Risedronate Sod 30mg Tablets
It is used to treat Paget's disease.It is used to prevent or treat soft, brittle bones (osteoporosis).
Drug Class
Bone Resorption Inhibitor
Pharmacologic Class
Bisphosphonate
Pregnancy Category
C
FDA Approved
Dec 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Risedronate is a medication used to strengthen bones and treat conditions like Paget's disease or osteoporosis. It works by slowing down the natural process where old bone is broken down, allowing new, stronger bone to form. This helps reduce the risk of fractures.
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 plain water only. Avoid taking it with mineral water, milk, or other drinks.
Swallow the medication whole. Do not chew, break, or crush it. Also, do not suck on the medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Take your medication with a full glass of water.
Take it at least 30 minutes before consuming your first food, drink, or other medications of the day.
After taking your medication, do not lie down for at least 30 minutes and wait until you have eaten your first meal of the day before lying down.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, do not take it later in the same day.
Take the missed dose the next morning as soon as you remember, and then return to your regular schedule.
Do not take two doses on the same day.
* If you are unsure about what to do if you miss a dose, contact your doctor for guidance.
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 plain water only. Avoid taking it with mineral water, milk, or other drinks.
Swallow the medication whole. Do not chew, break, or crush it. Also, do not suck on the medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Take your medication with a full glass of water.
Take it at least 30 minutes before consuming your first food, drink, or other medications of the day.
After taking your medication, do not lie down for at least 30 minutes and wait until you have eaten your first meal of the day before lying down.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, do not take it later in the same day.
Take the missed dose the next morning as soon as you remember, and then return to your regular schedule.
Do not take two doses on the same day.
* If you are unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Take the tablet with a full glass (6-8 ounces) of plain water only, first thing in the morning, at least 30 minutes before your first food, drink (other than plain water), or other medication of the day.
- Swallow the tablet whole; do not chew, crush, or suck on it.
- Remain upright (sitting or standing) for at least 30 minutes after taking the tablet and until after your first food of the day.
- Do not lie down for at least 30 minutes after taking the tablet.
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as recommended by your doctor.
- Engage in regular weight-bearing exercise as advised by your healthcare provider.
- Avoid smoking and excessive alcohol consumption, as these can negatively impact bone health.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Paget's disease: 30 mg orally once daily for 2 months. For osteoporosis: 5 mg orally once daily, 35 mg orally once weekly, or 150 mg orally once monthly.
Dose Range:
30 - 30 mg
Condition-Specific Dosing:
Paget's Disease of Bone:
30 mg orally once daily for 2 months. Retreatment may be considered if relapse occurs or if treatment fails, but not sooner than 2 months after the initial course.
Postmenopausal Osteoporosis:
Not typically used as 30mg for this indication. Standard doses are 5 mg daily, 35 mg weekly, or 150 mg monthly.
Glucocorticoid-Induced Osteoporosis:
Not typically used as 30mg for this indication. Standard doses are 5 mg daily or 35 mg weekly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary for CrCl âĨ 30 mL/min.
Moderate:
No dosage adjustment necessary for CrCl âĨ 30 mL/min.
Severe:
Contraindicated in patients with creatinine clearance < 30 mL/min.
Dialysis:
Contraindicated in patients with creatinine clearance < 30 mL/min; not studied in dialysis patients.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Pharmacology
Mechanism of Action
Risedronate is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone and inhibits the activity of osteoclasts, thereby decreasing bone turnover and increasing bone mineral density.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 0.63% (fasting state)
Tmax:
Approximately 1 hour
FoodEffect:
Food, beverages (other than plain water), and polyvalent cations (e.g., calcium, magnesium, iron, aluminum) significantly decrease absorption. Should be taken at least 30 minutes before the first food or drink of the day.
Distribution:
Vd:
Not available (primarily distributed to bone)
ProteinBinding:
Approximately 24%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life in bone is prolonged (up to several hundred hours); plasma elimination half-life is approximately 480 hours (due to slow release from bone).
Clearance:
Renal clearance is approximately 100 mL/min.
ExcretionRoute:
Renal (approximately 50% of absorbed dose excreted in urine within 24 hours)
Unchanged:
Approximately 50% of absorbed dose
Pharmacodynamics
OnsetOfAction:
Bone resorption markers decrease within days to weeks.
PeakEffect:
Maximal suppression of bone turnover markers typically seen within 3-6 months.
DurationOfAction:
Effects on bone mineral density persist as long as treatment is continued; residual effects on bone turnover may persist for months after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Vomiting blood or material that looks like coffee grounds
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
New or unusual pain in the groin, hip, or thigh area
Changes in eyesight, eye pain, or severe eye irritation
Difficulty passing urine
Pain when passing urine
Jawbone Problems
This medication may increase the risk of jawbone problems, particularly with long-term use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting disorders, or infection. The risk may also be higher if you have dental work, chemotherapy, radiation, or take other medications that can cause jawbone problems. If any of these factors apply to you, or if you have questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
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 help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Black, tarry, or bloody stools
Chest pain
Coughing up blood
Vomiting blood or material that looks like coffee grounds
Heartburn
Trouble swallowing
Severe pain when swallowing
Sore throat
New or unusual pain in the groin, hip, or thigh area
Changes in eyesight, eye pain, or severe eye irritation
Difficulty passing urine
Pain when passing urine
Jawbone Problems
This medication may increase the risk of jawbone problems, particularly with long-term use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting disorders, or infection. The risk may also be higher if you have dental work, chemotherapy, radiation, or take other medications that can cause jawbone problems. If any of these factors apply to you, or if you have questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Difficulty or pain when swallowing, chest pain, or new or worsening heartburn (signs of esophageal irritation). Stop taking the medication and contact your doctor immediately.
- New or unusual pain in your thigh, hip, or groin (could be a sign of an unusual thigh bone fracture).
- Jaw pain, swelling, or numbness (could be a sign of osteonecrosis of the jaw).
- Severe bone, joint, or muscle pain.
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.
Certain health conditions, including:
+ Esophageal problems
+ Difficulty swallowing
+ Low calcium levels
+ Kidney disease
If you are unable to stand or sit upright for 30 minutes
If you are taking any of the following medications:
+ Cimetidine
+ Dexlansoprazole
+ Esomeprazole
+ Famotidine
+ Lansoprazole
+ Nizatidine
+ Omeprazole
+ Pantoprazole
+ Rabeprazole
+ Ranitidine
* If you are taking another medication that contains the same active ingredient as this drug
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting 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.
Certain health conditions, including:
+ Esophageal problems
+ Difficulty swallowing
+ Low calcium levels
+ Kidney disease
If you are unable to stand or sit upright for 30 minutes
If you are taking any of the following medications:
+ Cimetidine
+ Dexlansoprazole
+ Esomeprazole
+ Famotidine
+ Lansoprazole
+ Nizatidine
+ Omeprazole
+ Pantoprazole
+ Rabeprazole
+ Ranitidine
* If you are taking another medication that contains the same active ingredient as this drug
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This drug can cause severe esophageal problems, such as irritation, swelling, ulcers, and bleeding. It is crucial to discuss these potential risks with your doctor.
If you have asthma, be aware that this medication may worsen your condition. Consult your doctor to discuss any concerns.
There is a potential increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this risk.
Regular blood tests and bone density assessments are necessary while taking this medication, as directed by your doctor.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.
To maximize the effectiveness of this medication, it is recommended to use it in conjunction with calcium and vitamin D supplements, as well as engage in weight-bearing exercises, such as walking or physical therapy.
Before initiating this medication, schedule a dental examination to ensure your teeth and gums are healthy. Maintain good oral hygiene and visit your dentist regularly for check-ups.
If you consume alcohol, consult your doctor to discuss any potential risks. Additionally, if you smoke, talk to your doctor about the potential effects on your health.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, potentially leading to death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin, with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
This drug can cause severe esophageal problems, such as irritation, swelling, ulcers, and bleeding. It is crucial to discuss these potential risks with your doctor.
If you have asthma, be aware that this medication may worsen your condition. Consult your doctor to discuss any concerns.
There is a potential increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this risk.
Regular blood tests and bone density assessments are necessary while taking this medication, as directed by your doctor.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.
To maximize the effectiveness of this medication, it is recommended to use it in conjunction with calcium and vitamin D supplements, as well as engage in weight-bearing exercises, such as walking or physical therapy.
Before initiating this medication, schedule a dental examination to ensure your teeth and gums are healthy. Maintain good oral hygiene and visit your dentist regularly for check-ups.
If you consume alcohol, consult your doctor to discuss any potential risks. Additionally, if you smoke, talk to your doctor about the potential effects on your health.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can cause severe health problems, potentially leading to death. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin, with or without fever, red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (low blood calcium), which may cause muscle cramps, spasms, or numbness/tingling.
- Hypophosphatemia (low blood phosphate).
- Upper gastrointestinal adverse events (e.g., upset stomach, heartburn, esophageal irritation).
What to Do:
There is no specific antidote. Treatment should be symptomatic and supportive. Milk or antacids containing calcium may be given to bind risedronate and reduce absorption. Dialysis is not expected to be beneficial. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Patients with hypocalcemia (must be corrected prior to initiation)
- Patients with abnormalities of the esophagus which delay esophageal emptying (e.g., stricture or achalasia)
Major Interactions
- Antacids (calcium, magnesium, aluminum-containing): Reduce absorption of risedronate. Administer at least 30 minutes after risedronate.
- Calcium supplements: Reduce absorption of risedronate. Administer at least 30 minutes after risedronate.
- Iron supplements: Reduce absorption of risedronate. Administer at least 30 minutes after risedronate.
- Magnesium supplements: Reduce absorption of risedronate. Administer at least 30 minutes after risedronate.
Moderate Interactions
- Proton Pump Inhibitors (PPIs) / H2-receptor antagonists: May increase gastric pH, potentially affecting risedronate absorption, though clinical significance is debated.
- NSAIDs: Concomitant use with bisphosphonates has been associated with increased risk of gastrointestinal irritation, though specific data for risedronate is limited.
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia, as hypocalcemia must be corrected prior to initiation.
Timing: Prior to initiation of therapy.
Serum 25-hydroxyvitamin D
Rationale: To ensure vitamin D sufficiency, as deficiency should be corrected prior to initiation.
Timing: Prior to initiation of therapy.
Renal Function (CrCl)
Rationale: To assess eligibility for therapy (contraindicated if CrCl < 30 mL/min).
Timing: Prior to initiation of therapy.
Dental Examination
Rationale: To identify and address pre-existing dental disease, especially for patients with risk factors for osteonecrosis of the jaw (ONJ).
Timing: Prior to initiation, especially if risk factors for ONJ are present.
Routine Monitoring
Serum Calcium
Frequency: Periodically, especially if symptoms of hypocalcemia occur.
Target: 8.5-10.2 mg/dL
Action Threshold: If below normal range, investigate cause and supplement as needed.
Serum 25-hydroxyvitamin D
Frequency: Periodically, especially if deficiency was noted at baseline or if patient has risk factors for deficiency.
Target: >30 ng/mL
Action Threshold: If below target, supplement with vitamin D.
Renal Function (CrCl)
Frequency: Periodically, especially in elderly patients or those with risk factors for renal decline.
Target: >30 mL/min
Action Threshold: If CrCl falls below 30 mL/min, discontinue risedronate.
Symptom Monitoring
- New or worsening heartburn
- Difficulty swallowing (dysphagia)
- Painful swallowing (odynophagia)
- Chest pain (suggestive of esophageal irritation)
- New or unusual pain in the thigh, hip, or groin (potential atypical femoral fracture)
- Jaw pain, swelling, or numbness (potential osteonecrosis of the jaw)
- Severe bone, joint, or muscle pain
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Risedronate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The amount of bisphosphonate incorporated into maternal bone and subsequently released is directly related to the total dose and duration of bisphosphonate use. There is a theoretical risk of fetal harm (e.g., hypocalcemia, skeletal abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Trimester-Specific Risks:
First Trimester:
Limited human data. Theoretical risk of fetal harm due to drug incorporation into bone.
Second Trimester:
Limited human data. Theoretical risk of fetal harm due to drug incorporation into bone.
Third Trimester:
Limited human data. Theoretical risk of fetal harm due to drug incorporation into bone, including hypocalcemia in the neonate.
Lactation
It is not known whether risedronate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately safe). Potential for serious adverse effects in the infant due to long half-life and potential for bone incorporation. Use with caution; consider alternatives or monitor infant for hypocalcemia.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No overall differences in efficacy or safety were observed between elderly and younger patients. No dosage adjustment is necessary based on age alone, but renal function should be monitored as elderly patients are more likely to have decreased renal function.
Clinical Information
Clinical Pearls
- Strict adherence to administration instructions is crucial to maximize absorption and minimize esophageal adverse events. Take with plain water only, at least 30 minutes before any food, drink, or other medications, and remain upright for at least 30 minutes.
- Ensure adequate calcium and vitamin D intake, as these are essential for bone health and the efficacy of risedronate.
- Patients should be advised to report any symptoms of esophageal irritation (e.g., difficulty/pain swallowing, chest pain, new/worsening heartburn) immediately and discontinue the drug.
- Be aware of the rare but serious adverse events: atypical femoral fractures and osteonecrosis of the jaw (ONJ). Patients should report any new hip, thigh, or groin pain, or any jaw pain/swelling/numbness.
- For Paget's disease, the 30mg dose is typically given for 2 months. Retreatment should not occur sooner than 2 months after the initial course.
Alternative Therapies
- Other Bisphosphonates (e.g., Alendronate, Ibandronate, Zoledronic Acid)
- Denosumab (Prolia)
- Teriparatide (Forteo)
- Abaloparatide (Tymlos)
- Romosozumab (Evenity)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., Raloxifene)
- Calcitonin (for Paget's disease)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30 tablets (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 (for brand)
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.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, 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.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, 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.