Rayos 5mg DR Tablets

Manufacturer HORIZON PHARMA Active Ingredient Prednisone Delayed-Release 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.
đŸˇī¸
Drug Class
Corticosteroid, Anti-inflammatory
đŸ§Ŧ
Pharmacologic Class
Glucocorticoid receptor agonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jul 2012
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Rayos is a delayed-release tablet containing prednisone, a type of corticosteroid. It works by reducing inflammation and suppressing the immune system. This specific formulation is designed to release the medicine about 4 hours after you take it, typically in the evening, so that its effects are strongest in the morning when symptoms like joint stiffness are often at their worst.
📋

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. Swallow the tablet whole - do not chew, break, or crush it.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment to ensure the best possible outcome.

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, as the humidity can affect the medication. Keep all medications in a secure location, out of the reach of children and pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
💡

Lifestyle & Tips

  • Take Rayos exactly as prescribed, usually once daily in the evening (e.g., 10 PM), with or without food.
  • Do not crush, chew, or split the tablets.
  • 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 gradually reduce the dose.
  • Avoid exposure to people with infections (especially chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual fatigue) to your doctor immediately.
  • Monitor your blood sugar if you have diabetes, as this medication can raise blood glucose levels.
  • Discuss calcium and vitamin D supplementation with your doctor to protect bone health, especially with long-term use.
  • Limit sodium intake to help manage fluid retention and blood pressure.
  • Regular exercise, if appropriate, can help maintain bone and muscle strength.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 5 mg once daily, administered orally in the evening (e.g., 10 PM) for rheumatoid arthritis.
Dose Range: 2 - 50 mg

Condition-Specific Dosing:

rheumatoidArthritis: 5 mg once daily in the evening
polymyalgiaRheumatica: 10-15 mg once daily in the evening
psoriaticArthritis: 5-10 mg once daily in the evening
ankylosingSpondylitis: 5-10 mg once daily in the evening
systemicLupusErythematosus: 5-15 mg once daily in the evening
asthma: 10-60 mg once daily in the evening (depending on severity)
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (Rayos is not indicated for pediatric use)
Infant: Not established (Rayos is not indicated for pediatric use)
Child: Not established (Rayos is not indicated for pediatric use)
Adolescent: Not established (Rayos is not indicated for pediatric use)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to potential for fluid retention.
Dialysis: Prednisone is not significantly removed by hemodialysis. No specific dose adjustment recommended.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Consider dose reduction in patients with moderate to severe hepatic impairment, as conversion of prednisone to active prednisolone may be impaired.
Severe: Consider dose reduction in patients with moderate to severe hepatic impairment, as conversion of prednisone to active prednisolone may be impaired.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Prednisone is a synthetic glucocorticoid. It exerts its anti-inflammatory and immunosuppressive effects 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) and inhibition of pro-inflammatory mediators (e.g., cytokines, prostaglandins, leukotrienes). It also suppresses the migration of polymorphonuclear leukocytes and reverses increased capillary permeability.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 70-90% (for prednisone, converted to prednisolone)
Tmax: Approximately 6 hours (range 4-8 hours) after evening administration of Rayos
FoodEffect: Food does not significantly affect the absorption of Rayos, but administration with food may reduce gastrointestinal upset.

Distribution:

Vd: Approximately 0.7 L/kg (for prednisone)
ProteinBinding: Prednisone: ~65% (primarily to albumin and transcortin); Prednisolone: ~90% (primarily to albumin)
CnssPenetration: Limited (prednisone and prednisolone can cross the blood-brain barrier, but CNS concentrations are lower than plasma)

Elimination:

HalfLife: Prednisone: 2-3 hours; Prednisolone: 2-4 hours (plasma half-life); Biological half-life is longer (18-36 hours)
Clearance: Approximately 1.5-2.5 mL/min/kg (for prednisolone)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: Less than 5% (of prednisolone) is excreted unchanged in urine
âąī¸

Pharmacodynamics

OnsetOfAction: Delayed (due to delayed-release formulation, drug release begins ~4 hours post-ingestion, aiming for morning peak effect)
PeakEffect: Anti-inflammatory effects are generally observed within hours to days, with the delayed-release formulation designed to provide peak systemic concentrations in the early morning hours to address morning symptoms.
DurationOfAction: 18-36 hours (biological half-life, reflecting duration of anti-inflammatory effect)

Safety & Warnings

âš ī¸

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 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 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 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, increased 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 symptoms that concern you, contact your doctor:

Nausea or vomiting
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 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Signs of infection (fever, chills, body aches, persistent cough)
  • Severe stomach pain, black or tarry stools, or vomiting blood
  • Unusual swelling in your hands or feet, rapid weight gain
  • Extreme mood changes (severe depression, euphoria, confusion)
  • Blurred vision or eye pain
  • Muscle weakness or severe fatigue
  • Persistent headache or dizziness
  • Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
📋

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 symptoms you experienced as a result of the allergy.
If you have any type of 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 infection
* If you have nerve problems in your eye

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

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 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 periodically.

Potential Side Effects and Risks

High blood pressure is a possible side effect of this medication. Your doctor will 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 your 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, and inform your doctor if you have been exposed.
Steroid medications, including this one, increase the risk of infection. They can cause existing infections to worsen and may mask symptoms of infection. The risk of infection is typically higher with higher doses of steroids.
To minimize your risk of infection, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu. Inform your doctor immediately if you experience any signs 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 stress 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 your 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 experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor promptly.

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 harm the unborn baby or affect milk production. Your doctor will discuss the benefits and risks with you.
If you took this medication during pregnancy, inform your baby's doctor.
🆘

Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: fluid retention, hypertension, hyperglycemia, hypokalemia, and gastrointestinal upset. Chronic overdose can lead to Cushingoid features (moon face, buffalo hump), muscle weakness, osteoporosis, and increased susceptibility to infection.

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)
🔴

Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine): May decrease prednisone/prednisolone levels, requiring dose increase.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase prednisone/prednisolone levels, requiring dose reduction.
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (either increase or decrease), requiring close INR monitoring.
  • Diuretics (thiazide or loop diuretics): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose levels, requiring dose adjustment of antidiabetic agents.
🟡

Moderate Interactions

  • Cardiac glycosides (e.g., digoxin): Increased risk of digitalis toxicity due to hypokalemia.
  • Cholestyramine, colestipol: May decrease absorption of prednisone.
  • Cyclosporine: Increased blood levels of both cyclosporine and corticosteroids.
  • Oral contraceptives/estrogens: May increase corticosteroid levels.
  • Fluoroquinolones: Increased risk of tendon rupture (rare, but reported with corticosteroids).
đŸŸĸ

Minor Interactions

  • Antacids: May decrease absorption (separate administration time).
  • Grapefruit juice: May increase prednisone levels (CYP3A4 inhibition).

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood glucose (fasting)

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Prior to initiation

Serum electrolytes (especially potassium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: Long-term corticosteroid use increases risk of osteoporosis.

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

Ophthalmic examination (intraocular pressure)

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

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

Complete Blood Count (CBC)

Rationale: To assess for leukocytosis or other hematologic changes.

Timing: Prior to initiation

📊

Routine Monitoring

Blood pressure

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

Target: Normal range for patient

Action Threshold: Sustained elevation above target; consider antihypertensive therapy or dose adjustment.

Blood glucose (fasting or HbA1c)

Frequency: Regularly (e.g., monthly or quarterly, more frequently if diabetic)

Target: Normal range or individualized glycemic targets

Action Threshold: Persistent hyperglycemia; consider antidiabetic medication or dose adjustment.

Serum electrolytes (especially potassium)

Frequency: Periodically (e.g., every 3-6 months, more frequently if on diuretics)

Target: Potassium 3.5-5.0 mEq/L

Action Threshold: Hypokalemia; consider potassium supplementation or dose adjustment.

Signs/symptoms of infection

Frequency: Ongoing

Target: Absence of infection

Action Threshold: Fever, malaise, localized pain/redness; prompt evaluation and treatment.

Weight and fluid balance

Frequency: Regularly (e.g., monthly)

Target: Stable weight, no edema

Action Threshold: Significant weight gain, edema; consider dietary changes or diuretic.

Bone mineral density (DEXA scan)

Frequency: Every 1-2 years for long-term therapy

Target: Stable or improving T-score

Action Threshold: Significant bone loss; consider anti-resorptive therapy.

Ophthalmic examination

Frequency: Annually for long-term therapy

Target: Normal intraocular pressure, no cataracts

Action Threshold: Elevated IOP, cataract formation; refer to ophthalmologist.

đŸ‘ī¸

Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, unusual fatigue)
  • Increased thirst or urination (hyperglycemia)
  • Swelling in ankles/feet, weight gain (fluid retention)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Stomach pain, black/tarry stools (GI ulceration)
  • Muscle weakness or cramps (hypokalemia)
  • Vision changes
  • Easy bruising or skin thinning

Special Patient Groups

🤰

Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animals. Human data are limited but suggest a possible association with cleft palate in infants exposed during the first trimester, and adrenal insufficiency in neonates exposed to high doses during pregnancy.

Trimester-Specific Risks:

First Trimester: Possible increased risk of oral clefts (though human data are inconsistent and limited).
Second Trimester: Generally considered safer than first or third trimester, but continued monitoring for fetal growth and well-being is advised.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism (e.g., hypoglycemia, hypotension) and potentially requiring corticosteroid replacement therapy.
🤱

Lactation

Prednisone and prednisolone are excreted into breast milk. While generally considered compatible with breastfeeding at low to moderate doses, caution is advised. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, delayed development) or other adverse effects.

Infant Risk: Low to moderate risk, depending on dose and duration. High doses or prolonged use may pose a higher risk of infant adrenal suppression or growth inhibition.
đŸ‘ļ

Pediatric Use

Rayos (prednisone delayed-release) is not indicated for pediatric use. Corticosteroids in general can cause growth retardation in children and adolescents. If corticosteroids are necessary, the lowest effective dose for the shortest duration should be used, and growth should be carefully monitored.

👴

Geriatric Use

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

Clinical Information

💎

Clinical Pearls

  • Rayos is specifically designed for evening administration to provide peak prednisone levels in the early morning, targeting morning stiffness and inflammation in conditions like rheumatoid arthritis.
  • Patients should be educated on the importance of not crushing, chewing, or splitting the delayed-release tablets.
  • Due to immunosuppressive effects, advise patients to avoid exposure to infections and report any signs of illness promptly.
  • Long-term corticosteroid use requires careful monitoring for bone density, blood glucose, blood pressure, and ophthalmic changes.
  • Always taper corticosteroids gradually to avoid adrenal insufficiency crisis, especially after prolonged therapy.
🔄

Alternative Therapies

  • Other oral corticosteroids (e.g., prednisone immediate-release, methylprednisolone, dexamethasone)
  • Biologic DMARDs (e.g., TNF inhibitors, IL-6 inhibitors, JAK inhibitors for RA)
  • Conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide for RA)
  • NSAIDs (for symptomatic relief of inflammation and pain)
💰

Cost & Coverage

Average Cost: $150 - $300+ per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for brand Rayos); Tier 1 (for generic prednisone immediate release)
📚

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 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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.