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Felden

Felden has a narrow registered footprint, available in just five countries — clustered across parts of Europe and the eastern Mediterranean, namely Turkey, Switzerland, Iceland, Austria, and Denmark. The brand has not been broadly internationalised, and travellers arriving in North America, Asia, or Latin America are unlikely to encounter this specific name on a pharmacy shelf.

The active ingredient in Felden is piroxicam, classified within the non-steroidal anti-inflammatory category and carrying analgesic, anti-inflammatory, and antipyretic properties. Piroxicam is used in the management of pain and inflammation linked to a range of rheumatic and musculoskeletal conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and other spondyloarthritides, as well as soft-tissue conditions such as tendinitis and tenosynovitis.

Outside the small cluster of countries where Felden is registered, the non-steroidal anti-inflammatory class is extensively represented under other active ingredients and other brand names. A patient who has been prescribed Felden in Austria or Turkey and is now travelling or relocating will usually find piroxicam itself, or another NSAID appropriate to the indication, available in the destination country — but typically under a different brand, and sometimes as a topical preparation rather than an oral one.

A local pharmacist familiar with the regional formulary is the right person to identify a sensible equivalent, since NSAID positioning varies considerably between regulatory regimes. Any change in long-term therapy for a chronic rheumatic condition should be made in consultation with the prescribing healthcare provider rather than improvised at a pharmacy counter abroad.

Countries
Austria Denmark Iceland Switzerland Turkey
Diseases
Arthritis,Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis Osteoarthritis Spondylitis Spondyloarthritis Tendinitis Tenosynovitis Crush Injury
Ingredients
Piroxicam
Drug Actions
Analgesic Pain reliever Anti-inflammatory Antipyretic Nonsteroidal anti-inflammatory Analgetic Topical products for joint and muscular pain Antiplatelet
How does this drug class actually work?
Read the plain-language explainer in Pharmacology Academy (Non-steroidal anti-inflammatory drugs) →

Drugs with the same active ingredients

Benisan Brionot Buta rut b12 Flexicamin Flogiatrin Flogiatrin forte Micar Nac Nac (piroxicam) Piroalgin Piroxicam dupomar Piroxicam vannier Solocalm Solocalm plus Solocalm-flex Tirovel Agipiro Brexin Chemmart piroxicam Feldene

Overdose

In the event of overdosage with Feldene, supportive and symptomatic therapy is indicated. Studies indicate that administration of activated charcoal may result in reduced re-absorption of piroxicam, thus reducing the total amount of active drug available.

Although there are no studies to date, haemodialysis is probably not useful in enhancing elimination of piroxicam since the drug is highly protein-bound.

Shelf life

36 months.

Incompatibilities

None stated.

List of excipients

Lactose

Corn starch

Vegetable magnesium stearate

Sodium lauryl sulphate

Capsule shell cap (red) contains:

Gelatin

Titanium dioxide (E171)

Red iron oxide (E172)

The body of the capsule shell (blue) contains:

Gelatin

Titanium dioxide (E171)

Indigotin (E132)

Undesirable effects

 

System Organ Class

Very Common

>1/10

Common

>1/100 to <1/10

Uncommon

>1/1000 to <1/100

Rare

>1/10 000 to <1 000

Very Rare

<1/10000

Not Known

(cannot be estimated from available data)

Blood and lymphatic system disorders

Anaemia

Eosinophilia

Leucopenia

Thrombo-cytopenia

Aplastic anaemia

Haemolytic anaemia

Immune system disorders

Anaphylaxis

Serum sickness

Metabolism and nutrition disorders

Anorexia

Hyperglycaemia

Hypoglycaemia

Fluid retention

Psychiatric disorders

Depression

Dream abnormalities

Hallucinations

Insomnia

Mental confusion

Mood alterations

Nervousness

Nervous system disorders

Dizziness

Headache

Somnolence

Vertigo

Paresthesia

Eye disorders

Blurred vision

Eye irritations

Swollen eyes

Ear and labyrinth disorders

Tinnitus

Hearing impairment

Cardiac disorders

Palpitations

Cardiac failure

Arterial thrombotic events

Vascular disorders

Vasculitis

Hypertension

Respiratory, thoracic and mediastinal disorders

Bronchospasm

Dyspnoea

Epistaxis

Gastrointestinal disorders

Abdominal discomfort

Abdominal pain

Constipation

Diarrhoea

Epigastric distress

Flatulence

Nausea

Vomiting Indigestion

Stomatitis

Gastritis

Gastrointestinal bleeding (including hematemesis and melena)

Pancreatitis

Perforation

Ulceration

Hepatobiliary disorders

Fatal hepatitis

Jaundice

Renal and urinary disorders

Interstitial nephritis

Nephrotic syndrome

Renal failure

Renal papillary necrosis

Skin and subcutaneous tissue disorders

Pruritis

Skin rash

Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)

Alopecia

Angioedema

Dermatitis exfoliative

Erythema multiforme

Non-thrombocytopenic purpura (Henoch-Schoenlein)

Onycholysis

Photoallergic reactions

Urticaria

Vesiculo bullous reactions

Reproductive system and breast disorders

Female fertility decreased

General disorders and administration site conditions

Oedema (mainly of the ankle)

Malaise

Investigations

Increased serum transaminase levels

Weight increase

Positive ANA

Weight decrease

Decreases in hemoglobin and hematocrit unassociated with obvious gastro-intestinal bleeding

Gastrointestinal: These are the most commonly encountered side-effects but in most instances do not interfere with the course of therapy.

Objective evaluations of gastric mucosa appearances and intestinal blood loss show that 20mg/day of Feldene administered either in single or divided doses is significantly less irritating to the gastrointestinal tract than aspirin.

Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastrointestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies. Administration of doses exceeding 20mg daily (of more than several days duration) carries an increased risk of gastrointestinal side effects, but they may also occur with lower doses.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Liver function: Changes in various liver function parameters have been observed. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g.eosinophilia, rash etc.), Feldene should be discontinued.

Other: Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes.

Preclinical safety data

None stated.

Pharmacodynamic properties

Piroxicam is a non-steroidal anti-inflammatory agent which also possesses analgesic and antipyretic properties. Oedema, erythema, tissue proliferation, fever and pain can all be inhibited in laboratory animals by the administration of piroxicam. It is effective regardless of the aetiology of the inflammation. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam interacts at several steps in the immune and inflammation responses through:

Inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclo-oxygenase enzyme.

Inhibition of neutrophil aggregation.

Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.

Inhibition of lyosomal enzyme release from stimulated leucocytes.

Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.

It is established that piroxicam does not act by pituitary-adrenal axis stimulation. In-vitro studies have not revealed any negative effects on cartilage metabolism.

Pharmacokinetic properties

Piroxicam is well absorbed following oral or rectal administration. With food there is a slight delay in the rate but not the extent of absorption following administration. The plasma half-life is approximately 50 hours in man and stable plasma concentrations are maintained throughout the day on once-daily dosage. Continuous treatment with 20mg/day for periods of 1 year produces similar blood levels to those seen once steady state is first achieved.

Drug plasma concentrations are proportional for 10 and 20mg doses and generally peak within 3 to 5 hours after medication. A single 20mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/ml while maximum plasma concentrations, after repeated daily ingestion of 20mg piroxicam, usually stabilise at 3 to 8 mcg/ml. Most patients approximate steady state plasma levels within 7 to 12 days.

Treatment with a loading dose regimen of 40mg daily for the first 2 days followed by 20mg daily thereafter allows a high percentage (approximately 76%) of steady state levels to be achieved immediately following the second dose. Steady state levels, area under the curves and elimination half-life are similar to that following a 20mg daily dose regimen.

A multiple dose comparative study of the bioavailability of the injectable forms with the oral capsule has shown that after intramuscular administration of piroxicam, plasma levels are significantly higher than those obtained after ingestion of capsules during the 45 minutes following administration the first day, during 30 minutes the second day and 15 minutes the seventh day. Bioequivalence exists between the two dosage forms.

A multiple dose comparative study of the pharmacokinetics and the bioavailability of Feldene FDDF with the oral capsule has shown that after once daily administration for 14 days, the mean plasma piroxicam concentration time profiles for capsules and Feldene FDDF were nearly superimposable. There were no significant differences between the mean steady state Cmax values, Cmin values, T½, or Tmax values. This study concluded that Feldene FDDF (Fast Dissolving Dosage Form) is bioequivalent to the capsule after once daily dosing. Single dose studies have demonstrated bioequivalence as well when the tablet is taken with or without water.

Piroxicam is extensively metabolised and less than 5% of the daily dose is excreted unchanged in urine and faeces. Piroxicam metabolism is predominantly mediated via cytochrome P450 CYP 2C9 in the liver. One important metabolic pathway is hydroxylation of the pyridyl ring of the piroxicam side-chain, followed by conjugation with glucuronic acid and urinary elimination.

Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.

Pharmacogenetics:

CYP2C9 activity is reduced in individuals with genetic polymorphisms, such as the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from two published reports showed that subjects with heterozygous CYP2C9*1/*2 (n=9), heterozygous CYP2C9*1/*3 (n=9), and homozygous CYP2C9*3/*3 (n=1) genotypes showed 1.7-, 1.7-, and 5.3-fold higher piroxicam systemic levels, respectively, than the subjects with CYP2C9*1/*1 (n=17, normal metabolizer genotype) following administration of an oral single dose. The mean elimination half life values of piroxicam for subjects with CYP2C9*1/*3 (n=9) and CYP2C9*3/*3 (n=1) genotypes were 1.7- and 8.8-fold higher than subjects with CYP2C9*1/*1 (n=17). It is estimated that the frequency of the homozygous*3/*3 genotype is 0% to 5.7% in various ethnic groups.

Date of revision of the text

01/2014

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Special precautions for storage

Store below 30°C.

Nature and contents of container

Original pack of 30 capsules contained in a white HDPE bottle with a blue round ribbed cap.

Marketing authorisation number(s)

PL 00057/0145

Special warnings and precautions for use

The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.

Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.

NSAID exposures of both short and long duration have an increased risk of serious GI event. Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.

Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration.

The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered.

Serious GI Complications

Identification of at-risk subjects

The risk for developing serious GI complications increases with age.).).

Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.

Skin reactions

Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of piroxicam.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.

If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued. The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.

If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reaction than other non-oxicam NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Feldene should be used with caution in patients with renal, hepatic and cardiac impairment. In rare cases, non-steroidal anti-inflammatory drugs may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. Such agents inhibit the synthesis of the prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of a non-steroidal anti-inflammatory drug may precipitate overt renal decompensation, which is typically followed by recovery to pre-treatment state upon discontinuation of non-steroidal anti-inflammatory therapy. Patients at greatest risk of such a reaction are with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease; such patients should be carefully monitored whilst receiving NSAID therapy. Because of reports of adverse eye findings with non-steroidal anti-inflammatory drugs, it is recommended that patients who develop visual complaints during treatment with Feldene have ophthalmic evaluation.

Impaired female fertility

The use of Feldene may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Feldene should be considered.

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Special precautions for disposal and other handling

No special requirements.

Date of first authorisation/renewal of the authorisation

08 August 1979 / 20 July 2009

Frequently asked questions

What conditions does Felden treat?

Felden is prescribed for the management of pain and inflammation associated with rheumatic and musculoskeletal conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis, tendinitis, and tenosynovitis. As a non-steroidal anti-inflammatory, it sits within a broader category of medications used both for analgesia and to reduce inflammation in joint and soft-tissue disorders. The structured indication block further down this page lists each registered use across the markets where Felden is sold.

Which active substance is in Felden?

Felden contains piroxicam, a non-steroidal anti-inflammatory medication with analgesic, anti-inflammatory, and antipyretic properties. Piroxicam is one of several molecules in the broader NSAID category and is available internationally under a number of different brand names, both as oral preparations and as topical products for joint and muscular pain, depending on the regulatory status in each market.

In how many countries is Felden available?

Felden is registered in five countries, with a footprint concentrated across parts of Europe and the eastern Mediterranean: Turkey, Switzerland, Iceland, Austria, and Denmark. Outside this small cluster the specific brand is rarely encountered, although piroxicam itself and other NSAIDs are widely available worldwide. If your country is not on this short list, a local pharmacist can confirm what is available regionally.

Are there other medications with the same active ingredient as Felden?

Piroxicam is sold internationally under a number of brand names, and the broader NSAID category includes many other molecules used for similar rheumatic and musculoskeletal indications. These are not freely interchangeable — different NSAIDs have meaningfully different profiles, and the choice depends on the individual situation. To identify a piroxicam-containing product available where you are, search the active ingredient on Pill2Trip or ask a local pharmacist.

Should I consult a doctor before taking Felden?

Yes. Felden is a prescription medication in most of the markets where it is registered, and decisions about NSAID therapy depend on a patient's full medical history and concurrent medications. This is particularly relevant for travellers and people relocating between countries, where prescription rules, available brands, and regulatory categories differ. A healthcare provider familiar with the patient is the appropriate person to lead any decision to start, stop, or substitute piroxicam.

Felden

Available in 5 countries