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Prelone

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Prelone

INDICATIONS

PRELONE (prednisolone (syrup)) Syrup 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 mineralo-corticoid supplementation is of particular importance).

2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:

4. Dermatologic Diseases:

5. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
6. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

7. Respiratory Diseases:

8. Hematologic Disorders:

9. Neoplastic Diseases: For palliative management of:
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:

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 PRELONE (prednisolone (syrup)) Syrup is indicated for systemic dermatomyositis (polymyositis).

DOSAGE AND ADMINISTRATION

Dosage of PRELONE (prednisolone (syrup)) ' Syrup should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight.

Hormone therapy is an adjunct to and not a replacement for conventional therapy.

Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days.

The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage.

If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.

Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper Gl X-rays are desirable in patients with known or suspected peptic ulcer disease.

The initial dosage of PRELONE (prednisolone (syrup)) Syrup may vary from 5 mg to 60 mg per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PRELONE (prednisolone (syrup)) Syrup should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patients individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of PRELONE (prednisolone (syrup)) Syrup for a period of time consistent with the patients condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

HOW SUPPLIED

PRELONE (prednisolone (syrup)) Syrup is a cherry flavored red liquid containing 15 mg of Prednisolone in each 5 mL (teaspoonful) and is supplied in 240 mL bottles (NDC #0451-1500-08) and 480 mL bottles (0451-1500-16).

Pharmacist: 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 USP/NF.

Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Do Not Refrigerate.


Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63043-2413
Revised 8/01
P3127-1

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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