Risedronate Sodium

RISEDRONATE SODIUM — risedronate sodium tablet, film coated
Aurobindo Pharma Limited

1 INDICATIONS AND USAGE

1.1 Postmenopausal Osteoporosis

Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce 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

Risedronate sodium tablets are is indicated for treatment to increase bone mass in men with osteoporosis.

1.3 Glucocorticoid-Induced Osteoporosis

Risedronate sodium tablets are 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 prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

1.4 Paget’s Disease

Risedronate sodium tablets are indicated for treatment of Paget’s disease of bone in men and women.

1.5 Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years 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.

2 DOSAGE AND ADMINISTRATION

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 dose 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 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 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 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 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.

3 Risedronate Sodium Dosage Forms and Strengths

  • 150 mg blue colored, circular shaped, film-coated biconvex tablets debossed with ‘Z’ on one side and ‘43’ on the other side.

4 CONTRAINDICATIONS

Risedronate sodium tablets are contraindicated in patients with the following conditions:

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.