Drug Catalog - Product Detail
TROSPIUM CHLORIDE ER CP 60MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-3636-30 | ACTAVIS PHARMA | 30 | 60MG | CAPSULE |
PACKAGE FILES
Generic Name
TROSPIUM CHLORIDE
Substance Name
TROSPIUM CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA091289
Description
11 DESCRIPTION Trospium chloride extended-release capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below: Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium chloride extended-release capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients:corn starch, ethylcellulose, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, polyvinyl alcohol, sodium lauryl sulfate, sucrose, talc, titanium dioxide and triethyl citrate. The capsule shell and imprinting ink have the following inactive ingredients: D&C Red #28, D&C Yellow # 10, FD&C Blue # 1, FD&C Blue # 2, FD&C Red #40, FDA/E172 Yellow iron oxide, gelatin, iron oxide black, propylene glycol, shellac glaze, and titanium dioxide. structural formula of trospium chloride
How Supplied
Indications & Usage
1 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. 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
2 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. Trospium chloride extended-release capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8 .6 ), and Clinical Pharmacology ( 12 .3 )]. 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 )