TROSPIUM CHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TROSPIUM CHLORIDE (UNII: 1E6682427E) (TROSPIUM - UNII:T4Y8ORK057)

Available from:

Actavis Pharma, Inc.

INN (International Name):

TROSPIUM CHLORIDE

Composition:

TROSPIUM CHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. 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

Product summary:

Trospium chloride extended-release capsules are supplied as 60 mg capsules (orange cap printed with “WPI” and white opaque body printed with “3636” ): 60 mg capsule, 30 count, HDPE bottle: NDC 0591-3636-30 60 mg capsule, 60 count, HDPE bottle: NDC 0591-3636-60 60 mg capsule, 500 count, HDPE bottle: NDC 0591-3636-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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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
CAPSULE S.
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES
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)
DOSAGE AND ADMINISTRATION
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 less than 30 mL/minute). (2)
DOSAGE FORMS AND STRENGTHS
60 mg capsules (3)
CONTRAINDICATIONS
Trospium Chloride Extended-release Capsules are contraindicated in
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)
WARNINGS AND PRECAUTIONS
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)
Angioedema of the face, lips, tongue and/or larynx has been reported
with trospium chloride (5.2)
In patients with narrow angle glaucoma, Trospium Chloride
Extended-release Capsules should be used only with
careful monitoring. (5.4)
Central Nervous System Effects: Somnolence has been reported with
Trospium Chloride Extended-release Capsules.
Advise patients not to drive