How to use Tevanate SODIUM Tablet Osteoporosis Agents
Read the Medication Guide provided by your pharmacist before you start taking Tevanate and each time you get a refill. Follow the instructions very closely to make sure your body absorbs as much drug as possible and to reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth once a day, after getting up for the day and before taking your first food, beverage, or other medication. Take it with a full glass (6-8 ounces or 180-240 milliliters) of plain water. Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after your first food of the day. Tevanate works only if taken on an empty stomach. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water.
Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects.
Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of Tevanate. Do not take these for at least 30 minutes (preferably 1 to 2 hours) after taking Tevanate.
Take this medication regularly to get the most benefit from it. Remember to use it at the same time each morning. Talk to your doctor about the risks and benefits of long-term use of this medication.
Q: I have pseudogout and take Fosamax. Is that wrong to take because of the extra calcium?
A: Fosamax (Tevanate) is classified as a bisphosphonate derivative. Fosamax is approved for the treatment of osteoporosis in women that are postmenopausal, treatment of osteoporosis in males, the treatment of Paget's disease, and the treatment of glucocorticoid induced osteoporosis in men and women. Fosamax works in the body to inhibit bone resorption by affecting the actions of osteoclasts or the precursors to osteoclasts. Bone resorption is defined as the process in the body that occurs when osteoclasts break down bones. This process releases the minerals, such as calcium, from the bones into the bloodstream. Therefore, Fosamax decreases bone resorption resulting in an increase in the bone mineral density. As a result of the way that Fosamax works, blood levels of calcium should be decreased instead of increased because, theoretically, less calcium is released from the bones into the blood. In fact, hypocalcemia or low levels of calcium in the blood is one of the listed possible side effects associated with treatment with Fosamax. This is not the only associated side effect of the medication. Pseudogout is defined as a sudden swelling of a joint, or joints, that results from a form of arthritis. Pseudogout occurs when crystals of calcium pyrophosphate dihydrate (CPPD) develop around or in the joints. The result is painful inflammation of the affected area. A review of medical literature discovered extremely rare reports of patients that were taking Fosamax developing pseudogout. It is stated, in a clinical study, that bisphosphonates are similiar in structure to pyrophosphate. However, the mechanism in which taking bisphosphonate medications could lead to deposits of CPPD crystals in and around the joints is unknown. The author of the study states that there are very few cases of this occuring considering the vast amount of patients that are treated with bisphosphonates. It appears that additional studies need to be performed to fully understand this possible connection. Talk to your physician regarding the questions and concerns that you have regarding your medical conditions and your medications. 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. Jen Marsico, RPh
Tevanate (Fosamax) is in a drug class of medications called bisphosphonates. Fosamax is prescribed for treating osteoporosis, bone pain from diseases such as breast cancer, multiple myeloma, and Paget's disease. Dosing, side effects, warnings and precautions, and safety during pregnancy should be reviewed prior to taking this medication.
Prevention of Osteoporosis in Postmenopausal Women
Tevanate sodium tablets are indicated for the prevention of postmenopausal osteoporosis .
Q: Am I safe in taking Tevanate (Fosamax)?
A: Only a health care provider who knows your health conditions and health status can determine if Fosamax (Tevanate) is safe for you to take. In general, do not take an Tevanate tablet if you cannot sit upright or stand for at least 30 minutes. Tevanate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. Before using Tevanate, tell your doctor if you have: low blood calcium (hypocalcemia); a vitamin D deficiency; kidney disease; or an ulcer in your stomach or esophagus. If you have any of these conditions, you may need a dose adjustment or special tests to safely take Tevanate. Lowell Sterler, RPh
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 Tevanate 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.
It is not known whether Tevanate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tevanate sodium is administered to nursing women.
Upper Gastrointestinal Adverse Reactions
Tevanate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Tevanate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including Tevanate sodium. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Tevanate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including Tevanate sodium and/or who fail to swallow oral bisphosphonates including Tevanate sodium with the recommended full glass (6 to 8 ounces) of water, and/or who continue to take oral bisphosphonates including Tevanate sodium after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are prov >. In patients who cannot comply with dosing instructions due to mental disability, therapy with Tevanate sodium should be used under appropriate supervision.
There have been postmarketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials .
Tevanate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Tevanate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.
The empirical formula of Tevanate sodium is C 4 H 12 NNaO 7 P 2 •3H 2 O and its formula weight is 325.12. The structural formula is:
What are the uses for Tevanate (Fosamax)?
Tevanate is used for treating osteoporosis in men and postmenopausal women. It also is used for Paget's disease of bone and osteoporosis caused by steroid treatment. Non-FDA approved (off-label) uses include vitamin D overdose and osteoporosis caused by spinal injury.
Q: A friend told me there was an osteoporosis study that said that if you take Fosamax for more than 5 years, it will do more harm than good. Are you aware of this study and is it true?
A: A recent ABC News report did raise questions about whether there is an increased risk of spontaneous femur fractures in patients with osteoporosis who have been on Fosamax (Tevanate) for more than5years. While the Food and Drug Administration is reviewing the claims from the news report and conducting further investigations, at this point the FDA states that the data they have reviewed have not shown a clear connection between the class of drugs that Fosamax is in and a risk of these femur fractures. Until the FDA
What Are Side Effects Associated with Using Tevanate?
Common side effects of Tevanate include:
Less common side effects of Tevanate include:
Serious side effects of Tevanate include:
- Severe pain (joints, bone, muscle, jaw, back or heartburn)
- Chest pain
- Difficulty swallowing
- Bloody stools
- Eye pain
- Skin blisters
- Swelling of the face, tongue, or throat
Postmarketing side effects of Tevanate reported include:
- Body as a whole: Hypersensitivity reactions including hives and skin swelling; transient muscle pain, feeling unwell (malaise), weakness/lack of energy, and fever; symptomatic hypocalcemia; swelling of extremities
- Gastrointestinal: Esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and mouth or throat ulceration; gastric or duodenal ulcers
- Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing
- Musculoskeletal: Bone, joint, and/or muscle pain, occasionally severe, and incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures
- Nervous system: dizziness, spinning sensation (vertigo)
- Pulmonary: Acuteasthma exacerbations
- Skin: Rash (occasionally with photosensitivity), itching, hair loss, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
- Special Senses: Uveitis, scleritis, or episcleritis, cholesteatoma of the external auditory canal (focal osteonecrosis)
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Of the patients receiving Tevanate sodium in the Fracture Intervention Trial (FIT), 71% (n=2302) were greater than or equal to 65 years of age and 17% (n=550) were greater than or equal to 75 years of age. Of the patients receiving Tevanate sodium in the United States and Multinational osteoporosis treatment studies in women, osteoporosis studies in men, glucocortico > , 45%, 54%, 37%, and 70%, respectively, were 65 years of age or over. No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
How should this medicine be used?
Tevanate comes as a tablet and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 35-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Tevanate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
What Other Drugs Interact with Tevanate?
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 Tevanate include:
Tevanate has no known serious interactions with other drugs.
Moderate interactions of Tevanate include:
Tevanate 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.
Q: Is Fosamax plus D dangerous?
A: Fosamax plus D (Tevanate 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 (Tevanate plus cholecalciferol ). For more general information on Fosamax plus D (Tevanate plus cholecalciferol ), visit our Web site //www.everydayhealth.com/drugs/fosamax. Fosamax plus D (Tevanate 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 (Tevanate 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 (Tevanate 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