Alendronate is in the group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. Alendronate slows down bone resorption while increasing bone mass or density, which may prevent pathologic bone fractures. It is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. Alendronate is also used to treat Paget's disease of bone. However, alendronate is only part of a regimen that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.
Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes after taking this drug. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). It is advisable that you must not lie down or recline for at least 30 minutes after taking this medication. Do not eat or drink anything other than plain water (not mineral water) with alendronate. It is better to take other medicines at a different time of the day. Do not take two (2) tablets in one day, if you missed a dose. Take alendronate exactly as it was prescribed for you. To ensure that this medication is helping your condition, bone mineral density will need to be tested on a regular basis. It is important not to miss follow up visits with your doctor.
Alendronate may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. If you are lactating, do not use this medicine without first discussing it with your doctor because it is not known it alendronate passes into breast milk or if it could harm a nursing baby. Before using alendronate, 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 not be able to use alendronate, or you may need a dosage adjustment or special tests during treatment.
Some people using medicines similar to alendronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. Those people who are at risk developing jaw osteonecrosis are
cancer patients and those who have been treated with chemotherapy, radiation, or steroids. Other conditions associated with jaw osteonecrosis include blood clotting disorders, anemia and dental surgery or pre-existing dental problems.
If you think you have used too much of this medicine, drink a full glass of milk and call your local poison control or emergency room right away. Do not make yourself vomit and do not lie down. Symptoms of an alendronate overdose may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.
You may also need emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other serious side effects may include: chest pain; difficulty or pain when swallowing; pain or burning under the ribs or in the back; new or worsening heartburn; severe joint, bone, or muscle pain; or jaw pain, numbness, or swelling.
You may continue using alendronate but talk with your doctor if you have any of these less serious side effects: mild heartburn or stomach upset; diarrhea, gas, or constipation;
mild joint or back pain; or headache. For any unusual side effect not listed here always tell your doctor about it.
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs alendronate. If you use these other medicines, do not that take them for at least 30 minutes after taking an alendronate tablet. Other drug interactions may happen with alendronate and use of aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others. All other prescription and over-the-counter medications you use must be reported to your doctor to avoid possible drug interactions. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.
The empirical formula of alendronate sodium is C4H12NNaO7P2·3H2O and its formula weight is 325.12. Tablets Alendronate for oral administration contain 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg also contain carnauba wax. Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid.
Alendronate has the following structural formula: