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Uses
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
- Pemphigus
- 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:
- Crohn's Disease
- Ulcerative colitis
- 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
- 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
- Acute or chronic solid organ rejection
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
- Allergic bronchopulmonary aspergillosis
- Aspiration pneumonitis
- Asthma
- 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
- Dermatomyositis/polymyositis
- 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
- Vasculitis
- Trichinosis with neurologic or myocardial involvement.
- Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.
History
There is currently no drug history available for this drug.
Other Information
Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Prednisolone acetate is a white to off-white in color, odorless, crystalline powder. It is insoluble in water, slightly soluble in acetone, in alcohol and in chloroform.
The chemical name for prednisolone acetate is 11β 17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate. Its molecular weight is 402.49. The molecular formula is C23H30O6 and the structural formula is:
Flo-Pred (prednisolone acetate oral suspension) is a viscous milky white formulation containing 15 mg of prednisolone (as 16.7 mg of prednisolone acetate) in each 5 mL. Flo-Pred is a spill resistant system that delivers semi-solid products for oral administration from a squeezable container. This system comprises of a liquid base and a thickening agent that ensures product homogeneity during storage. Butylparaben, 0.04% is added as a preservative. It also contains carbomer 934P, disodium edetate, glycerin, masking agent, poloxamer 188, propylene glycol, purified water, sodium hydroxide, sorbitol crystalline, sucralose liquid concentrate and cherry flavor.
Sources
Flo-pred Manufacturers
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Taro Pharmaceuticals U.s.a., Inc.
Flo-pred | Taro Pharmaceuticals U.s.a., Inc.
2.1 Recommended DosingDosage 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.
Multiple sclerosis
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.
Pediatric
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).
Nephrotic syndrome
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.
Asthma
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.
2.2 Recommended MonitoringBlood 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.
2.3 Corticosteroid Comparison ChartFor 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 mgThese 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.
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