What is/are Alendronate?
Alendronic acid (INN) or alendronate sodium (USAN) — sold as Fosamax by Merck — is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 IU and 5600 IU, under the name Fosamax+D). Merck's U.S. patent on alendronate expired in 2008 and Merck lost a series of appeals to block a generic version of the drug from being certified by the U.S. Food and Drug Administration (FDA).
On February 6, 2008, the US FDA approved the first generic versions of alendronate, which were marketed by Barr Pharmaceuticals and Teva Pharmaceuticals USA. Teva Pharmaceuticals manufactures generic alendronate in 5-milligram, 10-milligram, and 40-milligram daily doses, and in 35-milligram and 70-milligram weekly doses, while Barr made generic alendronate in 70-milligram tablets, which were taken once weekly. Barr pharmaceuticals were subsequently acquired by Teva in July 2008.
Fosamax is indicated for treatment and prevention of osteoporosis in postmenopausal women. For the treatment of osteoporosis, Fosamax increases bone mass and reduces the incidence of fractures, including those of the hip and spine. It is also indicated for the prevention of osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment of glucocorticoid. It is used to treat induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density, treatment of Paget's disease of bone in men and women.
Fosamax comes as a tablet to take by mouth. It should be taken once a day in the morning on an empty stomach. Fosamax should be taken with a full glass (6-8 ounces) of plain water. Wait at least 30 minutes after taking Fosamax before you eat, drink, or take other medications. Do not take Fosamax with mineral water, coffee, orange juice, milk, or other dairy products. Do not suck or chew the tablet; swallow the tablet whole. Do not lie down for at least 30 minutes after taking Fosamax. Standing or sitting upright helps you get the full dose and decreases heartburn or the risk of injury to your esophagus.
Before taking Fosamax, tell your doctor if you have a problem swallowing, such as a narrowing of the esophagus; have esophageal ulcers or an esophageal disease; have a condition that causes low levels of calcium in the body; have kidney disease; have stomach ulcers or other stomach or digestive problems; or are unable to stand or sit upright for at least 30 minutes. You may not be able to take Fosamax, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Fosamax is in the FDA pregnancy category C. This means that it is not known whether Fosamax will be harmful to an unborn baby. Do not take Fosamax without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Fosamax passes into breast milk. Do not take Fosamax without first talking to your doctor if you are breast-feeding a baby.
If you take Fosamax every day and you miss a dose, skip that dose and take the next regularly scheduled dose the following day. Missing one dose will not affect your treatment. Do not take two tablets at the same time. If you take a Fosamax once a week and you miss a dose, take the missed dose on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
Possible Side Effects
Stop taking Fosamax if you experience any of the following serious side effects: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); Seek emergency or talk to your doctor if you have difficulty or pain when swallowing; chest pain; pain or burning under the ribs or in the back; or new or worsening heartburn. Other, less serious side effects may be more likely to occur. Continue to take Fosamax and talk to your doctor if you experience abdominal discomfort; stomach upset, nausea, vomiting, diarrhea, or constipation; headache; muscle, bone, or joint soreness or aches; eye pain; a rash; or an altered sense of taste. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Store in a well-closed container at room temperature, 15-30°C (59-86°F).
Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral over dosage. If you do think that an overdose has occurred, call an emergency room or poison control center.
Follow you doctor's recommendations about drinking alcohol and smoking. These activities are related to decreased bone density. Antacids and other medicines taken by mouth may decrease the effects of Fosamax. Do not take any other medicines within 30 minutes after a dose of Fosamax. Talk to your doctor before taking any other medicines during treatment with Fosamax.
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
- Fosamax solution 70 mg/75ml
- Fosamax tablets 5 mg, 10 mg, 35 mg, 40 mg, and 70 mg
- Prophylaxis of osteoporosis in women: 5–10 mg daily or 35–70 mg weekly.
- Therapy of osteoporosis in women and men : 10 mg daily or 70 mg weekly.
- Osteoporosis under corticosteroids: 5–10 mg daily or 35–70 mg weekly in men and premenopausal women or those receiving concomitant HRT. In postmenopausal women not receiving HRT, the recommended dose is 10 mg daily or 70 mg weekly.
- Paget's Disease: 40 mg daily for 6 months.
The risk of esophageal irritation places special requirements on how this oral drug is taken. The patient should take the drug only upon rising for the day with three swallows of water, not to exceed 6-8 oz., and stand, walk, or sit, and remain fasting for 30–45 minutes afterwards, then eat breakfast. No other medications should be taken for this time. Lying down or reclining after taking the drug and prior to eating breakfast may cause gastroesophageal reflux and esophageal irritation.
Contraindications and Precautions
- Acute inflammations of the gastrointestinal tract (esophagitis, gastritis, ulcerations)
- Clinically manifest osteomalacia
- Certain malformations and malfunctions of the esophagus (strictures, achalasia)
- Inability to stand, walk, or sit for 30 minutes after oral administration
- Renal impairment with a creatinine clearance below 30ml/min
- Hypersensitivity to alendronate or another ingredient
- Pregnancy and breastfeeding
- Patients below 18 yrs. of age, as no clinical data exists
- Gastrointestinal tract:
- ulceration of the esophagus; this may require hospitalization and intensive treatment. Gastric and duodenal ulceration may also occur.
- esophageal cancer, a meta-analysis concluded that bisphosphonate treatment is not significantly associated with excess risk of esophageal cancer.
- General: infrequent cases of skin rash, rarely manifesting as Stevens–Johnson syndrome and toxic epidermal necrolysis, eye problems (uveitis, scleritis) and generalized muscle, joint, and bone pain (rarely severe) have been seen. In laboratory tests decreased calcium and phosphate values may be obtained but reflect action of the drug and are harmless.
- Osteonecrosis of the Jaw - Deterioration of the Temporomandibular Joint (TMJ) may occur while on this drug, if dental work of any kind is carried out. Although this side effect is uncommon, it occurs primarily in patients being administered intravenous biphosphonates, with most cases being reported in cancer patients.
- Neurological: Rare instances of auditory hallucinations and visual disturbances have been associated with alendronate and other bisphosphonates.
- Bone: Alendronate has been linked in long-term users to the development of low-impact femoral fractures. Further, studies suggest that users of alendronate have an increase in the numbers of osteoclasts and develop giant, more multinucleated osteoclasts; the significance of this development is unclear. Fosamax has been linked to a rare type of leg fracture that cuts straight across the upper thigh bone after little or no trauma. (Subtrochanteric fractures). This is because Fosamax makes the thigh bone more brittle and stops the cells in the body that remodel the bone. Studies are showing that people who have taken Fosamax for more than five years are at risk for developing these kind of fractures. In some cases, patients have reported that, after weeks or months of unexplained aching, their thigh bones simply snapped while they were walking or standing. One doctor reports that a 59-year old previously healthy woman visiting New York City was riding a subway train one morning when the train jolted. She shifted all her weight to one leg, felt a bone snap, and fell to the floor of the train. An x-ray in a local emergency room revealed a comminuted spiral fracture involving the upper half of the right femur. She had been taking Fosamax for 7 years. On Oct. 13, 2010 the Food and Drug Administration issued a warning about these fractures.
This article uses material from the Wikipedia article Alendronate , which is released under the Creative Commons Attribution-Share-Alike License 3.0.