Rayos 2mg DR Tablets

Manufacturer HORIZON Active Ingredient Prednisone Delayed-Release Tablets(PRED ni sone) Pronunciation RAY-ohs (for brand name); 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
Jul 2012
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Rayos is a delayed-release form of prednisone, a type of steroid medication. It's designed to be taken in the evening so that the medicine starts working in the morning, helping to reduce morning stiffness and pain, especially for conditions like rheumatoid arthritis. It works by reducing inflammation and calming down your immune system.
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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're taking it once a day, take it in the morning. Swallow the tablet whole - do not chew, break, or crush it.

It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. This will help you get the full benefit of the treatment and prevent any potential complications.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Make sure to store all your medications in a safe and secure location, out of the reach of children and pets.

When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

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 the missed one.
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Lifestyle & Tips

  • Take Rayos exactly as prescribed, usually once daily in the evening (e.g., around 10 PM), with or without food.
  • Do not stop taking this medication suddenly, especially after long-term use, as it can lead to withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
  • Avoid exposure to people with infections (especially chickenpox or measles) while taking this medication, as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual pain) to your doctor immediately.
  • Discuss vaccination plans with your doctor, as live vaccines may be contraindicated.
  • Maintain a diet rich in calcium and vitamin D, and engage in weight-bearing exercise to help protect bone health, especially with long-term use.
  • Limit sodium intake to help prevent fluid retention and high blood pressure.
  • Monitor blood sugar if you have diabetes, as this medication can increase blood glucose levels.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose 5 mg once daily in the evening (e.g., 10 PM) for rheumatoid arthritis. Dosage may be adjusted based on clinical response and tolerability.
Dose Range: 1 - 50 mg

Condition-Specific Dosing:

rheumatoidArthritis: Initial dose 5 mg once daily in the evening. Maintenance dose should be individualized to the lowest effective dose.
polymyalgiaRheumatica: Initial dose 10-15 mg once daily in the evening. Dosage may be tapered based on clinical response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dosage adjustment generally required.
Moderate: No specific dosage adjustment generally required.
Severe: No specific dosage adjustment generally required.
Dialysis: Prednisone is not significantly removed by hemodialysis. No specific dosage adjustment required.

Hepatic Impairment:

Mild: Caution advised; monitor for increased effects.
Moderate: Caution advised; monitor for increased effects. Prednisone is a prodrug converted to prednisolone in the liver; impaired conversion may occur.
Severe: Caution advised; monitor for increased effects. Prednisone is a prodrug converted to prednisolone in the liver; impaired conversion may occur.

Pharmacology

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Mechanism of Action

Prednisone is a synthetic glucocorticoid that is converted in the liver to prednisolone, its active metabolite. Prednisolone exerts its anti-inflammatory and immunosuppressive actions by binding to intracellular glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). It also suppresses the immune system by inhibiting the function of lymphocytes and macrophages.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% (for prednisolone after prednisone conversion)
Tmax: Approximately 6 hours (for prednisolone after Rayos administration)
FoodEffect: Food does not significantly affect the absorption of Rayos, but it should be taken consistently with or without food.

Distribution:

Vd: Approximately 0.22-0.7 L/kg (for prednisolone)
ProteinBinding: Approximately 90-95% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-4 hours (for prednisolone)
Clearance: Approximately 1.5-3 mL/min/kg (for prednisolone)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: Less than 5% (for prednisolone)
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Pharmacodynamics

OnsetOfAction: Delayed (due to DR formulation, peak effects designed for morning symptoms)
PeakEffect: Approximately 6 hours post-dose (for prednisolone after Rayos administration)
DurationOfAction: Approximately 18-36 hours (pharmacologic effects)

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 experience 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, trouble 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 sputum production or change in sputum color, 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 insufficiency (weak adrenal gland): 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, 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.
Menstrual changes.
Bone or joint pain.
Fatigue or weakness.
Changes in vision.
Confusion, difficulty concentrating, or changes in behavior.
Memory problems or loss.
Hallucinations (seeing or hearing things that are not 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 experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Nausea and vomiting.
Increased appetite.
Weight gain.
Insomnia.
Restlessness.
Excessive sweating.
Dizziness or headache.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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, cough, sore throat, painful urination)
  • Severe stomach pain, black or tarry stools, vomiting blood (signs of GI bleeding)
  • Swelling in your hands, ankles, or feet (fluid retention)
  • Unusual weight gain
  • Muscle weakness or severe fatigue
  • Vision problems (blurred vision, eye pain)
  • Mood changes (severe depression, anxiety, confusion, unusual thoughts or behavior)
  • Increased thirst or urination (signs of high blood sugar)
  • Easy bruising or skin thinning
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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

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

Be aware that medications like this one can cause high blood pressure. Your doctor will need to monitor your blood pressure as directed. Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

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

You may need to reduce your salt intake and increase your potassium consumption. Consult with your doctor to determine the best approach for your specific situation. If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, you should discuss the potential risks with your doctor.

It is also essential to talk to your doctor before receiving any vaccinations, as some vaccines may not be effective or may increase the risk of infection when taken with this medication. If you have not had chickenpox or measles before, it is crucial to avoid exposure to these diseases, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, inform your doctor immediately.

Steroid medications, including this one, can increase the risk of infection, which can be mild, severe, or 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 people with infections, colds, or flu, and inform your doctor if you experience any signs of infection.

In some cases, medications like this one can reactivate latent infections, such as tuberculosis or hepatitis B. If you have a history of these infections, inform your doctor. This medication can also suppress your body's natural production of steroids, which can affect your response to stress, such as fever, infection, surgery, or injury. In these situations, you may require additional doses of steroids, so it is essential to inform your doctor.

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 guide 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 promptly.

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 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 can also affect growth in children and adolescents, so regular growth checks may be necessary. Consult with your doctor to determine the best approach.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as this medication can harm the unborn baby. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy. 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: fluid retention, hypertension, hyperglycemia, hypokalemia, and gastrointestinal irritation.

What to Do:

Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (during immunosuppressive doses of corticosteroids)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine, primidone, ephedra, St. John's Wort) - may decrease prednisone levels
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase prednisone levels
  • NSAIDs (e.g., ibuprofen, naproxen) - increased risk of GI ulceration/bleeding
  • Anticoagulants (e.g., warfarin) - altered anticoagulant effect (increased or decreased)
  • Diuretics (e.g., thiazides, loop diuretics) - enhanced potassium depletion, increased risk of hypokalemia
  • Digitalis glycosides (e.g., digoxin) - increased risk of digitalis toxicity with hypokalemia
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics) - corticosteroids can increase blood glucose, requiring dose adjustments of antidiabetics
  • Cholestyramine, colestipol - may decrease prednisone absorption
  • Cyclosporine - increased risk of seizures and other CNS effects for both drugs
  • Aminoglutethimide - may decrease corticosteroid efficacy
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Moderate Interactions

  • Oral contraceptives/estrogens - may increase corticosteroid effects
  • Fluoroquinolones - increased risk of tendon rupture
  • Neuromuscular blocking agents - prolonged neuromuscular blockade
  • Isoniazid - decreased isoniazid levels
  • Aspirin (high dose) - decreased salicylate levels, increased risk of GI side effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Risk of hypertension

Timing: Prior to initiation

Serum electrolytes (Na, K, Cl)

Rationale: Risk of fluid retention and electrolyte imbalance (hypokalemia)

Timing: Prior to initiation

Blood glucose (fasting)

Rationale: Risk of hyperglycemia/diabetes

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: Risk of osteoporosis with long-term use

Timing: Prior to initiation (especially for long-term therapy)

Ophthalmologic exam (intraocular pressure, cataracts)

Rationale: Risk of glaucoma and cataracts with long-term use

Timing: Prior to initiation (especially for long-term therapy)

Complete Blood Count (CBC)

Rationale: May cause leukocytosis, lymphopenia, eosinopenia

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Regularly (e.g., weekly to monthly, then periodically)

Target: Individualized

Action Threshold: Significant elevation requiring intervention

Serum electrolytes (Na, K)

Frequency: Periodically (e.g., monthly, then every 3-6 months)

Target: Within normal limits

Action Threshold: Hypokalemia or significant sodium retention

Blood glucose (fasting or HbA1c)

Frequency: Periodically (e.g., monthly, then every 3-6 months)

Target: Individualized

Action Threshold: Persistent hyperglycemia or development of diabetes

Weight and fluid balance

Frequency: Regularly

Target: Stable

Action Threshold: Significant weight gain or edema

Growth (in pediatric patients)

Frequency: Regularly

Target: Normal growth curve

Action Threshold: Growth retardation

Signs/symptoms of infection

Frequency: Continuously

Target: Absence of infection

Action Threshold: Fever, malaise, localized signs of infection

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, unusual pain)
  • Hyperglycemia (increased thirst, urination, fatigue)
  • Fluid retention/edema (swelling in ankles, feet, hands)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Gastrointestinal upset (heartburn, indigestion, abdominal pain)
  • Muscle weakness or pain
  • Vision changes
  • Skin changes (thinning, bruising)
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Prednisone is classified as Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animal studies.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate in animal studies; human data are inconclusive but generally do not show a consistent pattern of major malformations.
Second Trimester: Risk of fetal growth restriction, premature delivery, and adrenal suppression in the neonate with prolonged or high-dose use.
Third Trimester: Risk of fetal growth restriction, premature delivery, and adrenal suppression in the neonate with prolonged or high-dose use. Neonates exposed to corticosteroids in utero should be carefully observed for signs of hypoadrenalism.
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Lactation

Prednisone and its active metabolite prednisolone are excreted into breast milk. While generally considered compatible with breastfeeding at low to moderate doses, caution is advised. The lowest effective dose should be used, and the infant should be monitored for adverse effects.

Infant Risk: L3 (Moderate risk). Potential for growth suppression, interference with endogenous corticosteroid production, and other adverse effects in the infant, especially with high doses or prolonged use. Consider taking the dose immediately after a feeding or waiting 4 hours after a dose before feeding to minimize infant exposure.
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Pediatric Use

Safety and effectiveness of Rayos (prednisone delayed-release) have not been established in pediatric patients. Standard prednisone formulations are used in pediatrics, but long-term use can cause growth retardation, cataracts, glaucoma, and other systemic adverse effects. Careful monitoring of growth and development is essential.

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Geriatric Use

Elderly patients may be at increased risk of adverse effects, including osteoporosis, hypertension, diabetes, fluid retention, and cataracts. Use the lowest effective dose and monitor closely for adverse reactions.

Clinical Information

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Clinical Pearls

  • Rayos is specifically formulated for delayed release, designed to be taken in the evening (e.g., 10 PM) to provide peak prednisone levels in the morning, which can be beneficial for conditions like rheumatoid arthritis with prominent morning stiffness.
  • Patients should be instructed not to crush, chew, or split the tablets, as this will disrupt the delayed-release mechanism.
  • Always emphasize the importance of not discontinuing corticosteroids abruptly due to the risk of adrenal insufficiency.
  • Educate patients on signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Long-term corticosteroid use requires monitoring for bone density, blood glucose, blood pressure, and ophthalmologic changes.
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Alternative Therapies

  • Immediate-release prednisone/prednisolone
  • Other systemic corticosteroids (e.g., methylprednisolone, dexamethasone)
  • NSAIDs (Non-steroidal anti-inflammatory drugs)
  • DMARDs (Disease-modifying antirheumatic drugs) for rheumatoid arthritis (e.g., methotrexate, biologics)
  • Immunosuppressants (e.g., azathioprine, cyclosporine)
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Cost & Coverage

Average Cost: $150 - $300 per 30 tablets (2mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand-name Rayos may be higher tier than generic prednisone)
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General Drug Facts

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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.