PREDNISTAB- prednisolone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Clipper Distributing Company LLC

INN (International Name):

PREDNISOLONE

Composition:

PREDNISOLONE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

PrednisTab is intended for use in dogs. The indications for PrednisTab are the same as those for other anti-inflammatory steroids and comprise the various collagen, dermal, allergic, ocular, otic, and musculoskeletal conditions known to be responsive to the anti-inflammatory corticosteroids. Representative of the conditions in which the use of steroid therapy and the benefits to be derived therefrom have had repeated confirmation in the veterinary literature are: (1) dermal conditions, such as nonspecific eczema, summer dermatitis, and burns; (2) allergic manifestations, such as acute urticaria, allergic dermatitis, drug and serum reactions, bronchial asthma, and pollen sensitivities; (3) ocular conditions, such as iritis, iridocyclitis, secondary glaucoma, uveitis, and chorioretinitis; (4) otic conditions, such as otitis externa; (5) musculoskeletal conditions, such as myositis, rheumatoid arthritis, osteoarthritis, and bursitis; (6) various chronic or recurrent diseases of unknown etiology such as ulcerativ

Product summary:

PrednisTab is available as 5 mg compressed quarter-scored tablets in bottles of 1000 and 20 mg compressed quarter-scored tablets in bottles of 500. Store at controlled room temperature 20° - 25° C (68° - 77° F), excursions permitted between 15°- 30° C (59° - 86° F)

Authorization status:

New Animal Drug Application

Summary of Product characteristics

PREDNISTAB- PREDNISOLONE TABLET
CLIPPER DISTRIBUTING COMPANY LLC
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PREDNISTAB
(PREDNISOLONE TABLETS), USP
For Oral Use in Dogs Only
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Prednisolone, like methylprednisolone, is a potent anti-inflammatory
steroid. Prednisolone, 11,17,21-
trihydroxypregna-1,4-diene-3,20-dione, is a synthetic dehydrogenated
analogue of cortisone.
Prednisolone and methylprednisolone have a greater anti-inflammatory
potency and less tendency to
induce sodium and water retention than the older corticoids, cortisone
and hydrocortisone. The relative
anti-inflammatory potency for hydrocortisone is 1.0; cortisone is 0.8;
prednisolone is 4 and
methylprednisolone is 5. The relative sodium retaining potency for
hydrocortisone is 4; prednisolone is
3 and methylprednisolone is 2.
INDICATIONS
PrednisTab is intended for use in dogs. The indications for PrednisTab
are the same as those for other
anti-inflammatory steroids and comprise the various collagen, dermal,
allergic, ocular, otic, and
musculoskeletal conditions known to be responsive to the
anti-inflammatory corticosteroids.
Representative of the conditions in which the use of steroid therapy
and the benefits to be derived
therefrom have had repeated confirmation in the veterinary literature
are: (1) dermal conditions, such as
nonspecific eczema, summer dermatitis, and burns; (2) allergic
manifestations, such as acute urticaria,
allergic dermatitis, drug and serum reactions, bronchial asthma, and
pollen sensitivities; (3) ocular
conditions, such as iritis, iridocyclitis, secondary glaucoma,
uveitis, and chorioretinitis; (4) otic
conditions, such as otitis externa; (5) musculoskeletal conditions,
such as myositis, rheumatoid arthritis,
osteoarthritis, and bursitis; (6) various chronic or recurrent
diseases of unknown etiology such as
ulcerative colitis and nephrosis.
In acute adrenal insufficiency, prednisolone may be effective because
of its ability to correct the defect
in carboh