商品名称：RAYOS

通用名称：PREDNISONE(强的松)

生产商：HORIZON PHARMA

剂型：缓释片

Pharmacological Class:
Glucocorticoid.

Active Ingredient(s):
Prednisone 1mg, 2mg, 5mg; delayed-release tablets.

Company
Horizon Pharma
Indication(s):
Corticosteroid-responsive disorders.

Pharmacology:
Prednisone is a synthetic adrenocortical steroid drug with predominantly corticosteroid properties. The pharmacokinetic profile of Rayos has an approximately 4-hour lag time from that of immediate-release prednisone formulations.

Clinical Trials:
The efficacy of Rayos in the treatment of rheumatoid arthritis was assessed in one multicenter, double-blind, placebo-controlled, randomized, 12-week trial in patients ≥18 years with active rheumatoid arthritis. Patients were enrolled who were not currently treated with corticosteroids but had received non-biologic DMARD therapy for at least 6 months before receipt of study medication, and had an incomplete response to DMARD therapy alone. Patients were randomized in a 2:1 ratio to treatment with Rayos 5mg (n=231) or placebo (n=119) administered at 10pm.

The primary endpoint was percentage of patients with improvement in rheumatoid arthritis at 12 weeks using the American College of Rheumatology (ACR) response criteria (ACR20). At 12 weeks, study results demonstrated that 47% of patients taking Rayos achieved improvement in ACR20 vs. 29% taking placebo (CI 95%; 7.2, 27.6), p=0.001; 22% in the Rayos group vs. 10% in placebo achieved an ACR50 response (CI 95%; 4.4, 19.6), p=0.007; and 7% in the Rayos group vs. 3% in placebo (CI 95%; 0.1, 9.7), p=0.10 showed an ACR70.

The relative change from baseline in the duration of morning stiffness at 12 weeks was assessed as a prespecified secondary endpoint. Patients treated with Rayos had a median decrease in the duration of morning stiffness of 55% compared to 33% in placebo-treated patients with a 95% confidence interval.

Legal Classification:
Rx

Contraindication(s):
Concomitant live vaccines.

Adults & Children:
See full labeling. Swallow whole with food. Individualize. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated. Use lowest effective dose. Initially 5–60mg day. Conversion from immediate-release prednisone, prednisolone, or methylprednisolone: give equivalent dose based on relative potency.

Warnings/Precautions:
For prednisone in general: Systemic fungal infections, cerebral malaria, optic neuritis: not recommended. Tuberculosis. Latent amebiasis. Strongyloides infestation. Ocular herpes simplex. May increase risk and mask signs of infection. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. HPA axis suppression. Cushing’s syndrome. Hyperglycemia. Thyroid disorders. Hypertension. CHF. Renal insufficiency. Recent MI. Risk of GI perforation. Peptic ulcer. Diverticulitis. Intestinal anastomoses. Myasthenia gravis. Osteoporosis. Kaposi’s sarcoma. May cause electrolyte imbalances or psychotic manifestations. Avoid abrupt cessation. Monitor weight, growth, BP, IOP, fluid and electrolyte balance. Elderly. Pregnancy (Cat.D). Nursing mothers.

Interaction(s)
See Contraindications. Potentiated by CYP3A4 inhibitors (eg, ketoconazole, macrolides), cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbama-zepine, rifampin), cholestyramine, aminoglutethimide. May potentiate cyclosporine. May antagonize anticoagulants (monitor), isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Increased GI effects with aspirin or NSAIDs. Caution with aspirin in hypoprothrombinemia. Monitor for hypokalemia with potassium-depleting drugs. Withdraw anticholinesterase agents at least 24hrs before initiating therapy. May suppress reactions to skin tests.

Adverse Reaction(s)
Fluid retention, alteration in glucose tolerance, BP elevation, behavioral/mood changes, increased appetite, weight gain.

How Supplied:
Tabs—30, 100

LAST UPDATED:
3/11/2013

FDA批准泼尼松缓释片增加多种适应证
2012年7月26日，Horizon制药公司宣布，美国食品药品管理局(FDA)已经批准Rayos(泼尼松)缓释片(1 mg、2 mg及5 mg)用于治疗类风湿性关节炎(RA)、风湿性多肌痛、银屑病关节炎、强直性脊柱炎、哮喘和慢性阻塞性肺病等多种疾病。FDA颁发此批准令的依据是将Rayos的药代动力学与速释泼尼松相衔接的数据以及2项在RA患者中开展的临床试验的数据。
这2项临床试验未在速释泼尼松的原有安全性问题之外新发现其他问题。与使用Rayos有关的最常见不良反应包括液体潴留、高血糖症、高血压、行为异常及情绪改变、食欲增加以及体重增加。
Indication: The FDA approved Rayos (prednisone) delayed-release tablets as an anti-inflammatory or immunosuppressive agent for a variety of conditions, including certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, respiratory, renal, nervous system, rheumatologic, and specific infectious diseases or conditions, as well as organ transplantation. It is also approved for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions. Rayos should be taken with daily with food, and the tablets should not be broken, divided, or chewed.
Dosage Form: Delayed-release tablets: 1, 2, and 5 mg