Atelvia
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1)].
The optimal duration of use has not been determined. The safety and effectiveness of Atelvia for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
History
There is currently no drug history available for this drug.
Other Information
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-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:
Molecular Weight:
Anhydrous: 305.10
Hemi-pentahydrate: 350.13
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.
Inactive Ingredients
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.
Sources
Atelvia Manufacturers
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Warner Chilcott (Us), Llc
![Atelvia (Risedronate Sodium) Tablet, Delayed Release [Warner Chilcott (Us), Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atelvia | Warner Chilcott (us), Llc
2.1 Treatment of Postmenopausal Osteoporosis[see Indications and Usage (1.1)]
The recommended regimen is:
one 35 mg delayed-release tablet orally, taken once-a-week 2.2 Important Administration InstructionsInstruct patients to do the following:
Take Atelvia in the morning immediately following breakfast. Atelvia should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting. Swallow Atelvia whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.2)]. Do not chew, cut, or crush Atelvia tablets. 2.3 Recommendations for Calcium and Vitamin D SupplementationInstruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.3)] and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of Atelvia.
2.4 Administration Instructions for Missed DosesIf the once-weekly dose is missed, instruct patients to take one tablet on the morning after they remember and return to taking one tablet once-a-week, as originally scheduled on their chosen day. Patients should not take two tablets on the same day.
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