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prednisolone oral
FLO-PRED 16.7(15) MG/5 ML SUSP
FLO-PRED 16.7(15) MG/5 ML SUSP
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prednisolone oral Overview

Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases (such as moderate allergic reactions) and (at higher doses) some types of cancer, but has significant adverse effects. Because it suppresses the immune system, it leaves patients more susceptible to infections.

Pharmacology

Prednisone has no substantial biological effects until converted via hepatic metabolism to prednisolone

Dependency

Adrenal suppression will begin to occur if prednisone is taken for longer than seven days. Eventually, this may cause the body to temporarily lose the ability to manufacture natural corticosteroids (especially cortisol), which results in dependence on prednisone. For this reason, prednisone should not be abruptly stopped if taken for more than seven days, instead, the dosage should be gradually reduced. This weaning process may be over a few days, if the course of prednisone was short, but may take weeks or months[citation needed] if the patient had been on long-term treatment. Abrupt withdrawal may lead to an Addison crisis. For those on chronic therapy, alternate-day dosing may preserve adrenal function and thereby reduce side-effects.

Glucocorticoids act to inhibit-feedback of both the hypothalamus, decreasing corticotropin-releasing hormone [CRH], and corticotrophs in the anterior pituitary gland, decreasing the amount of adrenocorticotropic hormone [ACTH]. For this reason, glucocorticoid analogue drugs such as prednisone down-regulate the natural synthesis of glucocorticoids. This mechanism leads to dependence in a short time and can be dangerous if medications are withdrawn too quickly. The body must have time to begin synthesis of CRH and ACTH and for the adrenal glands to begin functioning normally again.

Withdrawal

The magnitude and speed of dose reduction in corticosteroid withdrawal should be determined on a case-by-case basis, taking into consideration the underlying condition that is being treated, and individual patient factors such as the likelihood of relapse and the duration of corticosteroid treatment. Gradual withdrawal of systemic corticosteroids should be considered in those whose disease is unlikely to relapse and have:
received more than 40 mg prednisolone (or equivalent) daily for more than 1 week;
been given repeat doses in the evening;

Industry
Prednisone 20 mg oral tablet

The pharmaceutical industry uses prednisone tablets for the calibration of dissolution testing equipment according to the United States Pharmacopeia (USP).

History

The first isolation and structure identifications of prednisone and prednisolone were done in 1950 by Arthur Nobile. The first commercially feasible synthesis of prednisone was carried out in 1955 in the laboratories of Schering Corporation, which later became Schering-Plough Corporation, by Arthur Nobile and coworkers.

PREDNISOLONE ORAL WARNING

Prednisolone should be used with caution in:

the elderly, women who are pregnant or breastfeeding, patients who have been in contact with anyone who has chickenpox or shingles, family history of diabetes or the eye condition glaucoma, brittle or weak bones (osteoporosis), high blood pressure, stomach ulcer, fits (epilepsy), tuberculosis (an infection), septicaemia (a serious infection), thyroid gland inactivity (hypothyroidism), patients who have taken prednisolone or a similar medicine before and had muscle problems (steroid myopathy), those with heart, kidney or liver problems, patients who currently have or in the past had any mental illness, patients who are being treated with vaccines, those who have ever had severe depression or manic depression (this includes having had depression before whilst taking prednisolone or a similar medicine or a member of your close family has had these illnesses), previous infection caused by a virus or fungus (including athletes foot, thrush or cold sores), intolerance to some sugars (some medicines contain the sugar lactose), using soft contact lenses (if using prednisolone eye drops).

PREDNISOLONE ORAL USES

Prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.
How to use prednisolone acetate

Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

There are many brands, strengths, and forms of liquid prednisolone available. Read the dosing instructions carefully for each product because the amount of prednisolone may be different between products. See also Precautions and Storage sections.

Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take prednisolone 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

If you have used prednisolone regularly for a long time or in high doses, you may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. See also Precautions section.

Tell your doctor if your condition persists or worsens.

PREDNISOLONE ORAL SIDE EFFECTS

Nausea, heartburn, headache, dizziness, menstrual period changes, trouble sleeping, increased sweating, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, swelling ankles/feet, unusual weight gain, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, bone pain.

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, consult your doctor immediately: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.

Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

PREDNISOLONE ORAL PRECAUTIONS

Before taking prednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), heart problems (such as heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), brittle bones (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, blood clots, certain mental/mood conditions (such as psychosis, anxiety, depression), low salts in the blood (such as low potassium or calcium), seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may contain alcohol, sugar, and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Prednisolone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

Older adults may be more sensitive to the effects of this drug, especially stomach bleeding.

During pregnancy, prednisolone should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended period of time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

PREDNISOLONE ORAL INTERACTIONS

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aldesleukin, other drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy), mifepristone, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).

Other medications can affect the removal of prednisolone from your body, which may affect how prednisolone works. Examples include estrogens, azole antifungals (such as itraconazole), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product may interfere with certain lab tests (such as skin tests). Make sure laboratory personnel and all your doctors know you use this drug.

PREDNISOLONE ORAL OVERDOSE

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

If this medication is used for an extended time, laboratory and/or medical tests (such as blood sugar/mineral levels, blood counts, blood pressure, bone density tests, eye exams, height/weight measurements, X-rays) should be performed regularly to check for side effects. Consult your doctor for more details.

This medication may cause bone problems (osteoporosis). Lifestyle changes that may help reduce the risk of bone problems while taking this drug for an extended time include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.

Missed Dose

If you are taking this medication once daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. If you are taking this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.

Storage

Store this medication according to the directions on the product package away from light and moisture. Some brands must be refrigerated, and others must be stored at room temperature. Consult your pharmacist for more details. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.

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