DETROL LA Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Pharmacia and Upjohn Company LLC

Λέξεις κλειδιά

0009-5190 0009-5191

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1. Indications and Usage

DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see CLINICAL STUDIES (14)].

2. Dosage and Administration

2.1 Dosing Information The recommended dose of DETROL LA Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; ...

3. Dosage Forms and Strengths

The 2 mg capsules are blue-green with symbol and 2 printed in white ink. The 4 mg capsules are blue with symbol and 4 printed in white ink.

4. Contraindications

DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the ...

5. Warnings and Precautions

5.1 Angioedema Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL LA. In the event of difficulty in breathing, ...

6. Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.1. Clinical Trials Experience

The efficacy and safety of DETROL LA Capsules was evaluated in 1073 patients (537 assigned to DETROL LA; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included ...

6.2. Postmarketing Experience

The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylaxis and angioedema; Cardiovascular: tachycardia, palpitations, ...

7. Drug Interactions

7.1 Potent CYP2D6 Inhibitors Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive metabolizers, resulting in a ...

8.1. Pregnancy

Risk Summary There are no available data with DETROL LA use in pregnant women to inform drug-associated risks. In animal reproduction studies, oral administration of tolterodine and its 5-HMT metabolite ...

8.2. Lactation

Risk Summary There is no information on the presence of tolterodine or its 5-HMT metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. Based on limited data, ...

8.4. Pediatric Use

The effectiveness of DETROL LA has not been established in pediatric patients. Efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric ...

8.5. Geriatric Use

No overall differences in safety were observed between the older and younger patients treated with tolterodine. In multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, ...

8.6. Renal Impairment

Renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. In a study conducted in patients with creatinine clearance between 10 and 30 mL/min, tolterodine ...

8.7. Hepatic Impairment

Liver impairment can significantly alter the disposition of tolterodine immediate release. In a study of tolterodine immediate release conducted in cirrhotic patients (Child-Pugh Class A and B), the elimination ...

10. Overdosage

Overdosage with DETROL LA Capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage. In dogs, ...

11. Description

DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropanamine ...

12.1. Mechanism of Action

Tolterodine acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors. Both urinary bladder contraction and salivation are mediated via cholinergic muscarinic receptors. ...

12.2. Pharmacodynamics

Tolterodine has a pronounced effect on bladder function. Effects on urodynamic parameters before and 1 and 5 hours after a single 6.4 mg dose of tolterodine immediate release were determined in healthy ...

12.3. Pharmacokinetics

Absorption In a study with 14C-tolterodine solution in healthy volunteers who received a 5 mg oral dose, at least 77% of the radiolabeled dose was absorbed. Cmax and area under the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with tolterodine were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/kg/day), female rats (20 mg/kg/day), and male rats (30 mg/kg/day), exposure margins ...

14. Clinical Studies

DETROL LA Capsules 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study. DETROL LA 4 mg was evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence and ...

16.1. How Supplied

DETROL LA Capsules are supplied as follows: Bottles of 30: 2 mg Capsules NDC 0009-5190-01 4 mg Capsules NDC 0009-5191-01 Bottles of 500: 2 mg Capsules NDC 0009-5190-03 4 mg Capsules NDC ...

16.2. Storage and Handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Antimuscarinic Effects Inform patients that antimuscarinic agents such as DETROL LA may have side effects including blurred ...