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Flo-Pred (prednisolone acetate oral suspension) 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
- Sympathetic ophthalmia
- Uveitis and ocular inflammatory conditions unresponsive to topical steroids
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 Flo-Pred 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 initial dosage of Flo-Pred may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated. 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, Flo-Pred 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 Flo-Pred 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.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²/day).
The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.
The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or “burst” therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease.
Corticosteroid Comparison Chart
For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:
|Bethamethasone, 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
- 15 mg prednisolone (as 16.7 mg of prednisolone acetate) per 5 mL
Storage And Handling
Flo-Pred (prednisolone acetate oral suspension) is a cherry flavored milky white viscous liquid containing 16.7 mg of prednisolone acetate (equivalent to 15 mg prednisolone) in each 5 mL of formulation and is supplied as follows:
37 mL (NDC 51672-1338-5) for Professional Samples
52 mL (NDC 51672-1338-3)
65 mL (NDC 51672-1338-6)
Dispense in the original container. Do not transfer the bottle contents to other containers to prevent loss of the viscous formulation.
Flo-Pred is supplied with an oral syringe. The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 3 mL.
Store between 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
DO NOT REFRIGERATE.
Manufactured by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Distributed by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. Revised: June 2011
Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Flo-Pred Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Allergies & Asthma
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