Alendral

Alendral

  • Active Ingredient: Alendronate
  • 70 mg, 35 mg, 5 mg
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What is Alendral?

The active ingredient of Alendral brand is alendronate. Alendronate is a bisphosphonate (bis FOS fo nayt) medicine that slows bone loss while increasing bone mass, which may prevent bone fractures. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP, for oral administration contain 45.68 mg or 91.37 mg of Alendronate monosodium salt trihydrate, which is the molar equivalent of 35 mg and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. This product meets USP Dissolution Test 2.

Used for

Alendral is used to treat diseases such as: Aseptic Necrosis, Osteoporosis, Paget's Disease, Prevention of Osteoporosis.

Side Effect

Possible side effects of Alendral include: bone, joint, or muscle pain, severe and occasionally incapacitating; nausea; redness of the skin; shortness of breath; gas; irregular heartbeats; vomiting; muscle pain.

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Q: I have osteoporosis and was told by my local pharmasist that Fosamax should not be taken for longer than five years, according to the drug information. It accumulates in the bones and has no more effect after five years. Is this a true statement? I am also interested in Reclast. My osteoporosis is in my hips and lower spine. I understand that I am limited to Fosamax because the drug is specified for those areas. I was told I could not take Boniva due to the location of my osteoporosis.

A: According to the prescribing information given by the manufacturer, bisphosphonates such as Actonel (risedronate), Boniva (ibandronate), and Fosamax (Alendral) are indicated for treatment of osteoporosis. The specific location of the osteoporosis is not specified. The manufacturers also support the use of bisphosphonates indefinitely to treat osteoporosis. Whether they should be used long-term is controversial. Some studies suggest long-term use of bisphosphonates (over five years) may have no additional benefits. It is even suggested that long-term used may cause an increase risk for femur fractures because bisphosphonates may overly decrease bone turnover rate. Other studies show long-term use of bisphosphonates does not cause an increased risk of femur fractures. Currently, the FDA is advising prescribers to continue following the guideline set by the manufacturers but be aware of the possible risk of femur fractures when used long term. The FDA is informing patients to report signs of hip pain when taking bisphosphonates. It is common practice for patients at low risk to take bisphosphonates for no more than five years. For those who are at high risk (very low bone density), indefinite use of bisphosphonates may be necessary. Reclast (//www.everydayhealth.com/drugs/reclast) is an injectable form of zoledronic acid (Zometa) used to prevent spinal and hip fractures. Clinical studies show Reclast can reduce spinal fractures by 70 percent and hip fractures by 41 percent. Reclast is certainly a good alternative to bisphosphonates and is more specific for osteoporosis in the hip and spine. The drawback may be cost. Please consult the prescriber before discontinuing or make any change to current therapy. For further information regarding osteoporosis, please visit //www.everydayhealth.com/osteoporosis/guide/ For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Lori Mendoza, PharmD

Which drugs or supplements interact with Alendral (Fosamax)?

Calcium supplements and antacids reduce the absorption of Alendral. Therefore, Alendral should be taken at least 30 minutes before calcium and antacids.

Intravenous ranitidine (Zantac) increases blood levels of Alendral. The importance of this reaction is unknown.

The risk of stomach and intestinal side effects may increase when Alendral is combined with aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs).

What is Alendral (Binosto, Fosamax)?

Alendral 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.

Alendral 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.

Alendral is also used to treat Paget's disease of bone.

Alendral may also be used for purposes not listed in this medication guide.

Uses of Alendral Tablets:

  • It is used to prevent or treat soft, brittle bones (osteoporosis).
  • It is used to treat Paget's disease.
  • It may be given to you for other reasons. Talk with the doctor.
  • Upper gastrointestinal issues: This drug may cause ulcers and erosions in your esophagus (the tube that connects your throat to your stomach). This can sometimes be severe. Symptoms may include heartburn, trouble swallowing or pain when swallowing, chest pain, bloody vomit, or black or bloody stool. Tell your doctor right away if you have these symptoms.
  • Muscle and bone pain: This drug may cause severe bone, joint, and muscle pain. If you have these symptoms, stop taking Alendral and call your doctor right away.
  • Osteonecrosis of your jaw: This drug can cause poor blood supply to your jaw. This may lead to osteonecrosis (bone death) of your jaw. This is more likely to occur after a major dental procedure. If you need to have dental work done, tell your doctor. You may need to stop taking this drug.
  • Broken bones: This drug may cause unusual breaks in your hip or leg bones. You may have dull, aching pain in your thigh(s) or groin weeks or months before the bone breaks. If you have this pain, talk to your doctor.

Alendral oral tablet is a prescription drug that’s available as the brand-name drugs Fosamax and Binosto. It’s also available as a generic drug.

Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

Alendral also comes as an oral solution and an oral effervescent tablet.

Mechanism of Action

Alendral 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. Alendral differs from other bone-modifying supplements as it suppresses bone formation, but it does not modify bone mineral accrual in endocortical or intracortical bone.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to Alendral.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

The overall safety and tolerability profile in the glucocortico >

Paget's Disease of Bone In clinical studies (osteoporosis and Paget's disease), adverse events reported in 175 patients taking Alendral 40 mg/day for 3 to 12 months were similar to those in postmenopausal women treated with Alendral 10 mg/day. However, there was an apparent increased incidence of upper gastrointestinal adverse reactions in patients taking Alendral 40 mg/day (17.7% Alendral sodium vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.

Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget's disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with Alendral 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy. Discontinuation of therapy due to any clinical adverse events occurred in 6.4% of patients with Paget's disease treated with Alendral 40 mg/day and 2.4% of patients treated with placebo.

  • If you take Alendral Sodium Tablets Daily : ● Take 1 Alendral sodium tablet one time a day, every day after you get up for the day and before taking your first food, drink, or other medicine.
  • If you take Once Weekly Alendral Sodium Tablets : ● Choose the day of the week that best fits your schedule. ● Take 1 dose of Alendral sodium tablets every week on your chosen day after you get up for the day and before taking your first food, drink, or other medicine.

After swallowing Alendral sodium tablet, wait at least 30 minutes:

  • Before you lie down. You may sit, stand or walk, and do normal activities like reading.
  • Before you take your first food or drink except for plain water.
  • Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 30 minutes after you take Alendral sodium tablets and after you eat your first food of the day.

If you miss a dose of Alendral sodium tablets, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.

If you take too much Alendral sodium tablets, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of Alendral sodium tablets ?

Alendral sodium tablets may cause serious side effects.

  • See “What is the most important information I should know about Alendral sodium tablets ?”

The most common side effects of Alendral sodium tablets are:

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.

Worsening of asthma has been reported.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Alendral sodium tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Alendral sodium tablets ?

  • Store Alendral sodium tablets at 20° to 25ºC (68° to 77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF).
  • Keep Alendral sodium tablets in a tightly closed container.

Keep Alendral sodium tablets and all medicines out of the reach of children.

General information about the safe and effective use of Alendral sodium tablets .

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Alendral sodium tablets for a condition for which it was not prescribed. Do not give Alendral sodium tablets to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Alendral sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Alendral sodium tablets that is written for health professionals.

For more information, call 1-800-272-5525.

What are the ingredients in Alendral sodium tablets ? Active ingredient: Alendral sodium

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.

Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Revised: January 2016

This Medication Guide has been approved by the U.S. Food and Drug Administration.

What other drugs could interact with this medication?

There may be an interaction between Alendral and any of the following:

  • aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • ASA and ASA-containing products (when Alendral is taken in doses greater than 10 mg daily) - note that this does not apply to the 70 mg weekly dose
  • calcium supplements (wait at least 30 minutes after taking Alendral to take calcium supplements)
  • deferasirox
  • H2 antagonists (e.g., famotidine, ranitidine)
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • systemic angiogenesis inhibitors (e.g., axitinib, bevacizumab, lenalidomide, pazopanib, regorafenib, vandetanib)
  • supplements containing minerals such as aluminum, calcium, iron, magnesium and phosphate
  • other medications given by mouth (wait at least 30 minutes after taking Alendral to take any other medication by mouth)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Q: Is Fosamax plus D dangerous?

A: Fosamax plus D (Alendral plus cholecalciferol ) is a combination medication commonly used to treat osteoporosis. Some of the most common side effects of Fosamax plus D are gastroesophageal reflux disease (GERD), heartburn, nausea, vomiting, constipation, diarrhea, gas, abdominal pain, inflammation of the esophagus and esophageal ulcers. This is not a complete list of the side effects associated with Fosamax plus D (Alendral plus cholecalciferol ). For more general information on Fosamax plus D (Alendral plus cholecalciferol ), visit our Web site //www.everydayhealth.com/drugs/fosamax. Fosamax plus D (Alendral plus cholecalciferol ) should be taken in the morning with a full glass of water (6-8 ounces) at least 30 minutes before food, drink, or other medication. Wait at least 30 minutes after taking Fosamax plus D (Alendral plus cholecalciferol ) before taking any other medications. To help avoid esophageal pain and irritation, you should not lie down for at least 30 minutes after taking Fosamax plus D (Alendral plus cholecalciferol ). For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. When your doctor prescribes a new medication, be sure to discuss all your prescription and over-the-counter drugs, including dietary supplements, vitamins, botanicals, minerals, and herbals, as well as the foods you eat. Always keep a current list of the drugs and supplements you take and review it with your health care providers and your pharmacist. If possible, use one pharmacy for all your prescription medications and over-the-counter products. This allows your pharmacist to keep a complete record of all your prescription drugs and to advise you about drug interactions and side effects. Tell your health care provider about any negative side effects from prescription drugs. You can also report them to the U.S. Food and Drug Administration by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jennifer Carey, PharmD

Q: Recently I started taking Fosamax. I have been experiencing a lot of pain in my hands especially, also in my legs and arms. Could this pain be from the Fosamax?

A: According to the package insert, muscle, joint, and bone pain have been reported in patients taking Fosamax (Alendral) and other drugs like it. The pain can be severe and even limit activities in some patients. Most patients have relief of symptoms after stopping the medication, but please speak with your healthcare provider before stopping this medication. For more information, please visit //www.everydayhealth.com/drugs/fosamax. Michelle McDermott, PharmD

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 Alendral 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.

How should I take Alendral (Binosto, Fosamax)?

Alendral is taken either once daily or once per week. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Alendral first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take Alendral only once per week, take it on the same day each week and always first thing in the morning.

Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or suck on an Alendral regular tablet. Swallow it whole.

Dissolve the effervescent tablet in at least 4 ounces of water (at room temperature, not hot or cold). Let the tablet dissolve for 5 minutes. Stir this mixture for 10 seconds and drink all of it right away. Add a little more water to the glass, swirl gently and drink right away.

For at least 30 minutes after taking Alendral:

  • Do not lie down or recline.
  • Do not take any other medicine including vitamins, calcium, or antacids.

Pay special attention to your dental hygiene while taking Alendral. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Alendral.

Alendral 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. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

Your doctor will determine how long to treat you with this medicine. Alendral is often given for only 3 to 5 years.

What are some things I need to know or do while I take Alendral Tablets?

  • Tell all of your health care providers that you take this medicine (Alendral tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad swallowing tube (esophagus) problems like irritation, swelling, ulcers, and bleeding have happened with this medicine (Alendral tablets). Talk with the doctor.
  • Worsening of asthma has happened in people taking drugs like this one. Talk with the doctor.
  • This medicine may raise the chance of a broken leg. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
  • Follow the diet and workout plan that your doctor told you about.
  • Have a dental exam before starting this medicine (Alendral tablets).
  • Take good care of your teeth. See a dentist often.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • This medicine is not approved for use in children. However, the doctor may decide the benefits of taking this medicine (Alendral tablets) outweigh the risks. If your child has been given this medicine (Alendral tablets), ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this medicine (Alendral tablets) to your child.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Alendral tablets) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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 Alendral 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 (Alendral cholecalciferol), a single once weekly tablet containing 70 mg Fosamax (Alendral) 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

Renal Impairment

Alendral sodium is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35 to 60 mL/min .

Q: I have osteopenia. Do I have to take Fosamax?

A: Fosamax (Alendral) is in a class of medications called bisphosphonates that work by increasing bone formation and decreasing bone breakdown in the body. If you have osteopenia, then you have a high risk of developing osteoporosis and possibly having a bone fracture in the future. You should consult your physician about osteoporosis prevention. The most common side effects of Fosamax are mild heartburn, diarrhea, gas, constipation, swelling in your hands or feet, dizziness, weakness, and headache. Contact your physician if any of the following severe side effects occur: chest pain, difficulty swallowing, new or worsening heartburn, joint/muscle or bone pain, jaw pain. This is not a complete list of side effects of Fosamax. Fosamax can cause problems in the stomach or esophagus. Staying upright for at least 30 minutes after taking this medication and taking it with a full glass of water can lower the risk of stomach problems. Always take Fosamax first thing in the morning 30 minutes before you eat or drink anything or take any other medications. Burton Dunaway, PharmD


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