A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sanctura Warnings, Precautions, Pregnancy, Nursing, Abuse - Trospium
Sanctura Warnings, Precautions, Pregnancy, Nursing, Abuse - Trospium
WARNINGS
No specific information available.
PRECAUTIONS
General
Risk of Urinary Retention: Sanctura should be administered
with caution to patients with clinically significant bladder outflow obstruction
because of the risk of urinary retention.
Decreased Gastrointestinal Motility: Sanctura should
be administered with caution to patients with gastrointestinal obstructive disorders
because of the risk of gastric retention (See CONTRAINDICATIONS).
Sanctura, like other anticholinergic drugs, may decrease gastrointestinal motility
and should be used with caution in patients with conditions such as ulcerative
colitis, intestinal atony and myasthenia gravis.
Controlled Narrow-angle Glaucoma: In patients being
treated for narrow-angle glaucoma, Sanctura should only be used if the potential
benefits outweigh the risks and in that circumstance only with careful monitoring.
Patients with Renal Insufficiency: Dose modification
is recommended in patients with severe renal insufficiency (CLcr < 30mL/min).
In such patients, Sanctura should be administered as 20 mg once a day at bedtime
(See DOSAGE AND
ADMINISTRATION).
Patients with Hepatic Impairment: Caution should be
used when administering Sanctura in patients with moderate or severe hepatic
dysfunction (See CLINICAL PHARMACOLOGY:
Pharmacokinetics in Special Populations).
Information for Patients
Patients should be informed that anticholinergic agents, such
as Sanctura, may produce clinically significant adverse effects related to anticholinergic
pharmacological activity. For example, heat prostration (fever and heat stroke
due to decreased sweating) can occur when anticholinergics such as Sanctura
are used in a hot environment. Because anticholinergics such as Sanctura may
also produce dizziness or blurred vision, patients should be advised to exercise
caution. Patients should be informed that alcohol may enhance the drowsiness
caused by anticholinergic agents.
Sanctura should be taken 1 hour prior to meals or on an empty
stomach. If a dose is skipped, patients are advised to take their next dose
1 hour prior to their next meal.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with trospium chloride were conducted
in mice and rats. A 78-week carcinogenicity study in mice and a 104-week carcinogenicity
study in rats were conducted at doses of 2, 20, and 200 mg/kg/day. No evidence
of a carcinogenic effect was found in either mice or rats. The 200 mg/kg/day
dose in the mouse and rat represents approximately 25 and 60 times, respectively,
the human dose based on body surface area. At 200 mg/kg/day in the mouse and
rat after 4 weeks the AUC was 34 and 753 ng•h/mL, respectively. The exposure
in the rat is 8.6-fold higher than the AUC following 40 mg daily exposure in
healthy young or elderly subjects (88 ng•h/mL).
Trospium chloride was not mutagenic in tests for detection
of gene mutations in bacteria (Ames test) and mammalian cells (L5178Y mouse
lymphoma and CHO cells) or in vivo in the rat micronucleus test.
No evidence of impaired fertility was observed in rats administered
doses up to 200 mg/kg/day (about 10 multiples of the expected clinical exposure
via AUC).
Pregnancy
Teratogenic Effects
Pregnancy Category C: Trospium chloride has been shown
to cause maternal toxicity in rats and a decrease in fetal survival in rats
administered approximately 10 times the expected clinical exposure (AUC). The
no effect levels for maternal and fetal toxicity were approximately equivalent
to the expected clinical exposure in rats, and about 5-6 times the expected
clinical exposure in rabbits. No malformations or developmental delays were
observed. There are no adequate and well controlled studies in pregnant women.
Sanctura should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Nursing Mothers
Trospium chloride (2 mg/kg PO and 50 µg/kg IV) was excreted,
to a limited extent (<1%), into the milk of lactating rats. The activity
observed in the milk was primarily from the parent compound. It is not known
whether this drug is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when Sanctura is administered to
a nursing woman. Sanctura should be used during lactation only if the potential
benefit justifies the potential risk to the newborn.
Pediatric Use
The safety and effectiveness of Sanctura in pediatric patients
have not been established.
Geriatric Use
Of the 591 patients with overactive bladder who received treatment
with Sanctura in the two U.S., placebo-controlled, efficacy and safety studies,
249 patients (42%) were 65 years of age and older. Eighty-eight Sanctura-treated
patients (15%) were 75 years of age.
In these 2 studies, the incidence of commonly reported anticholinergic
adverse events in patients treated with Sanctura (including dry mouth, constipation,
dyspepsia, UTI, and urinary retention) was higher in patients 75 years of age
and older as compared to younger patients. This effect may be related to an
enhanced sensitivity to anticholinergic agents in this patient population (See
CLINICAL PHARMACOLOGY: Pharmacokinetics in
Special Populations and DOSAGE AND ADMINISTRATION).
Therefore, based upon tolerability, the dose frequency of Sanctura may be reduced
to 20 mg once daily in patients 75 years of age and older.
top
