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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:
- 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
- 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
- Trichinosis with neurologic or myocardial involvement.
- Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.
There is currently no drug history available for this drug.
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.