PENTOXIL pentoxifylline tablet film coated extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 产品特点 (SPC)
30-10-2017

有效成分:

pentoxifylline (UNII: SD6QCT3TSU) (pentoxifylline - UNII:SD6QCT3TSU)

可用日期:

UPSHER-SMITH LABORATORIES, INC.

INN(国际名称):

pentoxifylline

组成:

400 mg

处方类型:

PRESCRIPTION DRUG

产品特点

                                PENTOXIL- PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE
UPSHER-SMITH LABORATORIES, INC.
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PENTOXIL
(PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP) 400 MG
RX ONLY
DESCRIPTION
Pentoxil
(Pentoxifylline Extended-release Tablets, USP) for oral administration
contain 400 mg of the
active drug and the following inactive ingredients: D&C Red No. 27
Aluminum Lake, FD&C Blue No. 1
Aluminum Lake, hypromellose USP, magnesium stearate NF, polyethylene
glycol NF, polysorbate 80
NF, povidone USP, silicon dioxide NF and titanium dioxide USP, in an
extended-release formulation.
Pentoxifylline is a tri-substituted xanthine derivative designated
chemically as 3,7-Dihydro-3,7-
dimethyl-1-(5-oxohexyl)-1_H_-purine-2,6-dione that, unlike
theophylline, is a hemorrheologic agent, i.e.,
an agent that affects blood viscosity. Pentoxifylline is soluble in
water and ethanol, and sparingly
soluble in toluene. The structural formula is:
MEETS USP DISSOLUTION TEST 3.
CLINICAL PHARMACOLOGY
MODE OF ACTION: Pentoxifylline and its metabolites improve the flow
properties of blood by decreasing
its viscosity. In patients with chronic peripheral arterial disease,
this increases blood flow to the
affected microcirculation and enhances tissue oxygenation. The precise
mode of action of
pentoxifylline and the sequence of events leading to clinical
improvement are still to be defined.
Pentoxifylline administration has been shown to produce dose-related
hemorrheologic effects,
lowering blood viscosity, and improving erythrocyte flexibility.
Leukocyte properties of
hemorrheologic importance have been modified in animal and _in vitro_
human studies. Pentoxifylline has
been shown to increase leukocyte deformability and to inhibit
neutrophil adhesion and activation. Tissue
oxygen levels have been shown to be significantly increased by
therapeutic doses of pentoxifylline in
patients with peripheral arterial disease.
PHARMACOKINETICS AND METABOLISM: After oral administration in aqueous
solution pentoxifylline is
almost completely absorbed. It under
                                
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