ROXONIN 60/MG TAB 20/TAB

Indications

Approved Uses

Relief of pain and inflammation in musculoskeletal/arthritic conditions (e.g., rheumatoid arthritis, osteoarthritis, low back pain, periarthritis/shoulder disorders) and for acute pain such as dental pain and post‑operative/post‑traumatic pain; may also be used for antipyresis and pain in acute upper respiratory tract inflammation (per local labeling where applicable).

Off-Label Uses

Off-label use may include acute gout flare pain and other acute pain syndromes (e.g., headache/migraine) depending on local practice; not universally labeled.

Dosage & Administration

Dosing by Condition

Adults (typical): 60 mg orally three times daily after meals for pain/inflammation; for acute pain/fever, 60 mg per dose may be used as needed with usual maximum 180 mg/day unless otherwise directed by a prescriber.

Initial Dose

60mg

Maintenance Dose

60mg two to three times daily as needed

Maximum Dose

180mg per day.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; use caution in elderly and in renal/hepatic impairment (start lower and monitor), and avoid/use only with specialist advice in severe renal or severe hepatic impairment.

Side Effects

Side Effect Frequency

Common: gastrointestinal adverse effects (dyspepsia/stomach discomfort, abdominal pain, nausea ± vomiting), rash; edema and drowsiness can occur but are less consistently listed as common across references.

Safety & Warnings

Contraindications

Hypersensitivity to loxoprofen/other NSAIDs; history of NSAID/aspirin-induced asthma, urticaria or allergic-type reactions; active peptic ulcer or active GI bleeding; severe hepatic impairment; severe renal impairment; severe heart failure; third trimester of pregnancy.

Warnings & Precautions

Use lowest effective dose for shortest duration; caution with history of peptic ulcer/GI bleed, older age, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids; caution in cardiovascular disease/HTN/edema; renal impairment, dehydration, or use with ACEi/ARB+diuretic; hepatic impairment; asthma/NSAID hypersensitivity; may mask infection/fever; with long-term use monitor CBC, renal and liver function and blood pressure.

Drug Interactions

Drug Interactions

Anticoagulants (e.g., warfarin) and antiplatelets (↑ bleeding); other NSAIDs/aspirin (↑ GI/renal toxicity); corticosteroids and SSRIs/SNRIs (↑ GI bleeding); ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ AKI risk-"triple whammy"); lithium (↑ levels); methotrexate (↑ toxicity); sulfonylureas (↑ hypoglycemia risk reported with some NSAIDs); quinolones (↑ seizure risk).

Food Interaction

Take with food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Storage & Patient Advice

Patient Counseling

Take with/after food; do not exceed 180 mg/day unless prescribed; avoid combining with other NSAIDs; limit alcohol; stop and seek care for black stools, severe abdominal pain, vomiting blood, rash/swelling/wheezing; use caution with driving if dizzy/drowsy; check with a clinician/pharmacist if on anticoagulants/antiplatelets, steroids, SSRIs, lithium, methotrexate, or BP/diuretic medicines; avoid in late pregnancy (3rd trimester).

Monitoring Requirements

If used beyond short-term: monitor renal function (SCr/eGFR), liver enzymes, blood pressure/edema, and consider CBC for anemia/occult bleeding; urinalysis may be used as part of renal monitoring.

Pharmacology

Mechanism of Action

Prodrug converted to an active metabolite that non-selectively inhibits COX-1 and COX-2, reducing prostaglandin synthesis and thereby decreasing pain, inflammation, and fever.

Duration of Effect

Approximately 4-6 hours (typical analgesic effect), supporting dosing up to three times daily.

Half-Life

Approximately 1.2-1.3 hours (≈75-80 minutes) for the active trans-alcohol metabolite.

Bioavailability

Oral bioavailability is 95% with rapid and complete absorption from the gastrointestinal tract; absorption phase occurs within 4-6 hours after ingestion

Metabolism

Rapid hepatic conversion (prodrug) to the active trans-alcohol metabolite via carbonyl reductase, followed by further conjugation (e.g., glucuronidation); CYP involvement is not a primary pathway.

Protein Binding

Loxoprofen is 99% albumin-bound; protein binding percentage for active metabolite not specified in available sources

Product Information

Available Dosage Forms

Tablet (this SFDA-registered product is an oral tablet, 60 mg, blister pack of 20).

Composition per Dose

Each tablet: 60mg loxoprofen sodium

Pain Type

General/Muscular/Joint

Nsaid

Yes

Opioid

No

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