Risedronate Sod 35mg Imm Rel Tb Pk

Risedronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone and acts as an antiresorptive agent. It decreases the rate of bone turnover, leading to a net gain in bone mineral density and reduced fracture risk. It is incorporated into the bone matrix and, when osteoclasts attempt to resorb bone, risedronate is released and inhibits the farnesyl pyrophosphate synthase enzyme within the osteoclast, leading to osteoclast apoptosis and reduced bone resorption.

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
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 urinating
Pain while urinating

Jawbone Problems: Important Safety Information

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 of jawbone problems include:
Dental work
Chemotherapy
Radiation therapy
Taking other medications that may cause jawbone problems
Ill-fitting dentures
Anemia
Infection

If you have any concerns or questions, discuss them with your doctor. If you experience jaw swelling or pain, contact your doctor right away.

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, others may have more severe reactions. 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

This is not an exhaustive list of all 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 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 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 the potential risks and benefits.

There is an increased risk of fractures, particularly of the leg, 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. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this drug, as it may affect certain laboratory test results.

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, as it may interact with your medication. Similarly, 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, permanent damage, and 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.

• Calcium supplements, antacids, and other polyvalent cation-containing medications (e.g., magnesium, aluminum, iron): Significantly reduce risedronate absorption. Must be separated by at least 30 minutes after risedronate administration.
• Aspirin/NSAIDs: Increased risk of upper GI adverse events when co-administered with bisphosphonates.

• H2 blockers and proton pump inhibitors (PPIs): May increase gastric pH, potentially affecting risedronate absorption, though clinical significance is generally low for immediate-release formulations.
• Aminoglycosides: May lower serum calcium levels, potentially exacerbating hypocalcemia if present.

• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Retrosternal pain (chest pain behind the breastbone)
• Heartburn (new or worsening)
• Severe musculoskeletal pain (joint, muscle, or bone pain)
• Jaw pain, swelling, numbness, or heaviness (signs of ONJ)
• Thigh or groin pain (possible atypical femoral fracture)
• Symptoms of hypocalcemia (e.g., muscle cramps, spasms, numbness/tingling)

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 fetus. Bisphosphonates are incorporated into the bone matrix and gradually released over years. The extent of fetal exposure is unknown.

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 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 it often declines with age.

• Strict adherence to administration instructions (first thing in the morning, plain water only, upright for 30-60 minutes, 30-60 minutes before food/drink/other meds) is crucial to maximize absorption and minimize esophageal irritation.
• Ensure adequate calcium and vitamin D intake, but separate administration from risedronate.
• Patients should be advised to report any new or worsening severe musculoskeletal pain, jaw pain, or thigh/groin pain immediately.
• Consider a 'drug holiday' after 3-5 years of treatment for low-risk patients to reduce the risk of atypical femoral fractures and ONJ, as per clinical guidelines, but this should be individualized.
• Risedronate is not metabolized by the liver, making it a suitable option for patients with hepatic impairment.

• Other oral bisphosphonates (e.g., Alendronate, Ibandronate)
• IV bisphosphonates (e.g., Zoledronic Acid)
• RANK Ligand Inhibitors (e.g., Denosumab)
• Parathyroid Hormone Analogs (e.g., Teriparatide, Abaloparatide)
• Sclerostin Inhibitors (e.g., Romosozumab)
• Selective Estrogen Receptor Modulators (SERMs) (e.g., Raloxifene)

If your symptoms or health issues persist or worsen, it's 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 it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.