Trospium chloride

Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

• 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 , Use in Specific Populations , and Clinical Pharmacology ]
• 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 ]
• The recommended dose of trospium chloride tablets 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
• For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime
• 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

Trospium chloride tablets USP are supplied as 20 mg tablets (brownish yellow, round, biconvex, film coated tablets, debossed with ‘E’ on one side and plain on other). 20 mg tablets. ( 3 )

• The safety and effectiveness of trospium chloride tablets
• In pediatric patients have not been established

Of the 591 patients with overactive bladder who received treatment with trospium chloride tablets in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight trospium chloride tablets treated patients (15%) were greater than or equal to 75 years of age. …

• ?See FDA-approved Patient Labeling (Patient Information)” Angioedema Patients should be informed that trospium chloride, the active ingredient in trospium chloride tablets, may produce angioedema which could result in life-threatening airway obstruction
• Patients should be advised to promptly discontinue trospium chloride tablets and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing
• When Not to Use Prior to treatment, patients should fully understand the risks and benefits of trospium chloride tablets. …

• 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
• Trospium chloride tablets is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow- angle glaucoma, and in patients who are at risk for these conditions patients with known hypersensitivity

Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) Some drugs which are actively secreted by the kidney may interact with trospium chloride tablets by competing for renal tubular secretion. ( 7.2 ) Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.4 ) 7.1 Digoxin Concomitant use of trospium chloride tablets and digoxin did not affect the pharmacokinetics of either drug [ see Clinical Pharmacology (12.3) ]. …

Trospium chloride tablets 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 tablets should be used only with careful monitoring. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with trospium chloride tablets. Advise patients not to drive or operate heavy machinery until they know how trospium chloride tablets affects them ( 5.5 ). …

The most common adverse reactions (greater than or equal to 1%) with trospium chloride tablets are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zameer Pharmaceuticals LLC at 1-888-851-7033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …

8.1 Pregnancy Teratogenic Effects Pregnancy Category C : There are no adequate and well-controlled studies of trospium chloride tablets in pregnant women. Trospium chloride tablets 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 tablets treatment are encouraged to contact their physician. …

Overdosage with antimuscarinic agents, including trospium chloride tablets, 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. …

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.