TROSPIUM CHLORIDE ER- trospium chloride capsule, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Trospium Chloride (UNII: 1E6682427E) (Trospium - UNII:T4Y8ORK057)

Beschikbaar vanaf:

Padagis US LLC

INN (Algemene Internationale Benaming):

Trospium Chloride

Samenstelling:

Trospium Chloride 60 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are contraindicated in patients with: Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of Trospium Chloride Extended-Release Capsules in pregnant women. Trospium Chloride Extended-Release Capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Trospium Chloride Extended-Release Capsules treatment are encouraged to contact their physician. Trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. This corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommen

Product samenvatting:

Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque capsule, printed with PAD 0118): 60 mg capsule, 30 count, HDPE bottle: NDC 0574-0118-30 Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Dispense in a tight container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TROSPIUM CHLORIDE ER- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE
PADAGIS US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TROSPIUM CHLORIDE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES.
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES
FOR ORAL USE.
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Trospium Chloride Extended-Release Capsules are a muscarinic
antagonist indicated for the treatment of
overactive bladder (OAB) with symptoms of urge urinary incontinence,
urgency, and urinary frequency. (1)
(1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Trospium Chloride Extended-Release Capsules are contraindicated in
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥ 1%) with Trospium Chloride
Extended-Release Capsules are dry
mouth (10.7%) and constipation (8.5%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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The recommended dosage of Trospium Chloride Extended- Release Capsules
is one 60 mg capsule
daily in the morning. Trospium Chloride Extended-Release Capsules
should be dosed with water on an
empty stomach, at least one hour before a meal. (2)
Trospium Chloride Extended-Release Capsules are not recommended for
use in patients with severe
renal impairment (creatinine clearance < 30 mL/minute). (2)
60 mg capsules (3)
patients with urinary retention, gastric retention, or uncontrolled
narrow-angle glaucoma, and in
patients who are at risk for these conditions (4)
patients with known hypersensitivity (4)
Trospium Chloride Extended-Release Capsules should be administered
with caution to patients with
clinically significant bladder outflow obstruction or gastrointestinal
obstructive disorders due to risk of
urinary or gastric retention. (5.1, 5.3)
Angio