adjustment defined for mild-moderate renal impairment, but use with caution; avoid in severe renal impairment/advanced CKD unless benefits outweigh risks and monitor renal function, especially with diuretics/ACEi/ARB.

Storage & Patient Advice

Missed Dose

Apply a new patch when remembered; if it is close to the next scheduled change, skip the missed one and resume the regular schedule. Do not apply two patches at once.

Stopping the Medicine

May be stopped at any time; no taper is required.

Overdose

Overdose from topical use is unlikely; if excessive patches used, remove patches and wash skin; if accidental ingestion occurs, manage as NSAID overdose (GI upset, dizziness/drowsiness, possible GI bleeding/renal effects) and seek urgent medical care/poison center; treatment is supportive.

Patient Counseling

Apply to clean, dry, intact skin over the painful area; do not apply to broken/irritated/infected skin; wash hands after application; avoid occlusive/tight bandages and external heat sources; avoid using concurrently with other NSAIDs (topical or oral) unless advised; stop and seek advice if significant skin reaction occurs; use the lowest effective duration and consult a clinician if symptoms persist; fold used patches sticky-sides together for safe disposal and keep out of reach of children.

Pharmacology

Mechanism of Action

Inhibits COX-1 and COX-2, reducing prostaglandin synthesis locally and thereby decreasing pain, inflammation, and swelling at the application site.

Onset of Action

Analgesic effect is typically noticed within a few hours after application (often same day); systemic peak plasma timing is not a good proxy for clinical onset with topical patches.

Duration of Effect

Approximately 12 hours per patch.

Bioavailability

Systemic absorption is low compared with oral diclofenac (only a small fraction of the dose reaches systemic circulation).

Metabolism

Hepatic metabolism primarily via CYP2C9 (with minor CYP3A4/2C8), followed by hydroxylation and glucuronide/sulfate conjugation.

Product Information

Available Dosage Forms

Transdermal patch (this product).

Composition per Dose

Each patch: 140mg diclofenac sodium

OTC Alternatives

Topical NSAIDs (e.g., ibuprofen gel, ketoprofen gel) and oral analgesics such as paracetamol; if an oral NSAID is needed, short-course oral ibuprofen or naproxen can be considered if no contraindications.

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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