HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate, acetaminophen solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Physicians Total Care, Inc.

INN (International Adı):

ACETAMINOPHEN

Kompozisyon:

ACETAMINOPHEN 325 mg in 15 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. Misuse Abuse and Diversion of Opioids 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. 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 harm, and craving. Drug addiction is a t

Ürün özeti:

Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15mL) is a red-colored, tropical fruit punch flavored liquid containing hydrocodone bitartrate (WARNING: may be habit-forming ) 7.5 mg and acetaminophen 325 mg per 15 mL, with 7% alcohol. It is supplied in a container of 4 oz (118 mL) NDC 54868-6437-0. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure. Dispense the Patient Information Leaflet with the drug product. 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: Boca Pharmacal, LLC a Subsidiary of Qualitest Pharmaceuticals Huntsville, AL 35811 1-800-444-4011 Rev. 08/14 Distributed by: Physicians Total Care, Inc. Tulsa, OK   74146

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE,
ACETAMINOPHEN SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION (7.5 MG/325 MG
PER 15 ML)
CII
*WARNING: MAY BE HABIT-FORMING.
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 PRECAUTIONS, INFORMATION FOR
PATIENTS, AND DRUG
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 t