Bleduran capsules

Bleduran

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

The active ingredient of Bleduran 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

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

Side Effect

Possible side effects of Bleduran include: general body swelling; numbness or tingling in the hands, feet, or lips; sores, ulcers, or white spots on the lips or tongue or inside the mouth; Anxiety; pale or blue lips, fingernails, or skin; dark urine; shivering; nausea or vomiting.

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The apparent volume of distribution of Bleduran is approximately 0.14 L/kg. Ninety nine percent of plasma Bleduran is bound to plasma proteins. Bleduran is excreted into human milk. The presence in breast milk has been determined during initial and long term conditions (52 days). Bleduran appeared in breast milk at approximately 1% to 3% of the maternal concentration. No accumulation of Bleduran occurred in milk relative to that in plasma during treatment.

Bleduran

Bleduran (PIRO) is a nonselective NSAID used for its anti-inflammatory properties as well and for its value as a chemopreventive and antitumor agent. It has a much higher potency against COX-1 than COX-2. Bleduran has good oral bioavailability and a long half-life in mammals, but PD and PK studies have not been carried out in any avian species. Despite the high incidence of negative side effects of Bleduran used in humans, there are no reports of its toxicity in birds. It has been used clinically for the long-term treatment of chronic arthritis in cranes. 23

Mechanism of action – additional information

Bleduran is a member of the oxicam class of NSAIDs.

Other uses for this medicine

Bleduran is also sometimes used to treat gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints) and ankylosing spondylitis (arthritis that mainly affects the spine). It is also sometimes used to relieve muscle pain and swelling, menstrual pain, and pain after surgery or childbirth. Talk to your doctor about the risks of using this medication for your condition.

¿Cómo debo tomar Bleduran?

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.

Other Indications & Uses

20 mg PO qD or div BID; no more than 30-40 mg/d

Rheumatoid arthritis (incl. juvenile), osteoarthritis

Enter a drug name and Bleduran

Before taking this medicine

You should not use Bleduran if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Bleduran can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Bleduran may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Bleduran, especially in older adults.

Tell your doctor if you have ever had:

heart disease, high blood pressure, or if you smoke;

a heart attack, stroke, or blood clot;

a stomach ulcer or stomach bleeding (especially while using an NSAID);

liver or kidney disease.

Taking Bleduran during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant.

Ovulation (release of an egg from your ovary) could be delayed while you are taking Bleduran. This effect is usually not permanent. You should not take Bleduran while you are trying to get pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Bleduran is not approved for use by anyone younger than 18 years old.

Premature Closure of Fetal Ductus Arteriosus

Bleduran may cause premature closure of the fetal ductus arteriosus. Avo > .

Bleduran ↔ Alcohol (Ethanol)

Moderate Drug Interaction

Ask your doctor before using Bleduran together with ethanol. Do not drink alcohol while taking Bleduran. Alcohol can increase your risk of stomach bleeding caused by Bleduran. Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Clinical significance

Bleduran is one of the most widely prescribed non-steroidal anti-inflammatory drugs and appears to have no serious ocular side effects except a questionable optic neuritis. This possible drug-related event is described by Fraunfelder et al (1994) . Bleduran is one of the few non-steroidal anti-inflammatory agents with which intracranial hypertension has not been reported. Ocular side effects are infrequent and usually transient. This agent is a strong photosensitizer, and ultraviolet light-blocking lenses may be indicated. Patients allergic to thimersol have a high prevalence of Bleduran photosensitivity ( Varela et al 1998 ).

Bleduran pharmacokinetics have been investigated in patients with renal insufficiency. Studies indicate patients with mild to moderate renal impairment may not require dosing adjustments. However, the pharmacokinetic properties of Bleduran in patients with severe renal insufficiency or those receiving hemodialysis are not known.

Indications and clinical uses

Bleduran is primarily used to treat pain and inflammation associated with arthritis and other musculoskeletal conditions. It is not used as much for these conditions as other approved NSAIDs for animals. Another use in dogs and cats has been as an adjunct for treating cancer. This use is based on reports of its activity for treating or suppressing some tumors, including transitional cell carcinoma of the bladder, squamous cell carcinoma, and mammary adenocarcinoma. (This effect is not unique to Bleduran, as other NSAIDs also may have antitumor properties.) Bleduran has been used in combination with cisplatin to treat oral malignant melanoma and oral squamous cell carcinoma in dogs (0.3 mg/kg).

Pregnancy

Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation.

Use of NSAIDs, including Bleduran, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Bleduran, in pregnant women starting at 30 weeks of gestation (third trimester).

There are no adequate and well-controlled studies of Bleduran in pregnant women.

Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 times and 10 times the MRHD, respectively. In rat studies with Bleduran, fetotoxicity (postimplantation loss) was observed at exposures 2times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of Bleduran. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as Bleduran, resulted in increased pre- and post-implantation loss.

Labor or Delivery

There are no studies on the effects of Bleduran during labor or delivery. In animal studies, NSAIDS, including Bleduran inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Pregnant rats administered Bleduran at 2 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day during the period of organogenesis (Gestation Days 6 to Days 15) demonstrated increased post-implantation losses with 5 mg/kg/day and 10 mg/kg/day of Bleduran (equivalent to 2times and 5 times the maximum recommended human dose , of 20 mg respectively, based on a mg/m 2 body surface area ). There were no drug-related developmental abnormalities noted in offspring. Gastrointestinal tract toxicity was increased in pregnant rats in the last trimester of pregnancy compared to non-pregnant rats or rats in earlier trimesters of pregnancy. Pregnant rabbits administered Bleduran at 2mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day during the period of organogenesis (Gestation Days 7 to Days 18) demonstrated no drug-related developmental abnormalities in offspring (up to 10 times the MRHD based on a mg/m 2 BSA).

In a pre- and post-natal development study in which pregnant rats were administered Bleduran at 2 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day on Gestation Day 15 through delivery and weaning of offspring, reduced weight gain and death were observed in dams at 10 mg/kg/day (5 times the MRHD based on a mg/ m 2 BSA) starting on Gestation Day20. Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero. Parturition was delayed and there was an increased incidence of stillbirth in all Bleduran-treated groups (at doses equivalent to the MRHD). Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking Bleduran or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are:

Cardiovascular System: Edema

Digestive System: Anorexia, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting

Nervous System: Dizziness, headache, vertigo

Skin and Appendages: Pruritus, rash

Special Senses: Tinnitus

Additional adverse experiences reported occasionally include:

Cardiovascular System: Palpitations

Digestive System: Stomatitis Nervous System: Drowsiness Special Senses: Blurred vision

The pharmacokinetics of Bleduran have been characterized in healthy subjects, special populations and patients. The pharmacokinetics of Bleduran are linear. Proportional increase in exposure is observed with increasing doses. The prolonged half-life (50 hours) results in the maintenance of relatively stable plasma concentrations throughout the day on once daily doses and significant accumulation upon multiple dosing. Most patients approximate steady state plasma levels within 7–12 days. Higher levels, which approximate steady state at two to three weeks, have been observed in patients in whom longer plasma half-lives of Bleduran occurred.

Storage And Handling

FELDENE ® (Bleduran) 10 mg capsules are maroon and blue #322, supplied as:

FELDENE ® (Bleduran) 20 mg capsules are maroon #323, supplied as:

Can Bleduran gel cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with Bleduran gel, although these do not commonly occur. The best place to find a full list of the side-effects which can be associated with the gel, is from the manufacturer's printed information leaflet supplied with it. Alternatively, you can find an example of a manufacturer's information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.


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