risedronate

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: biphosphonates

REMS

Prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis.
Treatment of Paget's disease in men and women.
Treatment of osteoporosis in men.

Inhibits bone resorption by binding to bone hydroxyapatite, which inhibits osteoclast activity.

Therapeutic effects:

Reversal of the progression of osteoporosis with decreased fractures and other sequelae.
Reduced bone turnover and resorption; normalization of serum alkaline phosphatase with reduced complications of Paget’s disease.

Absorption: Rapidly but poorly absorbed following oral administration (0.63% bioavailability).

Distribution: 60% of absorbed dose distributes to bone.

Metabolism/Excretion: 40% of absorbed dose is excreted unchanged by kidneys; unabsorbed drug is excreted in feces.

Half-Life: Initial: 1.5 hr; terminal: 220 hr (reflects dissociation from bone).

(effects on serum alkaline phosphatase)

ROUTE	ONSET	PEAK	DURATION
PO	within days	30 days	up to 16 mo

Contraindicated in:

Hypersensitivity;
Severe renal impairment (CCr <30 mL/min);
Hypocalcemia;
Abnormalities of the esophagus, which delay esophageal emptying (i.e., strictures, achalasia);
Inability to stand/sit upright for at least 30 min;
OB: Pregnancy.

Use Cautiously in:

History of upper GI disorders;
Other disturbances of bone or mineral metabolism (correct abnormalities before initiating therapy);
Dietary deficiencies (supplemental vitamin D and calcium may be required);
Invasive dental procedures, cancer, receiving chemotherapy, corticosteroids, angiogenesis inhibitors, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly fitting dentures (may ↑ risk of jaw osteonecrosis);
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: chest pain, edema

Derm: rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

EENT: amblyopia, conjunctivitis, dry eyes, eye pain/inflammation, tinnitus

GI: abdominal pain, diarrhea, belching, colitis, constipation, dysphagia, esophageal cancer, esophageal ulcer, esophagitis, gastric ulcer, nausea

MS: arthralgia, musculoskeletal pain, femur fractures, osteonecrosis (primarily of jaw)

Neuro: weakness

Resp: asthma exacerbation

Misc: flu-like syndrome

Drug-drug:

Concurrent use with NSAIDs or aspirin↑ risk of GI irritation.
Absorption is ↓ by calcium supplements or antacids.
Proton pump inhibitors and H2 antagonists may cause a faster release of drug from the delayed-release product that can ↑ levels; concurrent use not recommended

Food ↓ absorption (administer at least 30 min before breakfast).

Prevention and Treatment of Postmenopausal Osteoporosis

PO (Adults ): 5 mg once daily (immediate-release tablets) or 35 mg once weekly (immediate- or delayed-release tablets) or 75 mg taken on 2 consecutive days for a total of 2 tablets each mo (immediate-release tablets) or 150 mg once monthly (immediate-release tablets).

Prevention and Treatment of Glucocorticoid-Induced Osteoporosis

PO (Adults ): 5 mg once daily (immediate-release tablets).

Treatment of Osteoporosis in Men

PO (Adults ): 35 mg once weekly (immediate-release tablets).

Treatment of Paget's Disease

PO (Adults ): 30 mg once daily for 2 mo (immediate-release tablets); retreatment may be considered after 2 mo off therapy.

(Generic available)

Immediate-release tablets: 5 mg; 30 mg; 35 mg; 150 mg
Delayed-release tablets (Atelvia): 35 mg

Perform a routine oral exam prior to initiation of therapy. Dental exam with appropriate preventative dentistry should be considered prior to therapy. Patients with history of tooth extraction, poor oral hygiene, gingival infections, diabetes, or use of a dental appliance or those taking immunosuppressive therapy, angiogenesis inhibitors, or systemic corticosteroids are at greater risk for osteonecrosis of the jaw.
Osteoporosis: Assess patients via bone density study for low bone mass before and periodically during therapy.
Paget’s disease: Assess for symptoms of Paget’s disease (bone pain, headache, decreased visual and auditory acuity, increased skull size).

Lab Test Considerations:

Osteoporosis: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating alendronate therapy. May cause mild, transient ↑ of calcium and phosphate.
- Paget’s disease: Monitor alkaline phosphatase prior to and periodically during therapy to monitor effectiveness of therapy.

Do not confuse Actonel with Actos.
PO: Administer Actonel first thing in the morning with 6–8 oz of water, 30 min prior to other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Administer Atelvia right after breakfast with at least 4 oz of water. DNC: Swallow tablet whole; do not crush, break, or chew.
- Calcium-, magnesium-, or aluminum-containing agents may interfere with absorption of risedronate and should be taken at a different time of day with food.
- Avoid administering delayed-release product with proton pump inhibitors or H₂ antagonists; may allow a faster release and increased drug level.

Instruct patient on the importance of taking as directed. Risedronate should be taken with 6–8 oz of water (mineral water, orange juice, coffee, and other beverages decrease absorption). If a dose of Actonel 35 is missed, take 1 tablet the morning remembered, then return to the 1 tablet/wk on the originally scheduled day; do not take 2 pills at once. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are more than 7 days away: if both Actonel 75 doses are missed, take 1 the morning remembered and 1 the next morning. If only 1 Actonel 75 tablet is missed: take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 75 mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next mo. If 1 or both tablets of Actonel 150 are missed and the next month's scheduled doses are more than 7 days away, take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 150-mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next mo. Encourage patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
Caution patients to remain upright for 30 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation.
Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D (see Food Sources for Specific Nutrients).
Inform patient that severe musculoskeletal pain may occur within days, mo, or yr after starting risedronate. Symptoms my resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
Advise patient to practice good mouth care during therapy and to notify health care professional if signs and symptoms of osteonecrosis of the jaw (jaw pain, toothache, sores on gums) occur.
Advise patient to inform health care professional of risedronate therapy prior to dental surgery.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. May impair female and male fertility.

Reversal of the progression of osteoporosis with decreased fractures and other sequelae. For patients at low risk of fracture, discontinue after 3 to 5 yr of use.
Decrease in serum alkaline phosphatase and the progression of Paget’s disease.

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3098- Risedronate Sodium
  - 0093-3098-29- 12 BLISTER PACK in 1 CARTON (0093-3098-29) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3098- Risedronate Sodium
  - 0093-3098-44- 4 BLISTER PACK in 1 CARTON (0093-3098-44) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3099- Risedronate Sodium
  - 0093-3099-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-3099-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3100- Risedronate Sodium
  - 0093-3100-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-3100-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-7771- Risedronate Sodium
  - 0093-7771-13- 3 BLISTER PACK in 1 CARTON (0093-7771-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-7771- Risedronate Sodium
  - 0093-7771-79- 1 BLISTER PACK in 1 CARTON (0093-7771-79) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19)

0430- Allergan, Inc.
- 0430-0470- Actonel
  - 0430-0470-15- 30 TABLET, FILM COATED in 1 BOTTLE (0430-0470-15)

0430- Allergan, Inc.
- 0430-0471- Actonel
  - 0430-0471-15- 30 TABLET, FILM COATED in 1 BOTTLE (0430-0471-15)

0430- Allergan, Inc.
- 0430-0472- Actonel
  - 0430-0472-03- 4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)

0430- Allergan, Inc.
- 0430-0472- Actonel
  - 0430-0472-07- 12 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-07)

0430- Allergan, Inc.
- 0430-0478- Actonel
  - 0430-0478-01- 1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)

0430- Allergan, Inc.
- 0430-0478- Actonel
  - 0430-0478-02- 3 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-02)

0430- Allergan, Inc.
- 0430-0979- Atelvia
  - 0430-0979-03- 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)

0591- Actavis Pharma, Inc.
- 0591-2044- risedronate sodium
  - 0591-2044-03- 3 TABLET, FILM COATED in 1 DOSE PACK (0591-2044-03)

0591- Actavis Pharma, Inc.
- 0591-2067- risedronate sodium
  - 0591-2067-02- 2 TABLET, FILM COATED in 1 DOSE PACK (0591-2067-02)

0591- Actavis Pharma, Inc.
- 0591-2075- risedronate sodium
  - 0591-2075-04- 4 TABLET, FILM COATED in 1 DOSE PACK (0591-2075-04)

0591- Actavis Pharma, Inc.
- 0591-2075- risedronate sodium
  - 0591-2075-39- 12 TABLET, FILM COATED in 1 DOSE PACK (0591-2075-39)

0591- Actavis Pharma, Inc.
- 0591-2102- risedronate sodium
  - 0591-2102-30- 30 TABLET, FILM COATED in 1 BOTTLE (0591-2102-30)

0591- Actavis Pharma, Inc.
- 0591-2109- risedronate sodium
  - 0591-2109-30- 30 TABLET, FILM COATED in 1 BOTTLE (0591-2109-30)

16714- NorthStar RxLLC
- 16714-870- Risedronate Sodium
  - 16714-870-02- 1 DOSE PACK in 1 CARTON (16714-870-02) > 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (16714-870-01)

33342- Macleods Pharmaceuticals Limited
- 33342-107- Risedronate Sodium
  - 33342-107-06- 3 BLISTER PACK in 1 CARTON (33342-107-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-107- Risedronate Sodium
  - 33342-107-07- 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07)

33342- Macleods Pharmaceuticals Limited
- 33342-107- Risedronate Sodium
  - 33342-107-49- 2000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49)

33342- Macleods Pharmaceuticals Limited
- 33342-108- Risedronate Sodium
  - 33342-108-06- 3 BLISTER PACK in 1 CARTON (33342-108-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-108- Risedronate Sodium
  - 33342-108-07- 30 TABLET, FILM COATED in 1 CONTAINER (33342-108-07)

33342- Macleods Pharmaceuticals Limited
- 33342-108- Risedronate Sodium
  - 33342-108-15- 500 TABLET, FILM COATED in 1 CONTAINER (33342-108-15)

33342- Macleods Pharmaceuticals Limited
- 33342-109- Risedronate Sodium
  - 33342-109-37- 1 BLISTER PACK in 1 CARTON (33342-109-37) > 4 TABLET, FILM COATED in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-109- Risedronate Sodium
  - 33342-109-50- 3 BLISTER PACK in 1 CARTON (33342-109-50) > 4 TABLET, FILM COATED in 1 BLISTER PACK

47335- Sun Pharmaceutical Industries, Inc.
- 47335-666- risedronate sodium
  - 47335-666-08- 100 TABLET, FILM COATED in 1 BOTTLE (47335-666-08)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-666- risedronate sodium
  - 47335-666-18- 1000 TABLET, FILM COATED in 1 BOTTLE (47335-666-18)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-666- risedronate sodium
  - 47335-666-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-666-83)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-666- risedronate sodium
  - 47335-666-88- 100 TABLET, FILM COATED in 1 BOTTLE (47335-666-88)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-667- risedronate sodium
  - 47335-667-08- 100 TABLET, FILM COATED in 1 BOTTLE (47335-667-08)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-667- risedronate sodium
  - 47335-667-18- 1000 TABLET, FILM COATED in 1 BOTTLE (47335-667-18)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-667- risedronate sodium
  - 47335-667-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-667-83)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-667- risedronate sodium
  - 47335-667-88- 100 TABLET, FILM COATED in 1 BOTTLE (47335-667-88)

47335- Sun Pharmaceutical Industries, Inc.
- 47335-668- risedronate sodium
  - 47335-668-62- 3 BLISTER PACK in 1 CARTON (47335-668-62) > 4 TABLET, FILM COATED in 1 BLISTER PACK

47335- Sun Pharmaceutical Industries, Inc.
- 47335-668- risedronate sodium
  - 47335-668-68- 1 BLISTER PACK in 1 CARTON (47335-668-68) > 4 TABLET, FILM COATED in 1 BLISTER PACK

47335- Sun Pharmaceutical Industries, Inc.
- 47335-727- risedronate sodium
  - 47335-727-98- 1 BLISTER PACK in 1 CARTON (47335-727-98) > 2 TABLET, FILM COATED in 1 BLISTER PACK

47335- Sun Pharmaceutical Industries, Inc.
- 47335-928- risedronate sodium
  - 47335-928-60- 1 BLISTER PACK in 1 CARTON (47335-928-60) > 1 TABLET, FILM COATED in 1 BLISTER PACK

47335- Sun Pharmaceutical Industries, Inc.
- 47335-928- risedronate sodium
  - 47335-928-67- 3 BLISTER PACK in 1 CARTON (47335-928-67) > 1 TABLET, FILM COATED in 1 BLISTER PACK

59762- Greenstone LLC
- 59762-0405- Risedronate Sodium
  - 59762-0405-4- 4 TABLET, FILM COATED in 1 DOSE PACK (59762-0405-4)

59762- Greenstone LLC
- 59762-0405- Risedronate Sodium
  - 59762-0405-5- 12 TABLET, FILM COATED in 1 DOSE PACK (59762-0405-5)

59762- Greenstone LLC
- 59762-0406- Risedronate Sodium
  - 59762-0406-1- 1 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)

59762- Greenstone LLC
- 59762-0406- Risedronate Sodium
  - 59762-0406-3- 3 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-3)

59762- Greenstone LLC
- 59762-0407- Risedronate Sodium
  - 59762-0407-4- 1 BLISTER PACK in 1 CARTON (59762-0407-4) > 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-3096- Risedronate Sodium
  - 60505-3096-2- 1 BLISTER PACK in 1 CARTON (60505-3096-2) > 2 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-3097- Risedronate Sodium
  - 60505-3097-2- 1 BLISTER PACK in 1 CARTON (60505-3097-2) > 1 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-3097- Risedronate Sodium
  - 60505-3097-4- 1 BLISTER PACK in 1 CARTON (60505-3097-4) > 3 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-3165- Risedronate Sodium
  - 60505-3165-0- 1 BLISTER PACK in 1 CARTON (60505-3165-0) > 4 TABLET, FILM COATED in 1 BLISTER PACK

60505- Apotex Corp.
- 60505-3165- Risedronate Sodium
  - 60505-3165-2- 3 BLISTER PACK in 1 CARTON (60505-3165-2) > 4 TABLET, FILM COATED in 1 BLISTER PACK

60723- Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
- 60723-041- Risedronate Sodium
  - 60723-041-04- 1 BLISTER PACK in 1 CARTON (60723-041-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)

60723- Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
- 60723-041- Risedronate Sodium
  - 60723-041-12- 3 BLISTER PACK in 1 CARTON (60723-041-12) > 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)

63304- Sun Pharmaceutical Industires Inc.
- 63304-440- RISEDRONATE SODIUM
  - 63304-440-09- 1 DOSE PACK in 1 CARTON (63304-440-09) > 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)

65862- Aurobindo Pharma Limited
- 65862-517- Risedronate Sodium
  - 65862-517-22- 2000 TABLET, FILM COATED in 1 BOTTLE (65862-517-22)

65862- Aurobindo Pharma Limited
- 65862-517- Risedronate Sodium
  - 65862-517-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-517-30)

65862- Aurobindo Pharma Limited
- 65862-517- Risedronate Sodium
  - 65862-517-78- 10 BLISTER PACK in 1 CARTON (65862-517-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-517-10)

65862- Aurobindo Pharma Limited
- 65862-518- Risedronate Sodium
  - 65862-518-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-518-30)

65862- Aurobindo Pharma Limited
- 65862-518- Risedronate Sodium
  - 65862-518-78- 10 BLISTER PACK in 1 CARTON (65862-518-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-518-10)

65862- Aurobindo Pharma Limited
- 65862-518- Risedronate Sodium
  - 65862-518-99- 1000 TABLET, FILM COATED in 1 BOTTLE (65862-518-99)

65862- Aurobindo Pharma Limited
- 65862-519- Risedronate Sodium
  - 65862-519-04- 1 BLISTER PACK in 1 CARTON (65862-519-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK

65862- Aurobindo Pharma Limited
- 65862-519- Risedronate Sodium
  - 65862-519-08- 3 BLISTER PACK in 1 CARTON (65862-519-08) > 4 TABLET, FILM COATED in 1 BLISTER PACK

65862- Aurobindo Pharma Limited
- 65862-870- Risedronate Sodium
  - 65862-870-03- 1 BLISTER PACK in 1 CARTON (65862-870-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK

65862- Aurobindo Pharma Limited
- 65862-870- Risedronate Sodium
  - 65862-870-11- 1 BLISTER PACK in 1 CARTON (65862-870-11) > 1 TABLET, FILM COATED in 1 BLISTER PACK

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-075- Risedronate Sodium
  - 68382-075-73- 1 BLISTER PACK in 1 CARTON (68382-075-73) > 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK

70771- Cadila Healthcare Limited
- 70771-1436- Risedronate Sodium
  - 70771-1436-4- 1 BLISTER PACK in 1 CARTON (70771-1436-4) > 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆