Ostemax

Ostemax

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

The active ingredient of Ostemax 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

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

Side Effect

Possible side effects of Ostemax include: red skin lesions, often with a purple center; irritation or pain of the esophagus; itching; hair loss or thinning of the hair; loosening of a tooth; Blurred vision or other change in vision; tearing.

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Q: Does Fosamax cause bones to break easily?

A: Your question regards Fosamax (Ostemax) //www.everydayhealth.com/drugs/fosamax and bone problems. I am assuming you are referring to the jaw bone issues associated with the medication that have been in the media. According to Lexi-Comp, Fosamax (Ostemax) has reported possible side effects of causing osteonecrosis of the jaw bone. Osteonecrosis means death of bone. The ADA (American Dental Association) addressed these concerns in 2008 and stated that the incidence of osteonecrosis of the jawbone is low. The ADA also stated that the benefits of medications in this class on preventing osteoporosis outweighs the small risk of developing osteonecrosis. The way that Fosamax (Ostemax) works is by having an indirect effect on increasing bone mineral density. The medication is approved to treat osteoporosis and Paget's disease. As always, please talk to your health care provider about any concerns you have regarding your medications. The following link provides information regarding osteoporosis. //www.everydayhealth.com/osteoporosis/guide/

Health risks

There are some more-serious but very rare health conditions associated with Ostemax:

  • Osteonecrosis of the jaw - when the mouth fails to heal quickly, usually following invasive dental procedures
  • Atypical (unusual) broken bones in the thigh - a break to the thigh bone that occurs with little or no force after taking the medication for a long time

If you are prescribed Ostemax, your doctor has decided the benefit of taking the treatment outweighs any risks.

It's perfectly natural to feel concerned and unsure, but be reassured that your risk of these is very small. Our specialist nurses are here for you, if you need to talk through your concerns and find out more about your risk.

Toxicity

There are no known toxicities reported at this time.

Ostemax has no FDA boxed warning.

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

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
  • dull, aching pain in your hips, groin, or thighs
  • spasms, twitches, or cramps in your muscles
  • numbness or tingling in your fingers, toes, or around your mouth
  • Severe bone, joint, or muscle pain
  • 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.

    Ostemax 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 Ostemax are listed below.

    Treatment of Paget's Disease of Bone

    Ostemax 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.

    Treatment of Glucocortico >The efficacy of Ostemax 5 mg and 10 mg once daily in men and women receiving glucocorticoids (at least 7.5 mg/day of prednisone or equivalent) was demonstrated in two, one-year, double-blind, randomized, placebo-controlled, multicenter studies of virtually identical design, one performed in the United States and the other in 15 different countries (Multinational ). These studies enrolled 232 and 328 patients, respectively, between the ages of 17 and 83 with a variety of glucocorticoid-requiring diseases. Patients received supplemental calcium and vitamin D. Figure 5 shows the mean increases relative to placebo in BMD of the lumbar spine, femoral neck, and trochanter in patients receiving Ostemax 5 mg/day for each study.

    Figure 5: Studies in Glucocorticoid - Treated Patients Increase in BMD Ostemax 5 mg/day at One Year

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

    Ostemax has not been studied in pregnant women.

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

    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 (Ostemax) 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

    Q: Can Fosamax cause high potassium levels?

    A: Increased potassium was not listed as a possible side effect of Fosamax (Ostemax), according to the prescribing information for the medication. Fosamax is a bisphosphonate medication. Bisphosphonates slow bone loss and increase bone mass, which may prevent fractures. Fosamax is approved for the treatment and prevention of postmenopausal osteoporosis in women, for the treatment of osteoporosis in men and for the treatment of steroid-induced osteoporosis in men and women. Fosamax is also approved for the treatment of Paget's disease, a disease of the bone. Fosamax is typically taken once weekly and should be taken first thing in the morning, at least 30 minutes before eating, drinking or taking any other medications. Weekly Fosamax should be taken on the same day each week. It is important to take each dose with approximately six to eight ounces of plain water. Do not crush, chew, break or suck on Fosamax tablets and swallow them whole. After administration of your weekly dose of Fosamax, do not lie down or recline, eat or drink anything but water, or take any other medications, including vitamins and supplements, for at least 30 minutes. The most commonly reported side effects possible with Fosamax include mild heartburn or stomach upset, constipation, diarrhea, gas, dizziness, weakness, headache, back or joint pain and swelling in hands and feet. If you experience any chest pain, difficult or painful swallowing, new or worsening heartburn, severe joint or muscle pain or jaw pain, numbness or swelling while taking Fosamax, contact your doctor immediately. A rare side effect associated with Fosamax treatment is osteonecrosis of the jaw. Risk factors for jaw osteonecrosis include cancer and various cancer therapies, anemia, infection and dental disease. According to the literature available, the effect on the jaw was mostly reported in patients receiving the drug through intravenous administration, although some reports were from patients receiving these medications orally. 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

    How should I use this medication?

    When used for postmenopausal women, the recommended dose of Ostemax to treat osteoporosis is one 10 mg tablet daily or 70 mg once weekly. To prevent osteoporosis, the recommended dose is 5 mg once a day.

    To treat osteoporosis for men, the recommended dose of Ostemax is one 10 mg tablet daily or 70 mg once weekly.

    To treat and prevent steroid-induced osteoporosis for men and women, the recommended dose is 5 mg daily, except for postmenopausal women not taking estrogen. For those women, the recommended dose is 10 mg once a day.

    When used to treat Paget's disease of the bone for men and women, the recommended dose is 40 mg once a day for 6 months.

    The tablet should be taken upon rising for the day, at least 30 minutes before the first food, beverage, or medication of the day. To reduce the risk of irritating the throat or esophagus, take the tablet with a full glass (250 mL) of plain water only.

    After swallowing, do not lie down until at least 30 minutes have passed and you have eaten your first food of the day. Swallow the tablets whole. Do not chew or suck on the tablets.

    Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

    It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose when taking this medication once a day, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

    If you miss a dose when taking this medication once weekly, take the missed dose the morning after you remember. Then return to your weekly dose on the original day of the week. Do not take 2 doses on the same day. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

    Store this medication at room temperature and keep it out of the reach of children.

    Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

    Nursing Mothers

    It is not known whether Ostemax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ostemax sodium is administered to nursing women.

    Prevention of Osteoporosis in Postmenopausal Women

    Daily Dosing Prevention of bone loss was demonstrated in two double-blind, placebo-controlled studies of postmenopausal women 40-60 years of age. One thousand six hundred nine patients (Ostemax 5 mg/day; n=498) who were at least six months postmenopausal were entered into a two-year study without regard to their baseline BMD. In the other study, 447 patients (Ostemax 5 mg/day; n=88), who were between six months and three years postmenopause, were treated for up to three years. In the placebo-treated patients BMD losses of approximately 1% per year were seen at the spine, hip (femoral neck and trochanter) and total body. In contrast, Ostemax 5 mg/day prevented bone loss in the majority of patients and induced significant increases in mean bone mass at each of these sites (see Figure 4). In addition, Ostemax 5 mg/day reduced the rate of bone loss at the forearm by approximately half relative to placebo. Ostemax 5 mg/day was similarly effective in this population regardless of age, time since menopause, race and baseline rate of bone turnover.

    Figure 4: Osteoporosis Prevention Studies in Postmenopausal Women

    More common side effects

    The more common side effects of Ostemax oral tablet can include:

    • stomach pain
    • acid reflux
    • constipation
    • diarrhea
    • upset stomach
    • nausea
    • muscle and joint pain

    If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

    What should I discuss with my healthcare provider before taking Ostemax (Binosto, Fosamax)?

    You should not take Ostemax if you are allergic to it, or if you have:

    • low levels of calcium in your blood (hypocalcemia); or
    • problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

    Do not take Ostemax if you cannot sit upright or stand for at least 30 minutes. Ostemax can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

    To make sure Ostemax is safe for you, tell your doctor if you have ever had:

    • trouble swallowing;
    • problems with your stomach or digestion;
    • hypocalcemia;
    • a dental problem (you may need a dental exam before you begin taking Ostemax);
    • kidney disease; or
    • any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

    The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of Ostemax.

    In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Ostemax, the more likely you are to develop this condition.

    Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

    Talk with your doctor about the risks and benefits of using this medication.

    It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

    It is not known whether Ostemax passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.


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