Rx Item-Atelvia 35mg Risedronate Sodium Tab 4 by Allergan Pharma

linical Information
Gen. Code and Des.
66815 risedronate sodium ORAL TABLET DR 35 MG
GCN and Des.
29223 risedronate sodium ORAL TABLET DR 35 MG
Strength
35MG DR
Dose Form
TABLET, DELAYED RELEASE (ENTERIC COATED)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92240000 BONE RESORPTION INHIBITORS
Active Ingredients
7621 risedronate sodium 115436721
Inactive Ingredients
3785 edetic acid 60004





1 Item info. These highlights do not include all the info. needed to use ACTONEL safely and effectively See Full Prescribing info. for ACTONEL ACTONEL ( risedronate sodium tablets Initial U.S. Approval: 199 RECENT MAJOR CHANGES Contraindications 4 03/2015 Warnings and Precautions 5.4 04/2015 -INDICATIONS AND USAGE -- ACTONEL is bisphosphonate indicated for ? Treatment and prevention of postmenopausal osteoporosis 1.1 ? Treatment to increase bone mass in men with osteoporosis 1.2 ? Treatment and prevention of glucocorticoid -induced osteoporosis 1.3 ? Treatment of Paget?s disease 1.4 Limitations of Use Optim al duration of use has not been determined. For patients at low -risk for fracture, consider drug discontinuation after to years of use. 1.5 --DOSAGE AND ADMINISTRATION Treatment of Postmenopausal Osteoporosis: mg daily, 35 mg once -a- week, 75 mg two consecutive days each month, 150 mg once -a- month 2.1 Prevention of Postmenopausal Osteoporosis: mg daily, 35 mg once -a- week (2.2 Men with Osteoporosis: 35 mg once -a- week 2.3 Glucocorticoid -Induced Osteoporosis: mg daily (2.4 Paget?s Disease: 30 mg daily for months 2.5 Instruct patients to: Swallow tablet whole with to ounces of plain water, at least 30 minutes before the first food beverage, or edication of the day Avoid lying down for 30 minutes 2 ? Take supplemental calcium and vitamin if dietary intake is inadequate 2. ) -DOSAGE FOR MS AND STRENGTHS -- Tablets: 5, 30, 35, 75, and 150 mg 3 -CONTRAINDICATIONS Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia 4, 5.1 ? Inability to stand or sit upright for at least 30 minutes 4, 5.1) Hypocalcemia 4, 5.2 ? Known hypersensitivity to any component of this product 4, 6. ) -WARNINGS AND PRECAUTIONS Products Containing Same Active Ingredient Patients receiving Atelvia should not be treated with ACTONEL 5.1 ? Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow osing instructions. Discontinue use if new or worsening symptoms occur 5. ) Hypocalcemia may worsen and must be corrected prior to use 5. ) Osteonecrosis of the aw has been reported 5. ) Severe Bone, Joint Muscle Pain may occur. Di scontinu use if severe symptoms develop (5. 5, 6.2 ? Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out femoral fracture 5. ) ADVERSE REACTIONS Most common adverse reactions reported in greater than 10 of patients treated with ACTONEL and with higher frequency than placebo are back pain, arthralgia, abdominal pain, and dyspepsia 6.1 Hypersensitivity reactions (angioedema, generalized rash bullous skin reactions, Stevens -J ohnson syndrome, and toxic epidermal necrolysis ), and eye inflammation iritis, uveitis) have been reported rarely 6. ) To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at -800- 521- 8813 or FDA at -800- FDA- 1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL 7.1 -USE IN SPECIFIC POPULATIONS ACTONEL is not recommended for use in patients with severe renal impairment creatin ine clearance less than 30 mL/min) 5. 6, 8.6 12.3 ACTONEL is not indicated for use in pediatric patients 8.4 )

Atelvia 35mg Risedronate Sodiu
NDC No. 00430-0979-03 UPC/GTIN No. 3-04300-97903-6 MPN 97903 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

Atelvia 35mg Risedronate Sodiu
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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