"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
(risedronate sodium) Delayed-release Tablets
Atelvia (risedronate sodium) delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA).
Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Atelvia tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:
Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.
Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.
What are the possible side effects of risedronate (Actonel, Atelvia)?
Get 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.
Stop using risedronate and call your doctor at once if you have a serious side effect such as:
- chest pain;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- new or worsening heartburn;
- severe or ongoing indigestion;
- severe joint, bone, or muscle pain;
- new or unusual pain in your thigh or hip; or
- jaw pain, numbness,...
What are the precautions when taking risedronate sodium delayed-release tablets (Atelvia)?
Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, inability to sit upright or stand for 30 minutes, low level of calcium in the blood (hypocalcemia), disorders of the esophagus (such as esophageal stricture or achalasia), difficult or painful swallowing, stomach/intestinal disorders (such as ulcers).
Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene,...
Last reviewed on RxList: 5/3/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Atelvia Information
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