ROXONIN 100/MG TAPE 7TAPES

Indications

Approved Uses

Topical relief of pain and inflammation in musculoskeletal conditions such as osteoarthritis and soft-tissue rheumatism (e.g., myalgia, tendinitis/periarthritis), and post‑traumatic pain/swelling (e.g., sprains/strains/contusions).

Dosage & Administration

Dosing by Condition

Musculoskeletal pain and inflammation: Apply one 100mg patch to the affected area once or twice daily. Osteoarthritis/joint pain: Apply one patch to the affected joint once or twice daily

Initial Dose

One 100mg patch applied to the affected area once daily

Maintenance Dose

One 100mg patch applied once or twice daily to the affected area

Maximum Dose

Apply 1 patch to the affected area once daily; do not apply more than 1 patch in 24 hours.

How to Take

Apply to clean, dry, intact skin over the painful area; remove the release liner and press firmly to ensure full contact. Use one patch once daily (leave in place up to 24 hours) unless the local label directs otherwise. Do not apply to broken/irritated skin, mucous membranes, or near the eyes; avoid occlusive dressings/heat sources; wash hands after application and after removal.

Side Effects

Common Side Effects

Application-site reactions: pruritus, erythema, rash, irritation, and contact dermatitis; systemic NSAID-type adverse effects are uncommon but possible with extensive/prolonged use.

Side Effect Frequency

Common: application-site reactions (pruritus, erythema, rash/irritation, contact dermatitis); systemic GI effects (e.g., gastric discomfort) are uncommon/rare with topical use compared with oral NSAIDs.

Drug Interactions

Interaction Severity

Clinically significant interactions are generally LOW with topical use, but use CAUTION with concurrent systemic NSAIDs/aspirin (additive NSAID toxicity) and anticoagulants/antiplatelets (theoretical increased bleeding risk) if large-area/prolonged use; major systemic interactions (e.g., methotrexate, lithium) are primarily concerns with oral NSAIDs and are unlikely with standard topical exposure.

Food Interaction

None clinically relevant (topical product; food does not affect absorption).

Special Populations

Kidney Impairment

No specific dose adjustment for topical use; use with caution in renal impairment and avoid prolonged use/large surface area application in significant renal disease

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required

Pharmacology

Mechanism of Action

Loxoprofen is a prodrug converted to an active trans-alcohol metabolite that inhibits COX-1/COX-2, reducing prostaglandin synthesis and thereby decreasing local inflammation and pain.

Duration of Effect

Approximately 24 hours per patch (once-daily application).

Bioavailability

Systemic absorption is low with topical loxoprofen patches and systemic exposure is substantially lower than with oral dosing; exact bioavailability varies and is not reliably stated as a single percentage.

Metabolism

Hepatic/extrahepatic reduction of the prodrug to the active trans-alcohol metabolite primarily via carbonyl reductase; CYP-mediated metabolism is not the primary activation pathway.

Product Information

Available Dosage Forms

For this SFDA-registered product: cutaneous patch (tape) only.

Composition per Dose

Each patch: 100mg loxoprofen sodium hydrate

OTC Alternatives

Topical diclofenac gel, topical ibuprofen gel, topical ketoprofen gel

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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