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
Elmiron Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentosan
Elmiron Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentosan
WARNINGS
None.
PRECAUTIONS
General
Elmiron® (pentosan polysulfate sodium) is a weak
anticoagulant (1/15 the activity
of heparin). Bleeding complications of ecchymosis,
epistaxis, and gum hemorrhage
have been reported (see ADVERSE REACTIONS).
Patients undergoing invasive
procedures or having signs/symptoms of underlying coagulopathy
or other increased risk
of bleeding (due to
other therapies such as
coumarin anticoagulants, heparin, t-PA, streptokinase, or high dose
aspirin) should be evaluated for hemorrhage. Patients with diseases
such as aneurysms, thrombocytopenia,
hemophilia, gastrointestinal ulcerations, polyps, or diverticula
should be carefully evaluated before starting Elmiron®.
A similar product that
was given subcutaneously, sublingually, or intramuscularly (and
not initially metabolized by the liver) is associated with delayed
immunoallergic thrombocytopenia
with symptoms of thrombosis
and hemorrhage. Caution should be exercised when using Elmiron®
in patients who have a history
of heparin induced
thrombocytopenia.
Hepatic Insufficiency: Pentosan polysulfate sodium
is desulfated by both the liver
and the spleen. The extent to which hepatic
insufficiency or splenic
disorders may increase the bioavailability
of the parent or active
metabolites of pentosan polysulfate sodium
is not known. Caution should be exercised when using Elmiron®
in these patients.Mildly (<2.5 x normal) elevated transaminase,
alkaline phosphatase,
g-glutamyl transpeptidase, and lactic
dehydrogenase
occurred in 1.2% of patients. The increases usually appeared 3 to
12 months after the start of Elmiron® therapy, and
were not associated with jaundice
or other clinical signs
or symptoms. These abnormalities are usually transient, may remain
essentially unchanged, or may rarely progress
with continued use. Increases in PTT and PT
(<1% for both) or thrombocytopenia
(0.2%) were noted.
Alopecia is associated with pentosan polysulfate and with heparin
products. In clinical
trials of Elmiron®, alopecia
could begin within the first 4 weeks of treatment. Ninety-seven
percent (97%) of the
cases of alopecia reported
were alopecia areata,
limited to a single area
on the scalp.
Information for Patients
Patients should take the
drug as prescribed, in
the dosage prescribed,
and no more frequently than
prescribed. Patients should be reminded that Elmiron®
has a weak anticoagulant
effect. This effect may
increase bleeding times.
Laboratory Test Findings
Pentosan polysulfate sodium
did not affect prothrombin
time (PT) or partial thromboplastin
time (PTT) up to 1200 mg
per day in 24 healthy
male subjects treated for 8 days. Pentosan polysulfate sodium
also inhibits the generation
of factor Xa in plasma
and inhibits thrombin-induced platelet aggregation in human
platelet rich plasma
ex vivo. (See Hepatic Insufficiency - above for additional
information).
Carcinogenicity, Mutagenesis, Impairment of Fertility
Long term studies in animals
have not been performed to evaluate the carcinogenic potential
of Elmiron®. Pentosan polysulfate sodium was not
clastogenic or mutagenic
when tested in the mouse
micronucleus test or the Ames test
(S. typhimurium). The effect
of pentosan polysulfate sodium on spermatogenesis
has not been investigated.
Pregnancy Category B
Reproduction studies have been performed in mice and rats with
intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg.
These doses are 0.42 and 0.14 times the daily oral
human doses of ELMIRON®
when normalized to body
surface area. These
studies did not reveal evidence of impaired fertility
or harm to the fetus from
Elmiron®. Direct in vitro bathing of cultured mouse
embryos with pentosan polysulfate sodium (PPS) at a concentration
of 1mg/mL may cause reversible
limb bud abnormalities.
Adequate and well controlled studies have not been performed in
pregnant women. Because
animal studies are not
always predictive of human response, this drug
should be used in pregnancy
only if clearly needed.
Nursing Mothers
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 Elmiron® is
administered to a nursing
woman.
Pediatric Use
Safety and effectiveness
in pediatric patients
below the age of 16 years
have not been established.
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