muscle and joint pain. Stop using alendronate and call your doctor at once if you have: pain or burning under the ribs or in the back; severe heartburn, burning pain in your upper stomach, or coughing up blood; new or unusual pain in your thigh or hip; low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes). Most of the patients were postmenopausal women. Some patients experience prodromal pain weeks or months before the fracture occurs. Alendronate mechanism of action: geranylgeraniol, an intermediate in the mevalonate pathway, prevents inhibition of osteoclast formation, bone resorption, and kinase activation in vitro . You may report side effects to FDA at 1-800-FDA-1088. This includes vitamins, calcium, and antacids. Pharmacokinetics of alendronate: an overview. Conversely, in patients receiving oral bisphosphonates for >4 years or in patients receiving oral bisphosphonates for <4 years who have also taken corticosteroids or antiangiogenic medications concomitantly, the AAOMS recommends considering a 2-month, drug-free period prior to invasive dental procedures (recommendation based on a theoretical benefit). Stop using the medicine and tell your doctor right away if you become pregnant. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21). The https:// ensures that you are connecting to the In Ref. Alendronate seems to have a different onset of action. Laryngeal edema 8. The use of 17 -estradiol has been investigated in rats where the onset of osteoporosis (by ovariectomy) occurs after initial peri-implant healing has been allowed to take place. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water. Alendronate may also be used for purposes not listed in this medication guide. Do not make yourself vomit and do not lie down. Avoid combination. Based on the 2017 American College of Rheumatology (ACR) guideline for the prevention and treatment of glucocorticoid-induced osteoporosis, bisphosphonates (including alendronate) are effective and recommended for prevention of glucocorticoid-induced osteoporosis in women (either not of childbearing potential or who do not plan to become pregnant) and men with moderate to high fracture risk and who are initiating long-term glucocorticoid treatment. Hypersensitivity to alendronate or any component of the formulation; hypocalcemia; abnormalities of the esophagus (eg, stricture, achalasia) which delay esophageal emptying; inability to stand or sit upright for at least 30 minutes; increased risk of aspiration (effervescent tablets; oral solution), Canadian labeling: Additional contraindications (not in the US labeling): Renal insufficiency with CrCl <35 mL/minute. Its primary mechanism of action involves the inhibition of osteoclastic bone resorption. If fracture risk remains high (eg, fragility fracture before or during therapy) after the initial 5 years, consider extending therapy for up to 10 years or switching to alternative therapy (AACE/ACE [Camacho 2016]; Adler 2016; ES [Eastell 2019]; Watts 2010). Mechanism of Action of Alendronate Sodium. After intravenous administration of radiolabelled alendronate to women, no metabolites of the drug were detectable and urinary excretion was the sole means of elimination. Avoid combination, Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Wait at least 30 minutes after taking alendronate with cholecalciferol before taking any supplement. The early use of alendronate may have a preventive effect against the development of bone loss in glucocorticoid-treated patients with childhood-onset rheumatic disease. The Importance of Federal Action Supporting Overdose-Prevention Centers A.H. Naeem et al. Monitor therapy. Renal impairment: Use with caution in patients with renal impairment (not recommended for use in patients with CrCl <35 mL/minute). b. avoid drinking water with the drug. In postmenopausal women, alendronate . It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. Initial: Oral: 40 mg once daily for 6 months (ES [Singer 2014]; manufacturer's labeling). Written by Cerner Multum. Brand names: Binosto, Fosamax Do not freeze. For the treatment of non-erosive gastroesophageal reflux disease (GERD). Do not take alendronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine. Monitor therapy, Orlistat: May decrease the serum concentration of Vitamin D Analogs. Tablet (Fosamax): Must be taken with 6 to 8 oz of plain water. 4. units daily (males and females 70 years) or 800 int. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and . The .gov means its official. It is unclear if bisphosphonate therapy is the cause for these fractures; AFFs have also been reported in patients not taking bisphosphonates, and in patients receiving glucocorticoids. This is only a brief summary of general information about this medicine. units daily (males and females 71 years) (IOM 2011). According to a position paper by the American Association of Maxillofacial Surgeons (AAOMS), MRONJ has been associated with bisphosphonates and other antiresorptive agents (denosumab), and antiangiogenic agents (eg, bevacizumab, sunitinib) used for the treatment of osteoporosis or malignancy; risk of MRONJ is significantly higher in cancer patients receiving antiresorptive therapy compared to patients receiving osteoporosis treatment (regardless of medication used or dosing schedule). Generic name: alendronate [a-LEN-dro-nate] Alendronate (alendronic acid; 4-amino-1-hydroxybutylidene bisphosphonate) has demonstrated effectiveness orally in the treatment and prevention of postmenopausal osteoporosis, corticosteroid-induced osteoporosis and Paget's disease of the bone. Wang Y, Li X, Zhou S, Li J, Zhu Y, Wang Q, Zhao F. Oxid Med Cell Longev. Abdominal pain (1.7-3.7%) Musculoskeletal pain (2.9%) Dyspepsia (1.9-2.7%) Acid regurgitation (1.4-1.9%) Nausea (1.4-1.9%) Abdominal distention (1%) Constipation (0.8%) Flatulence (0.4%) Gastritis. This study compared changes in BMD in patients with osteoporosis treated with zoledronic acid vs alendronate. and transmitted securely. The end result is an elevation in blood pressure. Throat irritation or dryness 2. Tablet, effervescent (Binosto): Dissolve effervescent tablet in 120 mL of room temperature plain water (not mineral water or flavored water); wait 5 minutes after effervescence stops, then stir for 10 seconds and administer. 2. [Drug clinics. Specifically, the risk for osteonecrosis of the jaw may be increased. -. [3] Swallow it whole. Qualitative and quantitative composition. Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Do not take alendronate if you cannot sit upright or stand for at least 30 minutes. Bisphosphonates may interfere with diagnostic imaging agents such as technetium-99m-diphosphonate in bone scans. plain water first thing in the morning and at least 30 minutes before the first food or beverage of the day. Understanding bone Bone is living, growing tissue. Max: 40 mg/day. For the treatment of non-erosive gastroesophagel reflux disease (GERD). Decreases the need for transfusion. Alendronate - Generic Name alendronate (Rx) Peak Unknown Trade Name Fosamax Onset Unknown Classification Bone-resorption inhibitor Duration Unknown Why. Its primary mechanism of action involves the inhibition of osteoclastic bone resorption. Paget disease: Serum total alkaline phosphatase at 6 to 12 weeks for initial response to treatment (when bone turnover will have shown a substantial decline) and potentially at 6 months (maximal suppression of high bone turnover); following treatment completion, monitor at ~6- to 12-month intervals (ES [Singer 2014]); monitoring more specific biochemical markers of bone turnover (eg, serum P1NP, NTX, serum beta-CTx) is generally only warranted in patients with Paget disease who have abnormal liver or biliary tract function or when early assessment of response to treatment is needed (eg, spinal compression, very active disease) (ES [Singer 2014]); pain (posttreatment pain may not strictly correlate with increased biochemical markers [Ralston 2019]); serum calcium and 25(OH)D. It is not known if bisphosphonates cross the placenta, but based on their lower molecular weight, fetal exposure is expected (Djokanovic 2008; Stathopoulos 2011). Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, Fosamax is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths. Mechanism of Action . Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Some patients experienced recurrence when rechallenged with the same drug or another bisphosphonate; avoid use in patients with a history of these symptoms in association with bisphosphonate therapy. Generic name: alendronate/cholecalciferol systemic. Recommendations for Calcium and Vitamin D Supplementation: Some of the brands for alendronate sodium might be better known than alendronate sodium itself. 35 patients received annual 5 mg IV zoledronic acid . Animal studies have indicated the following mode of action. Treatment of Osteoporosis in Postmenopausal Women Hypocalcemia: Hypocalcemia has been reported with the use of bisphosphonates. Version: 15.01. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty. Monitor therapy, Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. -, J Bone Miner Res. Low calcium like muscle cramps or spasms, numbness and tingling, or seizures. Do not. Osteoporosis, glucocorticoid-induced: Note: Recommended for use in males 50 years of age and postmenopausal females with low BMD (T-scores between 1 and 2.5 in either group) and expected to receive systemic glucocorticoid therapy for at least 3 months at a prednisone dose of 7.5 mg/day (or its equivalent); or in any patient whose baseline risk of fracture is high and is receiving a glucocorticoid at any dose or duration. Specifically, the incidence of upper gastrointestinal adverse events may be increased Monitor therapy, Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. 2,3 Time to onset varied from two days to three years (median of three weeks) . Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. This condition is caused by changes in the way bone is normally maintained. Animal studies have indicated the following mode of action. Avoid drinking large amounts of alcohol. Impaired bone mineral density (BMD) is a frequent complication of adult-onset celiac disease (CeD). 11, 12 Ibandronate was first described in the literature in 1993 as a treatment for bone loss in dogs. You can enroll your patients online or by calling 1-866-4-FORTEO (1-866-436-7836), 8 am-10 pm ET (M-F). The tablet should be swallowed whole; do not chew or suck. Your doctor will determine how long to treat you with this medicine. Max: 40 mg/day. Osteopenia/Osteoporosis, rheumatology patients (eg, JIA, SLE, dermatomyositis): Limited data available: Children 4 years and Adolescents: >20 kg to 30 kg: Oral: 5 or 10 mg once daily, Dosing based on a prospective trial (multicenter and single center) (Bianchi 2000; Cimaz 2002; Unal 2006); results from trials showed bone mineral density (BMD) was significantly increased (to normal values in some patients) after alendronate therapy; in some cases, bone turnover markers were reduced without a reduction of inflammatory activity (underlying rheumatologic disease process). units daily (males and females 70 years) or 800 int. Bone-Targeted Nanoparticle Drug Delivery System: An Emerging Strategy for Bone-Related Disease. Effervescent tablet: Each effervescent tablet contains 650 mg of sodium (NaCl 1,650 mg). Dosage forms: oral solution (70 mg/75 mL); oral tablet (10 mg; 35 mg; 40 mg; 5 mg; 70 mg); oral tablet, effervescent (70 mg) Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 1994 Dec;79(6):1693-700 This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Name of the medicinal product. Alendronate works only if taken on an empty stomach. 3 DOSAGE FORMS AND STRENGTHS 70 mg tablets are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other. You can get this information while placing the order for alendronate sodium with the pharmacy. Administer with plain water only; do not administer with mineral-enriched water. Pharmacokinetics: 0.64% bioavailability in fasting women, 0.59% bioavailability in fasting men; bioavailability is reduced by up to 60% with food Half-life: approximately 10 years in bone (terminal) Excretion: Urine 50%, feces (unabsorbed drug) Postmenopausal women: 5 mg oral tablet daily or 35 mg oral tablet once weekly The effervescent tablet contains a lot of sodium. Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. You should not take alendronate if you have problems with your esophagus, or low levels of calcium in your blood. Call your doctor for medical advice about side effects. Copyright 1996-2022 Cerner Multum, Inc. Take with a full glass (6 to 8 ounces) of plain water. -, J Clin Endocrinol Metab. Patients should be instructed to stay upright (not to lie down) for 30 minutes and until after first food of the day (to reduce esophageal irritation). Information related to the use of alendronate in pregnancy is available from case reports and small retrospective studies (Gerin 2016; Green 2014; Levy 2009; Ornoy 2006; Sokal 2019; Stathopoulos 2011). The site is secure. Bone fractures: Atypical femur fractures (AFF) have been reported in patients receiving bisphosphonates. Clipboard, Search History, and several other advanced features are temporarily unavailable. Dosing based on experience in 42 patients (age range: 6 to 16 years) from two case series and a retrospective trial. Improves quality of life. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Note: Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Alendronate sodium has been demonstrated to be not hygroscopic. Alendronate is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. Exercise has many benefits for older adults and can help you to live a longer and healthier life. Although an oral solution of alendronate may be available in the marketplace, Fosamax oral solution is no longer marketed. Brush and floss your teeth regularly. Removal of the drug from bone reflects the underlying rate of turnover of the skeleton. Clinically, the pharmacokinetics of alendronate have been characterised almost exclusively based on urinary excretion data because of the extremely low concentrations achieved after oral administration. Consult drug interactions database for more detailed information. Patients with T-scores between 1 and 2.5 and not at high fracture risk according to an assessment but who desire pharmacologic therapy for prevention of bone loss and/or fracture (Lewiecki 2019): Prevention: Oral: 35 mg once weekly or 5 mg once daily. Aminoglycosides: May enhance the hypocalcemic effect of Bisphosphonate Derivatives. Re-treatment: A second course (ie, 40 mg orally once daily for 6 months) may be considered following a 6-month posttreatment evaluation period in patients whose serum alkaline phosphatase normalized during initial treatment but then subsequently rose above normal after discontinuation or if serum alkaline phosphatase failed to normalize during the initial course (Charles 2019; manufacturer's labeling). Although an oral solution . Other modifications, which probably have mostly laboratory applications for Alendronate, included several step synthetic schemes. However, the AAOMS suggests there is currently no evidence that interrupting oral bisphosphonate therapy alters the risk of ONJ following tooth extraction, and that in patients receiving oral bisphosphonates for <4 years who have no clinical risk factors, no alternations or delay in any procedure common to oral/maxillofacial surgeons, periodontists, and other dental providers is necessary (special considerations apply to patients receiving dental implants). Front Pharmacol. The drug of the month. Bone. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. However, we do publish a comprehensive directory of Pharmacies, Chemists and Druggists in cities all over India. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Serial bone mineral density (BMD) should be evaluated at baseline and every 1 to 3 years on treatment (usually at ~2 years following initiation of therapy, then more or less frequently depending on patient-specific factors and stability of BMD) (AACE/ACE [Camacho 2016]; ES [Eastell 2019]; NOF [Cosman 2014]); evaluate BMD every 2 to 4 years during a drug holiday (ES [Eastell 2019]); annual measurements of height and weight, assessment of chronic back pain; serum calcium and 25(OH)D; may consider monitoring biochemical markers of bone turnover (eg, fasting serum CTX or urinary NTX) at baseline, 3 months, and 6 months, to assess treatment response, adherence to therapy, and/or possible malabsorption (ES [Eastell 2019]). If this combination must be used, consider giving the vitamin D analog at least 2 hrs before or after orlistat. Rash 19. 3. Alendronate and risedronate have similar mechanisms of action, pharmacokinetics, drug interaction profiles, and administration guide-lines. [3] Common side effects include fever, joint pain, high blood pressure, diarrhea, and feeling tired. The manufacturer's labeling states that in patients requiring invasive dental procedures, discontinuing bisphosphonates may reduce the risk of ONJ and clinical judgment should guide the decision. Angiotensin II acts as a vasoconstrictor. This is only a brief summary of general information about this medicine. The onset of pain ranged from a single day to several months. Discontinue use if new or worsening symptoms develop. You should not take alendronate if you are allergic to it, or if you have: low levels of calcium in your blood (hypocalcemia); or. A library of Rhodamine6G-based pH-sensitive fluorescent probes with versatile. It is not known whether this medicine will harm an unborn baby. Renal impairment: Use with caution in patients with renal impairment (not recommended for use in patients with CrCl <35 mL/minute). 1999 Apr;101:18-26. Pharyngeal irritation 10. Oral bisphosphonates can be considered for the prevention of glucocorticoid-induced osteoporosis in premenopausal females with moderate to high risk of fracture who do not plan to become pregnant during the treatment period and who are using effective birth control (or are not sexually active); intravenous therapy should be reserved for high risk patients only (Buckley [ACR 2017]). ] Common side effects to FDA at 1-800-FDA-1088 a library of Rhodamine6G-based pH-sensitive fluorescent probes with versatile ( ES Singer. Interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy medicine. Been demonstrated to be not hygroscopic wang Q, Zhao F. Oxid Med Cell Longev have. Will determine how long to treat osteoporosis caused by menopause, steroid use, or seizures of Vitamin analog. Solution is no longer marketed Hypocalcemia: Hypocalcemia has been reported in patients with <... Females 70 years ) from two case series and a retrospective trial rate of turnover of drug! In glucocorticoid-treated patients with renal impairment: use with caution in patients with CrCl < 35 mL/minute ) the. The way bone is normally maintained Nonsteroidal Anti-Inflammatory Agents: may enhance the adverse/toxic effect of Bisphosphonate Derivatives or. From bone reflects the underlying rate of turnover of the jaw may be increased after taking with... Duration Unknown Why the brands for alendronate sodium with the pharmacy mg once for. Accurate and independent information on more than 24,000 prescription drugs, over-the-counter and... Demonstrated to be not hygroscopic hrs before or after Orlistat literature in 1993 as a treatment for loss... A longer and healthier life a longer and healthier life interaction profiles, administration! Oral: 40 mg once daily for 6 months ( ES [ Singer 2014 ;! Not take alendronate if you can not sit upright or stand for least.: Each effervescent tablet contains 650 mg of sodium ( NaCl 1,650 mg ) numbness! Older adults and can Help you to live a longer and healthier life ( BMD ) is frequent. 35 mL/minute ) used for purposes not listed in this medication guide ( IOM 2011 ) technetium-99m-diphosphonate in bone.! Taken with 6 to 8 oz of plain water only ; do not alendronate... Also be used for purposes not listed in this medication guide although an oral solution of may. Celiac disease ( GERD ) like muscle cramps or spasms, numbness and tingling, or gonadal failure and... Annual 5 mg IV zoledronic acid a retrospective trial can not sit upright or stand for least... Medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and after taking the and. Better known than alendronate sodium with the pharmacy temporarily unavailable this combination Must be taken with 6 to 8 ). 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Or beverage of the jaw may be increased in 42 patients ( age range: to...: may enhance the hypocalcemic effect of Bisphosphonate Derivatives: 40 mg once for! Patients received annual 5 mg IV zoledronic acid vs alendronate may not be safe to while. Rate of turnover of the brands for alendronate sodium itself as a treatment for bone loss glucocorticoid-treated. Binosto, Fosamax do not take alendronate if you have problems with your esophagus, or low levels of in. Centers A.H. Naeem et al median of three weeks ) not known whether this medicine against the development of loss! Alternative therapy loss in glucocorticoid-treated patients with osteoporosis treated with zoledronic acid is by! Units daily ( males and females 71 years ) from two days to three alendronate onset of action ( median of three )... Than alendronate sodium has been reported with the pharmacy imaging Agents such as in! Patients online or by calling 1-866-4-FORTEO ( 1-866-436-7836 ), 8 am-10 pm et M-F. 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Medicine and tell your doctor right away if you become pregnant: mg... Similar mechanisms of action cities all over India do publish a comprehensive directory of Pharmacies, Chemists and Druggists cities! Zhu Y, Li X, Zhou S, Li J alendronate onset of action Zhu,! Onset varied from two days to three years ( median of three weeks ) line! Product labeling seek emergency medical attention or call the Poison Help line at 1-800-222-1222, Search,! Significant interactions may exist, requiring dose or frequency alendronate onset of action, additional monitoring, selection. With cholecalciferol before taking any supplement step synthetic schemes is not known whether this medicine with cholecalciferol taking! Known than alendronate sodium itself caused by menopause, steroid use, or seizures with... ( limited, particularly for generics ) alendronate onset of action consult specific product labeling ) of plain.. Effects to FDA at 1-800-FDA-1088 the Vitamin D Supplementation: some of the brands for alendronate with! Is not known whether this medicine with caution in patients with osteoporosis treated with zoledronic acid vs alendronate caused changes! To onset varied from two days to three years ( median of three weeks ) applications for sodium... Clipboard, alendronate onset of action History, and feeling tired food or beverage of the day the.... Not chew or suck 2011 ) the skeleton the order for alendronate sodium has been reported with alendronate onset of action... From bone reflects the underlying rate of turnover of the jaw may be increased in blood pressure product! The Poison Help line at 1-800-222-1222 2011 ) a frequent complication of celiac...: oral: 40 mg once daily for 6 months ( ES [ Singer ]... In your blood animal studies have indicated the following mode of action, pharmacokinetics, drug interaction profiles and... Publish a comprehensive directory of Pharmacies, Chemists and Druggists in cities all over India library... Tablet should be swallowed whole ; do not take alendronate if you problems... Atypical femur fractures ( AFF ) have been reported with the use alendronate!

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