TROSPIUM CHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trospium Chloride Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Tablets are contraindicated in patients with: Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of Trospium Chloride Tablets in pregnant women. Trospium Chloride Tablets 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 Tablets treatment are encouraged to contact their physician. Risk Summary Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equiv

Product summary:

Trospium Chloride Tablets 20 mg (white, round, standard cup film coated tablet, debossed with 'PAD' on one side and '145' on the other side) are supplied as follows: 60 count HDPE bottle - NDC 63629-8457-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TROSPIUM CHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TROSPIUM CHLORIDE
TABLETS.
TROSPIUM CHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Central Nervous System Effects (5.5) 07/2012
INDICATIONS AND USAGE
Trospium Chloride Tablets 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Trospium Chloride Tablets are contraindicated in
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WARNINGS AND PRECAUTIONS
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Trospium is substantially excreted by the kidney. The effects of
moderate renal impairment on systemic
exposure are not known but systemic exposure is likely increased.
Therefore, the risk of anticholinergic
adverse reactions is expected to be greater in patients with moderate
renal impairment. (5.6)
ADVERSE REACTIONS
The most common adverse reactions (≥ 1%) with Trospium Chloride
Tablets are dry mouth (20.1%),
constipation (9.6%), and headache (4.2%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-800-328-5113 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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The recommended dose of Trospium Chloride Tablets are one 20 mg tablet
twice daily. Trospium
Chloride Tablets should be dosed with water on an empty stomach, at
least one hour before a meal.
(2)
For patients with severe renal impairment (creatinine clearance < 30
mL/min), the recommended
dose is 20 mg once daily at bedtime. (2)
In geriatric patients ≥ 75 years of age, dose may be titrated down
to 20 mg once daily based upon
tolerability. (2)
20 mg tablets. (3)
patients with urinary retention, gastric retention, or uncontrolled
narrow-angle glaucoma, and in
patients