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This document outlines critical safety and warning information for Orapred ODT (prednisolone). It is essential to understand the potential risks and necessary precautions when using this medication. Consult your healthcare provider if you have concerns or questions regarding its use.

• Infection Risk: Prolonged use or high doses of Orapred ODT may increase susceptibility to infections and mask infection symptoms. Avoid contact with individuals with chickenpox or measles. If you have a history of tuberculosis, your healthcare provider will monitor you for possible reactivation and might prescribe antibiotics. Consult your healthcare provider before receiving any vaccines, as they may be less effective or unsafe during treatment.

• Heart and Kidney Function: This medication can lead to high blood pressure, fluid retention, and altered kidney function, exacerbating conditions such as hypertension, heart failure, and renal issues. Discuss with your healthcare provider if you have a history of these conditions to ensure the medication is safe for you.

• Bone Health: Long-term use can increase the risk of osteoporosis and fractures, particularly in children, where it may also impede growth. Monitor bone health and discuss any concerns with your healthcare provider, especially if there are pre-existing risk factors for osteoporosis.

• Adrenal Suppression: Extended use of Orapred ODT may result in reduced adrenal gland function, leading to withdrawal symptoms if the medication is reduced or stopped abruptly. Symptoms include fatigue, muscle or joint pain, and low energy. Always consult your healthcare provider before making any changes to your dosage.

• Eye Health: Long-term use raises the risk of cataracts, glaucoma, and eye infections. Do not use if you have herpes simplex of the eye. Report any vision changes to your healthcare provider and consider regular eye exams during prolonged treatment.

• Mood and Behavior: Be aware of potential mood or behavior changes, such as depression, mood swings, anxiety, or hallucinations. Report any such symptoms to your healthcare provider promptly.

• Gastrointestinal Issues: The risk of stomach irritation, ulcers, and bleeding is heightened, especially with a history of stomach issues or concurrent use of NSAIDs. Avoid alcohol to minimize stomach irritation. Seek immediate medical attention for persistent stomach pain or bloody stools.

• Pregnancy Risks: Use during the first trimester may increase the risk of birth defects such as cleft lip. Discuss the risks and benefits with your healthcare provider if you are pregnant or planning to become pregnant.

• Cancer Reports: There have been cases of Kaposi sarcoma in individuals using steroids like Orapred ODT for extended periods, although a direct link is unclear. Report any skin changes, such as unusual spots or bumps, to your healthcare provider.

In case of an overdose, seek emergency medical attention immediately. Always follow your healthcare provider's guidance regarding medication use and report any adverse effects or concerns promptly.

When taking this medication, some common side effects you may experience include nausea, vomiting, heartburn, headache, dizziness, trouble sleeping, changes in appetite, increased sweating, and acne. These effects are generally mild, and many individuals using this drug do not experience serious side effects. However, if these persist or worsen, consult your healthcare provider. Occasionally, this medication may lead to increased blood sugar levels, potentially affecting diabetes management. Watch for signs like increased thirst or urination and monitor your blood sugar if you have diabetes.

More serious side effects, although less common, require prompt medical attention. These include unusual weight gain, menstrual changes, bone or joint pain, easy bruising or bleeding, mental and mood changes like depression or mood swings, muscle weakness or pain, swelling of the face, hands, or feet, and vision problems. Stomach or intestinal bleeding is particularly serious and can manifest as stomach pain, black stools, or vomit resembling coffee grounds.

Rarely, some individuals may experience severe allergic reactions characterized by rash, itching, swelling, severe dizziness, or trouble breathing. Seek emergency medical help if you notice these symptoms. Additionally, conditions such as Cushing syndrome, low adrenal gland function, severe infections, and mood or behavior changes may occur. These conditions are serious and require immediate medical care. Always stay vigilant for symptoms such as difficulty breathing, high blood pressure, severe infections, or any unusual changes in your health, and contact a healthcare professional if needed.

Some medications may interact with this drug. These include aldesleukin, desmopressin, and mifepristone, as well as other drugs that can increase bleeding or bruising risk. This group includes antiplatelet medications like clopidogrel, anticoagulants such as warfarin and dabigatran, and NSAIDs including ibuprofen, celecoxib, aspirin, and salicylates. If your doctor has advised you to take low-dose aspirin (typically 81-162 mg daily) to reduce the risk of heart attack or stroke, continue to do so unless instructed otherwise by your doctor. Consult your doctor or pharmacist for more information.

Additionally, certain medications can influence the elimination of prednisolone from your body, potentially altering its effectiveness. These medications include azole antifungals like ketoconazole, cyclosporine, estrogens, St. John's wort, and some seizure medications such as phenobarbital and phenytoin.

This drug may also affect the results of certain laboratory tests, like skin tests, by potentially causing inaccurate results. Inform all healthcare providers and lab personnel that you are using this medication.