AsmalPred Plus

Name: AsmalPred Plus

What is the most important information I should know about AsmalPred Plus (prednisolone)?

You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Before taking prednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while using prednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using prednisolone.

Wear a medical alert tag or carry an ID card stating that you take prednisolone. Any medical care provider who treats you should know that you take steroid medication.

How should I take AsmalPred Plus (prednisolone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Measure the liquid form of prednisolone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may need to shake the oral suspension (liquid) well just before you measure a dose. Follow the directions on your medicine label.

Keep the disintegrating tablet in its blister pack until you are ready to take the medicine. Open the package using dry hands, and peel back the foil from the tablet blister (do not push the tablet through the foil). Remove the tablet and place it in your mouth.

Allow the disintegrating tablet to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Steroids can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisolone.

Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using prednisolone.

Wear a medical alert tag or carry an ID card stating that you take prednisolone. Any medical care provider who treats you should know that you take steroid medication.

Store at room temperature away from moisture and heat.

AsmalPred Plus (prednisolone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;

  • swelling, rapid weight gain, feeling short of breath;

  • severe depression, unusual thoughts or behavior, seizure (convulsions);

  • bloody or tarry stools, coughing up blood;

  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • sleep problems (insomnia), mood changes;

  • acne, dry skin, thinning skin, bruising or discoloration;

  • slow wound healing;

  • increased sweating;

  • headache, dizziness, spinning sensation;

  • nausea, stomach pain, bloating; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Allergic Reaction

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Adult Dose for Optic Neuritis

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Adult Dose for Hemolytic Anemia

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Adult Dose for Immunosuppression

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Adult Dose for Choroiditis

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Adult Dose for Synovitis

Dosing should be individualized based on disease and patient response:

Initial dose: 5 to 60 mg orally per day; may be give once a day or in divided doses
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Loeffler's Syndrome

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Corneal Ulcers

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Mycosis Fungoides

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Iridocyclitis

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Synovitis

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

Usual Pediatric Dose for Serum Sickness

Dosing should be individualized based on disease and patient response with less emphasis on strict adherence to age or body weight dosing:

Initial dose: 0.14 to 2 mg/kg/day OR 4 to 60 mg/m2/day OR 5 to 60 mg orally once a day or in divided doses 2 to 4 times a day
Maintenance dose: Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: As an anti-inflammatory or immunosuppressive agent when corticosteroid therapy is appropriate, such as for the treatment of certain allergic states; nervous system, neoplastic, or renal conditions; endocrine, rheumatologic, or hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, or gastrointestinal diseases; specific infectious diseases or conditions related to organ transplantation.

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