Feldene 20 mg Capsules

Brand Name

Feldene is the prominent brand name under which this medication is marketed, well-regarded in clinical practice for its effectiveness in alleviating pain and inflammation. It stands as a trusted option for healthcare professionals managing various musculoskeletal conditions.

International Nonproprietary Name (INN)

The active ingredient in this drug is recognized by its International Nonproprietary Name (INN) as piroxicam. This oxicam-class compound is specifically formulated to deliver potent anti-inflammatory and analgesic benefits within the body.

Forms of Release

Feldene is available in multiple forms to accommodate diverse patient preferences and treatment needs. These include capsules in strengths of 10 mg and 20 mg for oral administration, as well as a dispersible tablet form at 20 mg that can be dissolved in water for those who find swallowing difficult. Additionally, an injectable solution is offered at 20 mg/mL for intramuscular use in acute settings, and a topical gel at 0.5% concentration provides localized relief. Each formulation ensures flexible delivery of piroxicam tailored to specific therapeutic scenarios.

Composition

The primary active substance in Feldene is piroxicam, responsible for its pharmacological effects. Accompanying this core ingredient are several inactive components that enhance stability and usability across its forms. Capsules contain lactose, corn starch, and magnesium stearate, with a gelatin shell incorporating titanium dioxide and iron oxides for color. Dispersible tablets include microcrystalline cellulose and sodium starch glycolate for disintegration, while the injectable solution uses benzyl alcohol and sodium hydroxide in a sterile aqueous base. The topical gel features carbomer, propylene glycol, and ethanol as a base for skin application. These supporting elements ensure the drug’s consistency and effective administration.

Pharmacologic Properties

Pharmacodynamics

This medication exerts its influence by targeting the biochemical pathways that drive inflammation and pain. Piroxicam functions as a non-steroidal anti-inflammatory drug (NSAID) by inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, reducing the synthesis of prostaglandins—lipid mediators that amplify pain signals, swelling, and fever in inflamed tissues. This dual inhibition provides robust relief from discomfort and stiffness, particularly in joint-related disorders. Beyond prostaglandin suppression, it may also influence leukocyte migration and lysosomal enzyme release, further curbing inflammatory responses. Its broad action makes it effective for both acute and chronic inflammatory states.

Pharmacokinetics

The pharmacokinetic behavior of Feldene delineates how piroxicam is processed within the body. After oral administration, it is well-absorbed from the gastrointestinal tract, reaching peak plasma concentrations in 3 to 5 hours, with bioavailability nearing 100%, slightly enhanced by food. Intramuscular injection achieves peaks within 15–30 minutes, while topical application yields minimal systemic absorption (about 5%). It is 99% bound to plasma proteins, mainly albumin, with a volume of distribution of 0.14 L/kg, indicating limited tissue penetration. Metabolism occurs in the liver via hydroxylation and conjugation, producing inactive metabolites, with excretion primarily through urine (66%) and some via feces. Its long half-life of 30 to 86 hours—averaging 50 hours—supports once-daily dosing but requires caution in impaired organ function.

Indications for Use

This medication is prescribed for conditions characterized by inflammation and pain, leveraging its ability to soothe these symptoms across a range of musculoskeletal and systemic disorders.

Diseases and Conditions

Feldene is indicated for the symptomatic relief of osteoarthritis, reducing joint pain and improving mobility in adults. It is also approved for rheumatoid arthritis, addressing inflammation and stiffness, and for ankylosing spondylitis, easing spinal discomfort. Acute musculoskeletal conditions, such as sprains, strains, or postoperative pain, benefit from its injectable form, while the topical gel targets localized pain like tendonitis or bursitis. Its comprehensive anti-inflammatory action makes it a versatile choice for these clinical needs.

Contraindications

Though effective for many, certain conditions prohibit the use of this medication due to heightened risks, demanding thorough assessment before treatment begins.

Conditions Prohibiting Use

Feldene is contraindicated in patients with known hypersensitivity to piroxicam, other NSAIDs, or formulation components, as reactions could range from mild irritation to severe anaphylaxis. It is barred in individuals with active or historical gastrointestinal ulcers, bleeding, or perforation, given its COX-1 inhibition increasing such risks. Patients with severe heart failure, uncontrolled hypertension, or recent myocardial infarction should avoid it due to cardiovascular concerns. It is also prohibited in those with severe hepatic or renal failure, and in cases of aspirin-induced asthma or nasal polyps, ensuring safety across high-risk groups.

Method of Administration and Dosage

How to Take

This medication is administered according to its form, with oral capsules and dispersible tablets taken with a full glass of water, preferably with food to minimize gastric upset. Dispersible tablets dissolve in water before ingestion for ease. The injectable solution is given intramuscularly, typically in a healthcare setting, while the topical gel is applied thinly to affected areas, avoiding broken skin or eyes, with hands washed post-use. Consistent daily timing enhances steady levels, and patients should follow prescribed methods to maintain efficacy.

Dosages for Adults and Children

Dosing is tailored to the condition and patient age, with limited pediatric use. For osteoarthritis or rheumatoid arthritis in adults, oral Feldene starts at 20 mg daily, adjustable to 10 mg if tolerability is an issue, with a maximum of 20 mg/day. Acute pain or musculoskeletal disorders may use 20 mg daily, or 40 mg initially split over two days, then 20 mg/day. Injectable dosing is 20 mg once daily for 1–2 days, transitioning to oral forms. Topical gel applies 1 g (3 cm) 3–4 times daily. Children’s use lacks established safety, typically reserved for adults over 18, balancing relief with risk.

Dose Adjustment in Specific Conditions

Adjustments are critical in organ impairment. In mild to moderate renal dysfunction (creatinine clearance 30–80 mL/min), no routine reduction is needed, but severe cases (below 30 mL/min) require halving the dose (e.g., 10 mg/day) or avoidance, with monitoring. Moderate hepatic impairment (Child-Pugh B) suggests 10 mg daily, while severe cases contraindicate use. Elderly patients may start at 10 mg daily due to increased gastrointestinal and renal risks, with careful titration and oversight to ensure safety.

Side Effects

This medication can induce a spectrum of adverse effects, from minor annoyances to serious complications, and patients should be aware to address them promptly.

Possible Adverse Reactions

Common issues include gastrointestinal discomfort—nausea, dyspepsia, or abdominal pain—often mitigated by food. Skin reactions like rash or pruritus occur, with rare severe forms like exfoliative dermatitis. Edema, headache, and dizziness may affect daily function, while prolonged use raises risks of gastric ulcers or bleeding. Cardiovascular effects, including hypertension or rare thrombotic events, warrant caution in at-risk groups. Renal function declines or hepatic enzyme elevations are less frequent but significant, with regular monitoring essential to manage these potential outcomes.

Overdose

Symptoms of Overdose

Excessive intake of Feldene can produce notable symptoms requiring urgent care. These include severe nausea, vomiting, or epigastric pain from gastrointestinal distress, alongside drowsiness or confusion from systemic effects. Hypertension, tachycardia, or respiratory difficulties may indicate cardiovascular strain, while renal impairment or oliguria could emerge in extreme cases. Seizures or coma are rare but possible with high doses, underscoring the need for rapid response.

First Aid Measures

In an overdose event, immediate action is key. If the patient is alert and ingestion was recent, contact emergency services or poison control without inducing vomiting unless directed. Maintain airway and vital signs while awaiting help. In clinical settings, activated charcoal may be administered within an hour of ingestion to reduce absorption, followed by supportive care—IV fluids, symptom management, and monitoring. Dialysis is ineffective due to high protein binding, but gastric protection (e.g., PPIs) may aid recovery.

Drug Interactions

Effects on Other Medications

This medication can influence co-administered drugs via metabolic and pharmacodynamic effects. It increases levels of warfarin or lithium by competing for protein binding or metabolism, heightening their effects or toxicity, requiring adjustments. Diuretics and ACE inhibitors may lose efficacy, raising blood pressure risks, while aspirin co-use amplifies gastrointestinal hazards. Methotrexate levels can rise, necessitating caution. Monitoring ensures safe combination therapy.

Compatibility with Alcohol and Food

Alcohol should be avoided with Feldene, as it significantly increases gastrointestinal bleeding risk and may worsen dizziness. Food reduces gastric irritation, making administration with meals advisable, with no specific dietary limits beyond minimizing irritants. Consistent intake supports tolerability.

Special Precautions

Use During Pregnancy and Breastfeeding

This medication is Category C before 30 weeks gestation, used only if benefits outweigh fetal risks, shifting to Category D after 30 weeks due to ductus arteriosus closure risks, contraindicating late-term use. Piroxicam enters breast milk; breastfeeding is not recommended due to potential infant effects, with alternatives preferred.

Impact on Driving and Operating Machinery

Feldene may impair alertness or coordination due to dizziness or drowsiness, especially initially. Patients should avoid driving or machinery until they gauge its impact, ensuring safety in routine activities.

Considerations for Elderly and Pediatric Patients

In elderly patients, this drug requires cautious dosing due to heightened gastrointestinal and renal risks, starting at 10 mg daily with close monitoring. It’s not approved for children under 18, lacking pediatric safety data, with adult adjustments ensuring tolerability across age groups.