Ornopain8 mg

Ornopain is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, indicated for the short-term symptomatic relief of pain and inflammation in the following conditions:

Established Uses

• Osteoarthritis: Symptomatic relief of pain and inflammation.
• Rheumatoid arthritis: Symptomatic relief of pain and inflammation.
• Acute low back pain and sciatica: Short-term management.
• Postoperative pain: Management of mild to moderate acute pain following surgical procedures (e.g., orthopedic, dental, or gynecological surgery), typically starting with the injectable form followed by oral therapy.

Ornopain is intended for short-term use; it does not alter the underlying disease process in arthritis and should be used at the lowest effective dose for the shortest duration consistent with the treatment goal.

Each tablet of Lornoxicam contains Lornoxicam INN 4 mg or 8 mg as the active ingredient. The lyophilized powder for injection contains Lornoxicam INN 8 mg per vial, to be reconstituted with the accompanying solvent (water for injections) immediately before use.

Ornopain is a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the oxicam group, chemically related to piroxicam and tenoxicam but distinguished by a much shorter elimination half-life (approximately 3-5 hours), which reduces the risk of drug accumulation with repeated dosing.

It produces analgesic, anti-inflammatory, and antipyretic effects primarily through inhibition of both cyclo-oxygenase (COX-1 and COX-2) isoenzymes, thereby reducing prostaglandin synthesis at sites of inflammation. Ornopain is available as oral tablets and as a lyophilized powder for intramuscular/intravenous injection for short-term management of acute postoperative pain.

Ornopain belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, specifically the oxicam group of enolic acid derivatives.

Lornoxicam is a non-selective inhibitor of cyclo-oxygenase (COX-1 and COX-2), the enzymes responsible for converting arachidonic acid into prostaglandins and thromboxanes. By reducing prostaglandin synthesis, Lornoxicam produces analgesic, anti-inflammatory, and antipyretic effects. Some evidence also suggests Lornoxicam stimulates physiological release of endogenous cortisol and reduces nitric oxide production, contributing additional analgesic activity beyond pure COX inhibition.

Pharmacokinetics

• Absorption: Rapidly and almost completely absorbed after oral administration; peak plasma concentration reached within 1-2 hours.
• Distribution: Highly protein bound (greater than 99%); small volume of distribution.
• Metabolism: Extensively metabolized in the liver, mainly via the CYP2C9 enzyme, to an inactive hydroxylated metabolite.
• Elimination: Elimination half-life of approximately 3-5 hours; excreted as metabolites, roughly two-thirds via the kidneys and the remainder via bile/feces.

Ornopain tablets should be swallowed whole with a full glass of water, preferably with or after food to minimize stomach upset. The injectable form of Ornopain is for short-term use only and should be administered by slow intravenous or deep intramuscular injection by a healthcare professional after reconstitution.

Ornopain has clinically significant interactions with the following medicines:

• Other NSAIDs and aspirin: Concurrent use with Ornopain increases the risk of gastrointestinal ulceration and bleeding; the combination should be avoided.
• Anticoagulants (e.g., warfarin): Increased risk of serious bleeding when combined with Ornopain; requires close monitoring or should be avoided.
• Corticosteroids: Increased risk of gastrointestinal ulceration and bleeding when combined with Ornopain.
• Lithium: Ornopain can reduce renal clearance of lithium, raising plasma lithium levels and the risk of toxicity.
• Methotrexate: Ornopain may reduce renal elimination of methotrexate, increasing its toxicity.
• ACE inhibitors, angiotensin receptor blockers, and diuretics: Ornopain may reduce their antihypertensive effect and increase the risk of renal impairment, especially in dehydrated patients.
• Ciclosporin/tacrolimus: Increased risk of nephrotoxicity when used with Ornopain.
• Cholestyramine: May reduce absorption of Ornopain if taken together.
• Strong CYP2C9 inhibitors (e.g., fluconazole): May increase plasma levels of Ornopain.

Most side effects of Ornopain are mild and reversible on stopping treatment.

Common

• Dyspepsia, nausea, abdominal pain
• Diarrhea or constipation
• Headache, dizziness

Less Common / Serious

• Peptic ulceration and gastrointestinal bleeding
• Fluid retention, edema, elevated blood pressure
• Elevated liver enzymes
• Renal function impairment

Rare

• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Anaphylactoid reactions and bronchospasm
• Blood dyscrasias (thrombocytopenia, leukopenia)

Ornopain is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and impaired fetal renal function. Use during the first and second trimesters is not recommended unless clearly necessary; if used, the lowest effective dose for the shortest duration should be chosen, only under medical supervision, since the potential benefit must be weighed against potential risk to the fetus.

Ornopain is not recommended during breastfeeding, as it is likely excreted into breast milk and safety in nursing infants has not been established. Consult a physician before using Ornopain while breastfeeding.

Cardiovascular risk: As with other NSAIDs, Ornopain may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke; use the lowest effective dose for the shortest duration, particularly in patients with cardiovascular risk factors.

Gastrointestinal risk: Ornopain can cause serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, at any time during use, with or without warning symptoms; risk is higher in the elderly and in those with a prior history of peptic ulcer disease (see Contraindications for absolute exclusions).

Renal function: Use with caution in patients with pre-existing renal impairment, dehydration, heart failure, or those on diuretics/ACE inhibitors, as Ornopain may further reduce renal blood flow.

Hepatic function: Use with caution in patients with mild to moderate hepatic impairment; monitor liver function during prolonged use of Ornopain.

Elderly patients: More susceptible to adverse effects of Ornopain, particularly gastrointestinal bleeding and renal impairment; use the lowest effective dose.

Masking of infection: Ornopain may reduce fever and inflammation, potentially masking signs of an underlying infection.

Bleeding risk: Use Ornopain with caution in patients on anticoagulants or with other conditions predisposing to bleeding.

Symptoms of Ornopain overdose may include nausea, vomiting, abdominal pain, lethargy, and drowsiness. In more severe cases, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, coma, and seizures may occur.

There is no specific antidote for Ornopain overdose. If overdose is suspected, seek immediate medical attention or contact a poison control center or emergency services right away. Management is supportive and symptomatic; activated charcoal may be considered if the patient presents soon after ingestion, under medical supervision.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. The reconstituted injection solution of Ornopain should be used immediately after preparation.

Renal Impairment

Use Ornopain with caution and at a reduced dose in patients with mild to moderate renal impairment. Contraindicated in severe renal impairment.

Hepatic Impairment

Use Ornopain with caution and at a reduced dose in patients with mild to moderate hepatic impairment. Contraindicated in severe hepatic impairment.

Elderly

No specific dose adjustment is generally required, but elderly patients are at greater risk of gastrointestinal, renal, and cardiovascular adverse effects with Ornopain; use the lowest effective dose.

Pediatric

Safety and efficacy of Ornopain in children and adolescents under 18 years have not been established; use is not recommended in this age group.

Ornopain is intended for short-term use. For acute pain (e.g., postoperative pain, acute low back pain), treatment is generally limited to a few days, up to a maximum of about 7 days. For chronic conditions such as osteoarthritis or rheumatoid arthritis, Ornopain may be continued longer under regular medical supervision, with periodic review of the need for continued therapy at the lowest effective dose.

The lyophilized powder for injection form of Ornopain (8 mg per vial) should be reconstituted immediately before use with the accompanying solvent (water for injections), gently swirled until completely dissolved, and the resulting solution used promptly. Do not use if the reconstituted solution is discolored or contains particulate matter.

Non-Steroidal Anti-Inflammatory Drug (NSAID) - Oxicam derivative

Lornoxicam works by non-selectively inhibiting the cyclo-oxygenase (COX-1 and COX-2) enzymes, blocking the conversion of arachidonic acid into prostaglandins that mediate pain, inflammation, and fever. This reduction in prostaglandin synthesis at the site of tissue injury accounts for the analgesic and anti-inflammatory effects of Lornoxicam.

The safety and efficacy of Ornopain in pediatric patients under 18 years of age have not been established. Therefore, Ornopain is not recommended for use in children and adolescents.