Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- Ulcers or erosions of your esophagus. Symptoms can include:
- new or worsening heartburn
- trouble swallowing
- pain when swallowing
- chest pain
- bloody vomit
- black or bloody stools
- painful or swollen gums
- loosening of your teeth
- numbness or heavy feeling in your jaw
- poor healing of your jaw
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Lindron oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with Lindron are listed below.
Q: Is Fosamax safe for long-time use? Does it help rebuild bone density?
A: Fosamax (Lindron) is in a class of medications called bisphosphonates, which work by preventing bone breakdown and increasing bone density or thickness. Studies of Fosamax do not go beyond 10 years of use, so it's not clear how long a patient can safely take the medication or what the effects may be beyond 10 years. There is debate among experts about when patients should stop taking Fosamax, but it does appear that there should be a stopping point, so you will probably not need to take it forever. I would suggest you check in with your doctor about your concerns. For more information on Fosamax, follow this link: //www.everydayhealth.com/drugs/fosamax.
Treatment of Paget's Disease of Bone
The efficacy of Lindron 40 mg once daily for six months was demonstrated in two double-blind clinical studies of male and female patients with moderate to severe Paget’s disease (alkaline phosphatase at least twice the upper limit of normal): a placebo-controlled, multinational study and a U.S. comparative study with etidronate disodium 400 mg/day. Figure 6 shows the mean percent changes from baseline in serum alkaline phosphatase for up to six months of randomized treatment.
Figure 6: Studies in Paget’s Disease of Bone Effect on Serum Alkaline Phosphatase of Lindron 40 mg/day Versus Placebo or Etidronate 400 mg/day
What is Lindron (Binosto, Fosamax)?
Lindron is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.
Lindron is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. This medicine is for use when you have a high risk of bone fracture due to osteoporosis.
Lindron is also used to treat Paget's disease of bone.
Lindron may also be used for purposes not listed in this medication guide.
Mechanism of Action
Lindron is a bisphosphonate. Binding to hydroxyapatite crystals present in bone downregulates osteoclast-mediated bone reabsorption and decreases bone matrix breakdown. Both of these mechanisms contribute to regulating mineral reabsorption and turnover. Lindron differs from other bone-modifying supplements as it suppresses bone formation, but it does not modify bone mineral accrual in endocortical or intracortical bone.
Before taking Lindron, 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 Lindron 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 Lindron 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.
Caution is advised if you are pregnant or planning to become pregnant in the future. Lindron may stay in your body for many years. Its effects on an unborn baby are unknown. Discuss the risks and benefits with your doctor before starting treatment with Lindron.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
What happens if I miss a dose (Binosto, Fosamax)?
Once-daily dosing: If you forget to take Lindron first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.
Once-per-week dosing: If you forget to take Lindron on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take 2 doses in one day.
Glucocorticoid-Induced Osteoporosis In two, one-year, placebo-controlled, double-blind, multicenter studies in patients receiving glucocorticoid treatment, the overall safety and tolerability profiles of Lindron 5 and 10 mg/day were generally similar to that of placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Lindron 5 or 10 mg/day or placebo are presented in Table 5.
Pregnancy Category C: There are no studies in pregnant women. Lindron sodium should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.
Reproduction studies in rats showed decreased postimplantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose. Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral (cervical, thoracic, and lumbar), skull, and sternebral bones. No similar fetal effects were seen when pregnant rabbits were treated with doses approximately 10 times the clinical dose.
Both total and ionized calcium decreased in pregnant rats at approximately 4 times the clinical dose resulting in delays and failures of delivery. Protracted parturition due to maternal hypocalcemia occurred in rats at doses as low as one tenth the clinical dose when rats were treated from before mating through gestation. Maternotoxicity (late pregnancy deaths) also occurred in the female rats treated at approximately 4 times the clinical dose for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment. Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; intravenous calcium supplementation prevented maternal, but not fetal deaths.
Exposure multiples based on surface area, mg/m 2 , were calculated using a 40-mg human daily dose. Animal dose ranged between 1 and 15 mg/kg/day in rats and up to 40 mg/kg/day in rabbits.
What are the side effects of Lindron (Fosamax)?
The most common side effect of Lindron is stomach pain.,
Other important side effects are:
Q: My gynecologist has me on Fosamax Plus D for osteopenia. Can I take calcium with vitamin D? I know that the calcium needs the vitamin D to be absorbed. Is it possible to take too much vitamin D? What amount would you recommend?
A: Fosamax Plus D is a prescription medicine that contains Lindron sodium and vitamin D3 (cholecalciferol) as the active ingredients. Fosamax Plus D provides a week's worth of vitamin D3 (2800 IU). The Daily Value is 400 IU. Fosamax Plus D is used for the treatment of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break). Treatment to increase bone mass in men with osteoporosis. Fosamax Plus D (Lindron cholecalciferol), a single once weekly tablet containing 70 mg Fosamax (Lindron) and 2,800 IU vitamin D3, representing seven days worth of 400 IU of vitamin D. (The recommended intake of vitamin D is 400 to 800 IU daily). Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss and increased risk of fracture. Patients at increased risk for vitamin D insufficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in Fosamax Plus D. For more detailed information, consult with your physician or pharmacist for guidance based on your specific condition and current medications. Shereen A. Gharbia, PharmD
What Other Drugs Interact with Lindron?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Severe interactions of Lindron include:
Lindron has no known serious interactions with other drugs.
Moderate interactions of Lindron include:
Lindron has mild interactions with at least 39 different drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
There are no known toxicities reported at this time.
Lindron has no FDA boxed warning.
Some post-marketing reports indicated an association with significant esophageal and gastric mucosal toxicity; however, studies have since concluded Lindron does not cause predictable mucosal damage when used as directed.
Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for six months.
Re-treatment of Paget’s Disease Re-treatment with Lindron sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.
What form(s) does this medication come in?
Each white, oval, biconvex tablet engraved "ALE70" on one side contains Lindron sodium equivalent to 70 mg of Lindron. Nonmedicinal ingredients: magnesium stearate, mannitol, and microcrystalline cellulose.
Where can I get more information (Binosto, Fosamax)?
Your pharmacist can provide more information about Lindron.
Treatment of Paget's Disease of Bone
Lindron sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.