Prednisone Intensol 5mg/1ml Conc.

Prednisone is a synthetic glucocorticoid. It exerts its effects by binding to intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to both anti-inflammatory and immunosuppressive effects. It inhibits the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppresses the migration of polymorphonuclear leukocytes, reverses increased capillary permeability, and inhibits the release of hydrolytic enzymes from lysosomes. It also suppresses the immune system by reducing the activity and volume of the lymphatic system, decreasing immunoglobulin and complement concentrations, and inhibiting the passage of immune complexes through basement membranes.

Serious 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 or seek medical attention immediately:

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 low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of pancreatitis (pancreas problems): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Signs of adrenal gland problems: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Abnormal heartbeat: fast, slow, or irregular.
Chest pain or pressure.
Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Changes in menstrual periods.
Bone or joint pain.
Feeling extremely tired or weak.
Changes in vision.
Confusion, difficulty focusing, or changes in behavior.
Memory problems or loss.
Hallucinations (seeing or hearing things that aren't there).
Seizures.
Abnormal sensations: burning, numbness, or tingling.
Severe stomach pain.
Unexplained bruising or bleeding.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Upset stomach or nausea
Increased appetite
Weight gain
Difficulty sleeping
Restlessness
Excessive sweating
Dizziness or headache

This is not an exhaustive list of possible 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 symptoms you experienced as a result of the allergy.
If you have an active infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
If you have nerve problems in your eye

Additionally, to ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
* Any health problems you have

This information will help your doctor determine if it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 drug for an extended period, you will need to undergo regular blood tests, weight checks, and other laboratory tests as directed by your healthcare provider. Additionally, you may require periodic eye pressure and bone density checks.

Be aware that medications like this one can cause high blood pressure. Therefore, it is crucial to have your blood pressure monitored as advised by your doctor. Long-term use of this drug may increase the risk of developing cataracts or glaucoma, so it is essential to discuss this with your doctor.

Prolonged use of this medication may also lead to weak bones (osteoporosis). You should talk to your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any questions or concerns. Furthermore, this drug may interfere with allergy skin tests, so it is vital to inform your doctor and laboratory personnel that you are taking this medication.

You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor to determine the best course of action. If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before consuming alcohol, you should discuss it with your doctor. Additionally, you should talk to your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

It is essential to be aware that chickenpox and measles can be severe or even life-threatening in individuals taking steroid medications like this one. If you have not had these illnesses before, avoid contact with anyone who has chickenpox or measles. If you have been exposed to these illnesses, inform your doctor immediately. Steroid medications, including this one, can increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize the risk of infection, wash your hands frequently, avoid contact with people who have infections, colds, or flu, and inform your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, may reactivate in patients taking medications like this one. If you have a history of these infections, inform your doctor. This medication can suppress the production of natural steroids in your body. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stresses may be affected, and you may require additional steroid doses.

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually taper off the dose. If you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor.

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 with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may affect growth in children and adolescents, and they may require regular growth checks. Discuss this with your doctor.

This medication may harm the unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby. If you took this medication during pregnancy, inform your baby's doctor.

• Live or live attenuated vaccines (risk of severe infection)
• Mifepristone (antagonizes corticosteroid effects)
• Barbiturates, Phenytoin, Rifampin (induce CYP3A4, decreasing prednisone levels)
• Ketoconazole, Itraconazole (inhibit CYP3A4, increasing prednisone levels)
• Warfarin (may alter anticoagulant effect, monitor INR closely)
• NSAIDs (increased risk of GI ulceration/bleeding)
• Diuretics (loop and thiazide) (increased risk of hypokalemia)
• Digoxin (increased risk of toxicity with hypokalemia)
• Antidiabetic agents (may increase blood glucose, requiring dose adjustment)

• Cyclosporine (increased levels of both drugs)
• Oral contraceptives (may increase prednisone levels)
• Fluoroquinolones (increased risk of tendon rupture)
• Neuromuscular blockers (prolonged weakness/myopathy)
• Cholestyramine, Colestipol (may decrease prednisone absorption)
• Antacids (may decrease prednisone absorption, separate administration)

• Grapefruit juice (potential minor increase in levels)

• Signs of infection (fever, sore throat, malaise, localized pain)
• Mood changes (irritability, anxiety, depression, euphoria)
• Sleep disturbances (insomnia)
• Fluid retention (swelling in ankles/feet, weight gain)
• Gastrointestinal upset (heartburn, indigestion, abdominal pain)
• Muscle weakness or pain
• Skin changes (thinning, bruising, acne)
• Vision changes (blurred vision, eye pain)
• Increased thirst or urination (signs of hyperglycemia)
• Unusual fatigue or weakness (signs of adrenal insufficiency upon withdrawal)

Prednisone is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Prednisone is excreted into breast milk in small amounts. The American Academy of Pediatrics considers corticosteroids compatible with breastfeeding. However, high doses or prolonged use may potentially cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production).

Children are more susceptible to growth retardation and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Monitor growth and development closely. Alternate-day therapy may minimize growth suppression. Increased risk of cataracts and glaucoma with long-term use. Prednisone Intensol allows for precise, weight-based dosing in children.

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

• Prednisone Intensol is an oral concentrate, allowing for precise dosing and ease of administration for patients who have difficulty swallowing tablets or require very specific dose adjustments.
• Always advise patients to take prednisone with food or milk to minimize gastrointestinal upset.
• For once-daily dosing, instruct patients to take it in the morning to align with the body's natural cortisol rhythm and reduce insomnia.
• Emphasize the importance of not abruptly discontinuing prednisone, especially after prolonged therapy, due to the risk of adrenal insufficiency. A gradual tapering schedule is crucial.
• Educate patients about increased susceptibility to infections and to report any signs of illness promptly.
• Long-term use requires monitoring for bone density, blood glucose, blood pressure, and ophthalmic changes.

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.