Actonel 5mg 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
Category C
FDA Approved
Dec 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Risedronate is a medication used to strengthen bones and prevent fractures, especially in people with osteoporosis. It works by slowing down the natural process of bone breakdown in your body.
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 beverages.
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, avoiding the 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 beverages.
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, avoiding the 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.
- Do not lie down for at least 30 minutes after taking the tablet, and preferably until after your first meal of the day. This helps prevent irritation of the esophagus.
- Do not chew or suck on the tablet.
- Ensure adequate intake of calcium and vitamin D through diet or supplements, as directed by your doctor.
- Maintain good oral hygiene and inform your dentist that you are taking this medication.
- Avoid taking calcium, antacids, or other medications containing polyvalent cations (like iron or magnesium) within 30 minutes of taking risedronate, as they can interfere with absorption.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For osteoporosis: 5 mg orally once daily, or 35 mg orally once weekly, or 150 mg orally once monthly. Must be taken with 6-8 oz of plain water at least 30 minutes before the first food or drink (other than plain water) of the day, and before taking any other medication. Patient must remain upright for at least 30 minutes after taking the dose.
Dose Range:
5 - 150 mg
Condition-Specific Dosing:
Paget's Disease:
30 mg orally once daily for 2 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary (CrCl > 30 mL/min).
Moderate:
No dosage adjustment necessary (CrCl > 30 mL/min).
Severe:
Contraindicated (CrCl < 30 mL/min).
Dialysis:
Contraindicated (CrCl < 30 mL/min).
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 inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone and inhibits the activity of osteoclasts, thereby decreasing the rate of bone turnover and increasing bone mineral density.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 0.63% (fasting)
Tmax:
Approximately 1 hour
FoodEffect:
Food, beverages (other than plain water), and medications containing polyvalent cations (e.g., calcium, magnesium, iron, aluminum) interfere with absorption and significantly reduce bioavailability. Must be taken at least 30 minutes before first food/drink/medication.
Distribution:
Vd:
Not available (primarily distributes to bone)
ProteinBinding:
Approximately 24%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal elimination half-life: 480 hours (due to binding to bone); Plasma half-life: 1.5 hours
Clearance:
Renal clearance: 107 mL/min
ExcretionRoute:
Renal (approximately 50% of absorbed dose excreted unchanged in urine within 24 hours)
Unchanged:
Approximately 50% of absorbed dose
Pharmacodynamics
OnsetOfAction:
Bone resorption inhibition begins within weeks.
PeakEffect:
Bone mineral density increases typically observed after 6-12 months of therapy.
DurationOfAction:
Effects on bone turnover can persist for weeks to months after discontinuation due to bone binding.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent 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 immediate medical attention:
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: Important Safety Information
This medication may increase the risk of jawbone problems, particularly with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergone dental work, chemotherapy, or radiation
Taken other medications that may cause jawbone problems
If you have any of these conditions or concerns, 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. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
If you experience any of these side effects or others that bother you or persist, contact your doctor for guidance. 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 immediate medical attention:
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: Important Safety Information
This medication may increase the risk of jawbone problems, particularly with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergone dental work, chemotherapy, or radiation
Taken other medications that may cause jawbone problems
If you have any of these conditions or concerns, 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. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms
If you experience any of these side effects or others that bother you or persist, contact your doctor for guidance. 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).
- New or unusual pain in your hip, groin, or thigh (could be an atypical femur fracture).
- Jaw pain, numbness, swelling, or heaviness in the jaw (could be 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 allergic reaction 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 currently 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 consulting your doctor first.
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.
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 currently 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 consulting your doctor first.
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 an increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this potential risk.
Regular blood tests and bone density checks 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.
For optimal effectiveness, this medication should be used in conjunction with calcium and vitamin D supplements, as well as weight-bearing exercises like walking or physical therapy.
Before starting this medication, schedule a dental exam to ensure your teeth and gums are healthy. Practice good oral hygiene and visit your dentist regularly for check-ups.
If you consume alcohol, discuss this with your doctor to understand any potential risks. Additionally, if you smoke, consult your doctor about the best course of action.
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. You and your doctor will need 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 an increased risk of fractures, particularly in the legs, associated with this medication. Talk to your doctor about this potential risk.
Regular blood tests and bone density checks 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.
For optimal effectiveness, this medication should be used in conjunction with calcium and vitamin D supplements, as well as weight-bearing exercises like walking or physical therapy.
Before starting this medication, schedule a dental exam to ensure your teeth and gums are healthy. Practice good oral hygiene and visit your dentist regularly for check-ups.
If you consume alcohol, discuss this with your doctor to understand any potential risks. Additionally, if you smoke, consult your doctor about the best course of action.
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. You and your doctor will need to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (low blood calcium, symptoms include muscle cramps, spasms, numbness, tingling)
- Hypophosphatemia (low blood phosphate)
- Upper gastrointestinal adverse events (e.g., upset stomach, heartburn, esophagitis)
What to Do:
Seek immediate medical attention. Administer milk or antacids to bind risedronate. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Calcium supplements
- Antacids (containing calcium, magnesium, aluminum)
- Mineral supplements (containing polyvalent cations like iron, magnesium)
- Certain oral medications (e.g., iron salts, zinc supplements)
Moderate Interactions
- NSAIDs (increased risk of GI irritation)
- Proton pump inhibitors (PPIs) - potential for reduced efficacy of risedronate over long-term use, though clinical significance debated.
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as bisphosphonates can exacerbate hypocalcemia.
Timing: Before initiation of therapy
Serum 25-hydroxyvitamin D
Rationale: To ensure adequate vitamin D levels, as vitamin D deficiency can impair bone mineralization and reduce bisphosphonate efficacy.
Timing: Before initiation of therapy
Renal Function (Serum Creatinine, CrCl)
Rationale: To assess kidney function, as risedronate is renally eliminated and contraindicated in severe renal impairment.
Timing: Before initiation of therapy
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, supplement calcium and vitamin D, and consider temporary discontinuation of risedronate.
Serum 25-hydroxyvitamin D
Frequency: Periodically, especially if deficiency was noted at baseline or if patient is at risk.
Target: >30 ng/mL
Action Threshold: If below target, supplement vitamin D.
Renal Function (Serum Creatinine)
Frequency: Periodically, especially in elderly patients or those with risk factors for renal decline.
Target: Within normal limits for age/sex
Action Threshold: If CrCl falls below 30 mL/min, discontinue risedronate.
Bone Mineral Density (BMD) by DXA
Frequency: Every 1-2 years after initiation of therapy.
Target: Improvement or stabilization of T-score
Action Threshold: Significant decline in BMD may indicate non-adherence, secondary causes of osteoporosis, or need for alternative therapy.
Symptom Monitoring
- Dysphagia
- Esophagitis
- Esophageal ulcers
- Heartburn
- Chest pain (new or worsening)
- Difficulty or pain upon swallowing
- New or unusual pain in the hip, groin, or thigh (potential atypical femoral fracture)
- Jaw pain, swelling, numbness, or heaviness (potential osteonecrosis of the jaw)
- Severe bone, joint, or muscle pain
Special Patient Groups
Pregnancy
Category C. Use 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 extent of fetal exposure is unknown but could be significant.
Trimester-Specific Risks:
First Trimester:
Limited human data. Animal studies show adverse effects on ossification and skeletal development.
Second Trimester:
Potential for fetal skeletal abnormalities due to long-term bone incorporation.
Third Trimester:
Potential for fetal skeletal abnormalities due to long-term bone incorporation.
Lactation
L3 (Moderately safe). It is not known whether risedronate is excreted in human milk. Due to its long half-life and potential for serious adverse effects in the infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse effects on bone development in the infant. Risk of accumulation in infant due to long half-life.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
No overall differences in efficacy or safety were observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. 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 (first thing in the morning, plain water, upright for 30 mins, no food/other meds for 30 mins) is crucial to maximize absorption and minimize esophageal irritation.
- Patients should be advised to report any new or worsening symptoms of esophageal irritation (e.g., difficulty swallowing, chest pain, heartburn).
- Adequate calcium and vitamin D intake is essential for the efficacy of risedronate and overall bone health. Supplementation should be considered if dietary intake is insufficient.
- Patients should be informed about the rare but serious risks of osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFF), and advised to report any related symptoms promptly.
- Consider a 'drug holiday' after 3-5 years of treatment in low-risk patients to reduce the risk of long-term adverse effects like AFF and ONJ, as per clinical guidelines.
Alternative Therapies
- Other oral bisphosphonates (e.g., alendronate, ibandronate)
- Intravenous bisphosphonates (e.g., zoledronic acid)
- Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene)
- Parathyroid hormone analogs (e.g., teriparatide, abaloparatide)
- RANK ligand inhibitors (e.g., denosumab)
- Sclerostin inhibitors (e.g., romosozumab)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300 for brand (Actonel) 30 tablets, much lower for generic. per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or Tier 2 for generic, Tier 3 or higher for brand, depending on insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.