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:

BIOMES PHARMACEUTICALS LLC

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 chlorideis 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 in pregnant women. Trospium chlorideshould 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 is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were

Product summary:

Trospium chloride tablets USP 20 mg (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on other side) are supplied as   follows: Bottles of 60 NDC 69150-258-06 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]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TROSPIUM CHLORIDE- TROSPIUM CHLORIDE TABLET
BIOMES PHARMACEUTICALS LLC
----------
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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
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) (1)
DOSAGE AND ADMINISTRATION
The recommended dose of trospium chloride tablets USP is one 20 mg
tablet twice daily. Trospium chloride tablets
USP 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 is 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 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
should be used only with careful monitoring. (5.4)
Central Nervous System Effects: Somnolence has been reported with
trospium chloride. Advise patients not to drive
or operate heavy machinery until they know how trospium chloride
affects the