Actonel 35mg 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
Apr 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. 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 resume your regular dosing 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. 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 resume your regular dosing 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 oz) of plain water only, first thing in the morning, at least 30 minutes before your first food, drink, or other medication.
- 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 before your first food or drink.
- 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.
- Maintain good oral hygiene and have regular dental check-ups.
- Avoid taking calcium, antacids, or mineral supplements at the same time as risedronate; separate by at least 30 minutes, preferably longer.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
35 mg orally once weekly
Dose Range:
35 - 35 mg
Condition-Specific Dosing:
osteoporosis_treatment_and_prevention_postmenopausal_women:
35 mg orally once weekly
osteoporosis_treatment_men:
35 mg orally once weekly
glucocorticoid_induced_osteoporosis:
35 mg orally once weekly
pagets_disease:
30 mg orally once daily for 2 months (different strength)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl âĨ 30 mL/min)
Moderate:
No adjustment needed (CrCl âĨ 30 mL/min)
Severe:
Contraindicated (CrCl < 30 mL/min)
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (Risedronate is not metabolized in the liver)
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, leading to a decrease in bone turnover and an increase in bone mineral density.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 0.63% (oral)
Tmax:
Approximately 1 hour
FoodEffect:
Significantly reduced by food, beverages (other than plain water), and polyvalent cations. Must be taken at least 30 minutes before the first food or drink of the day.
Distribution:
Vd:
Not available (primarily distributes to bone)
ProteinBinding:
Approximately 24%
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life is very long (due to bone binding), estimated to be several weeks to years. Plasma half-life is approximately 480 hours.
Clearance:
Renal clearance is approximately 100 mL/min
ExcretionRoute:
Renal (unchanged)
Unchanged:
Approximately 50% of absorbed dose excreted unchanged in urine within 24 hours
Pharmacodynamics
OnsetOfAction:
Bone resorption markers decrease within weeks; BMD increases over months.
PeakEffect:
Maximal suppression of bone turnover markers typically seen within 3-6 months.
DurationOfAction:
Effects on bone mineral density persist for a period after discontinuation due to bone binding.
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 immediately or seek emergency 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
Difficulty 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
Trouble urinating
Pain while urinating
Jawbone Problems: Important Warning
This medication may increase the risk of jawbone problems, especially with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergoing dental work, chemotherapy, or radiation
Taking 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 mild ones, it's essential to monitor your body's response. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Dizziness
Fatigue
Weakness
Headache
Flu-like symptoms
Reporting 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 immediately or seek emergency 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
Difficulty 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
Trouble urinating
Pain while urinating
Jawbone Problems: Important Warning
This medication may increase the risk of jawbone problems, especially with long-term use. Your risk may be higher if you have:
Cancer
Dental problems
Ill-fitting dentures
Anemia
Blood clotting problems
Infection
Undergoing dental work, chemotherapy, or radiation
Taking 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 mild ones, it's essential to monitor your body's response. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Dizziness
Fatigue
Weakness
Headache
Flu-like symptoms
Reporting 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 swallowing or pain when swallowing
- New or worsening heartburn or chest pain
- Severe bone, joint, or muscle pain
- Jaw pain, swelling, or numbness, especially after a dental procedure
- New or unusual pain in your thigh or groin
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 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 of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify 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 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 of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify 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.
Be aware that severe esophageal problems, such as irritation, swelling, ulcers, and bleeding, have been associated with this drug. Consult your doctor to discuss the potential risks.
If you have asthma, note that medications like this one may worsen asthma symptoms. Discuss this with your doctor to determine the best course of action.
This medication may increase the risk of fractures, particularly in the legs. Consult your doctor to understand this potential risk and how to minimize it.
Regular blood tests and bone density checks are crucial while taking this medication. Adhere to the schedule recommended by your doctor.
As 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 like walking or physical therapy.
Before initiating this medication, schedule a dental exam 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 potential interactions and recommendations.
Smoking may impact the effectiveness or increase the risks associated with this medication. Discuss your smoking habits with your doctor.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can lead to severe health problems, permanent damage, or even 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 will need to discuss the potential benefits and risks of this medication to both you and your baby.
Be aware that severe esophageal problems, such as irritation, swelling, ulcers, and bleeding, have been associated with this drug. Consult your doctor to discuss the potential risks.
If you have asthma, note that medications like this one may worsen asthma symptoms. Discuss this with your doctor to determine the best course of action.
This medication may increase the risk of fractures, particularly in the legs. Consult your doctor to understand this potential risk and how to minimize it.
Regular blood tests and bone density checks are crucial while taking this medication. Adhere to the schedule recommended by your doctor.
As 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 like walking or physical therapy.
Before initiating this medication, schedule a dental exam 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 potential interactions and recommendations.
Smoking may impact the effectiveness or increase the risks associated with this medication. Discuss your smoking habits with your doctor.
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur with this medication. This condition can lead to severe health problems, permanent damage, or even 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 will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypocalcemia (e.g., muscle cramps, spasms, numbness, tingling)
- Hypophosphatemia
- Hypomagnesemia
- Upper gastrointestinal adverse events (e.g., esophageal irritation, heartburn, esophagitis, gastritis, ulcer)
What to Do:
Call 1-800-222-1222 (Poison Control). Administer milk or antacids to bind risedronate. Induce vomiting or gastric lavage may be considered if appropriate.
Drug Interactions
Major Interactions
- Calcium supplements
- Antacids (containing aluminum, magnesium, calcium)
- Mineral supplements (containing polyvalent cations like iron, zinc)
Moderate Interactions
- NSAIDs (potential for increased GI irritation)
- Proton Pump Inhibitors (PPIs) / H2 Blockers (may reduce gastric acidity, potentially affecting absorption, though clinical significance is debated)
Monitoring
Baseline Monitoring
Serum Calcium
Rationale: To ensure normocalcemia before initiating therapy, as hypocalcemia must be corrected.
Timing: Prior to initiation of therapy
Serum Phosphorus
Rationale: To assess baseline bone metabolism and rule out other bone disorders.
Timing: Prior to initiation of therapy
Serum Magnesium
Rationale: To ensure normomagnesemia, as hypomagnesemia must be corrected.
Timing: Prior to initiation of therapy
Renal Function (CrCl)
Rationale: Risedronate is renally eliminated; contraindicated in severe renal impairment.
Timing: Prior to initiation of therapy
Dental Examination
Rationale: To identify and address pre-existing dental disease before starting therapy, especially for patients at risk of ONJ.
Timing: Prior to initiation of therapy (especially for high-risk patients)
Routine Monitoring
Bone Mineral Density (BMD)
Frequency: Every 1-2 years
Target: Improvement or stabilization of T-score
Action Threshold: Significant decline in BMD or new fractures may indicate treatment failure or need for re-evaluation.
Serum Calcium
Frequency: Periodically, especially if symptoms of hypocalcemia occur
Target: Normal range (8.5-10.2 mg/dL)
Action Threshold: Below normal range; requires supplementation and re-evaluation.
Renal Function (CrCl)
Frequency: Periodically, as clinically indicated
Target: CrCl âĨ 30 mL/min
Action Threshold: CrCl < 30 mL/min; discontinue therapy.
Symptom Monitoring
- Dysphagia
- Odynophagia
- Retrosternal pain
- New or worsening heartburn
- Severe musculoskeletal pain
- Jaw pain or swelling
- Non-healing sores in the mouth
- New thigh or groin pain
Special Patient Groups
Pregnancy
Use during pregnancy is not recommended. Animal studies show adverse effects on fetal development. Limited human data. Bisphosphonates are incorporated into the bone matrix and gradually released over years, potentially exposing the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; long-term retention in maternal bone.
Second Trimester:
Potential for fetal harm based on animal data; long-term retention in maternal bone.
Third Trimester:
Potential for fetal harm based on animal data; long-term retention in maternal bone. May affect fetal bone mineralization.
Lactation
It is not known whether risedronate is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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:
Risk unknown; potential for serious adverse effects on infant bone development.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is 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.
Clinical Information
Clinical Pearls
- Strict adherence to administration instructions is crucial to minimize esophageal adverse events and maximize absorption.
- Patients should be advised to report any symptoms of esophageal irritation immediately.
- Consider a 'drug holiday' after 3-5 years of treatment for low-risk patients to reduce the risk of rare adverse events like ONJ and atypical femoral fractures.
- Ensure patients have adequate calcium and vitamin D intake, as these are essential for bone health and bisphosphonate efficacy.
- Dental evaluation is recommended before initiating therapy, especially for patients with risk factors for ONJ.
Alternative Therapies
- Alendronate (Fosamax)
- Ibandronate (Boniva)
- Zoledronic acid (Reclast)
- Denosumab (Prolia)
- Teriparatide (Forteo)
- Abaloparatide (Tymlos)
- Romosozumab (Evenity)
- Raloxifene (Evista)
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.