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«• HIGHLIGHTS OF PRESCRIBING INFORMATION Behavioral and mood disturbances: May Include euphoria, insomnia, mood These highlights do not include all ...»

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HIGHLIGHTS OF PRESCRIBING INFORMATION Behavioral and mood disturbances: May Include euphoria, insomnia, mood

These highlights do not include all the information needed to use Flo-Pred swings, personality changes, severe depression, and psychosis. Existing

safely and effectively. See full prescribing information for Flo-Pred. conditions may be aggravated. (5.5)

• Decreases in bone density: Monitor bone density in patients receiving long- Flo-Pred (prednisolone acetate) Suspension for Oral use term corticosteroid therapy. (5.6) Initial U.S. Approval: 1955

• Ophthalmic effects: May include cataracts, infections and glaucoma.

Monitor intraocular pressure if corticosteroid therapy is continued for more

-------------------------------INDICATIONS AND USAGE------------------------------ than 6 weeks.(5.7) Flo-Pred is a corticosteroid indicated •

• as an anti-inflammatory or immunosuppressive agent for certain allergic, Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids. (5.8) dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, • renal, respiratory, rheumatologic, specific infectious diseases or conditions and Negative effects on growth and development: Monitor pediatric patients on organ transplantation (1) long-term corticosteroid therapy. (5.9)

• for the treatment of certain endocrine conditions (1) • Use in pregnancy: Fetal harm can occur with first trimester use. Apprise

• for palliation of certain neoplastic conditions (1) women of potential harm to the fetus. (5.10)

-------------------------DOSAGE AND ADMINISTRATION------------------------ --------------------------ADVERSE REACTIONS----------------------------- Individualize dosing based on disease severity and

–  –  –

Reference ID: 2960745

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

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:

–  –  –

1.3 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

1.4 Gastrointestinal Diseases

During acute episodes in:

–  –  –

1.7 Nervous System Conditions • Acute exacerbations of multiple sclerosis • Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury

1.8 Ophthalmic Conditions Reference ID: 2960745 • Sympathetic ophthalmia • Uveitis and ocular inflammatory conditions unresponsive to topical steroids

1.9 Conditions Related to Organ Transplantation

–  –  –

1.10 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

1.11 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

1.12 Rheumatologic Conditions

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

–  –  –

1.13 Specific Infectious Diseases • Trichinosis with neurologic or myocardial involvement.

• Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.

2 DOSAGE AND ADMINISTRATION

2.1 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.





Reference ID: 2960745 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.

–  –  –

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 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.

2.3 Corticosteroid Comparison Chart

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

–  –  –

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.

3 DOSAGE FORMS AND STRENGTHS

Oral Suspension:

–  –  –

4 CONTRAINDICATIONS

Flo-Pred is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone, or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.

Reference ID: 2960745

5 WARNINGS AND PRECAUTIONS

5.1 Alterations in Endocrine Function Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Mineralocorticoid supplementation is of particular importance in infancy.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

5.2 Increased Risks Related to Infections Corticosteroids may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. The degree to which the dose, route and duration of corticosteroid administration correlates with the specific risks of infection is not well characterized, however, with increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.

Corticosteroids may mask some signs of infection and may reduce resistance to new infections.

Corticosteroids may exacerbate infections and increase risk of disseminated infection.

The use of Flo-Pred in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

Chickenpox and measles can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In children or adults who have not had these diseases, particular care should be taken to avoid exposure. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions.

Corticosteroids may increase risk of reactivation or exacerbation of latent infection.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.

During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

Corticosteroids should not be used in cerebral malaria.

5.3 Alterations in Cardiovascular/Renal Function Corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. These agents should be used with caution in patients with hypertension, congestive heart failure, or renal insufficiency.

Literature reports suggest an association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with caution in these patients.

5.4 Use in Patients with Gastrointestinal Disorders There is an increased risk of gastrointestinal perforation in patients with certain GI disorders. Signs of GI perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids.

Corticosteroids should be used with caution if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; and active or latent peptic ulcer.

Reference ID: 2960745

5.5 Behavioral and Mood Disturbances Corticosteroid use may be associated with central nervous system effects ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.



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