Tenoflex

Approved Indications:

• Rheumatoid Arthritis (RA): For symptomatic treatment including pain, stiffness, and joint inflammation.
• Osteoarthritis (OA): Used to relieve joint pain, swelling, and impaired mobility.
• Ankylosing Spondylitis (AS): For reducing spinal inflammation, stiffness, and pain.
• Acute Gouty Arthritis: Short-term use in managing acute flare-ups.
• Postoperative Pain and Inflammation: Especially after orthopedic or dental surgery.
• Soft Tissue Disorders: Including tendinitis, bursitis, and periarthritis for relief of pain and inflammation.
• Dysmenorrhea (Painful Menstruation): Occasionally used off-label to reduce menstrual pain.
• Musculoskeletal Pain (Off-label): For acute or chronic pain due to musculoskeletal injuries.

Route of Administration: Oral or intramuscular injection.

Adults:

• Oral: 20 mg once daily.
• Acute conditions (e.g., gout): 40 mg once daily for the first 2 days, followed by 20 mg once daily for 5 days.
• Intramuscular (IM): 20 mg once daily for up to 2 days when oral therapy is not feasible.

Elderly:

• Use the lowest effective dose due to increased risk of gastrointestinal and renal adverse effects.

Pediatric:

• Not recommended (safety and efficacy not established in children).

Renal Impairment:

• Mild to moderate impairment: Caution advised; monitor renal function.
• Severe renal impairment: Contraindicated due to risk of nephrotoxicity.

Hepatic Impairment:

• Use with caution; monitor liver enzymes periodically.

Duration:

• Acute conditions: Short-term use (5–7 days).
• Chronic conditions: Long-term use requires regular monitoring.

Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes. These enzymes are key in the biosynthesis of prostaglandins, which mediate inflammation, pain, and fever. By reducing prostaglandin levels in peripheral tissues, Tenoxicam decreases inflammation, alleviates pain, reduces swelling, and improves joint mobility. Its long half-life allows once-daily dosing for sustained anti-inflammatory action.

• Absorption: Rapidly and almost completely absorbed after oral administration; peak plasma levels reached within 1–2 hours.
• Bioavailability: ~100%
• Distribution: Widely distributed; ~99% plasma protein-bound.
• Metabolism: Primarily hepatic via hydroxylation and conjugation.
• Half-life: ~60–75 hours, enabling once-daily dosing.
• Excretion: Excreted via urine (~2–10%) and feces (~35%) mainly as inactive metabolites.
• Steady State: Achieved within 10–15 days.

• Pregnancy: Category C (first two trimesters), Category D (third trimester) – Avoid in late pregnancy due to risk of premature closure of ductus arteriosus and oligohydramnios.
• Lactation: Unknown whether excreted in human milk. Avoid during breastfeeding or use with caution if benefits outweigh risks.
• General Recommendation: Avoid use during pregnancy and lactation unless absolutely necessary.

• Primary Class: Non-Steroidal Anti-Inflammatory Drug (NSAID)
• Subclass: Oxicam derivative (enolic acid class)
• Generation: Long-acting NSAID

• Known hypersensitivity to Tenoxicam or other NSAIDs
• History of NSAID-induced asthma, urticaria, or allergic-type reactions
• Active peptic ulcer, gastrointestinal bleeding, or perforation
• Severe hepatic or renal impairment
• Advanced heart failure (NYHA Class III or IV)
• Pregnancy (especially third trimester)
• Children under 18 years of age

• Gastrointestinal risk: Increased risk of GI bleeding, ulceration, and perforation; co-administration with proton-pump inhibitors recommended in high-risk patients.
• Cardiovascular risk: May increase risk of thrombotic events, myocardial infarction, and stroke.
• Renal impairment: May cause renal dysfunction, particularly in volume-depleted patients.
• Hepatic effects: Monitor liver function tests periodically.
• Elderly patients: Greater risk of adverse effects; monitor closely.
• Skin reactions: Rare but serious skin reactions like Stevens-Johnson syndrome have been reported.
• Avoid with alcohol or other NSAIDs: Increases GI and renal risk.

Common:

• Gastrointestinal: Nausea, dyspepsia, abdominal pain, diarrhea, gastritis
• CNS: Headache, dizziness, somnolence
• Skin: Rash, pruritus
• General: Edema, fatigue

Less Common:

• Hematologic: Anemia, leukopenia
• Renal: Increased serum creatinine, renal impairment
• Hepatic: Elevated liver enzymes

Serious/Rare:

• Gastrointestinal bleeding or perforation
• Anaphylactic reactions
• Stevens-Johnson syndrome
• Acute renal failure
• Hepatotoxicity
• Myocardial infarction, stroke (with long-term use)

• Anticoagulants (e.g., Warfarin): Increased bleeding risk
• Antiplatelets (e.g., Aspirin): Additive GI bleeding risk
• ACE inhibitors/ARBs: Decreased renal function
• Diuretics: Reduced efficacy and risk of nephrotoxicity
• Methotrexate: Increased toxicity due to reduced renal clearance
• Lithium: Increased serum lithium levels and toxicity
• Cyclosporine: Increased nephrotoxicity
• Corticosteroids: Increased risk of GI ulcers
• Alcohol: Exacerbates GI side effects
• CYP450 interactions: Minimal CYP involvement; however, caution advised with highly protein-bound drugs

• EMA (European Medicines Agency): Reaffirmed cardiovascular risk with long-term use of NSAIDs, including Tenoxicam. Short-term use at the lowest effective dose is recommended.
• WHO Essential Medicines List: Tenoxicam is not currently listed due to availability of safer alternatives.
• Guideline Shift: Several regional rheumatology societies now recommend selective COX-2 inhibitors or other NSAIDs with lower GI risk in high-risk populations.

• Temperature: Store at 20°C to 25°C (controlled room temperature); excursions permitted between 15°C and 30°C.
• Humidity: Store in a dry place; protect from moisture.
• Light Protection: Keep away from direct sunlight.
• Handling Precautions: Keep out of reach of children; do not use after expiration.
• Injection Form: IM vials should not be frozen and must be used immediately after reconstitution.