ROXONIN 50/MG TAPE 7TAPES

Indications

Approved Uses

Local symptomatic relief of pain and inflammation in musculoskeletal conditions (e.g., osteoarthritis-related joint pain, myalgia, sprains/strains/contusions and other post‑traumatic pain/swelling).

Dosage & Administration

Dosing by Condition

Localized musculoskeletal pain/inflammation (including osteoarthritis pain, myalgia, and post-traumatic pain/swelling): apply one 100 mg patch to the affected area once daily; replace every 24 hours.

Initial Dose

One 50 mg patch applied to the affected area once daily

Maintenance Dose

One 100 mg patch once daily to the affected area

Maximum Dose

Follow product labeling; typical use is 1 patch to the affected area once daily (do not apply multiple patches to the same area simultaneously).

Dose Adjustment Notes

No specific dose adjustment is established for the topical patch; use with caution in renal/hepatic impairment and in patients at higher NSAID risk due to possible systemic absorption.

How to Take

Apply to clean, dry, intact skin: open pouch, remove liner, apply one patch to the painful area and press firmly (especially edges); leave in place up to 24 hours then replace. Avoid application to broken/irritated skin, mucous membranes, or eyes; wash hands after use.

Side Effects

Common Side Effects

Application-site reactions such as pruritus, erythema, rash/irritation, and contact dermatitis; systemic NSAID effects (e.g., GI upset) are uncommon but possible with absorption.

Side Effect Frequency

Common: application-site reactions (erythema, pruritus, rash, contact dermatitis); Uncommon/rare: photosensitivity/photoallergic dermatitis, vesicles/blistering; systemic NSAID adverse effects (e.g., GI upset, edema) are uncommon with topical use but can occur, especially with extensive/prolonged use or in susceptible patients.

Safety & Warnings

Warnings & Precautions

Do not apply to broken/diseased skin or mucosa; avoid eyes; avoid occlusion unless directed; stop if rash/irritation occurs; minimize sun/UV exposure on treated area (photoallergy risk); use caution in patients with NSAID hypersensitivity/asthma, history of GI ulcer/bleeding, cardiovascular disease/heart failure, renal/hepatic impairment, and when using other NSAIDs/anticoagulants.

Drug Interactions

Food Interaction

Not applicable (topical route); no clinically relevant food interaction expected.

Special Populations

Kidney Impairment

No specific dose adjustment established for topical patch; use with caution in severe renal impairment and avoid extensive/prolonged use.

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime.

Overdose

Topical overdose is unlikely; excessive application may increase local irritation and systemic NSAID effects; if ingested, manage as NSAID overdose with supportive care and consider decontamination per standard toxicology guidance.

Patient Counseling

Apply 1 patch to clean, dry, intact skin over the painful area once daily (leave in place up to 24 hours), then replace if needed; do not apply to broken/irritated skin, eyes, mouth, or mucous membranes; wash hands after handling; avoid heat sources (heating pads/hot baths) on the patch area; avoid direct sunlight/UV on the treated area during use and for several days after removal due to risk of photosensitivity/photoallergic reactions; stop and seek advice if significant redness, blistering, or rash occurs; use the lowest effective amount and avoid using multiple patches on the same area unless directed; fold used patches adhesive-to-adhesive and dispose safely away from children/pets.

Monitoring Requirements

Routine laboratory monitoring is not required for short-term use; monitor for local skin reactions and consider systemic NSAID monitoring (renal function, blood pressure, GI bleeding risk) only with prolonged use, large-area use, or in high-risk patients.

Pharmacology

Mechanism of Action

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

Duration of Effect

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

Bioavailability

Systemic exposure is low with topical loxoprofen patch compared with oral dosing (i.e., markedly reduced systemic absorption); an exact % bioavailability is product-specific and not reliably stated as a single universal value.

Metabolism

Loxoprofen is a prodrug reduced to the active trans-alcohol metabolite (via carbonyl reductases), followed by further hepatic metabolism including conjugation (e.g., glucuronidation).

Product Information

Available Dosage Forms

Cutaneous patch (this product/SKU).

Composition per Dose

Each cutaneous patch: 50 mg loxoprofen

OTC Alternatives

Topical diclofenac gel, topical ibuprofen gel, topical ketoprofen gel

Pain Type

Muscular/Joint

Nsaid

Yes

Opioid

No

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