DRUG CLASS

Prednisolone is a synthetic adrenal corticosteroid. Corticosteroids are natural substances produced by the adrenal glands located adjacent to the kidneys. Corticosteroids have potent anti-inflammatory properties, and are used in a wide variety of inflammatory conditions such as arthritis, colitis, asthma, bronchitis, certain skin rashes, and allergic or inflammatory conditions of the nose and eyes. There are numerous preparations of corticosteroids including tablets, capsules, liquids, topical creams and gels, inhalers, eye drops, as well as injectable and intravenous solutions. The FDA approved prednisolone in June 1955.

Possible Side Effects

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

USES:

It is a corticosteroid drug with predominantly glucocorticoid and low mineralocorticoid activity, making it useful for the treatment of a wide range of inflammatory and auto-immune conditions such as asthma, uveitis, rheumatoid arthritis, ulcerative colitis and Crohn's disease, Bell's palsy, multiple sclerosis, cluster headaches, and Systemic Lupus Erythematosus. It can also be used as an immunosuppressive drug for organ transplants and in cases of adrenal insufficiency (Addison's). Prednisolone acetate ophthalmic suspension is an adrenocortical steroid product prepared as a sterile ophthalmic suspension, used to reduce swelling, redness, itching, and allergic reactions affecting the eye. Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally-accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteriods are capable of producing a rise in intraocular pressure.

Missed Dose

If you miss a dose of Prednisolone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Drug Interactions

Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of prednisolone sodium phosphate oral solution be increased.

Increased activity of both cyclosporin and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect.

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.

Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Concomitant use of aspirin (or other non-steroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., diuretics, amphotericin-B), patients should be observed closely for development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

PRECAUTIONS:

This medication is not recommended for use if you have the following medical conditions: internal (systemic) fungal infection. Tell your doctor your medical history, especially of: liver problems, kidney problems, diabetes, thyroid disorder, eye problems (e.g., cataracts, glaucoma), heart problems, high blood pressure, stomach/intestinal problems (e.g., ulcers, ulcerative colitis), "soft bones" (osteoporosis), nerve or muscle disorders (e.g., myasthenia gravis), any infections (e.g., tuberculosis, herpes, bacterial infections), any allergies (especially to other corticosteroid drugs such as prednisone). Because this medication can decrease your immune system function, do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received live vaccines (e.g., oral polio vaccine). Also, avoid contact with people currently infected with the chickenpox or the measles. Consult your doctor immediately if you think you have been exposed to the chickenpox or measles virus. Serious infection or injury, severe emotional stress, or major surgery may increase your body's need for steroids. You may need to take supplemental corticosteroids in these cases, especially during the first year after stopping prolonged use of this medicine. Consult your doctor or pharmacist for details. This medication can affect the growth of infants and children if given for prolonged periods. Monitor growth progress carefully. Consult your doctor or pharmacist for details. If you have diabetes, this drug may increase your blood sugar levels. Check your blood glucose frequently as directed by your doctor. Your diabetes medication or treatment may need to be adjusted. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Storage

Store at 4?°-25?°C (39?°-77?°F). May be refrigerated. Keep tightly closed and out of the reach of children.