Osdren

Osdren

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

The active ingredient of Osdren 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

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

Side Effect

Possible side effects of Osdren include: unusual tiredness or weakness; eye pain; Skin rash; feeling of constant movement of self or surroundings; pain or burning in the throat; Difficulty with swallowing; muscle cramps in the hands, arms, feet, legs, or face; pain, swelling, or numbness in the mouth or jaw.

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  • If you take Osdren Sodium Tablets Daily : ● Take 1 Osdren 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 Osdren Sodium Tablets : ● Choose the day of the week that best fits your schedule. ● Take 1 dose of Osdren 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 Osdren 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 Osdren sodium tablets and after you eat your first food of the day.

If you miss a dose of Osdren 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 Osdren sodium tablets, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of Osdren sodium tablets ?

Osdren sodium tablets may cause serious side effects.

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

The most common side effects of Osdren 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 Osdren 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 Osdren sodium tablets ?

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

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

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Osdren sodium tablets for a condition for which it was not prescribed. Do not give Osdren 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 Osdren sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Osdren sodium tablets that is written for health professionals.

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

What are the ingredients in Osdren sodium tablets ? Active ingredient: Osdren 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.

Animal Toxicology and/or Pharmacology

The relative inhibitory activities on bone resorption and mineralization of Osdren 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 Osdren 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 Osdren administered in therapeutic doses is highly unlikely to induce osteomalacia.

How does this medication work? What will it do for me?

Osdren belongs to a family of medications known as bisphosphonates. It is used to treat and prevent osteoporosis for postmenopausal women. It is also used to treat osteoporosis for men.

Osdren may also be used to treat and prevent steroid-induced osteoporosis for men and women (osteoporosis caused by taking corticosteroids such as prednisone for long periods of time). It may also be used to treat Paget's disease of the bone for both men and women.

Osdren increases the thickness of bone (bone mineral density) by slowing down the cells that usually break down bone (osteoclasts). This allows the cells that build bone (osteoblasts) to work more efficiently. By making bones stronger, Osdren can help to reduce the incidence of osteoporosis-related fractures.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Q: Can Fosamax cause osteonecrosis after knee replacement surgery?

A: According to the prescribing information for Fosamax (Osdren), 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

Q: Once a week, I take Fosamax in the morning without food. I also take levothyroxine daily in the morning without food. I've been skipping the levothyroxine on the day that I take Fosamax. Can I take both medications on the same day?

A: I have reviewed your question regarding Fosamax (Osdren) and Synthroid (levothyroxine). The prescribing directions for Fosamax are to be taken on arising on an empty stomach with several swallows of water, then to stand, walk or sit upright for 30-45 minutes before eating. This is to prevent gastroesophageal reflux and esophageal irritation.

Toxicity

There are no known toxicities reported at this time.

Osdren has no FDA boxed warning.

Some post-marketing reports indicated an association with significant esophageal and gastric mucosal toxicity; however, studies have since concluded Osdren does not cause predictable mucosal damage when used as directed.

Pediatric Use

Osdren sodium is not indicated for use in pediatric patients.

The safety and efficacy of Osdren sodium were examined in a randomized, double-blind, placebo-controlled two-year study of 139 pediatric patients, aged 4 to 18 years, with severe osteogenesis imperfecta (OI). One-hundred-and-nine patients were randomized to 5 mg Osdren daily (weight less than 40 kg) or 10 mg Osdren daily (weight greater than or equal to 40 kg) and 30 patients to placebo. The mean baseline lumbar spine BMD Z-score of the patients was -4.5. The mean change in lumbar spine BMD Z-score from baseline to Month 24 was 1.3 in the Osdren sodium-treated patients and 0.1 in the placebo-treated patients. Treatment with Osdren sodium did not reduce the risk of fracture. Sixteen percent of the Osdren sodium patients who sustained a radiologically-confirmed fracture by Month 12 of the study had delayed fracture healing (callus remodeling) or fracture non-union when assessed radiographically at Month 24 compared with 9% of the placebo-treated patients. In Osdren sodium-treated patients, bone histomorphometry data obtained at Month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects. There were no statistically significant differences between the Osdren sodium and placebo groups in reduction of bone pain. The oral bioavailability in children was similar to that observed in adults.

The overall safety profile of Osdren sodium in osteogenesis imperfecta patients treated for up to 24 months was generally similar to that of adults with osteoporosis treated with Osdren sodium. However, there was an increased occurrence of vomiting in osteogenesis imperfecta patients treated with Osdren sodium compared to placebo. During the 24-month treatment period, vomiting was observed in 32 of 109 (29.4%) patients treated with Osdren sodium and 3 of 30 (10%) patients treated with placebo.

In a pharmacokinetic study, 6 of 24 pediatric osteogenesis imperfecta patients who received a single oral dose of Osdren 35 mg or 70 mg developed fever, flu-like symptoms, and/or mild lymphocytopenia within 24 to 48 hours after administration. These events, lasting no more than 2 to 3 days and responding to acetaminophen, are consistent with an acute-phase response that has been reported in patients receiving bisphosphonates, including Osdren sodium.

Side Effects

Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 Osdren 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.

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 Osdren, 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 Osdren 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 Osdren 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. Osdren 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 Osdren.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Q: What are the pros and cons of bone building drugs such as Boniva and Fosamax?

A: Boniva (ibandronate) is classified in the group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. Boniva is beneficial because it slows bone loss while increasing bone mass, which may prevent bone fractures. Boniva is taken once a month and should be taken with a full glass of water before any other medication or food. Do not lie down, recline or eat for 60 minutes after taking Boniva. Side effects of Boniva may include back pain, headache, nausea or upset stomach. Some patients who have taken Boniva have developed bone loss in the jaw. Symptoms include jaw pain, swelling, numbness, loss of teeth, and gum infections. According to the prescribing information, Boniva has been associated with renal (kidney) toxicities, so close monitoring is recommended when using Boniva. Fosamax (Osdren) is also classified as a bisphosphonate and works by slowing down the breakdown of bones. Fosamax is beneficial because it slows the breakdown of bone and increases bone formation. Fosamax is indicated for osteoporosis. Fosamax is available as a daily or weekly tablet. Fosamax should be administered with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day. Patients should remain upright for at least 30 minutes following administration of Fosamax. Common side effects of Fosamax include nausea, diarrhea, mild joint pain, and possibly dizziness. Fosamax can also cause bone loss of the jaw. Kidney function should also be monitored with Fosamax as well as the other bisphosphonates. Most of the drugs in the bisphosphonate class carry the same side effect profile and precautions. Kimberly Hotz, PharmD

Osdren may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • bloating or fullness in the stomach
  • change in ability to taste food
  • headache
  • dizziness
  • swelling of the joints, hands, or legs

Treatment to Increase Bone Mass in Men with Osteoporosis

Osdren sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis .

Is Osdren (Fosamax) safe to take if I'm pregnant or breastfeeding?

Osdren has not been studied in pregnant women.

It is not known whether Osdren is secreted in human milk.

Q: Can Fosamax cause protein in the urine, kidney or liver damage?

A: Fosamax (Osdren) is a bisphosphonate used to treat and prevent osteoporosis. The most common side effects with Fosamax are low calcium or low phosphate levels, upset stomach, constipation, diarrhea, or bone pain. A search of the prescribing information for Fosamax did not specifically list protein in the urine, liver damage or kidney damage as side effects. This is not a complete list of the side effects associated with Fosamax. Laura Cable, PharmD

What Is Fosamax (Osdren)?

Fosamax is the brand name of Osdren, a prescription medicine used to treat or prevent osteoporosis in women after menopause.

Fosamax can help to reduce the chance of having a spinal or hip fracture.

It can also increase bone mass in men with osteoporosis; treat osteoporosis in either men or women who are taking corticosteroid medicines; and treat certain men and women who have Paget's disease (a bone disorder).

In 1995, the Food and Drug Administration (FDA) approved Fosamax, which is manufactured by Merck & Co and is available in both tablets and as an oral solution.

During the 1990s, Fosamax was widely used to treat osteoporosis and other conditions that weaken bones, and it's estimated that millions of men and women across the world have taken Fosamax.

However, in 2013, Merck announced that it would pay $27.7 million to settle lawsuits by hundreds of people who claim that Fosamax caused bones in their jaw to break down (a condition known as osteonecrosis), requiring further medical care.

Treatment of Paget's Disease of Bone

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

Q: How long can you take Fosamax? I used it for about 13 years, but now I hear you shouldn't take it for more than five years.

A: Only your physician can determine if you need to continue with Fosamax (Osdren). Some researchers suggest that it might be appropriate to stop therapy for up to five years if you've taken the medication for five years or longer and you have a low risk of fractures and you're not losing bone density. Most likely, your physician will explore three main factors. These are your risk of an osteoporosis fracture, the likelihood of continued effects from the drug even after it's been stopped, and the risk of any adverse side effects from continuing to take it for a long time.

Musculoskeletal Pain

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis . This category of drugs includes Osdren sodium. Most of the patients were postmenopausal women. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.

In placebo-controlled clinical studies of Osdren sodium, the percentages of patients with these symptoms were similar in the Osdren sodium and placebo groups.

Uses of Osdren 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.

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