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RAYOS is indicated in the treatment of the following diseases or conditions:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with:
- Atopic dermatitis
- Drug hypersensitivity reactions
- Seasonal or perennial allergic rhinitis
- Serum sickness
- Bullous dermatitis herpetiformis
- Contact dermatitis
- Exfoliative erythroderma
- Mycosis fungoides
- Severe erythema multiforme (Stevens-Johnson syndrome)
- Congenital adrenal hyperplasia
- Hypercalcemia of malignancy
- Nonsuppurative thyroiditis
- Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable
During acute episodes in:
- Acquired (autoimmune) hemolytic anemia
- Diamond-Blackfan anemia
- Idiopathic thrombocytopenic purpura in adults
- Pure red cell aplasia
- Secondary thrombocytopenia in adults
For the treatment of:
- Acute leukemia
- Aggressive lymphomas
Nervous System Conditions
- Acute exacerbations of multiple sclerosis
- Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury
Conditions Related to Organ Transplantation
- Acute or chronic solid organ rejection
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
- Allergic bronchopulmonary aspergillosis
- Aspiration pneumonitis
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
- Hypersensitivity pneumonitis
- Idiopathic bronchiolitis obliterans with organizing pneumonia
- Idiopathic eosinophilic pneumonias
- Idiopathic pulmonary fibrosis
- Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV(+) individual who is also under treatment with appropriate anti-PCP antibiotics.
- Symptomatic sarcoidosis
- To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
- Acute gouty arthritis
During an exacerbation or as maintenance therapy in selected cases of:
- Ankylosing spondylitis
- Polymyalgia rheumatica
- Psoriatic arthritis
- Relapsing polychondritis
- Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)
- Sjogren's syndrome
- Systemic lupus erythematosus
Specific Infectious Diseases
DOSAGE AND ADMINISTRATION
Dosage of RAYOS should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.
The maximal activity of the adrenal cortex is between 2 am and 8 am and is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity. RAYOS is a delayed-release formulation of prednisone which releases the active substance beginning approximately 4 hours after intake [see CLINICAL PHARMACOLOGY]. The timing of RAYOS administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated.
The initial dosage of RAYOS may vary from 5 to 60 mg per day depending on the specific disease entity being treated. Patients currently on immediate release prednisone, prednisolone, or methylprednisolone should be switched to RAYOS at an equivalent dose based on relative potency (2.4).
In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period there is a lack of satisfactory clinical response, RAYOS should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of RAYOS for a period of time consistent with the patient's condition. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Blood pressure, body weight, routine laboratory studies (including 2-hour postprandial blood glucose and serum potassium), and chest X-ray should be obtained at regular intervals during prolonged therapy with RAYOS. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.
Method of Administration
RAYOS is for oral administration.
RAYOS should be taken daily with food. [see CLINICAL PHARMACOLOGY]
RAYOS tablets should not be broken, divided, or chewed because the delayed release of prednisone is dependent on an intact coating.
Corticosteroid Comparison Chart
For the purpose of comparison, one 5 mg RAYOS tablet is the equivalent milligram dosage of the following various corticosteroids:
|Betamethasone, 0.75 mg||Paramethasone, 2 mg|
|Cortisone, 25 mg||Prednisolone, 5 mg|
|Dexamethasone, 0.75 mg||Prednisone, 5 mg|
|Hydrocortisone, 20 mg||Triamcinolone, 4 mg|
|Methylprednisolone, 4 mg|
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
Dosage Forms And Strengths
- RAYOS 1 mg prednisone: Pale yellowish-white, round, unscored delayed-release tablet embossed with “NP 1” on one side.
- RAYOS 2 mg prednisone: Yellowish-white, round, unscored delayed-release tablet embossed with “NP 2” on one side.
- RAYOS 5 mg prednisone: Light yellow, round, unscored delayed-release tablet embossed with “NP 5” on one side.
Storage And Handling
RAYOS delayed-release tablets (1 mg prednisone) are pale yellowish-white, round, unscored tablets embossed with “NP 1” on one side and supplied as:
|75987-020-01||Bottle of 30 tablets|
|75987-020-02||Bottle of 100 tablets|
RAYOS delayed-release tablets (2 mg prednisone) are yellowish-white, round, unscored tablets embossed with “NP 2” on one side and supplied as:
|75987-021-01||Bottle of 30 tablets|
|75987-021-02||Bottle of 100 tablets|
RAYOS delayed-release tablets (5 mg prednisone) are light yellow, round, unscored tablets embossed with “NP 5” on one side and supplied as:
|75987-022-01||Bottle of 30 tablets|
|75987-022-02||Bottle of 100 tablets|
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].
Protect RAYOS tablets from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Distributed by: Horizon Pharma USA, Inc. 520 Lake Cook Road, Suite 520 Deerfield, IL 60015. Revised: July 2012
Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Rayos Information
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