Pirofel capsules


  • Active Ingredient: Piroxicam
  • 20 mg
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What is Pirofel?

The active ingredient of Pirofel brand is piroxicam. Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in Piroxicam include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.

Used for

Pirofel is used to treat diseases such as: Frozen Shoulder, Osteoarthritis, Pain, Rheumatoid Arthritis, Temporomandibular Joint Disorder.

Side Effect

Possible side effects of Pirofel include: constipation; peeling of the skin; swelling; seeing, hearing, or feeling things that are not there; pain or burning in the throat; shivering.

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Nonsteroidal anti-inflammatory drugs

Taking Pirofel with other NSAIDs may increase side effects, including stomach pain. Examples of other NSAIDs include:

Indications and Usage for Pirofel

Pirofel capsules, USP are indicated:

  • For relief of the signs and symptoms of osteoarthritis.
  • For relief of the signs and symptoms of rheumato > Carefully cons > .

After observing the response to initial therapy with Pirofel, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of Pirofel, steady-state blood levels are not reached for 7 days to 12 days. Therefore, although the therapeutic effects of Pirofel are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.

Anaphylactic Reactions

Pirofel has been associated with anaphylactic reactions in patients with and without known hypersensitivity to Pirofel and in patients with aspirin-sensitive asthma .

Seek emergency help if an anaphylactic reaction occurs.

Reproductive studies in which rats were administered Pirofel at doses of 2, 5, or 10 mg/kg/day (up to 5 times the maximum recommended human dose of 20 mg based on mg/m 2 body surface area ) revealed no impairment of male or female fertility.

Mechanism of Injury

The mechanism of Pirofel induced liver injury is not known, but may be due to a toxic metabolic intermediate of Pirofel metabolism, which occurs largely in the liver. Cases with allergic manifestations (fever, rash, eosinophilia) may also have a component of hypersensitivity.


FELDENE (Pirofel) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2- methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C15H13N3O4S, and it has the following chemical structure.

Pirofel occurs as a white crystalline solid, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8).

The inactive ingredients in FELDENE include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Pirofel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body As a Whole: Fever, infection, sepsis, anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope, arrhythmia, exacerbation of angina, hypotension, myocardial infarction, vasculitis

Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis

Hemic and Lymphatic System: Anemia, increased bleeding time, e cchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Hypersensitivity : Positive ANA

Metabolic and Nutritional: Weight changes, Fluid retention, hyperglycemia, hypoglycemia

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations

Respiratory System: Asthma, dyspnea, respiratory depression, pneumonia

Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction

Special Senses: Conjunctivitis, hearing impairment, swollen eyes

Urogenital System: Abnormal renal function, c ystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis

Reproductive system and breast disorders: Female fertility decreased

Cardiovascular Thrombotic Events

  • Nonstero > .
  • Pirofel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery .

Gastrointestinal Bleeding, Ulceration, and Perforation

NSA > .

How Supplied/Storage and Handling

Pirofel capsules USP, 10 mg are white to off-white powder filled in size '2' empty hard gelatin capsules with dark-green opaque cap imprinted with '742' with white ink and light-green opaque body and are supplied as follows:

NDC 68382-742-06 in bottle of 30 capsules

NDC 68382-742-16 in bottle of 90 capsules

NDC 68382-742-01 in bottle of 100 capsules

NDC 68382-742-05 in bottle of 500 capsules

NDC 68382-742-10 in bottle of 1,000 capsules

NDC 68382-742-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Pirofel capsules USP, 20 mg are white to off-white powder filled in size '2' empty hard gelatin capsules with dark-green opaque cap imprinted with '743' with white ink and dark-green opaque body and are supplied as follows:

NDC 68382-743-06 in bottle of 30 capsules

NDC 68382-743-16 in bottle of 90 capsules

NDC 68382-743-01 in bottle of 100 capsules

NDC 68382-743-05 in bottle of 500 capsules

NDC 68382-743-10 in bottle of 1,000 capsules

NDC 68382-743-77 in unit-dose blister cartons of 100 (10 x 10) unit dose capsules

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .

Dispense in tight, light-resistant containers (USP).

Heart Failure and Edema

​ The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

​ Additionally, flu > .

​ Avoid the use of Pirofel in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Pirofel is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Generic Name: Pirofel (peer OX i kam)Brand Name: Feldene

Medically reviewed by Drugs.com on Aug 13, 2019 – Written by Cerner Multum


Pirofel is considered the standard of care for TCC in dogs and may have specific advantages over other NSAIDs.

Inducible cyclooxygenase 2 (COX-2) enzymes are not expressed in the normal urinary bladder but are upregulated in tumors including TCC. a.

COX-2 is expressed in both primary and metastatic TCC.

COX-2 enzymes and their product, prostaglandin E2 (PGE2), a potent immunosuppressive compound, promote tumor growth by preventing apoptosis, stimulating tumor cell proliferation, and promoting angiogenesis.

PGE2 concentrations are increased in the bladder mucosa of patients with TCC growth as compared with normal bladder mucosa.

Pirofel, a COX enzyme inhibitor, has antitumor activity and decreases the size of tumors when used in dogs with TCC. a.

The mechanism of action is not based on cytotoxicity.

COX inhibition may provide some immunomodulation by suppressing PGE2 and thereby inducing apoptosis, inhibiting angiogenesis, and decreasing tumor cell proliferation.

Decreased inflammation alone cannot account for the partial and complete remissions achieved in vivo.

Pirofel provides good control of clinical signs and improves quality of life in some patients. Owners usually note increased activity and improvement in the attitude of their pet while the dog is receiving Pirofel.

Clinical studies of Pirofel in dogs with TCC indicate an overall response rate of 16%.

Pirofel provides good control of clinical signs, improving the quality of life in many dogs with TCC.

Complete remission is achieved in 4% of treated dogs.

Partial remission is observed in 13%.

Disease remained stable in 58%.

Progressive disease was noted in 25%.

Gastrointestinal toxicity occurred in 17% of treated dogs. a.

Signs of toxicity included anorexia, melena, and vomiting.

Gastroprotectants may be used in combination with Pirofel. (1)

H2 receptor blockers.

Proton pump inhibitors.

Misoprostol (prostaglandin E1 analogue).

Acute renal failure is a potential complication of nonsteroidal anti-inflammatory drugs (NSAIDs). Renal function should be monitored regularly while prescribing this medication for dogs with TCC.

Pirofel is used at a dosage of 0.3 mg/kg orally once daily if tolerated. It is given every other day to limit adverse effects in some patients. a.

Only 10 mg and 20 mg capsules are available.

Compounding pharmacies can reformulate this medication into varying concentrations to accommodate smaller animals.

Median survival with Pirofel as the sole form of treatment is approximately 6 months. About 20% of treated dogs survived for one year.

Pirofel may have unique effects against TCC as compared with other NSAIDs. This possibility has not been studied in TCC, but it is well known that each NSAID has its own profile of effect against a variety of other tumors in experimental studies in mice.

Mechanism of action – additional information

Pirofel is a member of the oxicam class of NSAIDs.

Before using Pirofel

To make sure that this is the right treatment for you, before you start using Pirofel gel it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have asthma or any other allergic disorder.
  • If you have a skin condition - eczema, for example.
  • If you have ever had an allergic reaction to a non-stero >

ВїQuГ© otro uso se le da a este medicamento?

El Pirofel es tambiГ©n usdado a veces para tratar la artritis gotosa (ataques de dolor de las articulaciones e hinchazГіn intensa causados por una acumulaciГіn de ciertas sustancias en las articulaciones) y la espondilitis anquilosante (artritis que afecta principalmente la columna vertebral). TambiГ©n es usado a veces para aliviar la inflamaciГіn y el dolor muscular, el dolor menstrual y el dolor despuГ©s de una operaciГіn quirГєrgica o un parto. Converse con su doctor acerca de los riesgos de usar este medicamento para tratar su condiciГіn.

Adverse effects

The inc >Pirofel is relatively high.

The synthetic prostaglandin E analog misoprostol may be administered concurrently to reduce the likelihood of gastric ulceration occurring.

¿Cómo debo tomar Pirofel?

Siga todas las instrucciones en la etiqueta de su prescripción. Tal vez su médico en ocasiones cambie su dosis para asegurarse de que está obteniendo los mejores resultados. No tome esta medicina en cantidades mayores, o por más tiempo de lo recomendado. Use la dosis más baja que es efectiva en el tratamiento de su condición.

Puede tomar hasta 2 semanas antes de que sus síntomas mejoren. Siga usando la medicina como indicado y dígale a su médico si sus síntomas no mejoran.

Si usted usa esta medicina a largo plazo, usted puede necesitar pruebas médicas frecuentes.

Guarde a temperatura ambiente fuera de la humedad y del calor.

Lea toda la información para el paciente, las guías del medicamento y las hojas de instrucción que le proporcionaron. Hable con su médico o farmacéutico si tiene alguna pregunta.

Serious Skin Reactions

NSAIDs, including Pirofel, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens- Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of FELDENE at the first appearance of skin rash or any other sign of hypersensitivity. FELDENE is contraindicated in patients with previous serious skin reactions to NSAIDs .

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