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Flo-Pred

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Flo-Pred

Indications
Dosage
How Supplied

INDICATIONS

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

Allergic Conditions

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with:

Dermatologic Diseases

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:

Hematologic Diseases

Neoplastic Conditions

For the treatment of:

Nervous System Conditions

Ophthalmic Conditions

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

Rheumatologic Conditions

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

During an exacerbation or as maintenance therapy in selected cases of:

Specific Infectious Diseases

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

DOSAGE AND ADMINISTRATION

Recommended Dosing

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.

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.

Recommended Monitoring

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.

HOW SUPPLIED

Dosage Forms And Strengths

Oral Suspension:

  • 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.

Indications
Dosage
How Supplied
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