Detrol LA Information
Detrol la (Tolterodine)
Detrol la (Tolterodine) Indications And Usage
Detrol la (Tolterodine) Capsules is indicated for the treatment of overactive
bladder with symptoms of urge urinary incontinence, urgency, and frequency [see
].
Detrol la (Tolterodine) Dosage And Administration
The recommended dose of Detrol la (Tolterodine) 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; however, limited efficacy data are
available for Detrol la (Tolterodine) 2 mg [].
For patients with mild to moderate hepatic impairment (Child-Pugh
Class A or B) or severe renal impairment (CCr 10 – 30 mL/min), the recommended
dose of Detrol la (Tolterodine) is 2 mg once daily. Detrol la (Tolterodine) is not recommended for use in
patients with severe hepatic impairment (Child-Pugh Class C). Patients with
CCr less than 10 mL/min have not been studied and use of Detrol la (Tolterodine) in this population
is not recommended [
For patients who are taking drugs that are potent inhibitors of
CYP3A4 [e.g. ketoconazole, clarithromycin, ritonavir], the recommended dose of
Detrol la (Tolterodine) is 2 mg once daily [see
Detrol la (Tolterodine) 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.
Detrol la (Tolterodine) Contraindications
Detrol la (Tolterodine) Warnings And Precautions
Administer Detrol la (Tolterodine) Capsules with caution to patients with
clinically significant bladder outflow obstruction because of the risk of
urinary retention. [].
Administer Detrol la (Tolterodine) with caution in patients with
gastrointestinal obstructive disorders because of the risk of gastric
retention.
Detrol la (Tolterodine) , like other antimuscarinic drugs, may decrease gastrointestinal
motility and should be used with caution in patients with conditions associated
with decreased gastrointestinal motility (e.g. intestinal atony) [see ].
Administer Detrol la (Tolterodine) with caution in patients being treated for
narrow-angle glaucoma [see ].
The clearance of orally administered tolterodine immediate
release was substantially lower in cirrhotic patients than in the healthy
volunteers. For patients with mild to moderate hepatic impairment (Child-Pugh
Class A or B), the recommended dose for Detrol la (Tolterodine) is 2 mg once daily. Detrol la (Tolterodine)
is not recommended for use in patients with severe hepatic impairment
(Child-Pugh Class C)
Renal impairment can significantly alter the disposition of
tolterodine and its metabolites. The dose of Detrol la (Tolterodine) should be reduced to 2 mg
once daily in patients with severe renal impairment (CCr: 10–30 mL/min).
Patients with CCr less than 10 mL/min have not been studied and use of Detrol la (Tolterodine) in
this population is not recommended [see
].
Administer Detrol la (Tolterodine) with caution in patients with myasthenia
gravis, a disease characterized by decreased cholinergic activity at the
neuromuscular junction
In a study of the effect of tolterodine immediate release tablets
on the QT interval [] the effect on the QT interval
appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4
mg/day and was more pronounced in CYP2D6 poor metabolizers (PM) than extensive
metabolizers (EMs). The effect of tolterodine 8 mg/day was not as large as that
observed after four days of therapeutic dosing with the active control
moxifloxacin. However, the confidence intervals overlapped.
These observations should be considered in clinical decisions to prescribe
Detrol la (Tolterodine) to patients with a known history of QT prolongation or to patients who
are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g.,
amiodarone, sotalol) antiarrhythmic medications. There has been no association
of Torsade de Pointes in the international post-marketing experience with DETROL
or Detrol la (Tolterodine) .
Detrol la (Tolterodine) 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 drug and
may not reflect the rates observed in practice.
The efficacy and safety of Detrol la (Tolterodine) Capsules was evaluated in
1073 patients (537 assigned to Detrol la (Tolterodine) ; 536 assigned to placebo) who were
treated with 2, 4, 6, or 8 mg/day for up to 15 months. These include a total of
1012 patients (505 randomized to Detrol la (Tolterodine) 4 mg once daily and 507 randomized to
placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week
clinical efficacy and safety study.
Adverse events were reported in 52% (n=263) of patients receiving Detrol la (Tolterodine)
and in 49% (n=247) of patients receiving placebo. The most common adverse events
reported by patients receiving Detrol la (Tolterodine) were dry mouth, headache, constipation,
and abdominal pain. Dry mouth was the most frequently reported adverse event for
patients treated with Detrol la (Tolterodine) occurring in 23.4% of patients treated with
Detrol la (Tolterodine) 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 (Tolterodine) and by 3.6% (n=18) of
patients receiving placebo.
Table 1 lists the adverse events, regardless of causality, that were reported
in the randomized, double-blind, placebo-controlled 12-week study at an
incidence greater than placebo and in greater than or equal to 1% of patients
treated with Detrol la (Tolterodine) 4 mg once daily.
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. Dry mouth was the
most common adverse event leading to treatment discontinuation among patients
receiving Detrol la (Tolterodine) [n=12 (2.4%) vs. placebo n=6 (1.2%)].
The following events have been reported in association with
tolterodine use in worldwide post-marketing experience:
Reports of aggravation of symptoms of dementia (e.g., confusion,
disorientation, delusion) have been reported after tolterodine therapy was
initiated in patients taking cholinesterase inhibitors for the treatment of
dementia.
Because these spontaneously reported events are from the worldwide
post-marketing experience, the frequency of events and the role of tolterodine
in their causation cannot be reliably determined.
Detrol la (Tolterodine) Drug Interactions
Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly
inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive
metabolizers, resulting in a 4.8-fold increase in tolterodine AUC. There was a
52% decrease in Cand a 20% decrease in AUC of
5-hydroxymethyl tolterodine (5-HMT), the pharmacologically active metabolite of
tolterodine []. The sums of unbound serum concentrations
of tolterodine and 5-HMT are only 25% higher during the interaction. No dose
adjustment is required when tolterodine and fluoxetine are co-administered
Ketoconazole (200 mg daily), a potent CYP3A4 inhibitor, increased
the mean Cand AUC of tolterodine by 2- and 2.5-fold,
respectively in CYP2D6 poor metabolizers.
For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as
itraconazole, clarithromycin or ritonavir, the recommended dose of Detrol la (Tolterodine) is
2 mg once daily [
].
No clinically relevant interactions have been observed when
tolterodine was co-administered with warfarin, with a combined oral
contraceptive drug containing ethinyl estradiol and levonorgestrel, or with
diuretics
Interactions between tolterodine and laboratory tests have not
been studied.
The concomitant use of Detrol la (Tolterodine) with other anticholinergic
(antimuscarinic) agents may increase the frequency and/or severity of dry mouth,
constipation, blurred vision, somnolence and other anticholienrgic
pharmacological effects.
Detrol la (Tolterodine) Use In Specific Populations
Pregnancy Category C.
At approximately 9–12 times the clinical exposure to the pharmacologically
active components of DETROL® LA, no anomalies or malformations were observed in
mice (based on the AUC of tolterodine and its 5-HMT metabolite at a dose of 20
mg/kg/day). At 14–18 times the exposure (doses of 30 to 40 mg/kg/day) in mice,
tolterodine has been shown to be embryolethal and reduce fetal weight, and
increase the incidence of fetal abnormalities (cleft palate, digital
abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities,
primarily reduced ossification). Pregnant rabbits treated subcutaneously at
about 0.3 – 2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show
any embryotoxicity or teratogenicity. There are no studies of tolterodine in
pregnant women. Therefore, Detrol la (Tolterodine) should be used during pregnancy only if the
potential benefit for the mother justifies the potential risk to the fetus.
Tolterodine is excreted into the milk in mice. Offspring of
female mice treated with tolterodine 20 mg/kg/day during the lactation period
had slightly reduced body weight gain. The offspring regained the weight during
the maturation phase.
It is not known whether tolterodine is excreted in human milk; therefore,
Detrol la (Tolterodine) should not be administered during nursing. A decision should be made
whether to discontinue nursing or to discontinue Detrol la (Tolterodine) in nursing
mothers.
Efficacy in the pediatric population has not been
demonstrated.
The pharmacokinetics of tolterodine extended release capsules have been
evaluated in pediatric patients ranging in age from 11–15 years. The dose-plasma
concentration relationship was linear over the range of doses assessed.
Parent/metabolite ratios differed according to CYP2D6 metabolizer status [
]. CYP2D6 extensive
metabolizers had low serum concentrations of tolterodine and high concentrations
of the active metabolite 5-HMT, while poor metabolizers had high concentrations
of tolterodine and negligible active metabolite concentrations.
A total of 710 pediatric patients (486 on Detrol la (Tolterodine) , 224 on placebo) aged
5–10 with urinary frequency and urge incontinence were studied in two
randomized, placebo-controlled, double-blind, 12-week studies. The percentage of
patients with urinary tract infections was higher in patients treated with
Detrol la (Tolterodine) (6.6%) compared to patients who received placebo (4.5%). Aggressive,
abnormal and hyperactive behavior and attention disorders occurred in 2.9% of
children treated with Detrol la (Tolterodine) compared to 0.9% of children treated with
placebo.
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, serum concentrations of tolterodine and of 5-HMT were
similar in healthy elderly volunteers (aged 64 through 80 years) and healthy
young volunteers (aged less than 40 years). In another clinical study, elderly
volunteers (aged 71 through 81 years) were given tolterodine immediate release 2
or 4 mg (1 or 2 mg bid). Mean serum concentrations of tolterodine and 5-HMT in
these elderly volunteers were approximately 20% and 50% higher, respectively,
than concentrations reported in young healthy volunteers. However, no overall
differences were observed in safety between older and younger patients on
tolterodine in the Phase 3, 12-week, controlled clinical studies; therefore, no
tolterodine dosage adjustment for elderly patients is recommended.
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 and
5-HMT levels were approximately 2–3 fold higher in patients with renal
impairment than in healthy volunteers. Exposure levels of other metabolites of
tolterodine (e.g., tolterodine acid, -dealkylated
tolterodine acid, -dealkylated tolterodine and -dealkylated hydroxy tolterodine) were significantly
higher (10–30 fold) in renally impaired patients as compared to the healthy
volunteers. The recommended dose for patients with severe renal impairment (CCr:
10–30 mL/min) is Detrol la (Tolterodine) 2 mg daily. Patients with CCr less than 10 mL/min have not
been studied and use of Detrol la (Tolterodine) in this population is not recommended [ and
Detrol la (Tolterodine) has not been studied in patients with mild to
moderate renal impairment [CCr 30–80 mL/min].
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
half-life of tolterodine immediate release was longer in cirrhotic patients
(mean, 7.8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4
hours). The clearance of orally administered tolterodine immediate release was
substantially lower in cirrhotic patients (1.0 ± 1.7 L/h/kg) than in the healthy
volunteers (5.7 ± 3.8 L/h/kg). The recommended dose for patients with mild to
moderate hepatic impairment (Child-Pugh Class A or B) is Detrol la (Tolterodine) 2 mg once
daily. Detrol la (Tolterodine) is not recommended for use in patients with severe hepatic
impairment (Child-Pugh Class C) [and
The pharmacokinetics of tolterodine immediate release and 5-HMT
are not influenced by gender. Mean Cof tolterodine
immediate release (1.6 µg/L in males versus 2.2 µg/L in females) and the active
5-HMT (2.2 µg/L in males versus 2.5 µg/L in females) are similar in males and
females who were administered tolterodine immediate release 2 mg. Mean AUC
values of tolterodine (6.7 µgh/L in males versus 7.8
µgh/L in females) and 5-HMT (10 µgh/L in males versus 11 µgh/L in
females) are also similar. The elimination half-life of tolterodine immediate
release for both males and females is 2.4 hours, and the half-life of 5-HMT is
3.0 hours in females and 3.3 hours in males.
Pharmacokinetic differences due to race have not been
established.
Detrol la (Tolterodine) Overdosage
Overdosage with Detrol la (Tolterodine) 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, changes in
the QT interval (slight prolongation of 10% to 20%) were observed at a
suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the
recommended human dose. In clinical trials of normal volunteers and patients, QT
interval prolongation was observed with tolterodine immediate release at doses
up to 8 mg (4 mg bid) and higher doses were not evaluated [].
A 27-month-old child who ingested 5 to 7 tolterodine immediate release 2 mg
tablets was treated with a suspension of activated charcoal and was hospitalized
overnight with symptoms of dry mouth. The child fully recovered.
Detrol la (Tolterodine) Description
Detrol la (Tolterodine) 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
L-hydrogen tartrate. The empirical formula of tolterodine tartrate is CHNO. Its
structure is:
Tolterodine tartrate is a white, crystalline powder with a molecular weight
of 475.6.. The pK value is 9.87 and the solubility in
water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and
practically insoluble in toluene. The partition coefficient (Log D) between
n-octanol and water is 1.83 at pH 7.3.
Detrol la (Tolterodine) 4 mg capsule for oral administration contains 4 mg of tolterodine
tartrate. Inactive ingredients are sucrose, starch, hypromellose,
ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C
Blue #2.
Detrol la (Tolterodine) 2 mg capsule for oral administration contains 2 mg of tolterodine
tartrate, and the following inactive ingredients: sucrose, starch, hypromellose,
ethylcellulose, medium chain triglycerides, oleic acid, gelatin, yellow iron
oxide, and FD&C Blue #2.
Both the 2 mg and 4 mg capsule strengths are imprinted with a pharmaceutical
grade printing ink that contains shellac glaze, titanium dioxide, propylene
glycol, and simethicone.
Detrol la (Tolterodine) Clinical Pharmacology
Tolterodine acts as a competitive antagonist of acetylcholine at
postganglionic muscarinic receptors. Both urinary bladder contraction and
salivation are mediated via cholinergic muscarinic receptors.
After oral administration, tolterodine is metabolized in the liver, resulting
in the formation of 5-hydroxymethyl tolterodine (5-HMT), the major
pharmacologically active metabolite. 5-HMT, which exhibits an antimuscarinic
activity similar to that of tolterodine, contributes significantly to the
therapeutic effect. Both tolterodine and 5-HMT exhibit a high specificity for
muscarinic receptors, since both show negligible activity or affinity for other
neurotransmitter receptors and other potential cellular targets, such as calcium
channels.
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 volunteers. The main
effects of tolterodine at 1 and 5 hours were an increase in residual urine,
reflecting an incomplete emptying of the bladder, and a decrease in detrusor
pressure. These findings are consistent with an antimuscarinic action on the
lower urinary tract.
The effect of 2 mg BID and 4 mg BID of DETROL immediate release (tolterodine
IR) tablets on the QT interval was evaluated in a 4-way crossover, double-blind,
placebo- and active-controlled (moxifloxacin 400 mg QD) study in healthy male
(N=25) and female (N=23) volunteers aged 18–55 years. Study subjects
[approximately equal representation of CYP2D6 extensive metabolizers (EMs) and
poor metabolizers (PMs)] completed sequential 4-day periods of dosing with
moxifloxacin 400 mg QD, tolterodine 2 mg BID, tolterodine 4 mg BID, and placebo.
The 4 mg BID dose of tolterodine IR (two times the highest recommended dose) was
chosen because this dose results in tolterodine exposure similar to that
observed upon coadministration of tolterodine 2 mg BID with potent CYP3A4
inhibitors in patients who are CYP2D6 poor metabolizers [
]. QT interval was measured over a 12-hour period
following dosing, including the time of peak plasma concentration (T) of tolterodine and at steady state (Day 4 of dosing).
Table 2 summarizes the mean change from baseline to steady state in corrected
QT interval (QT) relative to placebo at the time of peak
tolterodine (1 hour) and moxifloxacin (2 hour) concentrations. Both Fridericia's
(QTF) and a population-specific (QTP) method were used to correct QT interval for heart rate. No
single QT correction method is known to be more valid than others. QT interval
was measured manually and by machine, and data from both are presented. The mean
increase of heart rate associated with a 4 mg/day dose of tolterodine in this
study was 2.0 beats/minute and 6.3 beats/minute with 8 mg/day tolterodine. The
change in heart rate with moxifloxacin was 0.5 beats/minute.
The reason for the difference between machine and manual read of QT interval
is unclear.
The QT effect of tolterodine immediate release tablets appeared greater for 8
mg/day (two times the therapeutic dose) compared to 4 mg/day. The effect of
tolterodine 8 mg/day was not as large as that observed after four days of
therapeutic dosing with the active control moxifloxacin. However, the confidence
intervals overlapped.
Tolterodine's effect on QT interval was found to correlate with plasma
concentration of tolterodine. There appeared to be a greater QT interval increase in CYP2D6 poor metabolizers than in CYP2D6
extensive metabolizers after tolterodine treatment in this study.
This study was not designed to make direct statistical comparisons between
drugs or dose levels. There has been no association of Torsade de Pointes in the
international post-marketing experience with DETROL or Detrol la (Tolterodine) [see ].
A summary of mean (± standard deviation) pharmacokinetic parameters of
tolterodine extended release and 5-HMT in extensive (EM) and poor (PM)
metabolizers is provided in Table 3. These data were obtained following single
and multiple doses of tolterodine extended release administered daily to 17
healthy male volunteers (13 EM, 4 PM).
For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as
itraconazole, miconazole, clarithromycin, ritonavir, the recommended dose of
Detrol la (Tolterodine) is 2 mg daily [
].
Detrol la (Tolterodine) Nonclinical Toxicology
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 were approximately
6–9 times, 7 times, and 11 times the clinical exposure to the pharmacologically
active components of DETROL® LA (based on AUC of tolterodine and its 5-HMT
metabolite). At these exposure margins, no increase in tumors was found in
either mice or rats.
No mutagenic or genotoxic effects of tolterodine were detected in a battery
of tests, including bacterial mutation
assays (Ames test) in 4 strains of and in 2 strains of a gene
mutation assay in L5178Y mouse lymphoma cells, and chromosomal aberration tests
in human lymphocytes. Tolterodine was also negative in the bone marrow micronucleus test in the mouse.
In female mice treated for 2 weeks before mating and during gestation with 20
mg/kg/day (about 9–12 times the clinical exposure via AUC), neither effects on
reproductive performance or fertility were seen. In male mice, a dose of 30
mg/kg/day did not induce any adverse effects on fertility.
Detrol la (Tolterodine) Clinical Studies
Detrol la (Tolterodine) Capsules 2 mg were evaluated in 29 patients in a Phase
2 dose-effect study. Detrol la (Tolterodine) 4 mg was evaluated for the treatment of
overactive bladder with symptoms of urge urinary incontinence and frequency in a
randomized, placebo-controlled, multicenter, double-blind, Phase 3, 12-week
study. A total of 507 patients received Detrol la (Tolterodine) 4 mg once daily in the morning
and 508 received placebo. The majority of patients were Caucasian (95%) and
female (81%), with a mean age of 61 years (range, 20 to 93 years). In the study,
642 patients (42%) were 65 to 93 years of age. The study included patients known
to be responsive to tolterodine immediate release and other anticholinergic
medications, however, 47% of patients never received prior pharmacotherapy for
overactive bladder. At study entry, 97% of patients had at least 5 urge
incontinence episodes per week and 91% of patients had 8 or more micturitions
per day.
The primary efficacy assessment was change in mean number of incontinence
episodes per week at week 12 from baseline. Secondary efficacy measures included
change in mean number of micturitions per day and mean volume voided per
micturition at week 12 from baseline.
Patients treated with Detrol la (Tolterodine) experienced a statistically significant
decrease in number of urinary incontinence per week from baseline to last
assessment (week 12) compared with placebo as well as a decrease in the average
daily urinary frequency and an increase in the average urine volume per void.
Mean change from baseline in weekly incontinence episodes, urinary frequency,
and volume voided between placebo and Detrol la (Tolterodine) are summarized in Table 4.
Detrol la (Tolterodine) How Supplied/storage And Handling
Detrol la (Tolterodine) Capsules are supplied as follows:
2 mg Capsules:
Bottles of 30 NDC 54868-5126-0
Bottles of 90 NDC 54868-5126-1
4 mg Capsules:
Bottles of 30 NDC 54868-4514-0
Bottles of 90 NDC 54868-4514-1
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.
Detrol la (Tolterodine) Patient Counseling Information
See .
Patients should be informed that antimuscarinic agents such as
Detrol la (Tolterodine) may produce the following effects: blurred vision, dizziness, or
drowsiness. Patients should be advised to exercise caution in decisions to
engage in potentially dangerous activities until the drug's effects have been
determined.
LAB-0256-7.0December 2009
Detrol la (Tolterodine) is a prescription medicine for used
to treat the following symptoms due to a condition called :
Detrol la (Tolterodine) did not help the symptoms of overactive bladder when studied in
children.
Overactive bladder happens when you cannot control your bladder muscle. When
the muscle contracts too often or cannot be controlled, you get symptoms of
overactive bladder, which are leakage of urine (urge urinary incontinence),
needing to urinate right away (urgency), and needing to urinate often
(frequency).
Before starting Detrol la (Tolterodine) , tell your doctor about all of your medical
conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and
non-prescription medicines, vitamins and herbal supplements. Other drugs can
affect how your body handles Detrol la (Tolterodine) . Your doctor may use a lower dose of
Detrol la (Tolterodine) if you are taking:
Know the medicines you take. Keep a list of them with you to show your doctor
or pharmacist each time you get a new medicine.
The most common side effects with Detrol la (Tolterodine) are:
Medicines like Detrol la (Tolterodine) can cause blurred vision, dizziness, or drowsiness.
Use caution while driving or doing other dangerous activities until you know
how Detrol la (Tolterodine) affects you.
Call your doctor for medical advice about side effects. You may report side
effects to the FDA at 1-800-FDA-1088.
These are not all the side effects with Detrol la (Tolterodine) . For a complete list, ask
your doctor or pharmacist.
Medicines are sometimes prescribed for conditions that are not in the patient
information leaflet. Only use Detrol la (Tolterodine) the way your doctor tells you. Do not
share it with other people even if they have the same symptoms you have. It may
harm them.
This leaflet summarizes the most important information about Detrol la (Tolterodine) . If
you would like more information, talk with your doctor. You can ask your doctor
or pharmacist for information about Detrol la (Tolterodine) that is written for health
professionals. You can also visit
on the Internet, or call 1-888-4-DETROL (1-888-433-8765).
Active ingredients: tolterodine tartrate
Inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium
chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. 2 mg capsule
also contains yellow iron oxide. Capsules have pharmaceutical grade printing ink
that contains shellac glaze, titanium dioxide, propylene glycol, and
simethicone.
