Prednisolone 25mg/5ml Solution

Prednisolone is a synthetic glucocorticoid. It exerts its anti-inflammatory and immunosuppressive effects by binding to specific cytoplasmic glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression by either activating or repressing transcription of various genes. This leads to decreased synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), inhibition of leukocyte migration, stabilization of lysosomal membranes, and suppression of the immune response.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of adrenal gland weakness: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of pancreatitis: severe abdominal pain, severe back pain, or severe nausea and vomiting
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Purple, red, blue, brown, or black skin lesions or mouth sores
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Menstrual changes
Bone or joint pain
Vision changes
New or worsening mental, mood, or behavioral changes
Seizures
Unusual burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Abdominal swelling
Severe stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
New or worsening muscle weakness

This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. Inform your doctor if you experience any of these symptoms.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Mild stomach upset
Increased appetite
Weight gain
Sleep disturbances
Restlessness
Excessive sweating
Headache
* Fatigue or weakness

This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms.
If you have an active infection, including bacterial, viral, or fungal infections, such as amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other type of infection.
If you have nerve problems affecting your eyes.
If you have recently received or are scheduled to receive a smallpox vaccine.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this medication for an extended period, your doctor will likely recommend regular blood tests, weight checks, and other laboratory tests to monitor your health. You may also need to have your eye pressure and bone density checked regularly.

Be aware that medications like this one can cause high blood pressure. Your doctor will likely monitor your blood pressure regularly.

This medication may interfere with allergy skin tests, so it is crucial to inform your doctor and laboratory personnel that you are taking this medication.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Prolonged use of this medication can also lead to weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions.

Your doctor may recommend reducing your salt intake and increasing your potassium consumption. Discuss this with your doctor to determine the best approach for your individual needs.

If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication.

Before consuming alcohol, consult with your doctor to discuss any potential risks.

Before receiving any vaccinations, talk to your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you are taking this medication, it is crucial to avoid close contact with individuals who have chickenpox or measles, as these infections can be severe or even life-threatening. If you have been exposed to chickenpox or measles, inform your doctor immediately.

Medications like this one can increase the risk of infection, which can be mild or severe. To minimize this risk, wash your hands frequently, avoid close contact with individuals who have infections, and inform your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections.

This medication can lower the natural steroid levels in your body. If you experience a fever, infection, undergo surgery, or are injured, consult with your doctor, as you may require additional oral steroids to help your body cope with these stresses. Carry a warning card indicating that you may need extra steroids in certain situations.

Do not stop taking this medication abruptly without consulting your doctor, as this can increase the risk of side effects. If you need to stop taking this medication, your doctor will likely recommend a gradual tapering schedule.

If you miss a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor immediately.

Long-term use of medications like this one has been associated with an increased risk of a type of cancer called Kaposi's sarcoma. Discuss this potential risk with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

In some cases, this medication can affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this with your doctor.

This medication can lower sperm counts. If you have concerns, talk to your doctor.

If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as this medication can harm the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

If you took this medication during pregnancy, inform your baby's doctor to ensure the best possible care for your child.

• Live or live-attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids

• NSAIDs (increased risk of GI ulceration/bleeding)
• Antidiabetic agents (may increase blood glucose, requiring dose adjustment of antidiabetics)
• Diuretics (thiazide and loop diuretics: increased risk of hypokalemia)
• CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine: may decrease prednisolone levels)
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin: may increase prednisolone levels)
• Warfarin (may potentiate or inhibit anticoagulant effect, monitor INR)
• Digoxin (increased risk of digitalis toxicity with hypokalemia)

• Cyclosporine (increased risk of seizures and other CNS effects)
• Oral contraceptives (may increase prednisolone levels)
• Cholestyramine, colestipol (may decrease prednisolone absorption)
• Antacids (may decrease prednisolone absorption if given concurrently)
• Fluoroquinolones (increased risk of tendon rupture, especially in elderly)

• Grapefruit juice (may slightly increase prednisolone levels, generally not clinically significant)

• Signs of infection (fever, chills, sore throat, unusual fatigue)
• Mood changes (irritability, anxiety, depression, euphoria)
• Sleep disturbances (insomnia)
• Fluid retention (swelling in ankles/feet, weight gain)
• Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
• Muscle weakness or pain
• Vision changes
• Increased thirst or urination (signs of hyperglycemia)
• Easy bruising or skin thinning

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prednisolone crosses the placenta. Animal studies have shown teratogenic effects (e.g., cleft palate). Human data are inconclusive but suggest a possible small increased risk of oral clefts with first-trimester exposure.

Prednisolone is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, especially at lower doses. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, irritability) or other adverse effects.

Corticosteroids can cause growth retardation in children. Long-term use requires careful monitoring of growth and development. Adrenal suppression is a significant concern, especially with abrupt discontinuation. Increased susceptibility to infections. Bone health should be monitored.

Elderly patients may be at increased risk for adverse effects such as osteoporosis, diabetes, hypertension, fluid retention, and cataracts. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

• Always taper the dose of prednisolone gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
• Administer with food or milk to minimize gastrointestinal irritation.
• Patients on long-term therapy should be advised about the risk of adrenal suppression and provided with a steroid card.
• Monitor for signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
• Consider bone protection strategies (calcium, vitamin D, bisphosphonates) for patients on long-term corticosteroid therapy.
• Educate patients about potential mood changes and sleep disturbances.
• Prednisolone is the active metabolite of prednisone, so it does not require hepatic conversion and may be preferred in patients with severe liver dysfunction.

• Other systemic corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone)
• Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent)
• Disease-modifying antirheumatic drugs (DMARDs) for autoimmune conditions
• Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) for severe autoimmune or inflammatory diseases
• Biologic agents (e.g., TNF inhibitors) for specific inflammatory conditions
• Inhaled corticosteroids (for asthma/COPD)
• Topical corticosteroids (for skin conditions)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.