TROSPIUM CHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

TROSPIUM CHLORIDE

Composition:

TROSPIUM CHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trospium chloride tablets, USP 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: - 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 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 treatment are encouraged to contact their physician.   Risk Summary Based on animal data, trospium chloride tablets are predicted to have a low probability of increased risk of adverse developmental outcomes, above b

Product summary:

Trospium chloride tablets, USP 20 mg (brownish-yellow, round, biconvex, film-coated tablets, engraved “APO” on one side and “TR” over “20” on the other side) are supplied as follows: Bottles of 60       NDC 42291-846-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TROSPIUM CHLORIDE TABLET, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TROSPIUM CHLORIDE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TROSPIUM CHLORIDE
TABLETS, USP.
TROSPIUM CHLORIDE TABLETS, USP, 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, USP 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 dose of trospium chloride is 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 less
than 30 mL/min), the recommended dose is 20 mg
once daily at bedtime. ( 2)
In geriatric patients greater than or equal to 75 years of age, dose
may be titrated down to 20 mg once daily based upon
tolerability. ( 2)
DOSAGE FORMS AND STRENGTHS
20 mg tablets. ( 3)
CONTRAINDICATIONS
Trospium chloride tablets 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 tablets 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 controlled narrow angle glaucoma trospium chloride
tablets should be used only with careful
monitoring. ( 5.4)
Central Nervous System Effects: Somnolence has been