Risedronate Sodium

Add Info

Risedronate Sodium Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

1.1 Postmenopausal Osteoporosis

Risedronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1)].

1.2 Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Risedronate sodium for the treatment of osteoporosis are based on clinical data of one year duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

Risedronate sodium delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA).

Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate sodium tablet for oral administration contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:

Molecular Weight:

Anhydrous: 305.10

Hemi-pentahydrate: 350.13

Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.

Inactive Ingredients

Edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer, polysorbate 80, silicified microcrystalline cellulose (ProSolv SMCC90), simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.

Sources

Risedronate Sodium Manufacturers

Actavis Pharma, Inc.

Risedronate Sodium | Actavis Pharma, Inc.

2.1       Treatment of Postmenopausal Osteoporosis
[see Indications and Usage (1.1)]

The recommended regimen is:
one 35 mg delayed-release tablet orally, taken once-a-week 2.2       Important Administration Instructions
Instruct patients to do the following:
Take Risedronate sodium in the morning immediately following breakfast. Risedronate sodium should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting.
Swallow Risedronate sodium whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.2)].
Do not chew, cut, or crush Risedronate sodium tablets. 2.3       Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.3)] and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of Risedronate sodium.
2.4 Administration Instructions for Missed Doses
If the once-weekly dose is missed, instruct patients to take one tablet on the morning after they remember and return to taking one tablet once-a-week, as originally scheduled on their chosen day. Patients should not take two tablets on the same day.

No Recall
Teva Pharmaceuticals Usa Inc

Risedronate Sodium | L.n.k. International, Inc.

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12
years and over 1 to 2 tablets children 6 to under 12
years 1 tablet children under 6 years do not use

No Recall
Apotex Corp.

Risedronate Sodium | L'oreal Usa Products Inc

For sunscreen use:

● apply generously and evenly 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

No Recall
Sun Pharma Global Fze

Risedronate Sodium | Sun Pharma Global Fze

2.1 Treatment of Postmenopausal Osteoporosis
[see Indications and Usage (1.1)]

The recommended regimen is:
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:
alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or alternatively, one 150 mg tablet orally, taken once-a-month may be considered 2.6 Important Administration Instructions
Instruct patients to do the following:
Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [see Drug Interactions (7.1)]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. Swallow risedronate sodium tabletswhole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.1)]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instructpatients to take supplemental calcium and vitamin D if their dietary intake isinadequate; and to take calcium supplements, antacids, magnesium-basedsupplements or laxatives, and iron preparations at a different time of the dayas they interfere with the absorption of risedronate sodium.
2.8 Administration Instructions for Missed Doses
Instruct patients about missing risedronate sodium tablets doses as follows:
If one or both risedronate sodium tablets 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away:
If both tablets are missed, take one risedronate sodium tablet 75 mg in the morning after the day it is remembered and then the other tablet on the next consecutive morning.
If only one risedronate sodium tablet 75 mg is missed, take the missed tablet in the morning after the day it is remembered
Return to taking their risedronate sodium tablet 75 mg on two consecutive days per month as originally scheduled.
Do not take more than two 75 mg tablets within 7 days.
If one or both risedronate sodium tablets 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days:
Wait until their next month’s scheduled doses and then continue taking risedronate sodium tablets 75 mg on two consecutive days per month as originally scheduled.
If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away:
Take the missed tablet in the morning after the day it is remembered and then return to taking their risedronate sodium tablet 150 mg once-a-month as originally scheduled.
Do not take more than one 150 mg tablet within 7 days.
If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days:
Wait until their next month’s scheduled dose and then continue taking risedronate sodium tablet 150 mg once-a-month as originally scheduled.

No Recall
Mylan Pharmaceuticals Inc.

Risedronate Sodium | Mylan Pharmaceuticals Inc.

2.1 Treatment of Postmenopausal Osteoporosis
[See Indications and Usage (1.1).]

The recommended regimen is:
• 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 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or • one 150 mg tablet orally, taken once-a-month may be considered 2.6 Important Administration Instructions
Instruct patients to do the following:
• Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [ see Drug Interactions (7.1)]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. • Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [ see Warnings and Precautions (5.1)]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. • Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.
2.8 Administration Instructions for Missed Doses
Instruct patients about missing risedronate sodium tablet doses as follows:
• If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away: • If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning. • If only one risedronate sodium 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered. • Return to taking their risedronate sodium 75 mg tablets on two consecutive days per month as originally scheduled. • Do not take more than two 75 mg tablets within 7 days. • If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days: • Wait until their next month’s scheduled doses and then continue taking risedronate sodium 75 mg tablets on two consecutive days per month as originally scheduled. • If the dose of risedronate sodium 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away: • Take the missed tablet in the morning after the day it is remembered and then return to taking their risedronate sodium 150 mg tablet once-a-month as originally scheduled. • Do not take more than one 150 mg tablet within 7 days. • If the dose of risedronate sodium 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days: • Wait until their next month’s scheduled dose and then continue taking risedronate sodium 150 mg tablet once-a-month as originally scheduled.

No Recall
Actavis Pharma, Inc.

Risedronate Sodium | Actavis Pharma, Inc.

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-a-week
or alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered
or alternatively, one 150 mg tablet orally, taken once-a-month may be considered 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
[see Indications and Usage (1.2)]

The recommended regimen is:
one 35 mg tablet orally, taken once-a-week 2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
[see Indications and Usage (1.3)]

The recommended regimen is:
one 5 mg tablet orally, taken daily 2.5 Treatment of Paget’s Disease
[see Indications and Usage (1.4)]

The recommended treatment regimen is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of retreatment.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [see Drug Interactions (7.1)]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.1)]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.
2.8 Administration Instructions for Missed Doses
Instruct patients about missing risedronate sodium tablets doses as follows:
If a dose of risedronate sodium tablets 35 mg once-a-week is missed: Take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day. Do not take 2 tablets on the same day.

If one or both tablets of risedronate sodium tablets 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away: If both tablets are missed, take one risedronate sodium tablets 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning. If only one risedronate sodium tablets 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered Return to taking their risedronate sodium tablets 75 mg on two consecutive days per month as originally scheduled. Do not take more than two 75 mg tablets within 7 days.

If one or both tablets of risedronate sodium tablets 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days: Wait until their next month’s scheduled doses and then continue taking risedronate sodium tablets 75 mg on two consecutive days per month as originally scheduled.

If the dose of risedronate sodium tablets 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away: Take the missed tablet in the morning after the day it is remembered and then return to taking their risedronate sodium tablets 150 mg once-a-month as originally scheduled. Do not take more than one 150 mg tablet within 7 days.

If the dose of risedronate sodium tablets 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days: Wait until their next month’s scheduled dose and then continue taking risedronate sodium tablets 150 mg once-a-month as originally scheduled.

No Recall