1 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.

4 CONTRAINDICATIONS

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.

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)

3 DOSAGE FORMS AND STRENGTHS

Trospium chloride tablets are supplied as 20 mg tablets (round, white to off white, film coated tablets. Imprinted "HP" with black ink on one side and "530" on the reverse side).

20 mg tablets. (3)

2 DOSAGE AND ADMINISTRATION

The recommended dose is 20 mg twice daily. Trospium chloride tablets should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

•

For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3) ].

•

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 [see Use in Specific Populations (8.5) ].

The recommended dose of trospium chloride tablet 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)

10 OVERDOSAGE

Overdosage with antimuscarinic agents, including trospium chloride, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended.

A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby's weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification. While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.

16 HOW SUPPLIED/STORAGE AND HANDLING

Trospium Chloride Tablets USP, 20 mg intended for oral administration are round, white to off-white, film coated tablets. Imprinted "HP" with black ink on one side and "530" on the reverse side. They are supplied as follows:

Bottle of 60 tablets, NDC 0904-7059-52

Store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed

RECENT MAJOR CHANGES

Warnings and Precautions, Central Nervous System Effects (5.5) 07/2012