Prednisolone Tablets
Category:
Prednisolone Tablets
Common Name: Prednisolone Tablets
Active Ingredient(s)
Prednisolone
Appearance
Off-white scored tablets.
Pharmacological Actions
Pharmacodynamics:
Prednisolone is an adrenocorticosteroid with anti-inflammatory, antiallergic, and immunosuppressive properties. It suppresses inflammatory responses of various etiologies, reducing exudative edema in the early stages of inflammation to alleviate symptoms; in the later stages, it inhibits collagen synthesis and granulation tissue formation, thereby preventing adhesion and scar formation. Prednisolone exerts its antiallergic and immunosuppressive effects by inhibiting histamine formation and release, suppressing cell-mediated immune responses and delayed hypersensitivity reactions, and attenuating the amplification of primary immune responses.
Pharmacokinetics:
Prednisolone is readily absorbed from the gastrointestinal tract. It exists in an active form and exerts its biological effects without requiring hepatic conversion. It distributes into all tissues, body fluids, and cerebrospinal fluid. In After single oral administration at a dose of 5 mg/9 kg body weight in Beagle dogs, the time to peak concentration (Tmax) is approximately 0.92 h; the peak concentration (Cmax) is approximately 266 μg/L, and the area under the plasma concentration-time curve (AUC₀→t) is approximately 673 h·μg·L⁻¹.
Indications
For the treatment of allergic and inflammatory conditions in dogs, including: non-specific eczema, summer dermatitis, and burns of the skin; otitis externa; allergic conditions such as acute urticaria, allergic dermatitis, bronchial asthma, and pollen allergy.
Dosage and Administration
Calculated as prednisolone. Oral administration: 2.5 mg per 4.5 kg body weight per day for dogs; divide the total daily dose into 2 administrations at 6～10-hour intervals for 7 consecutive days. Discontinue if no response is observed.
Adverse Reactions
High doses or prolonged use may cause: negative nitrogen balance, aggravated diabetes, ecchymoses, elevated serum alkaline phosphatase (SAP) and serum alanine aminotransferase (SALT), weight loss, anorexia, polydipsia, polyuria, vomiting, diarrhea, and Cushing’s syndrome.
Precautions
(1) Contraindicated in dogs with viral or fungal infections.
(2) Contraindicated in dogs with peptic ulcer, corneal ulcer, or Cushing’s syndrome.
(3) Contraindicated in pregnant dogs.
(4) Use with caution and close monitoring in dogs with diabetes, osteoporosis, thrombophlebitis, hypertension, congestive heart failure, renal insufficiency, or active tuberculosis.
(5) Concurrent use with antimicrobial agents is recommended when dogs have acute bacterial infections.
(6) Owing to its suppression of leukocyte infiltration, phagocytosis, and other inflammatory responses, prednisolone may mask signs of infection and allow infections to progress. Dogs receiving prednisolone therapy should be monitored carefully for concurrent infections. If infection develops, appropriate antimicrobial therapy must be instituted, or treatment must be discontinued.
(7) Do not exceed the recommended dose. Dogs under treatment should be closely monitored.
(8) Do not discontinue abruptly after prolonged therapy; taper the dose gradually until complete cessation.
Withdrawal Period
Not required.
Specifications
5 mg / tablet
Packaging
7 tablets / blister pack × 15 B=blisters / carton
Storage
Store in a tightly sealed container, protected from light.
Shelf Life
36 months
Approval Number
Veterinary Drug Approval No.: 101848059