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Dezrol LA (tolterodine tartrate) Extended
Release Capsules
 DRUG DESCRIPTION
DETROL LA Capsules contain tolterodine tartrate. The active
moiety, tolterodine, is a muscarinic receptor antagonist.
DETROL LA for oral administration contains 2 mg or 4 mg of
tolterodine tartrate. Both capsule strengths are imprinted with a
pharmaceutical grade printing ink that contains shellac glaze,
titanium dioxide, propylene glycol, and simethicone.
INDICATIONS
DETROL LA Capsules are once daily extended release capsules
indicated for the treatment of overactive bladder with symptoms of
urge urinary incontinence, urgency, and frequency.
USES
This medication is used to treat an
overactive bladder. By relaxing the muscles in the bladder,
tolterodine improves your ability to control your urination. It
helps to reduce leaking of urine, feelings of needing to urinate
right away, and frequent trips to the bathroom. This medication
belongs to the class of drugs known as antispasmodics.
DOSAGE AND ADMINISTRATION
The recommended dose of DETROL LA Capsules are 4 mg daily. DETROL
LA should be taken once daily with liquids and swallowed whole.
The dose may be lowered to 2 mg daily based on individual response
and tolerability, however, limited efficacy data is available for
DETROL LA 2 mg (see Clinical Studies). For patients with
significantly reduced hepatic or renal function or who are
currently taking drugs that are potent inhibitors of CYP3A4, the
recommended dose of DETROL LA is 2 mg daily.
SIDE EFFECTS
The Phase 2 and 3 clinical trial program for DETROL LA Capsules
included 1073 patients who were treated with DETROL LA (n=537) or
placebo (n=536). The patients were treated with 2, 4, 6, or 8
mg/day for up to 15 months. 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 drug and may not reflect
the rates observed in practice. The adverse reaction information
from clinical trials does, however, provide a basis for
identifying the adverse events that appear to be related to drug
use and for approximating rates. The data described below reflect
exposure to DETROL LA 4 mg once daily every morning in 505
patients and to placebo in 507 patients exposed for 12 weeks in
the Phase 3, controlled clinical study.
Adverse events were reported in 52% (n=263) of patients receiving
DETROL LA and in 49% (n=247) of patients receiving placebo. The
most common adverse events reported by patients receiving DETROL
LA were dry mouth, headache, constipation, and abdominal pain. Dry
mouth was the most frequently reported adverse event for patients
treated with DETROL LA occurring in 23.4% of patients treated with
DETROL LA and 7.7% of placebo-treated patients. Dry mouth,
constipation, abnormal vision (accommodation abnormalities),
urinary retention, and dry eyes are expected side effects of
antimuscarinic agents. A serious adverse event was reported by
1.4% (n=7) of patients receiving DETROL LA and by 3.6% (n=18) of
patients receiving placebo.
The frequency of discontinuation due to adverse events was highest
during the first 4 weeks of treatment. Similar percentages of
patients treated with DETROL LA or placebo discontinued treatment
due to adverse events. Treatment was discontinued due to adverse
events and dry mouth was reported as an adverse event in 2.4%
(n=12) of patients treated with DETROL LA and in 1.2% (n=6) of
patients treated with placebo.
Table 4 lists the adverse events reported in 1% or more of
patients treated with DETROL LA 4 mg once daily in the 12-week
study. The adverse events were reported regardless of causality.
OVERDOSE
A 27-month-old child who ingested 5 to 7 tolterodine immediate
release tablets 2 mg was treated with a suspension of activated
charcoal and was hospitalized overnight with symptoms of dry
mouth. The child fully recovered.
CONTRAINDICATIONS
DETROL LA Capsules are contraindicated in patients with urinary
retention, gastric retention, or uncontrolled narrow-angle
glaucoma. DETROL LA is also contraindicated in patients who have
demonstrated hypersensitivity to the drug or its ingredients.
Do not take DETROL LA if
* you have trouble emptying your bladder (also called "urinary
retention")
* your stomach empties slowly (also called "gastric retention")
* you have an eye problem called "uncontrolled narrow-angle
glaucoma"
* you are allergic to DETROL LA or to any of its ingredients. See
the end of this leaflet for a complete list of ingredients.
STORAGE
Store at room temperature (77 degrees F or 25 degrees C) away
from light and moisture. Brief storage between 59-86 degrees F
(15-30 degrees C) is permitted. Do not store in the bathroom. Keep
all medicines away from children
Presentation
Dezrol LA Capsules
Blister of 10 Capsules
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Quality
