Ornopain

 4 mg Tablet
Incepta Pharmaceuticals Ltd.
Unit Price: ৳ 18.00 (3 x 10: ৳ 540.00)
Strip Price: ৳ 180.00
Indications

Approved Indications:

  • Acute Pain: Management of moderate to severe acute pain, including:
    • Post-operative pain
    • Musculoskeletal pain
    • Dental pain
    • Traumatic pain
  • Chronic Inflammatory Conditions:
    • Osteoarthritis (OA)
    • Rheumatoid arthritis (RA)
    • Ankylosing spondylitis (AS)
  • Low Back Pain and Sciatica
  • Primary Dysmenorrhea

Clinically Accepted Off-Label Uses:

  • Acute Gout Flares
  • Post-traumatic Inflammation
  • Painful Soft Tissue Disorders

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Dosage & Administration

Adults:

  • Oral: 4 mg to 8 mg twice daily (Maximum: 16 mg/day)
  • Parenteral (IM/IV): 8 mg once or twice daily for a short duration (usually not exceeding 2–3 days)

Pediatrics:

  • Not recommended for individuals under 18 years due to lack of safety and efficacy data.

Elderly:

  • Initiate treatment at the lower end of the dosing range (e.g., 4 mg twice daily). Monitor closely for gastrointestinal, renal, and cardiovascular complications.

Renal Impairment:

  • Mild to moderate impairment (CrCl 30–60 mL/min): Use with caution
  • Severe impairment (CrCl <30 mL/min): Contraindicated

Hepatic Impairment:

  • Mild to moderate: Use with caution
  • Severe hepatic dysfunction: Contraindicated

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Mechanism of Action (MOA)

Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. It acts by non-selectively inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which are responsible for the biosynthesis of prostaglandins. Prostaglandins mediate inflammation, pain, and fever. By reducing prostaglandin production, lornoxicam exerts anti-inflammatory, analgesic, and antipyretic effects. It also modulates peripheral and central pain pathways, contributing to its analgesic efficacy.

Pharmacokinetics
  • Absorption: Rapidly and almost completely absorbed after oral administration
  • Bioavailability: Approximately 90–100%
  • Time to Peak Concentration (Tmax): 1–2 hours
  • Protein Binding: >99% (mainly to albumin)
  • Metabolism: Hepatically metabolized via CYP2C9 to inactive metabolites
  • Half-life: Approximately 3–5 hours
  • Excretion:
    • ~42% in urine (mostly as metabolites)
    • ~54% in feces
  • Steady-State: No accumulation due to short half-life
Pregnancy Category & Lactation

Pregnancy:

  • FDA Category C (up to 30 weeks of gestation): Use only if clearly needed
  • FDA Category D (after 30 weeks): Contraindicated due to risk of fetal renal dysfunction and premature closure of the ductus arteriosus

Lactation:

  • It is unknown whether lornoxicam is excreted in human milk.
  • Use is not recommended during breastfeeding due to the potential for serious adverse effects in the infant.
Therapeutic Class
  • Primary Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
  • Subclass: Oxicam derivative
  • Generation: Traditional (non-selective COX inhibitor)
Contraindications
  • Known hypersensitivity to lornoxicam or any oxicam derivative
  • History of NSAID-induced asthma, urticaria, or other allergic-type reactions
  • Active gastrointestinal ulcer, bleeding, or perforation
  • Severe renal or hepatic impairment
  • Severe cardiac failure (NYHA Class III–IV)
  • Third trimester of pregnancy
  • Concomitant use with other NSAIDs or aspirin
  • Known bleeding disorders or active bleeding
  • Children and adolescents under 18 years
Warnings & Precautions
  • Gastrointestinal Risks: Increased risk of GI ulceration, bleeding, and perforation, especially in elderly or those on corticosteroids or anticoagulants
  • Cardiovascular Risks: May increase risk of thrombotic events such as myocardial infarction or stroke
  • Renal Effects: Risk of fluid retention, hypertension, and renal impairment—use with caution in patients with compromised renal function
  • Hepatic Effects: Monitor liver function tests in patients receiving long-term therapy
  • Hypersensitivity Reactions: Can occur even without prior exposure; discontinue immediately if severe reaction occurs
  • Use with Caution in: Elderly, dehydrated patients, patients with history of GI disease, or those with cardiovascular risk factors
Side Effects

Common Side Effects (≥1%):

  • Gastrointestinal: Nausea, vomiting, abdominal pain, dyspepsia, diarrhea, flatulence
  • Central Nervous System: Headache, dizziness, fatigue
  • Skin: Rash, itching
  • General: Edema

Serious or Rare Side Effects:

  • Gastrointestinal: GI bleeding, ulceration, perforation
  • Renal: Acute kidney injury, nephritis
  • Cardiovascular: Hypertension, arrhythmia, thromboembolism
  • Hepatic: Hepatitis, elevated liver enzymes
  • Hematologic: Anemia, leukopenia, thrombocytopenia
  • Allergic: Anaphylaxis, angioedema, Stevens-Johnson syndrome

Onset & Severity:

  • Gastrointestinal symptoms often appear early in therapy
  • Serious events may be dose-dependent or occur with prolonged use
Drug Interactions
  • Anticoagulants (e.g., warfarin): Increased risk of bleeding; monitor INR closely
  • Antiplatelets (e.g., aspirin, clopidogrel): Additive GI toxicity
  • Other NSAIDs or corticosteroids: Increased risk of GI and renal adverse effects
  • Methotrexate: Risk of increased methotrexate toxicity
  • ACE inhibitors/ARBs/Diuretics: Increased risk of renal impairment
  • Lithium: May elevate serum lithium levels; monitor closely
  • CYP2C9 inhibitors (e.g., fluconazole): May increase plasma levels of lornoxicam
  • Alcohol: Increases risk of GI bleeding and ulceration
Recent Updates or Guidelines
  • NSAID Use in Pregnancy: Updated FDA and international guidance discourages NSAID use from 20 weeks of gestation onward due to risks of oligohydramnios and fetal renal dysfunction
  • Clinical Guidelines: International rheumatology and pain management guidelines recommend using the lowest effective dose of lornoxicam for the shortest duration
  • No recent changes to indications or major safety profile for lornoxicam specifically
Storage Conditions
  • Temperature: Store below 25°C (77°F)
  • Humidity: Protect from moisture; store in a dry place
  • Light: Store in original packaging to protect from light
  • Handling Precautions:
    • Do not freeze parenteral formulations
    • Keep out of reach of children
    • Discard unused injectable solutions after opening
  • Shelf Life: Follow manufacturer’s instructions (typically 2–3 years if unopened)