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jak2(1)
jak2(1)

Compound Oclacitinib Maleate Chewable Tablets

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs.

Product Introduction

[ACTIVE SUBSTANCES]

 

Oclacitinib Maleate, Prednisolone

 

[DESCRIPTION]

 

Light brown to brown tablets.

 

[INDICATIONS]

 

 

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs.

 

 

[DOSAGE AND ADMINISTRATION]

 

The dose of Locadermin (Compound Oclacitinib Maleate Chewable Tablet) is 0.4 to 0.6 mg oclacitinib/kg body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy.

 

Dosing Chart

Weight Range(kg)

Number of Tablets to be Administered

3.6mg Tablets

5.4mg Tablets

16mg Tablets

3.0~4.4

0.5

-

-

4.5~5.9

-

0.5

-

6.0~8.9

1

-

-

9.0~13.4

-

1

-

13.5~19.9

-

-

0.5

20.0~26.9

-

2

-

27.0~39.9

-

-

1

40.0~54.9

-

-

1.5

55.0~80.0

-

-

2

 

 

[WITHDRAWAL PERIODS]

 

Not applicable

 

[STRENGTH]

 

Calculated on C15H23N5O2S: (1)3.6mg  (2)5.4mg  (3)16mg

 

 

[STORAGE CONDITION]

 

Preserve in well closed containers.

 

[SHELF LIFE]

 

36 months

jak2(1)
Adverse Reactions
  1. It may increase susceptibility to infection, including demodicosis,and exacerbation of neoplastic conditions.
  2. Diarrhea (2.3%), vomiting (2.3%), anorexia (1.4%), lethargy (1.8%), polydipsia (1.4% ), and other symptoms may occur. In most of these cases, signs spontaneously resolved with continued dosing.
  3. Prednisolone is similar to methylprednisolone in regard to kinds of side effects and metabolic alterations to be anticipated when treatment is intensive or prolonged. In animal patients with diabetes mellitus, use of prednisolone may be associated with an increase in the insulin requirement. Negative nitrogen balance may occur, particularly in animals that require protracted maintenance therapy; measures to counteract persistent nitrogen loss include a high protein intake and the administration, when indicated, of a suitable anabolic agent. Excessive loss of potassium, like excessive retention of sodium, is not likely to be induced by effective maintenance doses of prednisolone. However, these effects should be kept in mind and the usual regulatory measures employed as indicated. Ecchymotic manifestations in dogs may occur. If such reactions do occur and are serious, reduction in dose or discontinuance of prednisolone therapy may be indicated. Side effects, such as SAP and SALT enzyme elevations, weight loss, anorexia, polydipsia and polyuria have occurred following the use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have also been observed. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Since prednisolone suppresses endogenous adrenocortical activity, it is highly important that the animal patient receiving prednisolone be under careful observation, not only during the course of treatment but for some time after treatment is terminated. Adequate adrenocortical supportive therapy with cortisone or hydrocortisone, and including ACTH, must be employed promptly if the animal is subjected to any unusual stress such as surgery, trauma, or severe infection.
Precautions

1. The product is not for use in dogs less than 12 months of age or less than 3 kg of body weight. It is not for use in breeding dogs, or pregnant or lactating bitches. It is not for use in dogs with serious infections (systemic infections such as pneumonia or generalized fungal infections).

Prednisolone is a potent therapeutic agent influencing the biochemical behavior of most, if not all, tissues of the body. Because this anti-inflammatory steroid manifests little sodium-retaining activity, the usual early sign of cortisone or hydrocortisone overdosage (i.e., increase in body weight due to fluid retention) is not a reliable index of overdosage. Hence, recommended dose levels should not be exceeded, and all animal patients receiving prednisolone should be under close medical supervision. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid-acting corticosteroid should be considered in unusually stressful situations.

2. Consider the risks and benefits of treatment prior to initiating the product in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia.

3. The product modulates the immune system.

4. Dogs receiving the product should be monitored for the development of infections, including demodicosis, and neoplasia.

5. The product can be administered mixed with feed or on an empty stomach.

6. The use of this product has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents.

7. Wash hands immediately after handling the tablets. In case of accidental eye contact, flush immediately with water or saline for at least 15 minutes and then seek medical attention.

8. Keep out of reach of children.

9. For use in dogs only. In case of accidental ingestion, seek medical attention immediately.

 

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