OXIRA 8/MG FC TAB 20/TAB

Indications

Approved Uses

Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis; short‑term treatment of acute mild to moderate pain.

Dosage & Administration

Dosing by Condition

Acute pain: 8-16 mg/day in 2-3 divided doses (max 16 mg/day). Osteoarthritis/Rheumatoid arthritis: start 12 mg/day in 2-3 divided doses; usual maintenance 8-16 mg/day (max 16 mg/day).

Maintenance Dose

8mg once to twice daily

Children's Dosage

Not approved for children under 18 years

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; in mild to moderate renal or hepatic impairment, do not exceed 12 mg/day (in divided doses); avoid use in severe renal/hepatic impairment; consider lower starting doses/caution in the elderly.

Side Effects

Side Effect Frequency

Common (1-10%): dyspepsia, nausea, abdominal pain, diarrhea, vomiting, headache, dizziness. Uncommon (0.1-1%): constipation, gastritis, rash/pruritus, edema, increased liver enzymes, hypertension. Rare/very rare (<0.1%): peptic ulcer/GI bleeding/perforation, severe hypersensitivity (e.g., anaphylaxis, SJS/TEN), serious renal/hepatic events, thrombotic events.

Safety & Warnings

Contraindications

Hypersensitivity to lornoxicam or other NSAIDs (including aspirin/NSAID-induced asthma, urticaria, or anaphylactoid reactions); active peptic ulcer or gastrointestinal bleeding, or history of recurrent ulcer/bleeding; history of GI bleeding or perforation related to previous NSAID therapy; severe hepatic impairment; severe renal impairment; severe heart failure; third trimester of pregnancy; active bleeding/hemorrhagic diathesis (bleeding disorders).

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events and GI bleeding/ulcer/perforation; avoid in CABG perioperative pain; caution in elderly and in patients with prior ulcer/GI disease, hypertension, heart failure/edema, renal impairment/dehydration, hepatic impairment, asthma/NSAID hypersensitivity; monitor for GI bleeding, BP/edema, renal function (especially with ACEi/ARB/diuretic), and liver enzymes if prolonged use; avoid combining with other NSAIDs and use caution with anticoagulants/antiplatelets/SSRIs.

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (e.g., aspirin, clopidogrel) and SSRIs/SNRIs-↑ bleeding; other NSAIDs and systemic corticosteroids-↑ GI toxicity/bleeding; ACE inhibitors/ARBs and diuretics-↓ antihypertensive/diuretic effect and ↑ risk of acute kidney injury ("triple whammy"); lithium-↑ lithium levels/toxicity; methotrexate-↑ methotrexate toxicity; cyclosporine/tacrolimus-↑ nephrotoxicity; digoxin-possible ↑ digoxin levels; quinolone antibiotics-rare ↑ seizure risk.

Food Interaction

May be taken with food or milk to reduce GI upset; food can delay time to peak and modestly reduce peak exposure (clinical effect usually maintained).

Alcohol Interaction

Avoid

Special Populations

Children

Not approved for children under 18 years

Liver Impairment

Mild to moderate hepatic impairment: use with caution; maximum total daily dose 12 mg (in divided doses) with close monitoring. Severe hepatic impairment: contraindicated/avoid.

Storage & Patient Advice

Patient Counseling

Take exactly as prescribed; swallow whole with water and preferably with food if stomach upset occurs; do not combine with other NSAIDs/aspirin unless directed; limit alcohol; seek urgent care for black/tarry stools, vomiting blood, severe abdominal pain, chest pain/shortness of breath, or facial swelling/rash; tell your clinician about kidney/liver disease, ulcers/bleeding history, hypertension/heart disease, and all anticoagulants/SSRIs/diuretics; avoid in late pregnancy (3rd trimester) and use only if advised earlier in pregnancy/breastfeeding.

Monitoring Requirements

If used beyond short term or in at‑risk patients: monitor renal function (SCr/eGFR), liver enzymes, CBC (anemia/bleeding), blood pressure/edema; monitor for GI bleeding and cardiovascular thrombotic events.

Pharmacology

Mechanism of Action

Reversibly inhibits COX‑1 and COX‑2, decreasing prostaglandin synthesis and thereby reducing pain, inflammation, and fever.

Half-Life

Approximately 3-4 hours (terminal elimination half-life).

Bioavailability

~90-100%

Excretion

Approximately one-third excreted in urine and two-thirds in feces/bile, mainly as metabolites (minimal unchanged drug).

Protein Binding

>99%

Product Information

Available Dosage Forms

For this SFDA-registered product: 8 mg film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: Lornoxicam 8mg

Generic Availability

Yes

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.