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Actonel Generic Name & Formulations
Legal Class
Rx
General Description
Risedronate (as sodium) 5mg, 30mg, 35mg, 75mg, 150mg; tabs.
Pharmacological Class
Bisphosphonate.
How Supplied
Tabs 5mg, 30mg—30; 35mg—4, 12; 75mg—2; 150mg—1, 3
Manufacturer
Generic Availability
YES
Actonel Indications
Indications
Prevention and treatment of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis (men & women). Treatment to increase bone mass in men with osteoporosis. Treatment of Paget's disease of bone. Limitations of use: optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3–5yrs.
Actonel Dosage and Administration
Adult
Swallow whole; take in the AM with a full glass (6–8oz) plain (not mineral) water at least 30min before other food or drink; take in upright position; do not lie down for at least 30min afterwards. Postmenopausal: 5mg once daily or 35mg once weekly or one 75mg tab taken on 2 consecutive days per month or one 150mg tab once monthly. Glucocorticoid-induced: 5mg once daily. Osteoporosis in men: 35mg once weekly. Paget's: 30mg once daily for 2 months; may retreat after a 2-month post-treatment evaluation period.
Children
Not applicable.
Actonel Contraindications
Contraindications
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30min. Hypocalcemia.
Actonel Boxed Warnings
Not Applicable
Actonel Warnings/Precautions
Warnings/Precautions
Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <30mL/min): not recommended. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Obtain and correct sex steroid hormonal status before initiating therapy in glucocorticoid-induced osteoporosis. Ensure adequate Vit.D and calcium intake. Reevaluate periodically. Pregnancy: discontinue therapy when recognized. Nursing mothers.
Actonel Pharmacokinetics
See Literature
Actonel Interactions
Interactions
Calcium, aluminum, magnesium, other divalent cations reduce absorption (separate dosing). Caution with other GI irritants. May interfere with bone-imaging agents.
Actonel Adverse Reactions
Adverse Reactions
Back pain, arthralgia, abdominal pain, dyspepsia, constipation, others; atypical femur fractures; rarely: dysphagia, esophagitis, gastric ulcer, jaw osteonecrosis, musculoskeletal pain (discontinue if severe); hypersensitivity.
Actonel Clinical Trials
See Literature
Actonel Note
Not Applicable
Actonel Patient Counseling
See Literature
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