Actonel 129 mg/1

Risedronate Sodium · TABLET, FILM COATED · Allergan, Inc.

No Recall History

Plain English

Actonel is a tablet, film coated containing risedronate sodium at 129 mg/1, taken oral. Manufactured by Allergan, Inc..

Key Facts

Brand Name: Actonel
Generic Name: Risedronate Sodium
NDC Code (Product): 0430-0478
Manufacturer: Allergan, Inc.
Strength: 129 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020835
Marketing Start: 04/22/2008

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia3,753 reports

pain3,674 reports

drug ineffective3,653 reports

nausea2,997 reports

fatigue2,949 reports

dyspnoea2,902 reports

off label use2,859 reports

vomiting2,817 reports

diarrhoea2,673 reports

drug hypersensitivity2,501 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ACTONEL is a 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 Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.5 ) 1.1 Postmenopausal Osteoporosis ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ( 14.1 , 14.2 ) ] . 1.2 Osteoporosis in Men ACTONEL is indicated for treatment to increase bone mass in men with osteoporosis. 1.3 Glucocorticoid-Induced Osteoporosis ACTONEL is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of pr…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Treatment of Postmenopausal Osteoporosis: 5 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: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget’s Disease: 30 mg daily for 2 months ( 2.5 ) Instruct patients to: Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes ( 2 ) Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.7 ) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month or one 150 mg tablet orally, taken once-a-month 2.2 Prevention of Postmenopausal Osteoporosis [ see Indications and Usage ( 1.1 ) ] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once…

Contraindications

4 CONTRAINDICATIONS ACTONEL is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions ( 5.1 ) ] Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ) ] Hypocalcemia [ see Warnings and Precautions ( 5.2 ) ] Known hypersensitivity to ACTONEL or any of its excipients. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [ see Adverse Reactions ( 6.2 ) ] 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 , 5.3 ) Known hypersensitivity to any component of this product ( 4 , 6.2 )

Drug Interactions

7 DRUG INTERACTIONS No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL ( 7.1 ) 7.1 Calcium Supplements/Antacids Co-administration of ACTONEL and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of ACTONEL. 7.2 Hormone Replacement Therapy One study of about 500 early postmenopausal women has been conducted to date in which treatment with ACTONEL 5 mg daily plus estrogen replacement therapy was compared to estrogen replacement therapy alone. Exposure to study drugs was approximately 12 to 18 months and the primary endpoint was change in BMD. If considered appropriate, ACTONEL may be used concomitantly with hormone replacement therapy. 7.3 Aspirin/Nonsteroidal Anti-Inflammatory Drugs Of over 5700 patients enrolled in the ACTONEL Phase 3 osteoporosis studies, aspirin use was reported by 31% of patients, 24% of whom were regular users (3 or more days per week). Forty-eight percent of p…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions ( 5.1 ) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 ) ] Mineral Metabolism [see Warnings and Precautions ( 5.3 ) ] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 ) ] Musculoskeletal Pain [see Warnings and Precautions ( 5.5 ) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.6 ) ] Renal Impairment [see Warnings and Precautions ( 5.7 ) ] Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions ( 5.8 ) ] Laboratory Test Interactions [see Warnings and Precautions ( 5.9 ) ] Most common adverse reactions reported in greater than 10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia ( 6.1 ) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely ( 6.2 ) To report SUSPECTED ADVERSE REAC…

Frequently Asked Questions

What is Actonel used for?

Actonel contains Risedronate Sodium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Actonel a controlled substance?

Actonel is not classified as a controlled substance by the DEA.

What is the generic name for Actonel?

The generic name for Actonel is Risedronate Sodium. There are 12 other brand versions of Risedronate Sodium.

What is the NDC code for Actonel 129 mg/1?

The NDC (National Drug Code) for Actonel 129 mg/1 is 0430-0478, listed by Allergan, Inc..

Product NDC

0430-0478

Package NDC

0430-0478-01

Other Risedronate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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