HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate, acetaminophen solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Tilgjengelig fra:

Atlantic Biologicals Corps

INN (International Name):

ACETAMINOPHEN

Sammensetning:

ACETAMINOPHEN 325 mg in 15 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. Hydrocodone bitartrate oral solution contains hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Hydrocodone bitartrate oral solution, and other opioids used in analgesia can be abused and are subject to criminal diversion. Misuse Abuse and Diversion of Opioids Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite ha

Produkt oppsummering:

NDC:17856-0640-2 in a CUP, UNIT-DOSE of 15 SOLUTIONS Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Dispense the Patient Information Leaflet with the drug product. PHARMACIST: A Schedule CII Narcotic. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: a Subsidiary of Qualitest Pharmaceuticals Huntsville, AL 35811 1-800-444-4011 Rev. 09/2014 500309-01 Boca Pharmacal, LLC

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE,
ACETAMINOPHEN SOLUTION
ATLANTIC BIOLOGICALS CORPS
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION (7.5 MG/325 MG
PER 15 ML)
CII
RX ONLY
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 4,000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
DESCRIPTION
Hydrocodone bitartrate and acetaminophen is supplied in liquid form
for oral administration.
WARNING:MAY BE HABIT-FORMING (SEE , , AND ). PRECAUTIONSINFORMATION
FOR PATIENTSDRUG
ABUSE AND DEPENDENCE
Hydrocodone bitartrate is an opioid analgesic and antitussive and
occurs as fine, white crystals or as a
crystalline powder. It is affected by light. The chemical name is
4,5α-epoxy-3-methoxy-17-
methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the
following structural formula:
Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula:
Hydrocodone Bitartrate and Acetaminophen oral
solution contains:
Per
5 mL
Per
15
mL
Hydrocodone Bitartrate
……………………………
2.5
mg
7.5
mg
WARNING: MAY BE HABIT-FORMING.
Acetaminophen
……………………………………
108
mg
325
mg
Alcohol
…………………………………………….
7% 7%
In addition, the liquid contains the following inactive ingredients:
citric acid anhydrous, ethyl maltol,
glycerin, methylparaben, propylene glycol, propylparaben, purified
water, saccharin sodium, sorbitol
solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and
natural and artificial
flavoring.
CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with
multiple actions qualitatively
similar to those of codeine. Most of these inv