Prednisolone

WHY is this medicine prescribed?

Prednisolone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisolone is also used to treat certain conditions that affect the blood, skin, eyes, central nervous system, kidneys, lungs, stomach, and intestines. It is also used to treat allergic reactions; and certain types of arthritis; multiple sclerosis (a disease in which the nerves do not function properly); and to help prevent transplant rejection (attack of the transplanted organ by the body) in certain adults who have received a transplant. Prednisolone is also sometimes used to treat symptoms from certain types of cancer. Prednisolone is in a class of medications called corticosteroids. It works by reducing swelling and redness and by changing the way the immune system works.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Prednisolone comes as a tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), a solution (liquid), and as a suspension (liquid) to take by mouth with food. Your doctor will probably tell you to take your dose(s) of prednisolone at certain time(s) of day every day. Your personal dosing schedule will depend on your condition and on how you respond to treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take prednisolone exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

To take the orally disintegrating tablet, use dry hands to peel back the foil packaging. Immediately take out the tablet and place it on your tongue. The tablet will quickly dissolve and can be swallowed with or without water. Do not chew, split, or break the tablet.

Your doctor may change your dose of prednisolone during your treatment to be sure that you are always taking the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, infection, or a severe asthma attack. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

If you are taking prednisolone to treat an ongoing condition, this medication may help control your condition but will not cure it. Continue to take prednisolone even if you feel well. Do not stop taking prednisolone without talking to your doctor. If you suddenly stop taking prednisolone, your body may not have enough naturally produced steroids to function normally. This may cause symptoms such as extreme tiredness, weakness, slowed movements, upset stomach, weight loss, changes in skin color, sores in the mouth, and craving for salt. Call your doctor if you experience these or other unusual symptoms while you are taking decreasing doses of prednisolone or after you stop taking the medication.

What SPECIAL PRECAUTIONS should I follow?

Before taking prednisolone,

• tell your doctor and pharmacist if you are allergic to prednisolone, other corticosteroids such as prednisone (Rayos), any other medications, or any of the ingredients in prednisolone products. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: aminoglutethimide (Cytadren; no longer available in the US); amphotericin (Abelcet, Ambisome, Amphotec); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naproxen) and selective COX-2 inhibitors such as celecoxib (Celebrex); carbamazepine (Carbatrol, Epitol, Tegretol,others); cholestyramine (Prevalite); cyclosporine (Neoral, Gengraf, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); erthryomycin (E.E.S. Erythrocin); estrogens including hormonal contraceptives (birth control pills, patches, rings, implants, and injections); isoniazid (Laniazid, in Rifamate, in Rifater); ketoconazole (Nizoral); medications for diabetes including insulin; phenobarbital; phenytoin (Dilantin, Phenytek); and rifampin (Rifadin, Rimactane, in Rifater, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have a fungal infection (other than on your skin or nails). Your doctor will probably tell you not to take prednisolone.

• tell your doctor if you have an eye infection or have ever had eye infections that come and go. Also tell your doctor if you have or have ever had cataracts; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); threadworms (a type of worm that can live inside the body); Cushing's syndrome (condition where the body produces too much of the hormone cortisol); diabetes; high blood pressure; heart failure; malaria (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death); emotional problems, depression, or other types of mental illness; osteoporosis (condition in which the bones become weak and fragile and can break easily); tuberculosis (TB); ulcers; or liver, kidney, intestinal, heart, or thyroid disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking prednisolone, call your doctor.

• do not have any vaccinations (shots to prevent diseases) without talking to your doctor.

• you should know that prednisolone may decrease your ability to fight infection and may prevent you from developing symptoms if you get an infection. Stay away from people who are sick and wash your hands often while you are taking this medication. Be sure to avoid people who have chicken pox or measles. Call your doctor immediately if you think you may have been around someone who had chicken pox or measles.

What SPECIAL DIETARY instructions should I follow?

Your doctor may instruct you to follow a low-salt, high potassium, or high calcium diet. Your doctor may also prescribe or recommend a calcium or potassium supplement. Follow these directions carefully.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

Prednisolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• extreme changes in mood, including unusual happiness
• changes in personality
• difficulty falling asleep or staying asleep
• thin, fragile skin
• slowed healing of cuts and bruises
• acne
• thinning hair
• increased appetite
• changes in the way fat is spread around the body
• increased sweating
• irregular or absent menstrual periods

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sore throat, fever, chills, cough, or other signs of infection
• seizures
• muscle weakness
• vision problems
• depression
• loss of contact with reality
• sudden weight gain
• stomach swelling
• swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• rash
• hives
• itching

Prednisolone may slow growth and development in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor about the risks of giving prednisolone to your child.

Prednisolone may increase the risk that you will develop osteoporosis. Talk to your doctor about the risks of taking prednisolone and about things that you can do to decrease the chance that you will develop osteoporosis.

Some patients who took prednisolone or similar medications developed a type of cancer called Kaposi's sarcoma. Talk to your doctor about the risks of taking prednisolone.

Prednisolone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to prednisolone.

If you are having any skin tests such as allergy tests or tuberculosis tests, tell the doctor or technician that you are taking prednisolone.

If you have diabetes, prednisolone may increase your blood sugar level. If you monitor your blood sugar (glucose) at home, test your blood or urine more frequently than usual. Call your doctor if your blood sugar is high.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.