Risedronate Sod 150mg Tablets

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 (BMD).

Serious Side Effects: Seek Medical Help 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 attention 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, particularly 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 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 only minor 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 attention:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Headache
Flu-like symptoms

This is not an exhaustive list of possible 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 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 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all of 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 of 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. Maintain 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, 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.

• Antacids (calcium, magnesium, aluminum-containing)
• Calcium supplements
• Iron supplements
• Magnesium supplements

• NSAIDs (potential for increased GI irritation)
• Proton Pump Inhibitors (PPIs) (potential for reduced absorption of risedronate, though clinical significance debated)

• Dysphagia
• Esophagitis
• Esophageal ulcers
• Retrosternal pain
• Heartburn (new or worsening)
• Difficulty or pain upon swallowing
• Severe musculoskeletal pain
• Jaw pain or swelling
• Numbness or heavy sensation in the jaw
• Loosening of a tooth
• New or unusual thigh, hip, or groin pain

Category C. There are no adequate and well-controlled studies in pregnant women. Should be used during pregnancy 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. Dosage adjustment is not generally required based on age alone, but renal function should be monitored.

• Strict adherence to administration instructions is crucial to minimize esophageal irritation and maximize absorption. Patients must remain upright for at least 30-60 minutes after taking the dose and before consuming anything else.
• 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 new or worsening severe musculoskeletal pain, as this can be a symptom of atypical femur fractures or osteonecrosis of the jaw (ONJ).
• Atypical femur fractures (AFF) have been reported with bisphosphonate use. Patients presenting with new thigh, hip, or groin pain should be evaluated for an incomplete femoral fracture.
• Osteonecrosis of the jaw (ONJ) has been reported, particularly in patients with cancer receiving IV bisphosphonates, but also in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment in patients with risk factors (e.g., cancer, chemotherapy, corticosteroids, poor oral hygiene).
• Consider a 'drug holiday' after 3-5 years of treatment for patients at low-to-moderate risk of fracture, as long-term use may increase the risk of rare adverse events like ONJ and AFF. The optimal duration of treatment is still being studied.

• Other oral bisphosphonates (e.g., Alendronate, Ibandronate)
• IV bisphosphonates (e.g., Zoledronic Acid)
• Denosumab (Prolia)
• Teriparatide (Forteo)
• Abaloparatide (Tymlos)
• Romosozumab (Evenity)
• Selective Estrogen Receptor Modulators (SERMs) (e.g., Raloxifene)
• Calcitonin

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.