Risedronate

Risedronate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Overview

Risedronate is a Bisphosphonate that is FDA approved for the {{{indicationType}}} of Postmenopausal Osteoporosis, Osteoporosis in Men, Glucocorticoid-Induced Osteoporosis, Paget’s Disease. Common adverse reactions include Rash，Abdominal pain， Constipation，Diarrhea，Indigestion，Nausea，Backache，Urinary tract infectious disease，Influenza-like illness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Postmenopausal Osteoporosis

• Recommended regimen is:

• 5 mg PO qd
• 35 mg PO once-a-week
• 75 mg PO taken on two consecutive days for a total of two tablets each month
• 150 mg PO taken once-a-month

Prevention of Postmenopausal Osteoporosis

• Recommended regimen is:

• 5 mg PO qd
• 35 mg PO taken once-a-week
• alternatively, 75 mg PO taken on two consecutive days for a total of two tablets each month may be considered
• alternatively, ‘’‘150 mg PO’‘’, taken once-a-month may be considered

Treatment to Increase Bone Mass in Men with Osteoporosis

• Recommended regimen is:

• 35 mg PO once-a-week

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis

• Recommended regimen is:

• 5 mg PO qd

Treatment of Paget’s Disease

• Recommended treatment regimen: 30 mg PO qd 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Risedronate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Risedronate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Risedronate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Risedronate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Risedronate in pediatric patients.

Contraindications

There is limited information regarding Risedronate Contraindications in the drug label.

Warnings

There is limited information regarding Risedronate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Risedronate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Risedronate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Risedronate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Risedronate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Risedronate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Risedronate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Risedronate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Risedronate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Risedronate in geriatric settings.

Gender

There is no FDA guidance on the use of Risedronate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Risedronate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Risedronate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Risedronate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Risedronate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Risedronate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Risedronate Administration in the drug label.

Monitoring

There is limited information regarding Risedronate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Risedronate and IV administrations.

Overdosage

There is limited information regarding Risedronate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Risedronate Mechanism of Action in the drug label.

Structure

There is limited information regarding Risedronate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Risedronate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Risedronate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Risedronate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Risedronate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Risedronate How Supplied in the drug label.

Storage

There is limited information regarding Risedronate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Risedronate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Risedronate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Risedronate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Risedronate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.