RISEDRONATE SODIUM tablet delayed release
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
14-01-2018
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Active ingredient:
RISEDRONATE SODIUM MONOHYDRATE (UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z)
Available from:
Teva Pharmaceuticals USA Inc
INN (International Name):
RISEDRONATE SODIUM MONOHYDRATE
Composition:
RISEDRONATE SODIUM 35 mg
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, DELAYED RELEASE
TEVA PHARMACEUTICALS USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS.
RISEDRONATE SODIUM DELAYED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 04/2015
INDICATIONS AND USAGE
Risedronate sodium delayed-release tablets are a bisphosphonate in a
delayed-release formulation and is indicated for
treatment of postmenopausal osteoporosis (1.1)
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 (1.2)
DOSAGE AND ADMINISTRATION
One 35 mg delayed-release tablet once-a-week (2.1)
Instruct patients to:
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DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 35 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (greater than 5%) include: diarrhea,
influenza, arthralgia, back pain, and abdominal pain
(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 REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR DRUG.SAFETY@TEVAPHARM.COM; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Calcium supplements, antacids, proton pump inhibitors (PPIs), H
blockers, magnesium-based supplements or laxatives,
Contraindications (4) 03/2015
Take risedronate sodium delayed-release tablets in the morning
immediately _following breakfast_ with at least 4
ounces of plain water (2.2)
Avoid lying down for 30 minutes after taking risedronate sodium
delayed-release tablets (2.2)
Take supp
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