Alendran

Alendran

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

The active ingredient of Alendran 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

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

Side Effect

Possible side effects of Alendran include: chills; diarrhea; hair loss or thinning of the hair; hives or welts; confusion; blistering, peeling, or loosening of the skin.

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Generic Name: Alendran Tablets (a LEN droe nate)Brand Name: Fosamax

Medically reviewed by Drugs.com. Last updated on Jun 13, 2019.

What form(s) does this medication come in?

Each white, oval, biconvex tablet engraved "ALE70" on one side contains Alendran sodium equivalent to 70 mg of Alendran. Nonmedicinal ingredients: magnesium stearate, mannitol, and microcrystalline cellulose.

Q: Can Fosamax cause osteonecrosis after knee replacement surgery?

A: According to the prescribing information for Fosamax (Alendran), one of the side effects of bisphosphonates which may occur is called osteonecrosis of the jaw (ONJ). ONJ may occur spontaneously after dental procedures or tooth extractions. There may be delayed healing after dental procedures and the bone of the jaw becomes exposed. Symptoms of ONJ may include pain, swelling, infection, poor healing, loosening of teeth, or numbness of the jaw. According to the National Osteoporosis Foundation, it is important for patients taking bisphosphonates to maintain good oral hygiene and have regular dental visits. There was no mention of the development of osteonecrosis following a knee replacement in the prescribing information. Please consult with your health care provider in regards to your concerns and symptoms you may be experiencing. 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. Kristen Dore, PharmD

By Cathy Cassata | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2014-10-06 Copyright © 2014 Everyday Health Media, LLC

Who should NOT take this medication?

Do not take Alendran if you:

  • are allergic to Alendran or any ingredients of the medication
  • cannot stand or sit upright for at least 30 minutes
  • have an abnormality of the esophagus (passage leading from throat to stomach) that delays the emptying of the esophagus into the stomach
  • have low blood calcium
  • have severely reduced k >

Concomitant Use with Estrogen/Hormone Replacement Therapy In two studies (of one and two years’ duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with Alendran 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.

Osteoporosis in Men In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of Alendran 10 mg/day and a one-year study of once weekly Alendran 70 mg) the rates of discontinuation of therapy due to any clinical adverse event were 2.7% for Alendran 10 mg/day vs. 10.5% for placebo, and 6.4% for once weekly Alendran 70 mg vs. 8.6% for placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 2% of patients treated with either Alendran or placebo are presented in Table 4.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Alendran sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Animal Toxicology and/or Pharmacology

The relative inhibitory activities on bone resorption and mineralization of Alendran and etidronate were compared in the Schenk assay, which is based on histological examination of the epiphyses of growing rats. In this assay, the lowest dose of Alendran that interfered with bone mineralization (leading to osteomalacia) was 6000-fold the antiresorptive dose. The corresponding ratio for etidronate was one to one. These data suggest that Alendran administered in therapeutic doses is highly unlikely to induce osteomalacia.

Possible s >

It’s unlikely you’ll experience any side effects. But if you do, they shouldn't last for long.

Known side effects include:

  • Inflamed food pipe, sore throat, swallowing difficulties or heartburn
  • Bone, joint or muscle pain
  • Diarrhoea
  • Constipation
  • Headache
  • Inflammation in the eye, eye pain or disturbed vision

As research progresses, the list of known side effects may change. You can find more information on each side effect and how to reduce the symptoms in the Alendran factsheet.

You may have seen other symptoms and side effects in your patient information leaflet. These side effects are listed because they were reported by patients in research trials, but it’s unclear if they were directly caused by Alendran. They were also reported by patients taking the placebo (dummy treatment).

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

A: Fosamax (Alendran) 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

Treatment of Paget's Disease of Bone

The efficacy of Alendran 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 Alendran 40 mg/day Versus Placebo or Etidronate 400 mg/day

* Number evaluable for vertebral fractures: Alendran sodium, n=984; placebo, n=966 † p ‡ p=0.007, § p ¶ p Figure 1: Cumulative Incidence of Hip Fractures in the Three-Year Study of FIT (patients with radiographic vertebral fracture at baseline)

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Treatment of Osteoporosis in Postmenopausal Women Daily Dosing The safety of Alendran sodium in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44-84 years. Study 1 and Study 2 were >

Among patients treated with Alendran 10 mg or placebo in Study 1 and Study 2, and all patients in Study 3 and Study 4, the incidence of all-cause mortality was 1.8% in the placebo group and 1.8% in the Alendran sodium group. The incidence of serious adverse event was 30.7% in the placebo group and 30.9% in the Alendran sodium group. The percentage of patients who discontinued the study due to any clinical adverse event was 9.5% in the placebo group and 8.9% in the Alendran sodium group. Adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Alendran sodium or placebo are presented in Table 1.

Q: How long after stopping Fosamax will the side effects remain?

A: Fosamax (Alendran) belongs to the group of drugs called bisphosphonates. These drugs have been shown in scientific studies to increase bone mass and reduce fractures. Fosamax is approved for the treatment and prevention of postmenopausal osteoporosis. Fosamax, and the other bisphosphonates, can cause side effects including irritation of the esophagus and stomach, bone, joint, and muscle pain that can be severe and limit activities, and damage and/or death of bone cells in the jaw bones called osteonecrosis. According to the prescribing information, most cases of osteonecrosis of the jaw have been in cancer patients undergoing dental procedures who received a bisphosphonate by injection. However, some have occurred in patients with postmenopausal osteoporosis or other diagnoses who received the drug orally. The risk factors for osteonecrosis of the jaw include a diagnosis of cancer, use of other therapies including chemotherapy, radiation therapy, or corticosteroids, and other medical conditions, such as anemia, bleeding disorder, infection, or dental disease. The length of time that side effects remain, after discontinuation of Fosamax, depends on several factors including he side effect itself and the length of time the drug stays in the body. With respect to the side effect, if you experienced irritation or ulceration of the esophagus or stomach, the lining of your gastrointestinal tract would need to heal before the side effect goes away. Bone and joint pain is reported to go away in most patients after stopping the drug. Fosamax remains in the body for a long time because it is stored in the bone. However, the concentration of the drug in the blood after you stop taking it is approximately 25 percent of what it was when it is taken orally. If you are having side effects from your medication, please talk to your doctor. Do not stop or change your medication without first talking to your doctor. 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. Michelle McDermott, PharmD

Why it's used

Alendran is used to prevent and treat osteoporosis. With this condition, your bones become thin and weak, and break easily. This drug is also used to treat Paget’s disease. With this condition, your bones are soft and weak, and may be deformed or painful, or may break easily.

Alendran may be used as part of a combination therapy with calcium and vitamin D supplements.

  • 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 Alendran 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.

Alendran 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.

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


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