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ACTONEL
Bone disorders
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Drug Name:

ACTONEL Rx

Generic Name and Formulations:
Risedronate (as sodium) 5mg, 30mg, 35mg, 150mg; tabs.

Company:
Allergan

Therapeutic Use:

Indications for ACTONEL:

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.

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.

Contraindications:

Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30min. Hypocalcemia.

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 (Cat.C). Nursing mothers: not recommended.

Interactions:

Calcium, aluminum, magnesium, other divalent cations reduce absorption (separate dosing). Caution with other GI irritants. May interfere with bone-imaging agents.

Pharmacological Class:

Bisphosphonate.

Adverse Reactions:

Back pain, arthralgia, abdominal pain, dyspepsia, constipation, others; atypical femur fractures; rarely: dysphagia, esophagitis, gastric ulcer, jaw osteonecrosis; hypersensitivity.

Generic Availability:

YES

How Supplied:

Tabs 5mg, 30mg—30; 35mg—4, 12; 150mg—1, 3

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