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Flo-Pred (Prednisolone Acetate) - Summary



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.

Flo-Pred (prednisolone acetate oral suspension) is indicated in the treatment of the following diseases or conditions:

1.1   Allergic 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
1.2   Dermatologic Diseases

  • Bullous dermatitis herpetiformis
  • Contact dermatitis
  • Exfoliative erythroderma
  • Mycosis fungoides
  • Pemphigus
  • Severe erythema multiforme (Stevens-Johnson syndrome)
Endocrine Conditions

  • 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
Gastrointestinal Diseases

During acute episodes in:

  • Crohn's Disease
  • Ulcerative colitis
Hematologic Diseases

  • Acquired (autoimmune) hemolytic anemia
  • Diamond-Blackfan anemia
  • Idiopathic thrombocytopenic purpura in adults
  • Pure red cell aplasia
  • Secondary thrombocytopenia in adults
Neoplastic Conditions

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
Ophthalmic Conditions

  • Sympathetic ophthalmia
  • Uveitis and ocular inflammatory conditions unresponsive to topical steroids
Conditions Related to Organ Transplantation

  • Acute or chronic solid organ rejection
Pulmonary Diseases

  • 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
Renal Conditions

  • To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
Rheumatologic Conditions

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
Specific Infectious Diseases

  • Trichinosis with neurologic or myocardial involvement.
  • Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.

See all Flo-Pred indications & dosage >>


Published Studies Related to Flo-Pred (Prednisolone)

Effect of timing and route of methylprednisolone administration during pediatric cardiac surgical procedures. [2015]
cardiopulmonary bypass (CPB) prime... CONCLUSIONS: Methylprednisolone administration at anesthesia induction was

Combined oral prednisolone and heparin versus heparin: the effect on peripheral NK cells and clinical outcome in patients with unexplained recurrent miscarriage. A double-blind placebo randomized controlled trial. [2014]
CONCLUSION: The addition of prednisolone to heparin and low dose aspirin might be

A comparison of the effects of methylprednisolone and tenoxicam on pain, edema, and trismus after impacted lower third molar extraction. [2014]
CONCLUSIONS: Preoperative administration of 80 mg methylprednisolone achieves

Effects of long-acting bronchodilators and prednisolone on inspiratory lung function parameters in stable COPD. [2014]
dyspnea (visual analog scale (VAS)) and clinical COPD questionnaire (CCQ)... CONCLUSIONS: After a single dose of long-acting bronchodilator salmeterol,

Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinded, crossover clinical trial. [2013]
swelling after surgical removal of mandibular third molars... CONCLUSIONS: Bupivacaine combined with methylprednisolone reduced the

more studies >>

Clinical Trials Related to Flo-Pred (Prednisolone)

A Comparison of Three Different Formulations of Prednisolone Acetate 1% [Completed]

Prednisolone Priming Study in Patients With Chronic Hepatitis B [Recruiting]
Study purpose: To investigate whether ALT rebound following corticosteroid priming enhances response to telbivudine therapy. Efficacy assessments: The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without prednisolone priming. Data analysis: A summary table will be presented as frequency tables for categorical variables as number, and percentage, whereas descriptive tables for continuous variables as number, mean ▒ SD and median (minimum, maximum). All statistical assessments will be two-sided and evaluated at significance level of 0. 05. Continuous variables will be analyzed using t-test, or ANOVA, and categorical variables will be analyzed using chi-square or Fisher's exact test. A non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous, and categorical variables if data is far from normal distribution.

Biomarkers of Prednisolone Treatment (P05888) [Completed]
Primary objective:

- To identify a biomarker or biomarker-set for the adverse metabolic effects of various

doses of prednisolone treatment. Secondary objectives:

- To describe the PK of prednisolone and PD of a series of biomarkers.

- To identify biomarkers that reflect side effects of prednisolone.

- To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Preoperative Methylprednisolone in Endovascular Aortic Repair [Completed]

The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia [Completed]
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.

more trials >>

Page last updated: 2015-08-10

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