ROXICET- oxycodone and acetaminophen tablet ROXICET- oxycodone and acetaminophen solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

זמין מ:

West-Ward Pharmaceuticals Corp

INN (שם בינלאומי):

OXYCODONE HYDROCHLORIDE

הרכב:

OXYCODONE HYDROCHLORIDE 5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

ROXICET is indicated for the relief of moderate to moderately severe pain. ROXICET should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus. ROXICET is a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and co

leaflet_short:

ROXICET™ Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg) White, round, scored tablets (Identified 54 543) NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. NDC 0054-4650-25: Bottles of 100 tablets. NDC 0054-4650-29: Bottles of 500 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container, as defined in the USP/NF. ROXICET™ Oral Solution, Oxycodone and Acetaminophen Oral Solution (Oxycodone Hydrochloride 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL) Clear, dark red solution NDC 0054-8648-16: Unit dose Patient Cups™ filled to deliver 5 mL (Oxycodone Hydrochloride 5 mg, Acetaminophen 325 mg), ten 5 mL Patient Cups™ per shelf pack, four shelf packs per shipper. NDC 0054-3686-63: Bottles of 500 mL. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. DEA Order Form Required.  4073402//06 Revised October 2013 ©RLI, 2013

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ROXICET- OXYCODONE AND ACETAMINOPHEN TABLET
ROXICET- OXYCODONE AND ACETAMINOPHEN SOLUTION
WEST-WARD PHARMACEUTICALS CORP
----------
ROXICET™ CII
OXYCODONE 5 MG AND ACETAMINOPHEN 325 MG TABLETS, USP
OXYCODONE 5 MG AND ACETAMINOPHEN 325 MG ORAL SOLUTION PER 5 ML
Rx only
BOXED WARNING
HEPATOTOXICITY
Acetaminophen has been associated with cases of acute liver failure,
at times resulting in liver
transplant and death. Most of the cases of liver injury are associated
with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
DESCRIPTION
Each tablet for oral administration contains:
Oxycodone Hydrochloride
USP..................................................................
5 mg+
(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
Acetaminophen......................................................................................
325 mg
Each 5 mL of oral solution for oral administration contains:
Oxycodone
Hydrochloride........................................................................
5 mg+
(+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
Acetaminophen......................................................................................
325 mg
Alcohol
......................................................................................................
0.4%
INACTIVE INGREDIENTS
The tablets contain colloidal silicon dioxide, croscarmellose sodium,
microcrystalline cellulose and
stearic acid.
The solution contains alcohol (0.4%), citric acid, disodium edetate,
FD&C Red #40, flavors, fructose,
polyethylene glycol, potassium sorbate, sodium saccharin and water.
ROXICET™ contains oxycodone, 14-hydroxydihydrocodeinone, a
semisynthetic opioid analgesic
which occurs as a white, odorless, crystalline powder having a saline,
bitter taste. The molecular
formula for oxycodone hydrochloride is C
H NO · HCl and the molecular weight is 381.82. It is
derived from the opium alkaloid, thebaine, and may be rep