Cycladol capsules

Cycladol

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

The active ingredient of Cycladol 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

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

Side Effect

Possible side effects of Cycladol include: fruit-like breath odor; joint pain; difficult, burning, or painful urination; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; redness, swelling, or soreness of the tongue.

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Introduction

Cycladol is a commonly used nonsteroidal antiinflammatory drug (NSAID) that is available by prescription only and is used in therapy of chronic arthritis. Cycladol can cause mild serum aminotransferase elevations and, in rare instances, leads to clinically apparent acute liver injury that can be severe and even fatal.

Algunos efectos secundarios podrГ­an provocar graves consecuencias para la salud. Si experimenta alguno de los siguientes sГ­ntomas o de los enumerados en la secciГіn de ADVERTENCIA, llame a su doctor de inmediato. No tome Cycladol hasta que hable con su doctor.

  • problemas con la visiГіn
  • aumento de peso inexplicable
  • respiraciГіn entrecortada o dificultad para respirar
  • hinchazГіn del abdomen, los pies, los tobillos, o las piernas
  • fiebre
  • ampollas
  • dolor de las articulaciones
  • sarpullido (erupciones en la piel)
  • prurito (picazГіn)
  • urticarias
  • hinchazГіn de los ojos, cara, labios, lengua, garganta, brazos, o manos
  • dificultad para respirar o tragar
  • ronquera
  • palidez
  • ritmo cardГ­aco mГЎs rГЎpido que lo normal
  • cansancio excesivo
  • sangrado o moretones inusuales
  • falta de energГ­a
  • malestar estomacal
  • pГ©rdida del apetito
  • dolor en la parte superior derecha del abdomen
  • sГ­ntomas similares a los de la gripe
  • coloraciГіn amarillenta de la piel o los ojos
  • orina oscura, descolorida o con sangre
  • dolor de espalda
  • dificultad o dolor al orinar

El Cycladol puede causar otros efectos secundarios. Llame a su doctor si usted tiene cualquier problema extraГ±o mientras toma este medicamento.

Mechanism of Action

Cycladol has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of Cycladol, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Cycladol is a potent inhibitor of prostaglandin (PG) synthesis in vitro . Cycladol concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Cycladol is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Dosage Forms and Strengths

Cycladol 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.

Cycladol 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.

Cycladol

Cycladol is a member of the oxicam family of NSAIDs. In vitro data suggest that Cycladol is COX-2 selective in dogs. 14,104 However, in vivo data are not available to confirm these results. Cycladol has an elimination half-life of approximately 40 hours in the dog. 105 Cycladol has been used as an antineoplastic agent to treat transitional cell neoplasia in dogs. Although antineoplastic activity has been linked to COX-2 inhibitory activity, other factors may also play a role in the antineoplastic activity of Cycladol. Based on clinical response and this long elimination half-life, once daily or once every other day dosing has been successfully used in the dog. Cycladol has been administered at a dose of 0.3 mg/kg orally once daily for many months for the treatment of canine transitional cell neoplasia. At this dose, approximately 18% of patients demonstrated adverse GI signs. 106 Gastroendoscopic evaluation of healthy dogs given Cycladol at a dose of 0.3 mg/kg orally once daily for 28 days failed to demonstrate a difference in gastroduodenal lesion development between treated and control dogs. 107 Additional data are needed before sweeping recommendations on use in pain management can be made. Pharmacokinetic data are available in cats given single and multiple doses of Cycladol. However, until efficacy and long-term safety studies are completed in cats, Cycladol cannot be recommended. 108,109

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More common side effects

The more common side effects that can occur with Cycladol include:

Cycladol

Cycladol is a non-steroidal anti-inflammatory drug of the ‘oxicam’ class used to relieve the symptoms of rheumatoid and osteoarthritis. It has also been used in small animal veterinary medicine to treat certain neoplasia expressing cyclooxygenase (COX) receptors, such as bladder, colon and prostate cancers. 68 There are few reports of its use in horses, but it would seem to be potentially valuable in the management of bladder and urethral tumours. There are reports of its adjunctive value in supporting treatment of some ocular and mucocutaneous carcinoma cases at 150 mg/kg per os q 24 h × 10, then q 48 h for several months. 69

The possible side-effects are not established in horses.

Adverse effects

The inc >Cycladol is relatively high.

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

Indications and clinical uses

Cycladol 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 Cycladol, as other NSAIDs also may have antitumor properties.) Cycladol has been used in combination with cisplatin to treat oral malignant melanoma and oral squamous cell carcinoma in dogs (0.3 mg/kg).

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FELDENE ® (Cycladol) Capsules, for Oral Use

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Before taking this medicine

You should not use Cycladol 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.

Cycladol 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).

Cycladol may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Cycladol, 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 Cycladol 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 Cycladol. This effect is usually not permanent. You should not take Cycladol while you are trying to get pregnant.

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

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

Hepatotoxicity

Elevated serum aminotransferase levels have been reported in 3% to 18% of patients taking Cycladol, but symptomatic liver disease with jaundice is rare (estimated at 1 to 5 cases per 100,000 prescriptions). The latency to onset of symptoms of clinically apparent liver injury due to Cycladol is variable from a few days to several months, but is generally within the first 1 to 6 weeks of treatment. The pattern of injury is predominantly cholestatic, although cases presenting with mixed or hepatocellular patterns have been reported (Case 1). Eosinophilia, rash and fever can occur, but are not always present and are usually not prominent. Autoantibodies are rarely found. The injury is usually self-limited and recovery occurs within 1 to 2 months. Rare cases of acute liver failure have been reported.

Advertencia:

Las personas que toman los medicamentos antiinflamatorios sin esteroides (NSAIDs, por sus siglas en inglГ©s; diferentes a la aspirina) como el Cycladol pueden tener mayor riesgo de tener un ataque cardГ­aco o un accidente cerebrovascular, que las personas que no toman estos medicamentos. Estos casos podrГ­an ocurrir de forma imprevista y hasta causar la muerte. Este riesgo puede aumentar en las personas que toman estos medicamentos durante mucho tiempo. No use un NSAID como Cycladol si sufriГі un ataque cardГ­aco recientemente, a menos que se lo indique su mГ©dico. DГ­gale a su doctor si usted o alguien en su familia tiene o alguna vez ha tenido enfermedades al corazГіn, un ataque cardГ­aco, o un accidente cerebrovascular, si fuma, y si tiene o alguna vez han tenido colesterol alto, hipertensiГіn (alta presiГіn arterial), o diabetes. Obtenga ayuda mГ©dica de emergencia en forma inmediata si experimenta cualquiera de los siguientes sГ­ntomas: dolor en el pecho, dificultad para respirar, debilidad en una parte o un lado del cuerpo, o dificultad para hablar.

Si va a ser sometido a una operaciГіn en las arterias coronarias (CABG, por sus siglas en inglГ©s; un tipo de operaciГіn quirГєrgica del corazГіn), no tome Cycladol antes ni despuГ©s de la operaciГіn quirГєrgica.

Los antiinflamatorios sin esteroides como el Cycladol pueden causar Гєlceras, hemorragia, o perforaciones en el estГіmago o el intestino. Estos problemas pueden desarrollarse en cualquier momento durante el tratamiento, presentarse sin sГ­ntomas previos y causar la muerte. El riesgo podrГ­a ser mayor en las personas que toman antiinflamatorios sin esteroides durante mucho tiempo, las personas mayores, aquellos que no tienen buena salud o quienes beben mucho alcohol mientras toman este medicamento. DГ­gale a su doctor si estГЎ tomando cualquiera de los siguientes medicamentos: anticoagulantes como la warfarina (Cumadina, Jantoven); aspirina; otros antiinflamatorios sin esteroides como ibuprofeno (Advil, Motrin) y naproxeno (Aleve, Naprosyn); esteroides orales como dexametasona, metilprednisolona (Medrol), y prednisona (Rayos); inhibidores selectivos de recaptaciГіn de serotonina (SSRIs, por sus siglas en inglГ©s) como citalopram (Celexa), fluoxetina (Prozac, Sarafem, Selfemra, en Symbyax), fluvoxamina (Luvox), paroxetina (Brisdelle, Paxil, Pexeva), y sertralina (Zoloft); o inhibidores de la recaptaciГіn de serotonina/norepinefrina (SNRIs, por sus siglas en inglГ©s) como desvenlafaxina (Khedezla, Pristiq), duloxetina (Cymbalta), y venlafaxina (Effexor XR). TambiГ©n dГ­gale a su doctor si tiene o alguna vez ha tenido Гєlceras o hemorragias en el estГіmago o los intestinos, o trastornos hemorrГЎgicos de otro tipo. Si usted experimenta cualquiera de los siguientes sГ­ntomas, deje de tomar Cycladol y llame a su doctor: dolor de estГіmago, pirosis (acidez estomacal), vГіmitos con material parecido a los granos de cafГ©, sangre en las heces, o heces oscuras o alquitranadas (de color petrГіleo).

Cumpla con todas las citas con su doctor y el laboratorio. Su doctor pedirГЎ ciertas pruebas de laboratorio que comprueben la respuesta de su cuerpo al Cycladol. AsegГєrese de decirle a su doctor cГіmo se siente, para que pueda prescribirle la cantidad correcta de medicamento y asГ­ tratar su condiciГіn con el riesgo mГЎs bajo que ocurran efectos secundarios graves.

Su doctor o farmacГ©utico le darГЎ la hoja de informaciГіn del fabricante para el paciente (guГ­a del medicamento) cuando usted empieza el tratamiento con Cycladol y siempre que renueva su prescripciГіn. Lea la informaciГіn cuidadosamente y pregГєntele cualquier cosa que no entienda. Usted tambiГ©n puede obtener la guГ­a del medicamento del sitio Web de la AdministraciГіn de Alimentos y Medicamentos (FDA, por su sigla en inglГ©s): http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm o del sitio Web del fabricante.

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

There are no adequate and well-controlled studies of FELDENE 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 2–4% for major malformations, and 15– 20% for pregnancy loss.

In animal reproduction studies in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the MRHD, respectively. In rat studies with Cycladol, fetotoxicity (postimplantation loss) was observed at exposures 2 times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of Cycladol. 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 Cycladol, resulted in increased pre- and post-implantation loss.


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