Description:
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Methylprednisolone 4mg, 100 Tablets
Product Description:
The indications for Methylprednisolone
Tablets 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 there from have had repeated confirmation in the
veterinary literature are: (1) dermal conditions, such as non-specific 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, Methylprednisolone may be effective because of
its ability to correct the defect in carbohydrate metabolism and relieve the
impaired diuretic response to water characteristic of primary or secondary
adrenal insufficiency. However, because this agent lacks significant mineral
corticoid activity, the parent hormones, Solu-Cortef® containing hydrocortisone
sodium succinate, Cortef® containing hydrocortisone, or cortisone should be used
when salt retention is indicated.
Pharmacology:
Methylprednisolone, a potent
anti-inflammatory steroid synthesized and developed in the Research Laboratories
of The Upjohn Company is the 6-methyl derivative of prednisolone. It has a
greater anti-inflammatory potency than prednisolone and even less tendency than
prednisolone to induce sodium and water retention. Its advantage over the older
corticoids lies in its ability to achieve equal anti-inflammatory effect with
lower dose, while at the same time enhancing the split between anti-inflammatory
and mineral corticoid activities.
Dosage and Administration:
For oral use in dogs and cats.
Dosage: Average total daily oral doses for dogs and cats are as follows:
| 5 to 15 lb
body wt |
2 mg |
| 15 to 40
lb body wt |
2 to 4 mg |
| 40 to 80
lb body wt |
4 to 8 mg |
The total daily dose should be given in divided
doses, 6 to 10 hours apart.
Administration: The keystone of satisfactory therapeutic management with
Methylprednisolone Tablets, as with its steroid predecessors, is
individualization of dosage in reference to the severity of the disease, the
anticipated duration of steroid therapy, and the animal patient's threshold or
tolerance for steroid excess. The prime objective of steroid therapy should be
to achieve a satisfactory degree of control with a minimum effective daily dose.
The dosage recommendations are suggested average total daily doses and are
intended as guides. As with other orally administered corticosteroids, the total
daily dose of Methylprednisolone should be given in equally divided doses. The
initial suppressive dose level is continued until a satisfactory clinical
response is obtained, a period usually of 2 to 7 days in the case of
musculoskeletal diseases, allergic conditions affecting the skin or respiratory
tract, and ocular inflammatory diseases. If a satisfactory response is not
obtained in 7 days, reevaluation of the case to confirm the original diagnosis
should be made. As soon as a satisfactory clinical response is obtained, the
daily dose should be reduced gradually, either to termination of treatment in
the case of acute conditions (e.g., seasonal asthma, dermatitis, acute ocular
inflammations) or to the minimal effective maintenance dose level in the case of
chronic conditions (e.g., rheumatoid arthritis). In chronic conditions, and in
rheumatoid arthritis especially, it is important that the reduction in dosage
from initial to maintenance dose levels be accomplished slowly. The maintenance
dose level should be adjusted from time to time as required by fluctuation in
the activity of the disease and the animal's general status. Accumulated
experience has shown that the long-term benefits to be gained from continued
steroid maintenance are probably greater the lower the maintenance dose level.
In rheumatoid arthritis in particular, maintenance steroid therapy should be at
the lowest possible level.
Important: In the therapeutic management of animal patients with chronic
diseases such as rheumatoid arthritis, methylprednisolone should be regarded as
a highly valuable adjunct, to be used in conjunction with but not as replacement
for standard therapeutic measures.
Contraindications:
Methylprednisolone Tablets like
prednisolone, are contraindicated in animals with arrested tuberculosis, peptic
ulcer, acute psychoses, and Cushingoid syndrome. The presence of diabetes,
osteoporosis, chronic psychotic reactions, predisposition to thrombophlebitis,
hypertension, congestive heart failure, renal insufficiency, and active
tuberculosis necessitates carefully controlled use. Some of the above conditions
occur only rarely in dogs and cats but should be kept in mind.
Precautions:
Store at controlled room temperature
20° to 25° C (68° to 77° F) [see USP].
Cautions:
Federal (USA) law restricts this drug
to use by or on the order of a licensed veterinarian.
Because of its inhibitory effect on fibroplasias, methylprednisolone may mask
the signs of infection and enhance dissemination of the infecting organism.
Hence, all animal patients receiving methylprednisolone should be watched for
evidence of intercurrent infection. Should infection occur, it must be brought
under control by use of appropriate antibacterial measures, or administration of
methylprednisolone should be discontinued.
Methylprednisolone Tablets, like prednisolone and other adrenocortical steroids
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 Methylprednisolone should be
under close medical supervision. All cautions pertinent to the use of
prednisolone apply to methylprednisolone. Moreover, the veterinarian should
endeavor to keep informed of current studies with Methylprednisolone as they are
reported in the veterinary literature.
Warnings:
Not for human use. Clinical and
experimental data have demonstrated that corticosteroids administered orally or
parenterally to animals may induce the first stage of parturition when
administered during the last trimester of pregnancy and may precipitate
premature parturition followed by dystocia, fetal death, retained placenta, and
metritis.
Additionally, corticosteroids administered to dogs, rabbits and rodents during
pregnancy have resulted in cleft palate in offspring. Corticosteroids
administered to dogs during pregnancy have also resulted in other congenital
anomalies including deformed forelegs, phocomelia, and anasarca.
Adverse Reactions:
With therapeutically equivalent doses,
the likelihood of occurrence of troublesome side effects is less with
methylprednisolone than with prednisolone; moreover, side effects actually have
been conspicuously absent during clinical trials with Methylprednisolone Tablets
in dogs and cats. However, methylprednisolone is similar to prednisolone 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 methylprednisolone 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 Methylprednisolone. However, these effects should be kept
in mind and the usual regulatory measures employed as indicated. Ecchymotic
manifestations, while not noted during the clinical evaluation in dogs and cats,
may occur. If such reactions do occur and are serious, reduction in dosage or
discontinuance of methylprednisolone therapy may be indicated. Concurrent use of
daily oral supplements of ascorbic acid may be of value in helping to control
Ecchymotic tendencies.
Since methylprednisolone, like prednisolone, suppresses endogenous
adrenocortical activity, it is highly important that the animal patient
receiving Methylprednisolone 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.
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