Friday, September 16, 2016

Prednisolone Syrup




Dosage Form: oral solution
Prednisolone Syrup

(PrednisoLONE Oral Solution USP)

15 mg/5 mL

Rx only



Prednisolone Syrup Description


Prednisolone Syrup (Prednisolone Oral Solution USP) contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.


Prednisolone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.


The chemical name for prednisolone is Pregna-1,4-diene-3,20-dione,11,17,21-trihydroxy-,(11β)-.



Prednisolone Syrup (Prednisolone Oral Solution USP) contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5% v/v, cherry flavor, citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose. Prednisolone Syrup (Prednisolone Oral Solution USP) may contain sodium citrate for pH adjustment.



Prednisolone Syrup - Clinical Pharmacology


Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.


Glucocorticoids such as prednisolone cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.



Indications and Usage for Prednisolone Syrup


Prednisolone Syrup (Prednisolone Oral Solution USP) is indicated in the following conditions:


1. Endocrine Disorders


Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).


Congenital adrenal hyperplasia


Nonsuppurative thyroiditis


Hypercalcemia associated with cancer


2. Rheumatic Disorders


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


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


3. Collagen Diseases


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


Systemic lupus erythematosus


Acute rheumatic carditis


4. Dermatologic Diseases


Pemphigus


Bullous dermatitis herpetiformis


Severe erythema multiforme


(Stevens-Johnson syndrome)


Exfoliative dermatitis


Mycosis fungoides


Severe psoriasis


Severe seborrheic dermatitis


5. Allergic States


Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:


Seasonal or perennial allergic rhinitis


Bronchial asthma


Contact dermatitis


Atopic dermatitis


Serum sickness


Drug hypersensitivity reactions


6. Ophthalmic Diseases


Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:


Allergic corneal marginal ulcers


Herpes zoster ophthalmicus


Anterior segment inflammation


Diffuse posterior uveitis and choroiditis


Sympathetic ophthalmia


Allergic conjunctivitis


Keratitis


Chorioretinitis


Optic neuritis


Iritis and iridocyclitis


7. Respiratory Diseases


Symptomatic sarcoidosis


Loeffler's syndrome not manageable by other means


Berylliosis


Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy


Aspiration pneumonitis


8. Hematologic Disorders


Idiopathic thrombocytopenic purpura in adults


Secondary thrombocytopenia in adults


Acquired (autoimmune) hemolytic anemia


Erythroblastopenia (RBC anemia)


Congenital (erythroid) hypoplastic anemia


9. Neoplastic Diseases


For palliative management of:


Leukemias and lymphomas in adults


Acute leukemia of childhood


10. Edematous States


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


11. Gastrointestinal Diseases


To tide the patient over a critical period of the disease in:


Ulcerative colitis


Regional enteritis


12. Miscellaneous


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


In addition to the above indications Prednisolone Syrup (Prednisolone Oral Solution USP) is indicated for systemic dermatomyositis (polymyositis).



Contraindications


Systemic fungal infections.



Warnings


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.


Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.


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. All corticosteroids increase calcium excretion.


While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.


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. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.


The use of Prednisolone Syrup (Prednisolone Oral Solution USP) 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.


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.


Use 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. Infants born of mothers who have received substantial doses of corticosteroid during pregnancy should be carefully observed for signs of hypoadrenalism.



Precautions



General:


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.


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. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.



Information for Patients:


Patients 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.



Adverse Reactions


Fluid and Electrolyte Disturbances

     Sodium retention

     Fluid retention

     Congestive heart failure in susceptible patients

     Potassium loss

     Hypokalemic alkalosis

     Hypertension


Musculoskeletal

     Muscle weakness

     Steroid myopathy

     Loss of muscle mass

     Osteoporosis

     Vertebral compression fractures

     Aseptic necrosis of femoral and humeral heads

     Pathologic fracture of long bones


Gastrointestinal

     Peptic ulcer with possible perforation and hemorrhage

     Pancreatitis

     Abdominal distention

     Ulcerative esophagitis


Dermatologic

     Impaired wound healing

     Thin fragile skin

     Petechiae and ecchymoses

     Facial erythema

     Increased sweating

     May suppress reactions to skin tests


Neurological

     Convulsions

     Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment

     Vertigo

     Headache


Endocrine

     Menstrual irregularities

     Development of Cushingoid state

     Suppression of growth in children

     Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness

     Decreased carbohydrate tolerance

     Manifestations of latent diabetes mellitus

     Increased requirements for insulin or oral hypoglycemic agents in diabetics


Ophthalmic

     Posterior subcapsular cataracts

     Increased intraocular pressure

     Glaucoma

     Exophthalmos


Metabolic

     Negative nitrogen balance due to protein catabolism



Prednisolone Syrup Dosage and Administration


Dosage of Prednisolone Syrup (Prednisolone Oral Solution USP) should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.


Hormone therapy is an adjunct to and not a replacement for conventional therapy. Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.


The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.


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.


The initial dosage of Prednisolone Syrup (Prednisolone Oral Solution USP) 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 of time there is a lack of satisfactory clinical response, Prednisolone Syrup (Prednisolone Oral Solution USP) 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 Prednisolone Syrup (Prednisolone Oral Solution USP) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.



How is Prednisolone Syrup Supplied


Prednisolone Syrup (Prednisolone Oral Solution USP) is a cherry flavored red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied in 240 mL and 480 mL bottles.



Pharmacist:


Dispense with a suitable calibrated measuring device to assure proper measuring of dose.















DOSE/VOLUME CHART
 15 mg prednisolone =1 teaspoon
 10 mg prednisolone =2/3 teaspoon
 7.5 mg prednisolone =1/2 teaspoon
 5 mg prednisolone =1/3 teaspoon

Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF.


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Refrigerate.



Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811


8182239

R5/08-R1



PRINCIPAL DISPLAY PANEL










PREDNISOLONE 
prednisolone  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0603-1567
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREDNISOLONE (PREDNISOLONE)PREDNISOLONE15 mg  in 5 mL




























Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
ALCOHOL 
CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SUCROSE 
SODIUM CITRATE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10603-1567-56240 mL In 1 BOTTLENone
20603-1567-58480 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04077509/21/2007


Labeler - Qualitest Pharmaceuticals (011103059)









Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville958430845MANUFACTURE
Revised: 09/2009Qualitest Pharmaceuticals

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