Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
TROSPIUM CHLORIDE (UNII: 1E6682427E) (TROSPIUM - UNII:T4Y8ORK057)
BluePoint Laboratories
TROSPIUM CHLORIDE
TROSPIUM CHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
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
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 68001-228-04 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
TROSPIUM CHLORIDE- TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE BLUEPOINT LABORATORIES ---------- 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 CAPSULES. 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 no Прочитајте комплетан документ