Flo-pred

What is Flo-pred?

• Flo-pred (prednisolone acetate) is a corticosteroid used as an anti-inflammatory or immunosuppressive agent ,treatment of certain endocrine conditions, palliation of certain neoplastic conditions.

Prednisolone acetate

What are the uses of this medicine?

• Flo-pred (prednisolone acetate) is used 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:

• Atopic dermatitis
• Drug hypersensitivity reactions
• Seasonal or perennial allergic rhinitis
• Serum sickness

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
• Non suppurative 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 anti tuberculous chemotherapy.

How does this medicine work?

• Prednisolone acetate - the acetate salt form of prednisolone, a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties.
• As a glucocorticoid receptor agonist, prednisolone acetate binds to specific intracellular glucocorticoid receptors, and causes the ligand-receptor complex to be translocated to the nucleus where it initiates the transcription of glucocorticoid-responsive genes such as various cytokines and lipocortins.
• Lipocortins inhibit phospholipase a2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes, both potent mediators of inflammation.
• This agent also decreases the number of circulating lymphocytes, induces cell differentiation, and stimulates apoptosis in sensitive tumor cell populations.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• Hypersensitivity to prednisolone or any component of this product.

What drug interactions can this medicine cause?

• Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
• Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
• Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
• Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Flo-Pred be increased.
• Ketoconazole has been reported to decrease the metabolism of certain corticosteroids.
• Cholestyramine may increase the clearance of corticosteroids.
• Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with concurrent use.
• Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
• Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect.
• Concomitant use of aspirin or other non-steroidal anti-inflammatory agents and corticosteroids increases the risk of gastrointestinal side effects.
• When corticosteroids are administered concomitantly with potassium-depleting agents, patients should be observed closely for development of hypokalemia.
• Corticosteroids may suppress reactions to skin tests.
• Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines.

Is this medicine FDA approved?

• Initial U.S. Approval: 1955

How should this medicine be used?

Recommended dosage: Individualize dosing based on disease severity and patient response:

• Initial Dose: 5 mg to 60 mg of prednisolone (as 5.6 mg to 67 mg of prednisolone acetate)
• Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response.
• Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
• Take with food to avoid gastrointestinal (GI) irritation.

Administration:

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Oral Suspension:

• 15 mg per 5 mL (as 16.7 mg/5 mL of prednisolone acetate)
• Dispense only in original containers

This medicine is available in fallowing brand namesː

• Flo-pred

What side effects can this medication cause?

The most common side effects of this medicine include:

• fluid retention
• alteration in glucose tolerance
• elevation in blood pressure
• behavioral and mood changes
• increased appetite and weight gain

What special precautions should I follow?

• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.
• Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. Signs and symptoms of infection may be masked.
• Elevated blood pressure, salt and water retention and hypokalemia may occur. Monitor blood pressure and sodium, potassium serum levels.
• There is an increased risk of gastrointestinal perforation in patients with certain GI disorders. Signs and symptoms may be masked.
• 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. Existing conditions may be aggravated.
• Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. Monitor bone density in patients receiving long-term corticosteroid therapy.
• Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks.
• Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Do not administer to patients receiving immunosuppressive doses of corticosteroids.
• Long-term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long-term corticosteroid therapy.
• Prednisolone can cause fetal harm when administered to a pregnant woman. Fetal harm can occur with first trimester use. Apprise women of potential harm to the fetus.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency.
• Hepatomegaly and abdominal distention have been observed in children.

Management of overdosage:

• Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
• For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisolone may be reduced only temporarily, or alternate day treatment may be introduced.

Can this medicine be used in pregnancy?

• Prednisolone can cause fetal harm when administered to a pregnant woman.
• Fetal harm can occur with first trimester use.
• Apprise women of potential harm to the fetus.

Can this medicine be used in children?

• The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Prednisolone Acetate

Inactive ingredient:

• Butylparaben
• CARBOMER HOMOPOLYMER TYPE B
• Edetate Disodium
• Glycerin
• Poloxamer 188
• propylene glycol
• water
• sodium hydroxide
• sucralose

Who manufactures and distributes this medicine?

• Manufactured by: Taro Pharmaceuticals Inc.
• Brampton, Ontario, Canada

• Distributed by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc.
• Hawthorne, NY

What should I know about storage and disposal of this medication?

• Store between 20°-25°C (68°-77°F).
• DO NOT REFRIGERATE.

• Dailymed label info on Flo-pred
• FDA Flo-pred

Flo-pred Resources
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