Oxiflam20 mg

Oxiflam 20 mg is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, used for the symptomatic relief of pain and inflammation in the following conditions:

Established / Approved Uses

• Osteoarthritis - relief of joint pain, stiffness, and swelling.
• Rheumatoid arthritis - reduction of inflammatory joint pain and swelling.
• Ankylosing spondylitis - relief of spinal pain and stiffness.
• Acute musculoskeletal disorders - short-term relief of pain from sprains, strains, tendinitis, bursitis, and periarthritis of the shoulder or hip.

Oxiflam 20 mg provides symptomatic relief of pain and inflammation; it does not alter the underlying course of arthritic disease.

Each tablet contains Oxiflam 20 mg 20 mg as the active ingredient. Oxiflam 20 mg is also available in some markets as a powder/lyophilisate for injection for short-term use in acute pain, reconstituted with the supplied diluent before administration.

Oxiflam 20 mg is a long-acting non-steroidal anti-inflammatory drug (NSAID) belonging to the oxicam class, chemically related to piroxicam. It is used to relieve pain, swelling, and stiffness associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute musculoskeletal injuries.

A key feature of Oxiflam 20 mg is its long elimination half-life, which allows for convenient once-daily dosing while providing sustained anti-inflammatory and analgesic effect throughout the day.

Oxiflam 20 mg belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, specifically the oxicam subgroup of NSAIDs, which also includes piroxicam and meloxicam.

Oxiflam 20 mg exerts its anti-inflammatory, analgesic, and antipyretic effects primarily through non-selective, reversible inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins, key mediators of pain, inflammation, and fever.

Pharmacokinetics

• Absorption: Well absorbed orally, with peak plasma concentrations reached within a few hours; food may slightly delay but does not significantly reduce absorption.
• Distribution: Highly protein-bound (greater than 99%), with good penetration into synovial fluid.
• Metabolism: Extensively metabolized in the liver, largely via CYP2C9, into inactive metabolites.
• Elimination: Has an unusually long elimination half-life (approximately 60-75 hours), which permits once-daily dosing; excreted mainly via the kidneys and to a lesser extent in bile.
• Steady state: Because of its long half-life, steady-state plasma concentrations are reached only after approximately 10-15 days of regular once-daily dosing.

Oxiflam 20 mg tablets should be taken orally, swallowed whole with a full glass of water, preferably with or immediately after food or milk to minimize gastrointestinal upset. Tablets should not be crushed or chewed unless specifically formulated for that purpose. Because of its long half-life, Oxiflam 20 mg should be taken at approximately the same time each day.

Oxiflam 20 mg has clinically significant interactions with the following drug classes:

• Anticoagulants (e.g. warfarin) and antiplatelet agents: increased risk of gastrointestinal and other bleeding due to additive effects on hemostasis; concurrent use requires close monitoring.
• Other NSAIDs and aspirin: additive risk of gastrointestinal ulceration/bleeding and renal impairment; concurrent use should generally be avoided.
• ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics: Oxiflam 20 mg may reduce the antihypertensive effect of these agents and, particularly in combination with diuretics, increases the risk of acute renal impairment ("triple whammy" effect).
• Lithium: Oxiflam 20 mg can reduce renal clearance of lithium, leading to increased plasma lithium levels and toxicity; lithium levels should be monitored.
• Methotrexate: Oxiflam 20 mg can reduce renal clearance of methotrexate, increasing the risk of methotrexate toxicity, especially at higher methotrexate doses.
• Corticosteroids and SSRIs: concurrent use increases the risk of gastrointestinal ulceration and bleeding.
• Cyclosporine: increased risk of nephrotoxicity when used together.

Side effects of Oxiflam 20 mg are generally dose- and duration-related and consistent with the NSAID class.

Common

• Dyspepsia, nausea, abdominal pain
• Diarrhea or constipation
• Headache, dizziness
• Peripheral edema
• Skin rash

Less Common / Serious

• Gastrointestinal ulceration, bleeding, or perforation
• Elevated liver enzymes
• Renal impairment, fluid retention, hypertension
• Tinnitus, vertigo

Rare but Serious

• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Anaphylaxis, bronchospasm (especially in aspirin-sensitive individuals)
• Cardiovascular thrombotic events (myocardial infarction, stroke)

Pregnancy: Oxiflam 20 mg should be avoided during pregnancy unless clearly necessary. Use during the first and second trimesters should occur only if the potential benefit justifies the potential risk to the fetus, and only under medical supervision. Oxiflam 20 mg, like other NSAIDs, is contraindicated during the third trimester of pregnancy because of the risk of premature closure of the fetal ductus arteriosus, fetal renal impairment, and complications during labor and delivery.

Lactation: It is not established whether Oxiflam 20 mg is excreted in human breast milk; because many NSAIDs pass into breast milk, use during breastfeeding is not recommended unless a physician determines the benefit outweighs the potential risk to the infant.

Oxiflam 20 mg shares the cardiovascular and gastrointestinal risks common to the NSAID class:

• Cardiovascular risk: NSAIDs, including Oxiflam 20 mg, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal; this risk may increase with duration of use and in patients with existing cardiovascular disease or risk factors.
• Gastrointestinal risk: NSAIDs increase the risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time and without warning symptoms, especially in elderly patients.
• Renal effects: Long-term use may impair renal function, particularly in patients with pre-existing renal impairment, heart failure, liver dysfunction, or those on diuretics or ACE inhibitors/ARBs; adequate hydration should be maintained.
• Hepatic effects: Elevations of liver enzymes may occur; discontinue if signs of liver dysfunction develop.
• Delayed onset of full effect: Because of its long half-life, it may take 1-2 weeks of regular once-daily dosing for Oxiflam 20 mg to reach steady-state plasma levels and full anti-inflammatory effect.
• Fluid retention: Use with caution in patients with a history of hypertension or heart failure due to potential fluid retention and edema.
• Masking of infection signs: As an anti-inflammatory and antipyretic agent, Oxiflam 20 mg may mask the usual signs of infection.

For hypersensitivity, gastrointestinal bleeding, severe heart failure, severe renal/hepatic impairment, and third-trimester pregnancy, see Contraindications.

Symptoms of Oxiflam 20 mg overdose may include nausea, vomiting, abdominal pain, gastrointestinal bleeding, drowsiness, dizziness, headache, and in severe cases, hypotension, respiratory depression, seizures, or acute kidney injury.

There is no specific antidote for Oxiflam 20 mg overdose. In case of suspected overdose, seek immediate medical attention or contact emergency services / a poison control center. Treatment is supportive and symptomatic, and should be initiated promptly by qualified medical personnel; do not attempt to manage an overdose at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly

Elderly patients are at greater risk for serious gastrointestinal, renal, and cardiovascular adverse effects with Oxiflam 20 mg. Use the lowest effective dose for the shortest duration and monitor closely.

Renal Impairment

Oxiflam 20 mg should be used with caution in patients with mild to moderate renal impairment, with close monitoring of renal function; it is contraindicated in severe renal impairment (see Contraindications).

Hepatic Impairment

Use with caution in mild to moderate hepatic impairment, with monitoring of liver function; Oxiflam 20 mg is contraindicated in severe hepatic impairment (see Contraindications).

Pediatric Use

Safety and efficacy of Oxiflam 20 mg in children have not been established; its use in the pediatric population is not recommended.

Pregnancy and Lactation

See Pregnancy and Lactation section for full details.

Oxiflam 20 mg should be used for the shortest duration consistent with the treatment goal. For acute musculoskeletal pain, treatment courses of about 7 days (including an initial higher-dose phase) are typical. For chronic conditions such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, treatment duration should be periodically reassessed by the prescribing physician to confirm continued need and to monitor for adverse effects.

Non-Steroidal Anti-Inflammatory Drug (NSAID), oxicam class

Oxiflam 20 mg works by non-selectively and reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby blocking the conversion of arachidonic acid to prostaglandins and thromboxanes. This reduction in prostaglandin synthesis underlies its analgesic, anti-inflammatory, and antipyretic effects, while inhibition of COX-1 in the gastric mucosa and platelets accounts for its gastrointestinal and bleeding-related adverse effects.

C (D in third trimester)

The safety and efficacy of Oxiflam 20 mg have not been established in children, and its use is not recommended in the pediatric population. Alternative analgesic/anti-inflammatory agents with established pediatric safety data should be used for children requiring NSAID therapy.