PREDNISOLONE syrup

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PREDNISOLONE (UNII: 9PHQ9Y1OLM) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Commercializzato da:

Lannett Company, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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). Systemic fungal infections.

Dettagli prodotto:

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 as follows: NDC 0527-5406-68                   240 mL NDC 0527-5406-70                   480 mL 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PREDNISOLONE- PREDNISOLONE SYRUP
LANNETT COMPANY, INC.
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PREDNISOLONE SYRUP
(PREDNISOLONE ORAL SOLUTION, USP)
15 MG/5 ML
RX ONLY
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.
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
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).