PROPOXYPHENE- propoxyphene hydrochloride capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PROPOXYPHENE HYDROCHLORIDE (UNII: CB2TL9PS0T) (PROPOXYPHENE - UNII:S2F83W92TK)

Tilgjengelig fra:

Stat Rx USA

INN (International Name):

PROPOXYPHENE HYDROCHLORIDE

Sammensetning:

PROPOXYPHENE HYDROCHLORIDE 65 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Propoxyphene hydrochloride capsules are indicated for the relief of mild to moderate pain. Propoxyphene hydrochloride capsules are contraindicated in patients with known hypersensitivity to propoxyphene. Propoxyphene hydrochloride capsules are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. Propoxyphene hydrochloride capsules are contraindicated in any patient who has or is suspected of having paralytic ileus.

Produkt oppsummering:

Propoxyphene Hydrochloride Capsules, USP are available containing 65 mg of propoxyphene hydrochloride, USP. The 65 mg capsule is a hard-shell hypromellose capsule with a rose opaque cap and a rose opaque body, axially printed with MYLAN over 7065 in black ink on both the cap and the body. The capsule is filled with white to off-white powder. They are available as follows: NDC 0378-7065-01 bottles of 100 capsules NDC 0378-7065-05 bottles of 500 capsules Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PROPOXYPHENE - PROPOXYPHENE HYDROCHLORIDE CAPSULE
STAT RX USA
----------
INS ERT
DESCRIPTION
Propoxyphene hydrochloride, USP is an odorless, white crystalline
powder with a bitter taste. It is
freely soluble in water. Chemically, it is
(2_S_,3_R_)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-
butanol propionate (ester) hydrochloride, which can be represented by
the accompanying structural
formula. Its molecular formula is C
H NO ·HCl and its molecular weight is 375.93.
Each capsule contains 65 mg (172.9 μmol) propoxyphene hydrochloride.
It also contains the following
inactive ingredients: anhydrous lactose, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch and sodium lauryl sulfate. The empty hard-shell hypromellose
capsule shells contain carnauba
wax, carrageenan, hypromellose, potassium chloride, synthetic red iron
oxide and titanium dioxide. In
addition, the imprinting ink contains black iron oxide, potassium
hydroxide, propylene glycol, shellac
and strong ammonia solution.
CLINICAL PHARMACOLOGYPharmacology
Propoxyphene is a centrally acting opiate analgesic. _In vitro_
studies demonstrated propoxyphene and the
metabolite norpropoxyphene inhibit sodium channels (local anesthetic
effect) with norpropoxyphene
being approximately 2-fold more potent than propoxyphene and
propoxyphene approximately 10-fold
more potent than lidocaine. Propoxyphene and norpropoxyphene inhibit
the voltage-gated potassium
current carried by cardiac rapidly activating delayed rectifier (hERG)
channels with approximately
equal potency. It is unclear if the effects on ion channels occur
within therapeutic dose range.
PharmacokineticsAbsorption
Peak plasma concentrations of propoxyphene are reached in 2 to 2.5
hours. After a 65 mg oral dose of
propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 mcg/mL
for propoxyphene and 0.1 to
0.2 mcg /mL for norpropoxyphene (major metabolite) are achieved.
Repeated doses of propoxyphene at
6 hour intervals lead to increasing plasma concentrations, with a
plateau after th