Trospium Chloride label

Trospium Chloride

Trospium Chloride Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Trospium chloride tablets, USP are a quaternary ammonium compound with the chemical name of (1α,3β,5α)-3-[(Hydroxydiphenylacetyl)oxy]spiro[8-azoniabicyclo[3.2.1]octane-8,1’-pyrrolidinium] chloride. The molecular formula of trospium chloride is C25H30ClNO3 and its molecular weight is 427.96. The structural formula of trospium chloride is represented below:

Structural Formula Trospium chloride

Trospium chloride, USP is a white to off-white powder. Very soluble in water.

Each trospium chloride tablet, USP contains 20 mg of trospium chloride and is to be given orally. Each tablet also contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hypromellose, hydroxypropylcellulose, polyethylene glycol, titanium dioxide and yellow iron oxide.

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Trospium Chloride Manufacturers

American Health Packaging
No Recall
Trospium Chloride | American Health Packaging
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)].
Golden State Medical Supply, Inc.
No Recall
Trospium Chloride | Golden State Medical Supply, Inc.
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)].
Paddock Llc
No Recall
Trospium Chloride | Paddock Laboratories, Llc
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 < 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 ≥ 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [ see USE IN SPECIFIC POPULATIONS (8.5)].
Apotex Corp.
No Recall
Trospium Chloride | Apotex Corp.
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)].
Glenmark Generics Inc., Usa
No Recall
Trospium Chloride | Glenmark Generics Inc., Usa
The recommended dose is 20 mg twice daily. Trospium chloride tablets USP 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)].
Watson Laboratories, Inc.
No Recall
Trospium Chloride | Actavis Pharma, Inc.
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)].
Bluepoint Laboratories
No Recall
Trospium Chloride | Direct Rx
2.1 General Dosing Considerations

Tramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].

Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS (5.12)].

2.2 Patients Not Currently on Tramadol Immediate-Release Products

Initiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary to 150 mg, 200 mg and 300 mg every five days to achieve a balance between relief of pain and tolerability.

2.3 Patients Currently on Tramadol Immediate-Release Products

Calculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.

2.4 Patients 65 Years of Age and Older

Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

2.5 Patients with Renal Impairment

The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].

2.6 Patients with Hepatic Impairment

The limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

2.7 Discontinuation of Treatment

Withdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].

2.8 Food Effects

Tramadol Hydrochloride Extended-Release may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
Golden State Medical Supply, Inc.
No Recall
Trospium Chloride | Golden State Medical Supply, Inc.
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)].