RISEDRONATE SODIUM tablet, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

RISEDRONATE SODIUM (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Διαθέσιμο από:

Sun Pharmaceutical Industires Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Risedronate sodium delayed-release tablets are 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) ]. The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets 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. Risk Summary Available data on use of risedronate sodium in pregnant women are insufficient to inform drug-associated risk of adverse maternal or fetal outcomes. Discon

Περίληψη προϊόντος:

Risedronate sodium delayed-release tablets are: 35 mg, oval-shaped, yellow colored coated tablets with ‘S’ imprinted on one side and plain on the other side. NDC 63304-440-09 Blister pack of 4 tablets. Store at 20º - 25º C (68º - 77º F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, DELAYED RELEASE
SUN PHARMACEUTICAL INDUSTIRES 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
INDICATIONS AND USAGE
Risedronate sodium delayed-release tablets are bisphosphonate in a
delayed-release formulation and is indicated for
treatment of postmenopausal osteoporosis (1.1) (1)
Limitations of Use (1)
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). (1)
DOSAGE AND ADMINISTRATION
One 35 mg delayed-release tablet once-a-week (2.1) (2)
Instruct patients to: (2)
• Take risedronate sodium delayed-release tablets in the morning
immediately _following breakfast_ with at least 4 ounces of
plain water (2.2) (2)
• Avoid lying down for 30 minutes after taking risedronate sodium
delayed-release tablets (2.2) (2)
• Take supplemental calcium and vitamin D if dietary intake is
inadequate (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Delayed-release tablets: 35 mg (3) (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) (6)
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) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES INC. AT 1-800-818-4555
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
Calcium supplements, antacids, proton pump inhibitors (PPIs), H
blockers, magnesium-based supplements or