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    The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate and low-dose prednisone in participants with m HNPC. Listing a study does not mean it has been evaluated by the U. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] along with 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (m HNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration). Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos). metformin quizlet October 2006 Tapering steroids (also called corticosteroids or glucosteroids) while at a high dose is often not so difficult, since in a way your body is oversaturated with them. However, at a lower dose some of your symptoms may return, especially when the steroid tapering is done too early or too quickly. At any time it's important to find the lowest dose you need to control your disease. For most CSS patients it takes quite a while to reach a low dose of steroids and be well. It takes as long as it takes, so patience seems to be the right thing here, to avoid a flare. prednisone/ prednisolone (a steroid) tapering usually gets more difficult. Most patients mentioned that they had to do this very slowly, and only if they were feeling really well - and not more then 10% of the total dose each time. While tapering, discomfort is not unusual, with pain in the joints, arms or legs, low energy, sweating etc. Often patients get instructions from their doctor at diagnosis and in the beginning of their illness.

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    Medscape - Anti-inflammatory-specific dosing for Prednisone Intensol prednisone, frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. cheap prices on levitra East Street Methuen, MA 01844 978-683-2959 – phone 978-794-3379 – fax. [email protected] PREDNISONE Tablets, USDESCRIPTION. Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

    Parker boats proudly serves in commercial, governmental agencies, recreational and high-tech sports fishing use around the world. To experience the pure genuine pleasure that comes from handling a fine quality boat, visit the Parker dealer in your area. Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime Day 4: 5 mg PO before breakfast, after lunch, and at bedtime Day 5: 5 mg PO before breakfast and at bedtime Day 6: 5 mg PO before breakfast Immediate-release: ≤10 mg/day PO added to disease-modifying antirheumatic drugs (DMARDs) Delayed-release: 5 mg/day PO initially; maintenance: lowest dosage that maintains clinical response; may be taken at bedtime to decrease morning stiffness with rheumatoid arthritis Take with meal or snack High-dose glucocorticoids may cause insomnia; immediate-release formulation is typically administered in morning to coincide with circadian rhythm Delayed-release formulation takes about 4 hours to release active substances; thus, with this formulation, timing of dose should take into account delayed-release pharmacokinetics and disease or condition being treated (eg, may be taken at bedtime to decrease morning stiffness with rheumatoid arthritis) Allergic: Anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture after recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper- or hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in children Fluid and electrolyte disturbances: Fluid retention, potassium loss, hypertension, hypokalemic alkalosis, sodium retention Gastrointestinal: Abdominal distention, elevation of serum liver enzymes levels (usually reversible upon discontinuance), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis General: Increased appetite and weight gain Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Osteonecrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures Neurologic: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri; usually following discontinuance of treatment), insomnia, meningitis, mood swings, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, central serous chorioretinopathy Reproductive: Alteration in motility and number of spermatozoa Untreated serious infections Documented hypersensitivity Varicella Administration of live or attenuated live vaccine (Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) state that administration of live virus vaccines usually is not contraindicated in patients receiving corticosteroid therapy as short-term ( Monitor for hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing syndrome, and hyperglycemia Prolonged use associated with increased risk of infection; monitor Use with caution in cirrhosis, ocular herpes simplex, hypertension, diverticulitis, hypothyroidism, myasthenia gravis, peptic ulcer disease, osteoporosis, ulcerative colitis, psychotic tendencies, renal insufficiency, pregnancy, diabetes mellitus, congestive heart failure, thromboembolic disorders, GI disorders Long-term treatment associated with increased risk of osteoporosis, myopathy, delayed wound healing Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored) Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy Methylprednisolone is preferred in hepatic impairment because prednisone must be converted to prednisolone in liver Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts May cause impairment of mineralocorticoid secretion; administer mineralocorticoid concomitantly May cause psychiatric disturbances; monitor for behavioral and mood changes; may exacerbate pre-existing psychiatric conditions Monitor for Kaposi sarcoma Pregnancy category: C (immediate release); D (delayed release) Drug may cause fetal harm and decreased birth weight; maternal corticosteroid use during first trimester increases incidence of cleft lip with or without cleft palate Lactation: Of maternal serum metabolites, 5-25% are found in breast milk; not recommended, or, if benefit outweighs risk, use lowest dose Glucocorticosteroid; elicits mild mineralocorticoid activity and moderate anti-inflammatory effects; controls or prevents inflammation by controlling rate of protein synthesis, suppressing migration of polymorphonuclear leukocytes (PMNs) and fibroblasts, reversing capillary permeability, and stabilizing lysosomes at cellular level; in physiologic doses, corticosteroids are administered to replace deficient endogenous hormones; in larger (pharmacologic) doses, they decrease inflammation The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

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