Risedronate Sod 35mg Delayed Rel Tb

Risedronate is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. It decreases the rate of bone turnover, leading to a net gain in bone mineral density and reduced fracture risk.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 passing urine
Pain when passing urine

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, ill-fitting dentures, anemia, blood clotting problems, or infection. The risk may also be higher if you have dental work, chemotherapy, radiation, or take other medications that can cause jawbone problems. 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 minor ones, it's essential to report any concerns to your doctor. 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 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 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 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. 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. Maintain 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.

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.

• Calcium supplements, antacids (containing calcium, magnesium, aluminum), iron supplements: Significantly interfere with risedronate absorption. Administer at a different time of day (e.g., at least 30 minutes after risedronate DR).
• Highly mineral water: Can interfere with absorption.

• H2 blockers, Proton Pump Inhibitors (PPIs): May slightly increase risedronate absorption by increasing gastric pH, though less critical for delayed-release formulation designed to bypass stomach.
• NSAIDs: Increased risk of gastrointestinal irritation/ulceration when co-administered with bisphosphonates.

• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Retrosternal pain (chest pain behind the breastbone)
• New or worsening heartburn (signs of esophageal adverse events)
• Severe bone, joint, and/or muscle pain
• New or unusual pain in the hip, groin, or thigh (potential atypical femoral fracture)
• Jaw pain, swelling, numbness, or a 'heavy jaw' feeling (potential osteonecrosis of the jaw)

Category C. Use 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, but there is a theoretical risk of fetal harm (e.g., hypocalcemia, skeletal abnormalities).

Not recommended. It is not known whether risedronate is excreted in human milk. Due to its long half-life in bone and potential for serious adverse effects in the infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Not recommended for use.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Renal function should be monitored as elderly patients are more likely to have decreased renal function.

• Risedronate delayed-release (Actonel DR) is unique in its administration: it is taken *after* breakfast, unlike immediate-release bisphosphonates which are taken before the first food/drink.
• Must be taken with at least 4 oz (120 mL) of plain water. No other beverages (e.g., coffee, juice, mineral water) or food should be consumed for at least 30 minutes after taking the tablet.
• Patient must remain in an upright position (sitting or standing) for at least 30 minutes after taking the tablet and until after the first food or drink of the day (after breakfast).
• Do not chew, crush, or suck the tablet. Swallow whole.
• Ensure adequate calcium and vitamin D intake, as these are crucial for bone health and risedronate efficacy.
• Patients should be advised to report any symptoms of esophageal irritation (dysphagia, odynophagia, retrosternal pain, new or worsening heartburn) immediately.
• Patients should be advised to report any new or unusual pain in the hip, groin, or thigh, or severe bone/joint/muscle pain, as these could indicate serious adverse events.
• A dental examination should be considered prior to initiation of bisphosphonate therapy, especially for patients with risk factors for osteonecrosis of the jaw (ONJ).

• 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)

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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.