Actonel 150mg Tablet Dosepak

Risedronate is a pyridinyl 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.

Serious 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
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, especially 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 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. Many people may not experience any side effects or may only have mild ones. However, 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

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
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 consulting your doctor first.

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.

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 to understand any potential risks.

Smoking may also impact your health while taking this medication; consult your doctor for guidance.

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 benefits and risks of this medication to both you and your baby.

• Patients with hypocalcemia (must be corrected prior to initiation)
• Patients with severe renal impairment (CrCl < 30 mL/min)
• Patients with abnormalities of the esophagus which delay esophageal emptying (e.g., stricture or achalasia)
• Inability to stand or sit upright for at least 30-60 minutes

• Calcium supplements, antacids, iron, magnesium-containing products (significantly reduce absorption of risedronate if taken concurrently or within 30-60 minutes)
• Aspirin/NSAIDs (potential for increased gastrointestinal irritation)

• H2 blockers, proton pump inhibitors (may increase gastric pH, potentially affecting absorption, though less critical than calcium/antacids)
• Other agents affecting bone metabolism (e.g., corticosteroids, loop diuretics, calcitonin, vitamin D analogs) - monitor calcium levels

• Not many specific minor interactions beyond general GI irritants.

• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Retrosternal pain (chest pain behind the breastbone)
• New or worsening heartburn (signs of esophageal irritation/ulceration)
• Jaw pain, swelling, numbness, or heaviness (signs of osteonecrosis of the jaw - ONJ)
• Unusual pain in the thigh, hip, or groin (signs of atypical femur fracture)

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 mother and fetus.

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.

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

No overall differences in efficacy or safety have been observed between elderly and younger patients. No dose adjustment is necessary based on age alone, but renal function should be monitored as it commonly declines with age.

• Strict adherence to the dosing instructions (taking with plain water, remaining upright, taking on an empty stomach) is critical to minimize the risk of esophageal adverse events.
• Ensure patients have adequate calcium and vitamin D intake, as these are essential for bone health and bisphosphonate efficacy.
• A dental examination is recommended prior to initiating risedronate, especially for patients with risk factors for osteonecrosis of the jaw (ONJ).
• Patients should be advised to report any new or unusual pain in the thigh, hip, or groin, as this could be a symptom of an atypical femur fracture.
• Consider a 'drug holiday' after 3-5 years of treatment for patients at low-to-moderate fracture risk, as long-term use may increase the risk of atypical femur fractures and ONJ, while benefits may persist.

• Other oral bisphosphonates (e.g., alendronate, ibandronate)
• Intravenous bisphosphonates (e.g., zoledronic acid)
• Denosumab (Prolia)
• Teriparatide (Forteo)
• Abaloparatide (Tymlos)
• Romosozumab (Evenity)
• Selective Estrogen Receptor Modulators (SERMs) (e.g., raloxifene)
• Calcitonin (less effective, generally for pain management in Paget's)

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 is a valuable resource that provides important 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, 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 details about the overdose, including the amount taken and the time it occurred.