ELMIRON- pentosan polysulfate sodium capsule, gelatin coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PENTOSAN POLYSULFATE SODIUM (UNII: 914032762Y) (PENTOSAN POLYSULFATE - UNII:F59P8B75R4)

Boleh didapati daripada:

Janssen Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

PENTOSAN POLYSULFATE SODIUM

Komposisi:

PENTOSAN POLYSULFATE SODIUM 100 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. ELMIRON ® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

Ringkasan produk:

ELMIRON ® is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg pentosan polysulfate sodium. Supplied in bottles of 100 capsules. NDC NUMBER 50458-098-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.

Status kebenaran:

New Drug Application

Risalah maklumat

Janssen Pharmaceuticals, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration Revised: 03/2021
MEDICATION GUIDE
ELMIRON ® (EL ma ron)
(pentosan polysulfate sodium)
capsules, for oral use
What is the most important information I should know about ELMIRON?
Serious side effects have been reported with the use of ELMIRON,
including:
•
Changes in the retina of the eye (pigmentary maculopathy). Taking
ELMIRON may be associated
with pigment changes in the retina of the eye that may continue even
after stopping treatment with
ELMIRON. Tell your healthcare provider including your eye doctor right
away if you have any
vision changes including any of these symptoms:
•
difficulty reading
•
your vision takes longer to adjust to low or
reduced light
•
blurred vision
Throughout your treatment, regular eye examinations that include
retinal examinations are suggested for
early detection of retinal/macular changes. Your doctor will discuss
with you when to get your first eye
examination and follow up exams, and whether the treatment should be
continued.
•
Increased bleeding. ELMIRON may increase bleeding. Tell your
healthcare provider right away if
you have any of these symptoms:
•
bruising easily
•
nosebleeds
•
bleeding gums
•
blood in your
stool
Your risk of bleeding may be increased if you take ELMIRON along with
other medicines such as:
•
warfarin sodium
•
heparin
•
high doses of aspirin
•
anti-inflammatory medicines such as ibuprofen
Tell your healthcare provider if you are taking any of these
medicines.
Before you start taking ELMIRON, tell your healthcare provider if you
are going to have surgery. Your
healthcare provider may stop ELMIRON before you have surgery. Talk to
your healthcare provider about
when to stop taking ELMIRON and when to start taking it again.
What is ELMIRON?
•
ELMIRON is a prescription medicine used to treat bladder pain or
discomfort associated with
interstitial cystitis.
•
It is not known if ELMIRON is safe and effective in ch

Ciri produk

ELMIRON- PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED
JANSSEN PHARMACEUTICALS, INC.
----------
ELMIRON
-100 MG
(PENTOSAN POLYSULFATE SODIUM)
CAPSULES
PRESCRIBING INFORMATION
DESCRIPTION
Pentosan polysulfate sodium is a semi-synthetically produced
heparin-like
macromolecular carbohydrate derivative, which chemically and
structurally resembles
glycosaminoglycans. It is a white odorless powder, slightly
hygroscopic and soluble in
water to 50% at pH 6. It has a molecular weight of 4000 to 6000 Dalton
with the
following structural formula:
ELMIRON
is supplied in white opaque hard gelatin capsules containing 100 mg
pentosan polysulfate sodium, microcrystalline cellulose, and magnesium
stearate. It also
contains pharmaceutical glaze (modified) in SD-45, synthetic black
iron oxide, FD&C Blue
No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1
aluminum lake,
D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol,
SDA-3A alcohol, and
titanium dioxide. It is formulated for oral use.
CLINICAL PHARMACOLOGY
GENERAL
Pentosan polysulfate sodium is a low molecular weight heparin-like
compound. It has
anticoagulant and fibrinolytic effects. The mechanism of action of
pentosan polysulfate
sodium in interstitial cystitis is not known.
PHARMACOKINETICS
Absorption
In a clinical pharmacology study in which healthy female volunteers
received a single oral
300 or 450 mg dose of pentosan polysulfate sodium containing
radiolabeled drug as a
®
®
300 or 450 mg dose of pentosan polysulfate sodium containing
radiolabeled drug as a
solution under fasted conditions, maximal levels of plasma
radioactivity were seen
approximately at a median of 2 hours (range 0.6-120 hours) after
dosing. Based on
urinary excretion of radioactivity, a mean of approximately 6% of a
radiolabeled oral
dose of pentosan polysulfate sodium is absorbed and reaches the
systemic circulation.
Food Effects: In clinical trials, ELMIRON
was administered with water 1 hour before or
2 hours after meals; the effect of food on absorption of pent