Prednisone 1mg Tablets

Manufacturer STRIDES PHARMA Active Ingredient Prednisone Tablets(PRED ni sone) Pronunciation PRED ni sone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Corticosteroid, Anti-inflammatory, Immunosuppressant
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Prednisone is a type of medicine called a corticosteroid. It works by reducing inflammation (swelling and redness) and calming down your immune system. It's used to treat many conditions like allergies, asthma, arthritis, and certain skin or blood disorders.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food or milk to help your body absorb it. If you take your medication once a day, it's best to take it in the morning. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medication suddenly, especially if you've been on it for more than a few days or at high doses. Your doctor will provide a tapering schedule to gradually reduce the dose.
  • Avoid contact with people who are sick or have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, chills, sore throat) to your doctor immediately.
  • Limit salt intake to help prevent fluid retention.
  • Consider calcium and vitamin D supplementation, especially with long-term use, to protect bone health.
  • Wear a medical alert tag or carry an identification card stating you are taking prednisone, especially if on long-term therapy, in case of emergency.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and severity of condition. Typical initial doses range from 5 mg to 60 mg daily.
Dose Range: 1 - 250 mg

Condition-Specific Dosing:

Allergic Reactions: 20-60 mg/day, tapered over 5-10 days
Asthma Exacerbation: 40-60 mg/day for 3-10 days
Autoimmune Disorders: Initial doses often 10-60 mg/day, then tapered to lowest effective dose
Inflammatory Bowel Disease: 40-60 mg/day for induction of remission, then tapered
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions may warrant use under specialist guidance (e.g., congenital adrenal hyperplasia).
Infant: Dosing is weight-based and highly variable (e.g., 0.5-2 mg/kg/day, depending on indication).
Child: Dosing is weight-based and highly variable (e.g., 0.5-2 mg/kg/day, depending on indication). Max 60 mg/day or 80 mg/day depending on condition.
Adolescent: Dosing is weight-based and highly variable (e.g., 0.5-2 mg/kg/day, depending on indication). May transition to adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Prednisone is not significantly removed by hemodialysis. No dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: May require dose reduction due to impaired conversion to prednisolone and reduced clearance of active drug. Monitor closely.
Severe: Significant dose reduction may be necessary due to impaired conversion to prednisolone and reduced clearance. Monitor closely for signs of toxicity.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic corticosteroid that is converted in the liver to its active metabolite, prednisolone. Prednisolone exerts its effects by binding to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses immune cell function, including lymphocyte proliferation and activity, thereby reducing inflammation and immune responses.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% (oral)
Tmax: 1-2 hours (for prednisolone, after prednisone administration)
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 0.7-1.5 L/kg
ProteinBinding: Approximately 90-95% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Limited, but sufficient to cause CNS effects (e.g., mood changes, insomnia).

Elimination:

HalfLife: Prednisone: 3-4 hours; Prednisolone: 2-4 hours (biological half-life is longer, 18-36 hours)
Clearance: Approximately 1.5-3 mL/min/kg
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <5% (prednisone); <15% (prednisolone)
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Pharmacodynamics

OnsetOfAction: Hours to days (depending on indication and dose)
PeakEffect: Variable, often days to weeks for full therapeutic effect in chronic conditions.
DurationOfAction: 18-36 hours (biological effect, allowing for once-daily dosing)

Safety & Warnings

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Side Effects

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 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 discolored sputum, 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 problem): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache or 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, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Shortness of breath, sudden 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 period.
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 are not there).
Seizures.
Burning, numbness, or tingling sensations that are not normal.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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 concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of infection (fever, chills, body aches, sore throat, cough, painful urination, non-healing sores)
  • Severe stomach pain, black or tarry stools, or vomiting blood
  • Unusual swelling in your hands, ankles, or feet
  • Sudden weight gain
  • Blurred vision, eye pain, or seeing halos around lights
  • Severe mood changes (depression, anxiety, confusion, hallucinations)
  • Muscle weakness or severe fatigue
  • Easy bruising or unusual bleeding
  • Persistent high blood sugar symptoms (increased thirst, increased urination, blurred vision)
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Before Using This Medicine

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 that occurred.
If you have an active infection, including bacterial, viral, or fungal infections, as well as conditions like 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 any nerve problems affecting your eyes.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health concerns with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you 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 healthcare provider will need to monitor your blood work, body weight, and other laboratory tests regularly. Additionally, you may require regular checks of your eye pressure and bone density.

Potential Side Effects and Risks

High blood pressure is a possible side effect of this medication. Your doctor will need to monitor your blood pressure regularly.
Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this risk with your doctor.
Prolonged use may also lead to weak bones (osteoporosis). Talk to your doctor about your individual risk factors and any concerns you may have.
This medication may interfere with allergy skin tests. Be sure 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 for personalized advice.
If you have diabetes, it is essential to closely monitor your blood sugar levels while taking this medication.
Before consuming alcohol, discuss the potential risks with your doctor.
Prior to receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Infection Risks

Chickenpox and measles can be severe or even life-threatening in individuals taking steroid medications like this one. Avoid close contact with anyone who has these illnesses if you have not previously been infected. If you have been exposed, inform your doctor immediately.
Steroid medications, including this one, increase the risk of infection. They can exacerbate existing infections and make it more challenging to detect signs of infection. The risk of complications from infections is typically higher with higher doses of steroids.
To minimize the risk of infection, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. Inform your doctor if you experience any symptoms of infection.

Reactivation of Infections

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

Adrenal Insufficiency

This medication can suppress your body's natural production of steroids. If you experience fever, infection, surgery, or injury, inform your doctor, as your body's response to these stressors may be impaired. You may require additional steroid doses.

Stopping the Medication

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

Additional Risks

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk 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. Regular growth checks may be necessary. Consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as this medication may pose risks to the unborn baby or infant. Your doctor will help you weigh the benefits and risks.
If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: nausea, vomiting, stomach upset, fluid retention, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity), hypertension, hyperglycemia, osteoporosis, and increased susceptibility to infection.

What to Do:

In case of suspected overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Major Interactions

  • Live or live-attenuated vaccines (risk of severe infection in immunosuppressed patients)
  • Mifepristone (antagonizes corticosteroid effects)
  • Aldesleukin (increased risk of adverse effects)
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Moderate Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • Anticoagulants (warfarin - may alter anticoagulant effect, monitor INR)
  • Antidiabetics (insulin, oral hypoglycemics - may increase blood glucose, requiring dose adjustment)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine - decreased prednisone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased prednisone levels)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Cholestyramine, colestipol (may decrease prednisone absorption)
  • Oral contraceptives (may increase prednisone levels)
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Minor Interactions

  • Antacids (may decrease absorption, separate administration)
  • Grapefruit juice (potential minor increase in levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause fluid retention and hypertension.

Timing: Prior to initiation

Blood Glucose (Fasting)

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Electrolytes (Potassium, Sodium)

Rationale: Risk of hypokalemia and sodium retention.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: For patients anticipated to be on long-term therapy (>3 months) due to risk of osteoporosis.

Timing: Prior to initiation

Ophthalmic Exam

Rationale: For patients anticipated to be on long-term therapy (>6 months) due to risk of cataracts and glaucoma.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during dose adjustments or initiation; at least monthly for chronic therapy.

Target: <130/80 mmHg (or individualized)

Action Threshold: Sustained elevation requiring intervention.

Blood Glucose (Fasting or HbA1c)

Frequency: Weekly/bi-weekly initially, then monthly for chronic therapy. HbA1c every 3-6 months.

Target: Fasting <100 mg/dL; HbA1c <7%

Action Threshold: Persistent hyperglycemia requiring antidiabetic medication or dose adjustment.

Electrolytes (Potassium)

Frequency: Weekly initially, then monthly for chronic therapy, especially with concomitant diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L) requiring supplementation.

Weight and Fluid Balance

Frequency: Weekly initially, then monthly for chronic therapy.

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain or edema.

Signs/Symptoms of Infection

Frequency: Ongoing clinical assessment at every visit.

Target: Absence of fever, localized pain, redness, swelling, or purulent discharge.

Action Threshold: Any signs of infection, requiring prompt evaluation and treatment.

Growth (Pediatric Patients)

Frequency: Every 3-6 months.

Target: Normal growth velocity for age.

Action Threshold: Growth suppression.

Bone Mineral Density (DEXA scan)

Frequency: Every 1-2 years for chronic therapy.

Target: Stable or improving T-score.

Action Threshold: Significant bone loss or fracture.

Ophthalmic Exam

Frequency: Annually for chronic therapy.

Target: Absence of cataracts or glaucoma.

Action Threshold: Development or progression of cataracts/glaucoma.

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue, non-healing wounds)
  • Hyperglycemia (increased thirst, frequent urination, blurred vision)
  • Fluid retention/edema (swelling in ankles, feet, hands, sudden weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria, insomnia)
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Muscle weakness or pain
  • Vision changes (blurred vision, halos around lights)
  • Easy bruising or thinning skin
  • Adrenal insufficiency symptoms upon withdrawal (severe fatigue, weakness, dizziness, nausea, vomiting, loss of appetite)

Special Patient Groups

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Pregnancy

Prednisone is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but 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.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts (though data is conflicting and overall risk is low).
Second Trimester: Risk of fetal growth restriction and adrenal suppression, especially with prolonged high-dose use.
Third Trimester: Risk of fetal growth restriction and adrenal suppression. Neonates should be monitored for signs of hypoadrenalism.
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Lactation

Prednisone is excreted into breast milk. While generally considered compatible with breastfeeding at typical doses (L3 - Moderately safe), caution is advised. Infant exposure can be minimized by waiting 4 hours after a dose before breastfeeding. Monitor the infant for signs of adverse effects such as growth suppression or adrenal suppression, especially with high maternal doses or prolonged therapy.

Infant Risk: Low to moderate. Potential for growth suppression or adrenal suppression in the infant, especially with high maternal doses. Monitor infant for adverse effects.
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Pediatric Use

Corticosteroids can cause growth retardation in children. The lowest effective dose for the shortest possible duration should be used. Monitor growth and development closely. Long-term use can also lead to adrenal suppression, osteoporosis, and cataracts.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, diabetes, hypertension, fluid retention, and cataracts. Use the lowest effective dose and monitor closely for side effects. Consider bone density monitoring and prophylactic measures for osteoporosis.

Clinical Information

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Clinical Pearls

  • Always taper prednisone doses gradually to prevent adrenal insufficiency, especially after prolonged therapy or high doses. The rate of taper depends on the dose and duration of therapy.
  • Administer prednisone with food or milk to minimize gastrointestinal irritation.
  • Patients on long-term prednisone therapy should carry a steroid card or wear medical identification to alert healthcare providers in emergencies.
  • Educate patients about the signs and symptoms of infection, as corticosteroids can mask these signs and increase susceptibility to infections.
  • Monitor blood glucose levels, blood pressure, and electrolytes regularly, especially in patients with pre-existing conditions like diabetes or hypertension.
  • Consider calcium and vitamin D supplementation, and potentially a bisphosphonate, for patients on long-term prednisone to mitigate bone loss.
  • Mood changes (euphoria, depression, anxiety, insomnia) are common side effects and should be discussed with patients and caregivers.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., methylprednisolone, dexamethasone, hydrocortisone)
  • NSAIDs (for inflammatory conditions, if appropriate)
  • Immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine, biologics - for autoimmune or inflammatory conditions, often as steroid-sparing agents)
  • Disease-modifying antirheumatic drugs (DMARDs) for rheumatologic conditions
  • Antihistamines (for allergic reactions)
  • Bronchodilators (for asthma exacerbations)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (1mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. 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.