Active Ingredient: Piroxicam

Excipients: May include lactose, maize starch, povidone, sodium lauryl sulfate, magnesium stearate, hypromellose, talc, titanium dioxide (E171), and other inactive ingredients depending on the formulation.

FELDENE is available in various formulations, including:

• Capsules: Available in strengths such as 10 mg and 20 mg.
• Tablets: Available in strengths such as 10 mg and 20 mg.
• Gel: Available in tubes of various sizes containing piroxicam gel for topical application.

FELDENE belongs to the pharmacological group of nonsteroidal anti-inflammatory drugs (NSAIDs) of the oxicam class (ATC code: M01AC01).

Pharmacological Properties:

• Pharmacodynamics: Piroxicam exhibits anti-inflammatory, analgesic, and antipyretic properties by inhibiting prostaglandin synthesis through the reversible inhibition of cyclooxygenase (COX) enzymes, particularly COX-1 and COX-2.
• Pharmacokinetics: Piroxicam is well-absorbed following oral administration, with peak plasma concentrations reached within 2-4 hours. It is extensively bound to plasma proteins and undergoes hepatic metabolism. The elimination half-life is approximately 30-50 hours, allowing for once-daily dosing.

FELDENE is indicated for the relief of pain and inflammation associated with various conditions, including:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Acute gout
• Musculoskeletal disorders
• Painful menstruation (dysmenorrhea)

FELDENE is contraindicated in individuals with a known hypersensitivity to piroxicam or any component of the formulation, as well as those with a history of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs. It should not be used in patients with active peptic ulcer disease, severe heart failure, or renal impairment.

FELDENE may interact with various medications, including anticoagulants, corticosteroids, lithium, methotrexate, and certain antihypertensive drugs, potentially altering their efficacy or increasing the risk of adverse effects. Caution is advised when using FELDENE concomitantly with other NSAIDs or medications that affect renal function.

FELDENE capsules or tablets should be taken orally with or after food to minimize gastrointestinal irritation. The dosage and duration of therapy should be individualized based on the patient’s response and the severity of the condition being treated. Topical FELDENE gel should be applied to the affected area and gently rubbed in until absorbed, typically 3-4 times daily.

FELDENE should be avoided during the third trimester of pregnancy due to the potential risk of premature closure of the fetal ductus arteriosus and other adverse effects on the fetus. It is not recommended for use during breastfeeding as it may be excreted in breast milk.

FELDENE may cause dizziness, drowsiness, or visual disturbances in some patients. Patients should exercise caution when driving or operating machinery, especially when initiating therapy or changing dosage.

The recommended dosage of FELDENE varies depending on the indication, formulation, and patient characteristics. Healthcare providers will determine the appropriate dose and duration of therapy based on clinical judgment and guidelines. For oral formulations, the usual starting dose is 20 mg once daily, which may be adjusted based on individual response.

In the event of overdose, supportive measures should be initiated as needed. Symptoms of overdose may include nausea, vomiting, gastrointestinal bleeding, renal dysfunction, seizures, and respiratory depression. Activated charcoal may be administered to reduce absorption, and symptomatic treatment should be provided.

Common side effects of FELDENE may include gastrointestinal disturbances (e.g., dyspepsia, abdominal pain), headache, dizziness, edema, and skin rash. Serious adverse effects such as gastrointestinal bleeding, cardiovascular events, renal impairment, and hypersensitivity reactions are rare but may occur.

FELDENE capsules and tablets should be stored at room temperature (15-30°C) in a dry place, protected from light and moisture. Tubes of FELDENE gel should be tightly closed when not in use and stored according to the manufacturer’s instructions. Check the expiration date on the packaging and discard any expired or unused medication.

This comprehensive guide provides detailed information on the composition, pharmacological properties, indications, contraindications, interactions, administration, side effects, storage, and usage of FELDENE, aiding healthcare professionals and patients in safe and effective NSAID therapy. Always consult a healthcare provider for personalized medical advice.