מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
PROPOXYPHENE HYDROCHLORIDE (UNII: CB2TL9PS0T) (PROPOXYPHENE - UNII:S2F83W92TK)
Stat Rx USA
PROPOXYPHENE HYDROCHLORIDE
PROPOXYPHENE HYDROCHLORIDE 65 mg
ORAL
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
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 קרא את המסמך השלם