Pediapred

When you start to take prednisolone, ask your doctor what to do if you forget to take a dose. Write down these instructions so that you can refer to them later. Call your doctor or pharmacist if you miss a dose and do not know what to do. Do not take a double dose to make up for a missed dose.

If you take prednisolone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• PD-Rx Pharmaceuticals, Inc.

• Quality Care Pharmaceuticals

• Quality Care Products, LLC

• Royal Pharmaceuticals

• UCB Manufacturing, Inc.

• UCB, Inc.

Pediapred is part of the drug classes:

• Corticosteroids acting locally

• Antiinflammatory Corticosteroids

• Corticosteroids, weak group I

• Corticosteroids, weak, other combinations

• Corticosteroids/antiinfectives/mydriatics in combination

• Glucocorticoids

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

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure prednisolone is safe for you, tell your doctor about your other medical conditions, especially:

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• diabetes;

• a history of malaria;

• tuberculosis;

• osteoporosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• stomach ulcers, ulcerative colitis, or diverticulitis;

• depression or mental illness;

• congestive heart failure; or

• high blood pressure

FDA pregnancy category C. It is not known whether prednisolone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Prednisolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

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.

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. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid drinking alcohol while you are taking prednisolone.

Many drugs can interact with prednisolone. Below is just a partial list. Tell your doctor if you are using:

• aspirin (taken on a daily basis or at high doses);

• a diuretic (water pill);

• a blood thinner such as warfarin (Coumadin, Jantoven);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• insulin or diabetes medications you take by mouth;

• ketoconazole (Nizoral);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

• seizure medications such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with prednisolone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to prednisolone: oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet disintegrating

Along with its needed effects, prednisolone (the active ingredient contained in PediaPred) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking prednisolone:

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal cramping and/or burning (severe)
• abdominal pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Some side effects of prednisolone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair