Actonel 150mg Tablets Dosepak (3pk)

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. This action helps to reduce the incidence of fractures.

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 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 coffee ground-like material
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

This medication may increase the risk of jawbone problems, particularly with long-term use or in people with certain medical conditions, such as cancer, dental problems, or blood clotting disorders. Other factors that may increase the risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or taking other medications that can 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 Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, some may be bothersome or persistent. If you experience any of the following side effects, contact your doctor or seek medical attention if they worsen or do not improve:

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.

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 at least 30 minutes
Current medications, including:
+ Cimetidine
+ Dexlansoprazole
+ Esomeprazole
+ Famotidine
+ Lansoprazole
+ Nizatidine
+ Omeprazole
+ Pantoprazole
+ Rabeprazole
+ Ranitidine
* If you are taking any other 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. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.

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 checks are necessary while taking this medication, as directed by your doctor.

This medication may interfere with certain laboratory tests. Be sure to 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 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 beforehand. Additionally, if you smoke, consult your doctor about the potential risks and benefits of continuing to smoke while taking this medication.

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, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.

• Calcium supplements
• Antacids (containing calcium, magnesium, aluminum)
• Mineral supplements (containing polyvalent cations like iron, magnesium, aluminum)
• Certain laxatives (e.g., magnesium hydroxide)

• NSAIDs (increased risk of GI irritation/ulceration)
• Proton Pump Inhibitors (PPIs) (potential for reduced absorption of bisphosphonates, though clinical significance debated)
• H2-receptor antagonists (potential for reduced absorption of bisphosphonates)

• New or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Chest pain (especially retrosternal)
• New or unusual pain in the thigh, hip, or groin (potential atypical femoral fracture)
• Jaw pain, swelling, numbness, or loosening of a tooth (potential osteonecrosis of the jaw)
• Muscle or joint pain
• Signs of hypocalcemia (e.g., muscle cramps, numbness/tingling)

Risedronate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The amount of bisphosphonate incorporated into maternal bone and then released during pregnancy is directly related to the dose and duration of bisphosphonate use. Potential fetal harm cannot be ruled out. Use only if the potential benefit justifies the potential risk to the fetus.

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 to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Use is not recommended.

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.

• Strict adherence to administration instructions (first thing in the morning, plain water only, upright for 30-60 min, 30-60 min before food/drink/meds) is crucial to maximize absorption and minimize esophageal irritation.
• Patients should be advised to report any new or worsening pain in the thigh, hip, or groin, as this could be a prodrome to an atypical femoral fracture.
• A dental examination should be performed prior to initiating bisphosphonate therapy, especially in patients with risk factors for osteonecrosis of the jaw (e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene).
• Consider a 'drug holiday' after 3-5 years of treatment for patients at low-to-moderate fracture risk, as the drug persists in bone and benefits may continue. Re-evaluate fracture risk periodically.
• Ensure adequate calcium and vitamin D intake, as these are essential for bone health and bisphosphonate efficacy.

• 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 inhibitor (e.g., denosumab)
• Sclerostin inhibitor (e.g., romosozumab)
• Calcitonin

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for patients. 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, we encourage you 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.