Risedronate Sod 5mg Tablets

Risedronate is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It binds to hydroxyapatite crystals in bone and inhibits the activity of osteoclasts, leading to a decrease in bone turnover and an increase in bone mineral density. This action helps to reduce the incidence of fractures.

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: A Potential Risk

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 this risk include ill-fitting dentures, anemia, infection, dental work, chemotherapy, radiation, or taking other medications that may 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 immediately.

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 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

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 at least 30 minutes
If you are currently 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is essential to verify that it is safe to take this medication with all of your other medications and health conditions.

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 medications like this one can worsen asthma symptoms. 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. 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.

• Hypocalcemia (must be corrected prior to initiation)
• Esophageal abnormalities (e.g., stricture or achalasia) which delay esophageal emptying
• Inability to stand or sit upright for at least 30 minutes

• Calcium supplements, antacids, or other oral medications containing polyvalent cations (e.g., magnesium, aluminum, iron): Significantly interfere with risedronate absorption. Must be taken at a different time.
• Aspirin/NSAIDs: Increased risk of gastrointestinal irritation/ulceration when co-administered, though not a strict contraindication.

• H2 blockers/PPIs: May theoretically increase gastric pH, potentially affecting absorption, but clinical significance is generally low.
• Vitamin D supplements: Essential for efficacy, but excessive doses could lead to hypercalcemia if not monitored.

• New or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Retrosternal pain (chest pain behind the breastbone)
• Severe musculoskeletal pain (joint, muscle, or bone pain)
• New or unusual pain in the thigh, hip, or groin (potential atypical femoral fracture)
• Jaw pain, swelling, or numbness (potential osteonecrosis of the jaw)

Category C. There are no adequate and well-controlled studies in pregnant women. Risedronate is incorporated into the bone matrix and is gradually released over years. The amount of risedronate incorporated into fetal bone, and the potential for harm, is unknown. Use only if the potential benefit justifies the potential risk to the fetus.

Not recommended. 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 safety or effectiveness were observed between elderly and younger patients. Dosage adjustment is not generally required based on age, but renal function should be monitored, as elderly patients are more likely to have decreased renal function.

• Strict adherence to administration instructions is crucial to maximize absorption and minimize esophageal adverse events. Take risedronate with a full glass (6-8 oz) of plain water only, at least 30 minutes before the first food or drink of the day (other than plain water).
• Remain in an upright position (sitting or standing) for at least 30 minutes after taking the dose and until after the first food of the day.
• Do not lie down for at least 30 minutes after taking the dose.
• Do not chew or suck the tablet, as this can cause oropharyngeal irritation.
• Ensure adequate calcium and vitamin D intake, as these are essential for risedronate's efficacy.
• Patients should be advised to report any symptoms of esophageal irritation (e.g., dysphagia, odynophagia, retrosternal pain, new or worsening heartburn) immediately.
• Consider a 'drug holiday' after 3-5 years of treatment in low-risk patients to reduce the risk of long-term adverse effects like atypical femoral fractures or ONJ, as per clinical guidelines.

• 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)

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, which provides important information for patients. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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.