Orapred

(Prednisolone Sodium Phosphate)

Check Drug InteractionsCheck known drug interactions.

Orapred Prescribing Information

Immunosuppression and Increased Risk of Infection (

5.2 Immunosuppression and Increased Risk of Infection

Corticosteroids, including Orapred ODT, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:

Reduce resistance to new infections
Exacerbate existing infections
Increase the risk of disseminated infections
Increase the risk of reactivation or exacerbation of latent infections
Mask some signs of infection

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider Orapred ODT withdrawal or dosage reduction as needed.

Tuberculosis

If Orapred ODT is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged Orapred ODT therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections

Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including Orapred ODT. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:

If an Orapred ODT-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered.
If an Orapred ODT-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including Orapred ODT. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with Orapred ODT. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections

Corticosteroids, including Orapred ODT, may exacerbate systemic fungal infections; therefore, avoid Orapred ODT use in the presence of such infections unless Orapred ODT is needed to control drug reactions. For patients on chronic Orapred ODT therapy who develop systemic fungal infections, Orapred ODT withdrawal or dosage reduction is recommended.

Amebiasis

Corticosteroids, including Orapred ODT, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Orapred ODT in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation

Corticosteroids, including Orapred ODT, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria

Avoid corticosteroids, including Orapred ODT, in patients with cerebral malaria.

) 3/2024

Individualize dosing based on disease severity and patient response:

Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate) (
2 DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
Take with food to avoid gastrointestinal (GI) irritation
DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT.
2.1 Recommended Dosing
Dosage of Orapred ODT 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.
Do not break or use partial Orapred ODT tablets.
Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on 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 that 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 patient's 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
Pediatric

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²bsa/day).
Nephrotic Syndrome

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.
Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic
prednisone, prednisolone or methylprednisolone
in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
2.2 Recommended Monitoring
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
2.3 Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:
Betamethasone 1.75 mg Paramethasone 4 mg
Cortisone 50 mg Prednisolone 10 mg
Dexamethasone 1.75 mg Prednisone 10 mg
Hydrocortisone 40 mg Triamcinolone 8 mg
Methylprednisolone 8 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response (
2 DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
Take with food to avoid gastrointestinal (GI) irritation
DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT.
2.1 Recommended Dosing
Dosage of Orapred ODT 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.
Do not break or use partial Orapred ODT tablets.
Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on 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 that 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 patient's 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
Pediatric

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²bsa/day).
Nephrotic Syndrome

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.
Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic
prednisone, prednisolone or methylprednisolone
in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
2.2 Recommended Monitoring
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
2.3 Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:
Betamethasone 1.75 mg Paramethasone 4 mg
Cortisone 50 mg Prednisolone 10 mg
Dexamethasone 1.75 mg Prednisone 10 mg
Hydrocortisone 40 mg Triamcinolone 8 mg
Methylprednisolone 8 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
)
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy (
2 DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
Take with food to avoid gastrointestinal (GI) irritation
DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT.
2.1 Recommended Dosing
Dosage of Orapred ODT 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.
Do not break or use partial Orapred ODT tablets.
Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on 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 that 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 patient's 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
Pediatric

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²bsa/day).
Nephrotic Syndrome

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.
Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic
prednisone, prednisolone or methylprednisolone
in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
2.2 Recommended Monitoring
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
2.3 Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:
Betamethasone 1.75 mg Paramethasone 4 mg
Cortisone 50 mg Prednisolone 10 mg
Dexamethasone 1.75 mg Prednisone 10 mg
Hydrocortisone 40 mg Triamcinolone 8 mg
Methylprednisolone 8 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
)
Take with food to avoid gastrointestinal (GI) irritation (
2 DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
Take with food to avoid gastrointestinal (GI) irritation
DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT.
2.1 Recommended Dosing
Dosage of Orapred ODT 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.
Do not break or use partial Orapred ODT tablets.
Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.
The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on 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 that 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 patient's 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.
Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.
Pediatric

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²bsa/day).
Nephrotic Syndrome

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.
Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic
prednisone, prednisolone or methylprednisolone
in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.
It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
2.2 Recommended Monitoring
Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.
2.3 Corticosteroid Comparison Chart
For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:
Betamethasone 1.75 mg Paramethasone 4 mg
Cortisone 50 mg Prednisolone 10 mg
Dexamethasone 1.75 mg Prednisone 10 mg
Hydrocortisone 40 mg Triamcinolone 8 mg
Methylprednisolone 8 mg
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
)

DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT. (

2 DOSAGE AND ADMINISTRATION

Individualize dosing based on disease severity and patient response:

Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate)
Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response
Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy
Take with food to avoid gastrointestinal (GI) irritation

DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT.

2.1 Recommended Dosing

Dosage of Orapred ODT 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.

Do not break or use partial Orapred ODT tablets.

Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg.

The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) 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, Orapred should be discontinued and the patient placed on 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 that 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 patient's 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 Orapred ODT for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Orapred ODT are packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where tablets may be swallowed whole as any conventional tablet, or allowed to dissolve in the mouth, with or without the assistance of water. Orally disintegrating tablet dosage forms are friable and are not intended to be cut, split, or broken.

Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for one month have been shown to be effective.

Pediatric

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m²bsa/day).

Nephrotic Syndrome

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m²/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m²/day.

Asthma

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic

prednisone, prednisolone or methylprednisolone

in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.

It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

2.2 Recommended Monitoring

Blood pressure, body weight, routine laboratory studies, including serum potassium and fasting blood glucose, should be obtained at regular intervals during prolonged therapy. Appropriate diagnostic studies should be performed in patients with known or suspected peptic ulcer disease and in patients at risk for reactivation of latent tuberculosis infections.

2.3 Corticosteroid Comparison Chart

For the purpose of comparison, one 10 mg Orapred ODT tablet (13.4 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:

Betamethasone 1.75 mg	Paramethasone 4 mg
Cortisone 50 mg	Prednisolone 10 mg
Dexamethasone 1.75 mg	Prednisone 10 mg
Hydrocortisone 40 mg	Triamcinolone 8 mg
Methylprednisolone 8 mg

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

)

Risk Summary

Based on findings from human and animal studies, corticosteroids including Orapred, can cause fetal harm when administered to a pregnant woman

(see Data) [see

5.10 Embryo-Fetal Toxicity

Prednisolone can cause fetal harm when administered to a pregnant woman. Human studies suggest a small but inconsistent increased risk of orofacial clefts with use of corticosteroids during the first trimester of pregnancy. Published animal studies show prednisolone to be teratogenic in rats, rabbits, hamsters, and mice with increased incidence of cleft palate in offspring. Intrauterine growth restriction and decreased birth weight have also been reported with corticosteroid use during pregnancy, however, the underlying maternal condition may also contribute to these risks. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, advise the patient about the potential harm to the fetus.

[see

Use in Specific Populations (8.1)

]

. Published epidemiological studies suggest a small but inconsistent increased risk of orofacial clefts with use of corticosteroids during the first trimester. Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of corticosteroids during pregnancy; however, the underlying maternal condition may also contribute to these risks

(see Clinical Considerations)

. Published animal studies show prednisolone to be teratogenic in rats, rabbits, hamsters, and mice with increased incidence of cleft palate in offspring

(see Data)

. Advise a pregnant woman about the potential harm to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Infants born to pregnant women who have received corticosteroids should be carefully monitored for signs and symptoms of hypoadrenalism

[see

5.1 Alterations in Endocrine Function

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Mineralocorticoid supplementation is of particular importance in infancy.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Data

Human Data

Published epidemiological studies on the association between prednisolone and fetal outcomes have reported inconsistent findings and have important methodological limitations. Multiple cohort and case-controlled studies in humans report that maternal corticosteroid use during the first trimester increases the incidence of cleft lip with or without cleft palate from about 1/1000 infants to 3-5/1000 infants; however, a risk for orofacial clefts has not been reported in all studies. Methodological limitations of these studies include non-randomized design, retrospective data collection, and the inability to control for confounders such as underlying maternal disease and use of concomitant medications.

Two prospective case control studies showed decreased birth weight in infants exposed to maternal corticosteroids in utero. In humans, the risk of decreased birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses. It is likely that underlying maternal conditions contribute to intrauterine growth restriction and decreased birth weight, but it is unclear to what extent these maternal conditions contribute to the increased risk of orofacial clefts.

Animal Data

Published literature indicates prednisolone has been shown to be teratogenic in rats, rabbits, hamsters, and mice with increased incidence of cleft palate in offspring, supportive of the clinical data. In teratogenicity studies, cleft palate along with an elevation of fetal lethality (or increase in resorptions) and reductions in fetal body weight occurred in rats at maternal doses of 30 mg/kg (equivalent to 290 mg in a 60 kg individual based on mg/m² body surface comparison) and higher. Cleft palate was observed in mice at a maternal dose of 20 mg/kg (equivalent to 100 mg in a 60 kg individual based on mg/m² comparison). Additionally, constriction of the ductus arteriosus was observed in fetuses of pregnant rats exposed to prednisolone.

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