Adverse effects fosamax. Fosamax Side Effects: Understanding Risks and Complications of Alendronic Acid
What are the common and rare side effects of Fosamax. How does Fosamax affect the esophagus and femur. What precautions should patients take when using alendronic acid for osteoporosis treatment.
Common Side Effects of Fosamax: Gastrointestinal Issues and Discomfort
Fosamax, known generically as alendronic acid, is a widely prescribed medication for treating osteoporosis. While effective in strengthening bones, it’s not without its share of side effects. The most frequently reported adverse reactions are gastrointestinal in nature.
What are the most common side effects of Fosamax? According to Merck, the drug’s manufacturer, patients often experience:
- Heartburn
- Upset stomach
- Stomach pain
- Nausea
- Diarrhea
- Constipation
- Bloating
- Gas
Additionally, some patients report:
- Bone, muscle, or joint pain
- Headache
- Changes in the ability to taste food
- Dizziness
How prevalent are these side effects? Clinical trial data suggests that adverse reactions such as bone, muscle, or joint pain affect approximately 4% of Fosamax users. However, it’s important to note that even these side effects are rarely severe.
Timing and Duration of Fosamax Side Effects
When do Fosamax side effects typically occur? The onset of side effects can sometimes be observed shortly after commencing treatment. However, it’s crucial to understand that many side effects tend to diminish over time as the body adjusts to the medication.
How long do Fosamax side effects last? Most side effects cease immediately upon discontinuation of the medication. Some individuals may experience lingering effects for a day or so longer, but these typically subside once the drug is out of their system.
Managing Fosamax Side Effects
What can patients do to mitigate Fosamax side effects? Your doctor may provide advice on how to prevent or alleviate some side effects. This could include recommendations on when and how to take the medication, as well as dietary adjustments.
Rare but Serious Side Effects of Fosamax
While less common, Fosamax can cause more severe adverse reactions in some patients. The U.S. Food and Drug Administration (FDA) has documented several serious side effects and issued numerous warnings to highlight potential dangers associated with Fosamax use.
What are the rare but serious side effects of Fosamax? These include:
- Bloody stools
- Chest pain
- Difficulty swallowing
- Skin blisters
- Eye pain
- Swelling of the face, throat, and tongue
- Itching or eye pain
- Sunlight-sensitive rash
- Allergic reactions
- Severe musculoskeletal pain (joints, muscle, bone, or jaw)
- Mouth ulcers
Impact on Blood Calcium Levels
How does Fosamax affect calcium levels in the body? The drug’s medication insert warns that it can lower blood calcium levels because it hinders the natural breakdown of bone. Long-term studies have shown that calcium in the blood decreased by about 2% in the first month of using Fosamax.
What can be done to address potential calcium deficiency? The studies suggest adding calcium and vitamin D supplements to counteract this effect. Patients should consult with their healthcare provider about appropriate supplementation while taking Fosamax.
Fosamax and Femur Fractures: A Concerning Connection
One of the most alarming side effects associated with long-term Fosamax use is the increased risk of femur fractures. Peer-reviewed research has shown a connection between prolonged use of the drug and these serious bone injuries.
What are the symptoms of potential femur fractures related to Fosamax use? Some patients have reported unexplained aching in their thigh bones for weeks or months before experiencing unexplained breaks. This suggests that the drug may be altering the structure of the bone over time.
The “Frozen Bone” Theory
Why might Fosamax increase the risk of femur fractures? One theory posits that Fosamax causes “frozen bone,” making the bones more susceptible to clean fractures. This hypothesis suggests that while the drug increases bone density, it may also alter the bone’s ability to remodel and repair itself, potentially leading to increased brittleness.
Weighing the Risks and Benefits
How do the benefits of Fosamax compare to the risk of femur fractures? One review encouraged people with osteoporosis to continue bisphosphonate therapy, noting that while the rates of atypical femur fractures were 11 in 100,000, the rate of hip fractures decreased by 20-50%. This suggests that for many patients, the benefits of preventing osteoporotic fractures may outweigh the risk of atypical femur fractures.
Osteonecrosis of the Jaw: A Rare but Serious Complication
Another serious side effect associated with Fosamax and other bisphosphonates is osteonecrosis of the jaw (ONJ). This condition occurs when the gums fail to cover parts of the jawbone, primarily affecting the mandible.
What factors increase the risk of developing ONJ while taking Fosamax? Several factors can heighten the chances of jawbone complications:
- Extensive dental surgeries (e.g., tooth extractions, teeth implants)
- Oral infections
- Pre-existing conditions such as cancer, diabetes, or kidney failure
How can patients reduce their risk of developing ONJ while on Fosamax? It’s crucial for patients to maintain good oral hygiene and inform their dentist about their Fosamax use before undergoing any dental procedures. In some cases, doctors may recommend temporarily discontinuing the medication before and after major dental work.
Long-Term Effects and Persistent Risks
Recent research has shed light on the potential long-term effects of Fosamax use, even after discontinuation of the medication. A study published in August 2022 in Diabetes, Endocrinology & Metabolism Case Reports found that the risk of developing fractures persists long after stopping treatment with bisphosphonates such as Fosamax.
Why do the effects of Fosamax persist after discontinuation? This phenomenon is likely due to the drug’s mechanism of action, which alters bone metabolism. Bisphosphonates like Fosamax can accumulate in bone tissue and continue to affect bone remodeling for an extended period after the last dose.
Implications for Treatment Duration
How should this information impact treatment decisions? The persistent effects of Fosamax highlight the importance of carefully considering the duration of treatment. Some experts advocate for “drug holidays” – planned breaks in treatment – to potentially reduce long-term risks while maintaining the benefits of improved bone density.
Balancing Efficacy and Safety: The Fosamax Dilemma
The use of Fosamax presents a complex risk-benefit analysis for patients and healthcare providers. While the drug has proven effective in reducing the risk of osteoporotic fractures, particularly in high-risk populations, the potential for serious side effects cannot be ignored.
How can patients and doctors make informed decisions about Fosamax use? Consider the following factors:
- Individual fracture risk: Patients at higher risk of osteoporotic fractures may derive greater benefit from Fosamax.
- Duration of use: Long-term use may increase the risk of atypical fractures and ONJ.
- Alternative treatments: Other osteoporosis medications or non-pharmacological interventions may be appropriate for some patients.
- Monitoring: Regular follow-ups and bone density scans can help track the drug’s efficacy and potential side effects.
The Role of Personalized Medicine
How can personalized medicine improve Fosamax treatment outcomes? Advances in genetic testing and biomarker analysis may help identify patients who are more likely to benefit from Fosamax or those at higher risk of adverse effects. This tailored approach could optimize treatment strategies and minimize risks.
Legal Implications and Fosamax Lawsuits
The serious side effects associated with Fosamax have led to legal action against its manufacturer, Merck. Numerous patients have filed Fosamax lawsuits, citing various adverse effects, particularly atypical femur fractures and osteonecrosis of the jaw.
What are the grounds for Fosamax lawsuits? Many plaintiffs allege that Merck failed to adequately warn patients and healthcare providers about the potential risks associated with long-term use of the drug. Some lawsuits claim that the company knew or should have known about these risks but did not disclose them fully.
Regulatory Response and Label Changes
How has the FDA responded to concerns about Fosamax safety? In response to mounting evidence and legal pressure, the FDA has required several label changes for Fosamax and other bisphosphonates. These updates include warnings about the risk of atypical femur fractures and osteonecrosis of the jaw, as well as recommendations for periodic reevaluation of the need for continued therapy.
Future Directions in Osteoporosis Treatment
As concerns about Fosamax and other bisphosphonates persist, researchers are exploring alternative approaches to osteoporosis prevention and treatment. These efforts aim to maintain the benefits of improved bone density while minimizing the risk of serious side effects.
What are some promising avenues for future osteoporosis treatments? Emerging research focuses on several areas:
- Anabolic agents: Medications that stimulate bone formation rather than just slowing bone loss
- Targeted therapy: Drugs that more selectively affect bone cells without impacting other tissues
- Combination therapies: Using multiple medications with different mechanisms of action to optimize bone health
- Non-pharmacological interventions: Advanced exercise programs, dietary interventions, and fall prevention strategies
The Role of Patient Education and Shared Decision-Making
How can patient education improve outcomes in osteoporosis treatment? Empowering patients with comprehensive information about their treatment options, including the potential risks and benefits of medications like Fosamax, is crucial. Shared decision-making between patients and healthcare providers can lead to more personalized treatment plans that align with individual preferences and risk tolerances.
In conclusion, while Fosamax remains an important tool in the management of osteoporosis, its use requires careful consideration of potential side effects and long-term risks. Ongoing research and improved patient-provider communication will be key to optimizing treatment outcomes and ensuring the safety of those dealing with bone health issues.
Fosamax Side Effects | Problems With Esophagus & Femur Pain
Fosamax (alendronic acid) is used to treat osteoporosis. Side effects include heartburn, upset stomach, nausea, diarrhea and constipation, as well as stomach, muscle, joint and bone pain. Rare and serious effects such as femur fractures and jaw problems (osteonecrosis of the jaw) have been reported.
Common Fosamax Side Effects
The most common side effects are gastrointestinal issues, such as nausea, diarrhea, constipation and cramping, according to Merck, the drug’s manufacturer. Studies show that side effects of Fosamax range from mild to severe.
Fosamax was introduced in 1995 to prevent age-related bone damage and other bone damaging diseases. However, people who are more susceptible to side effects from alendronate are the elderly, especially women who are more prone to developing osteoporosis.
Common side effects of Fosamax include:
- Heartburn
-
Upset stomach -
Stomach pain -
Nausea -
Diarrhea -
Constipation -
Bone, muscle or joint pain -
Bloating -
Gas -
Headache -
Changes in the ability to taste food -
Dizziness
Adverse reactions, such as bone, muscle or joint pain, affect about 4% of people who take Fosamax according to clinical trial data, but even those are rarely severe.
The onset of side effects can sometimes occur after commencing treatment. Your doctor may advise you on how to prevent or mitigate some side effects.
Many side effects go away during treatment as your body adjusts to the medication. And most stop immediately after discontinuing the medication. Some people can experience lingering effects for a day or so longer, but those also go away without the drug in their system.
Rare Serious Side Effects of Fosamax
The U.S Food and Drug Administration documented several of Fosamax’s serious side effects and subsequently distributed numerous warnings to highlight the potential dangers of Fosamax. Severe side effects include bloody stools, chest pain, difficulty swallowing, skin blisters, eye pain and swelling of the face, throat and tongue.
The drug’s medication insert warns it can lower blood calcium levels because the drug hinders the natural breakdown of bone. Long-term studies showed that calcium in the blood decreased about 2% in the first month of using Fosamax and suggested adding calcium and vitamin D as supplements.
Rare Serious Side Effects of Fosamax Include:
- Itching or eye pain
-
Sunlight sensitive rash -
Allergic reactions -
Severe musculoskeletal pain (joints, muscle, bone or jaw. -
Mouth ulcers -
Swelling in the face, tongue or throat -
Skin blisters
The FDA found that Fosamax patients can also develop intense bone, muscle and joint pains within days, months or years after starting the drug. For some people, this pain stops almost immediately after discontinuing the medication. For others, the side effects persist. Some side effects have led people to file Fosamax lawsuits against Merck.
Femur Fractures from Fosamax
Peer-reviewed research shows a connection between the long-term use of Fosamax and femur fractures. Some people reported unexplained aching in their thigh bones for weeks and months before experiencing unexplained breaks.
One meta-analysis of multiple studies concluded that people undergoing long-term treatment may be at an increased risk of an atypical femur fracture.
One theory is that Fosamax causes “frozen bone,” making the bones more susceptible to clean fractures.
One review encouraged people with osteoporosis to have bisphosphonate therapy because rates of atypical femur fractures were 11 in 100,000. The rate of hip fractures decreased 20-50%.
Another study looked at 13 women with femur fractures from low levels of force and noted that nine had been taking alendronate, the generic form of Fosamax. Researchers said that the fractures may have occurred because alendronate stops the body from breaking down bone to create thick, but brittle bones.
One August 2022 study in Diabetes, Endocrinology & Metabolism Case Reports found that the risk of developing fractures persists long after stopping treatment with bisphosphonates such as Fosamax.
Osteonecrosis of the Jaw (ONJ)
The common use of bisphosphonates, including Fosamax, caused more awareness of the medication’s link to osteonecrosis of the jaw (ONJ), a condition where gums don’t cover parts of the jawbone — mostly the mandible. Extensive dental surgeries like tooth extractions and teeth implants, oral infections, and conditions such as cancer, diabetes and kidney failure heighten the chances of jawbone death.
People who take 4 to 6 doses of Fosamax and similar drugs should expect unpredictable and inconsistent healing of their jawbone after an invasive oral procedure. Two separate studies documented the side effect, though rates varied in people who received bisphosphonates via an IV.
Merck’s clinical trials of Fosamax found a much lower incidence rate — 0.001% (1 in 100,000 people).
Esophagus Problems
A case-control study of U.S. military veterans shows an increased risk of Barrett’s esophagus and other esophageal problems with the use of Fosamax.
Some people develop irritation, inflammation and bleeding ulcers in the esophagus, the tube that connects the mouth and stomach.
People with pre-existing upper gastrointestinal problems, such as Barrett’s esophagus, dysphagia, H. pylori infection or gastroesophageal disorder (GERD), should not take Fosamax.
Some studies suggest Fosamax can lead to a small risk of esophageal cancer.
In some people, Fosamax leads to esophageal erosion with bleeding and esophageal perforation. Because of these potentially dangerous side effects, Merck recommends sitting upright or standing for 30 minutes after taking the drug with a full glass of water.
However, the FDA believes the benefits of oral bisphosphonate drugs, including Fosamax, outweigh their potential risks.
Fosamax Warnings and Precautions
Please seek the advice of a medical professional before making health care decisions.
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Fosamax Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Uses
Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults.
Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time.This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.
How to use Fosamax oral
Read the Medication Guide provided by your pharmacist before you start taking alendronate and each time you get a refill. Follow the instructions very closely to make sure your body absorbs as much drug as possible and to reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth once a day, after getting up for the day and before taking your first food, beverage, or other medication. Take it with a full glass (6-8 ounces or 180-240 milliliters) of plain water.
Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after your first food of the day. Alendronate works only if taken on an empty stomach. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water.
Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects.
Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of alendronate. Do not take these for at least 30 minutes (preferably 1 to 2 hours) after taking alendronate.
Take this medication regularly to get the most benefit from it. Remember to use it at the same time each morning. Talk to your doctor about the risks and benefits of long-term use of this medication.
Side Effects
Stomach pain, constipation, diarrhea, gas, or nausea may occur.
If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: jaw/ear pain, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, swelling of joints/hands/ankles/feet, black/tarry stools, vomit that looks like coffee grounds.
This medication may rarely cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as esophageal stricture or achalasia), trouble swallowing, trouble standing or sitting upright for at least 30 minutes, low calcium levels, kidney problems, stomach/intestinal disorders (such as ulcers).
Some people taking alendronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.
Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking alendronate before your surgery. Follow all instructions about stopping or starting this medication.
This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting, fever, and flu-like symptoms.
Tell your doctor if you are pregnant or plan to become pregnant.
Alendronate may stay in your body for many years. You should not become pregnant while using alendronate. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Interactions
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Does Fosamax oral interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911.
Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, painful heartburn, pain in the esophagus (chest pain), muscle weakness/cramps, mental/mood changes.
Do not share this medication with others.
Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.
Lab and/or medical tests (X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
If you miss a dose, skip the missed dose. Take your next dose at the regular time the following day.
Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals.
The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
💊 Composition of Fosamax ® ✅ Application of Fosamax ® Keep for yourself Search for analogues Interaction Description of the active ingredients of the preparation Fosamax ® The scientific information provided is general and cannot be used to make decisions. Renewal date: 2020.02.25 Marketing authorization holder: MERCK SHARP & DOHME, B.V. Manufactured:AESICA Pharmaceuticals GmbH (Germany) Issuing quality control:MERCK SHARP & DOHME, B.V. (Netherlands) ATX code: M05BA04 (alendronic acid) Active substance: Rec.INN WHO registered Dosage form
Release form, packaging and composition |
70 mg: 4 or 12 pcs.
Aminobisphosphonate, is an analogue of pyrophosphate. The mechanism of action is associated with the suppression of osteoclast activity. Stimulates osteogenesis, restores a positive balance between bone resorption and restoration, progressively increases bone mineral density (regulates phosphorus-calcium metabolism), promotes the formation of bone tissue with a normal histological structure.
T 1/2 in the final phase can be more than 10 years, which is associated with the release of the active substance from the bones.| M80.0 | Postmenopausal osteoporosis with pathological fracture |
| M80.1 | Osteoporosis with pathological fracture after ovariectomy |
| M80.4 | Medicinal osteoporosis with pathological fracture |
M80. 5 | Idiopathic osteoporosis with pathological fracture |
| M80.8 | Other osteoporosis with pathological fracture |
| M81.0 | Postmenopausal osteoporosis |
| M81.1 | Osteoporosis after spay |
| M81.4 | Medicinal osteoporosis |
| M81.5 | Idiopathic osteoporosis |
| M81.8 | Other osteoporosis (senile osteoprosis) |
| M88 | Paget’s disease (of the bones) [osteitis deformans] |
Dosing regimen
The method of administration and dosing regimen of a particular drug depends on its form of release and other factors.
The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
Individual, depending on indication.
Side effect
From the digestive system: pain in the epigastric region; rarely – constipation, diarrhea, flatulence, dysphagia.
From the side of metabolism: asymptomatic hypocalcemia.
Dermatological reactions: skin rash, erythema.
Other: headache, myalgia.
Contraindications
Esophageal stricture, achalasia, inability of the patient to stand or sit upright for at least 30 minutes after taking the drug, hypocalcemia, hypersensitivity to alendronic acid.
Use in pregnancy and lactation
Adequate and well-controlled clinical studies of the safety of the use of alendronic acid during pregnancy and lactation have not been conducted. If necessary, use during lactation, breastfeeding should be discontinued.
In experimental studies on rats, it was shown that alendronic acid at doses of 2 mg/kg/day and above causes discoordination of labor due to hypocalcemia; at doses greater than 5 mg/kg/day, a decrease in fetal weight was noted.
Use in impaired renal function
Not recommended for use in severe impaired renal function.
Use in children
Not recommended for use in children.
Special instructions
Not recommended for use in severely impaired renal function, as well as in children.
Use with caution in diseases of the gastrointestinal tract in the acute phase.
Before starting treatment, patients with mineral metabolism disorders should be completely corrected.
The interval between taking alendronic acid and other drugs should be at least 1 hour.
Drug interactions
When taken orally with other drugs and products containing calcium, the absorption of alendronic acid is impaired.
Postmenopausal women treated with estrogen have not experienced side effects associated with the use of alendronic acid.
In clinical studies, an increase in the frequency of adverse reactions from the digestive system was observed with the use of alendronic acid at a dose of more than 10 mg / day during therapy with acetylsalicylic acid.
Save
If you want to place a link to the description of this drug – use this code
Fosamax ® . Description of the drug in the reference book Vidal.
💊 The composition of the drug Fosamax ® ✅ The use of the drug Fosamax ® Save Search for analogues Interaction ⚠️ The registration certificate for this product has been replaced Description of the active ingredients of the preparation Fosamax ® The scientific information provided is general and cannot be used to make decisions. Renewal date: 2020.02.25 Marketing authorization holder: MERCK SHARP & DOHME, B.V. ATX code: M05BA04 (alendronic acid) Active substance: Rec.INN WHO registered Dosage form
Release form, packaging and composition |
08.10
Aminobisphosphonate, is an analogue of pyrophosphate. The mechanism of action is associated with the suppression of osteoclast activity. Stimulates osteogenesis, restores a positive balance between bone resorption and restoration, progressively increases bone mineral density (regulates phosphorus-calcium metabolism), promotes the formation of bone tissue with a normal histological structure.
T 1/2 in the final phase can be more than 10 years, which is associated with the release of the active substance from the bones.| M80.0 | Postmenopausal osteoporosis with pathological fracture |
| M80.1 | Osteoporosis with pathological fracture after ovariectomy |
| M80.4 | Medicinal osteoporosis with pathological fracture |
M80. 5 | Idiopathic osteoporosis with pathological fracture |
| M80.8 | Other osteoporosis with pathological fracture |
| M81.0 | Postmenopausal osteoporosis |
| M81.1 | Osteoporosis after spay |
| M81.4 | Medicinal osteoporosis |
| M81.5 | Idiopathic osteoporosis |
| M81.8 | Other osteoporosis (senile osteoprosis) |
| M88 | Paget’s disease (of the bones) [osteitis deformans] |
Dosing regimen
The method of administration and dosing regimen of a particular drug depends on its form of release and other factors.
The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
Individual, depending on indication.
Side effect
From the digestive system: pain in the epigastric region; rarely – constipation, diarrhea, flatulence, dysphagia.
From the side of metabolism: asymptomatic hypocalcemia.
Dermatological reactions: skin rash, erythema.
Other: headache, myalgia.
Contraindications
Esophageal stricture, achalasia, inability of the patient to stand or sit upright for at least 30 minutes after taking the drug, hypocalcemia, hypersensitivity to alendronic acid.
Use in pregnancy and lactation
Adequate and well-controlled clinical studies of the safety of the use of alendronic acid during pregnancy and lactation have not been conducted. If necessary, use during lactation, breastfeeding should be discontinued.
In experimental studies on rats, it was shown that alendronic acid at doses of 2 mg/kg/day and above causes discoordination of labor due to hypocalcemia; at doses greater than 5 mg/kg/day, a decrease in fetal weight was noted.
Use in impaired renal function
Not recommended for use in severe impaired renal function.
Use in children
Not recommended for use in children.
Special instructions
Not recommended for use in severely impaired renal function, as well as in children.
Use with caution in diseases of the gastrointestinal tract in the acute phase.
Before starting treatment, patients with mineral metabolism disorders should be completely corrected.
The interval between taking alendronic acid and other drugs should be at least 1 hour.
Drug interactions
When taken orally with other drugs and products containing calcium, the absorption of alendronic acid is impaired.