Prednisolone

What is Prednisolone?

• Prednisolone is a synthetic, intermediate acting glucocorticoid used to treat certain types of allergies, inflammatory conditions, autoimmune disorders, and cancers.

Prednisolone

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What are the uses of this medicine?

Prednisolone is used in the treatment of: Endocrine disorders:

• Congenital adrenal hyperplasia
• Nonsuppurative thyroiditis
• Hypercalcemia associated with cancer

Rheumatic disorders:

• Psoriatic arthritis
• Rheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
• Ankylosing spondylitis
• Acute and subacute bursitis
• Acute nonspecific tenosynovitis
• Acute gouty arthritis
• Post-traumatic osteoarthritis
• Synovitis of osteoarthritis
• Epicondylitis

Collagen diseases:

• Systemic lupus erythematosus
• Acute rheumatic carditis
• Systemic dermatomyositis (polymyositis)

Dermatologic diseases:

• Pemphigus
• Bullous dermatitis herpetiformis
• Severe erythema multiforme (Stevens-Johnson syndrome)
• Exfoliative dermatitis
• Mycosis fungoides
• Severe psoriasis
• Severe seborrheic dermatitis

Allergic states:

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

Ophthalmic diseases:

• Allergic conjunctivitis
• Keratitis
• Allergic corneal marginal ulcers
• Herpes zoster ophthalmicus
• Iritis and iridocyclitis
• Chorioretinitis
• Anterior segment inflammation
• Diffuse posterior uveitis and choroiditis
• Optic neuritis
• Sympathetic ophthalmia

Respiratory diseases:

• Symptomatic sarcoidosis
• Loeffler's syndrome not manageable by other means
• Berylliosis
• Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
• Aspiration pneumonitis

Hematologic disorders:

• Idiopathic thrombocytopenic purpura in adults
• Secondary thrombocytopenia in adults
• Acquired (autoimmune) hemolytic anemia
• Erythroblastopenia (RBC anemia)
• Congenital (erythroid) hypoplastic anemia

Neoplastic diseases:

• Leukemias and lymphomas in adults
• Acute leukemia of childhood

• Edematous states:

Gastrointestinal diseases:

• Ulcerative colitis
• Regional enteritis

• Acute exacerbations of multiple sclerosis

• Tuberculous meningitis

• Trichinosis with neurologic or myocardial involvement

How does this medicine work?

• Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
• Prednisolone is primarily used for its potent anti-inflammatory effects in disorders of many organ systems.
• Glucocorticoids cause profound and varied metabolic effects.
• In addition, they modify the body's immune responses to diverse stimuli.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Systemic fungal infections

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the medications listed below:

• aminoglutethimide (Cytadren; no longer available in the US)
• amphotericin (Abelcet, Ambisome, Amphotec)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naproxen) and selective COX-2 inhibitors such as celecoxib (Celebrex)
• carbamazepine (Carbatrol, Epitol, Tegretol,others)
• cholestyramine (Prevalite)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• digoxin (Lanoxin)
• diuretics ('water pills')
• erthryomycin (E.E.S. Erythrocin)
• estrogens including hormonal contraceptives (birth control pills, patches, rings, implants, and injections)
• isoniazid (Laniazid, in Rifamate, in Rifater)
• ketoconazole (Nizoral)
• medications for diabetes including insulin
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• rifampin (Rifadin, Rimactane, in Rifater, in Rifamate).

Is this medicine FDA approved?

• Prednisolone was discovered and approved for medical use in 1955.

How should this medicine be used?

Recommended dosage:

• The initial dosage of prednisolone tablets may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated.
• After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
• Alternate-Day Therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.

Administration:

• Prednisolone comes as a tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), a solution (liquid), and as a suspension (liquid) to take by mouth with food.
• Your personal dosing schedule will depend on your condition and on how you respond to treatment.
• To take the orally disintegrating tablet, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with or without water. Do not chew, split, or break the tablet.
• Your doctor may change your dose of prednisolone during your treatment to be sure that you are always taking the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, infection, or a severe asthma attack.
• If you are taking prednisolone to treat an ongoing condition, this medication may help control your condition but will not cure it. Continue to take prednisolone even if you feel well. Do not stop taking prednisolone without talking to your doctor. If you suddenly stop taking prednisolone, your body may not have enough naturally produced steroids to function normally.

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

This medicine is available in fallowing doasage form:

• As as a tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), a solution (liquid), and as a suspension (liquid)

This medicine is available in fallowing brand namesː

• Flo-Pred
• Orapred
• Pediapred

What side effects can this medication cause?

The most common side effects of this medicine include:

• Sodium retention
• Fluid retention
• Congestive heart failure in susceptible patients
• Potassium loss
• Hypokalemic alkalosis
• Hypertension
• Muscle weakness
• Steroid myopathy
• Loss of muscle mass
• Osteoporosis
• Vertebral compression fractures
• Aseptic necrosis of femoral and humeral heads
• Peptic ulcer with possible perforation and hemorrhage
• Pancreatitis
• Abdominal distention
• Ulcerative esophagitis
• Impaired wound healing
• Thin fragile skin
• Petechiae and ecchymoses
• Facial erythema
• Increased sweating
• Convulsions
• Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
• Vertigo
• Headache
• Posterior subcapsular cataracts
• Increased intraocular pressure
• Glaucoma
• Exophthalmos
• Negative nitrogen balance
• Menstrual irregularities
• Suppression of growth in children

What special precautions should I follow?

• Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
• In patients on corticosteroid therapy subjected to unusual stress increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
• Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.
• 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.
• There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.
• Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
• The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.
• Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.
• Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
• Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
• Tell your doctor if you have a fungal infection (other than on your skin or nails).
• Tell your doctor if you have an eye infection or have ever had eye infections that come and go.
• Do not have any vaccinations (shots to prevent diseases) without talking to your doctor.

What to do in case of emergency/overdose?

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Can this medicine be used in children?

• The efficacy and safety of corticosteroids 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:

• PREDNISONE

Inactive Ingredients:

• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• STARCH, CORN
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• SILICON DIOXIDE

Who manufactures and distributes this medicine?

Dist. by:

• Par Pharmaceutical
• Chestnut Ridge, NY U.S.A.

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

• Store at 20° to 25°C (68° to 77°F).

• Dailymed label info on Prednisolone
• FDA Prednisolone

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