Epicotil Tenoxicam 20 mg 3 vials + 3 ampoules 2 ml

Epicotil Tenoxicam 20 mg 3 vials + 3 ampoules 2 ml

Composition: 

Each lyophilized vial contains:
Tenoxicam 20 mg.
Solvent ampoule:
2 ml sterile water for injection. 

Product Description: 

Epicotil is a non-steroidal anti-inflammatory drug (NSAID) with potent anti-inflammatory, analgesic, and antipyretic properties.
It acts as an inhibitor of prostaglandin biosynthesis and platelet aggregation.
Provides strong anti-inflammatory and pain-relieving action by inhibiting prostaglandin synthesis at the site of inflammation.
It acts as a scavenger for active oxygen radicals at inflammatory sites, effectively reducing swelling, stiffness, and joint pain.

Indications for Use:

Symptomatic relief of painful inflammatory and degenerative disorders of the musculoskeletal system, including:
Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
Extra-articular disorders such as tendinitis, bursitis, and periarthritis.
Acute gout, low back pain, sprains, and strains.
Post-traumatic and post-operative pain.
Primary dysmenorrhea and other painful gynaecological conditions.

Method of Administration and Dosage:

For Intramuscular (I.M.) or Intravenous (I.V.) injection after reconstitution with the provided 2 ml solvent:
Standard Dosage: 20 mg (1 vial) once daily.
Acute Conditions: Start with 40 mg once daily for the first 2 days, followed by 20 mg once daily.

Contraindications:

Known hypersensitivity or allergy to tenoxicam, aspirin, or other NSAIDs.
Active peptic ulceration, gastrointestinal bleeding, or severe history of recurrent GI lesions.
Severe heart failure, severe liver insufficiency, or severe renal impairment.
Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Precautions:

Patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) or elderly patients should be monitored closely.
Exercise caution when co-administered with oral anticoagulants or oral antidiabetic agents.
May cause fluid retention or mild elevated renal function parameters (urea/creatinine); monitor kidney and liver function during extended therapy.

Adverse Reactions / Side Effects:

Gastrointestinal: Dyspepsia, nausea, heartburn, abdominal discomfort, flatulence, and stomatitis.
Central Nervous System: Dizziness, headache, or somnolence.
Dermatological: Pruritus, skin rash, or allergic skin reactions.

Pregnancy and Lactation:

Pregnancy: Avoid use during pregnancy, especially during the third trimester (due to risks of premature closure of the foetal ductus arteriosus and impaired foetal renal function).
Use only during early pregnancy if explicitly prescribed when clinical benefits outweigh risks.
Lactation: Tenoxicam passes into breast milk in tiny quantities; use with caution or discontinue breastfeeding if required by medical evaluation.

Storage Conditions: 

Store at room temperature (below 30°C) in a dry place, protected from direct light and heat.
Keep out of reach of children.

Packaging: 

Cardboard box containing 3 lyophilized vials and 3 solvent ampoules (2 ml each).