LORTAB- hydrocodone bitartrate and acetaminophen syrup

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Hydrocodone Bitartrate (UNII: NO70W886KK) (Hydrocodone - UNII:6YKS4Y3WQ7), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Saatavilla:

Atlantic Biologicals Corps

INN (Kansainvälinen yleisnimi):

Hydrocodone Bitartrate

Koostumus:

Hydrocodone Bitartrate 10 mg in 15 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

LORTAB ELIXIR 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. LORTAB ELIXIR contains hydrocodone, an opioid agonist, and is a Schedule II controlled substance. LORTAB ELIXIR, 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 treatable disease utilizing a multidisciplinary approach, but relapse is common. “Drug seeking” behavior is very common in addicts

Tuoteyhteenveto:

NDC:17856-0450-1 15 mL in a CUP, UNIT-DOSE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. STORAGE: Dispense in a tight, light-resistant container with a child-resistant closure. PHARMACIST: A Schedule CII Narcotic. Manufactured for Lake Forest, IL 60045 Manufactured by Atlanta, GA 30318 Akorn, Inc. Mikart Inc.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

LORTAB- HYDROCODONE BITARTRATE AND ACETAMINOPHEN SYRUP
ATLANTIC BIOLOGICALS CORPS
----------
WARNING
DESCRIPTION
Hydrocodone bitartrate and acetaminophen is supplied in liquid form
for oral administration.
(see , and ). 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:
WARNING: MAY BE HABIT-FORMINGPRECAUTIONS, Information for
Patients/CaregiversDRUG
ABUSE AND DEPENDENCE
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:
LORTAB ELIXIR (hydrocodone bitartrate and acetaminophen oral solution)
contains :
Per
Per
5 mL
15 mL
Hydrocodone Bitartrate
......................
3.33 mg
10 mg
Acetaminophen
..................................
100 mg
300 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 involve the central nervous
system and smooth muscle. The
precise mechanism of action of hydrocodone and other opiates is not
known, although it is believed to
relate to the existence of opiate receptors in the central nervous
system. In addition to analgesia,
narcotics may produce drowsiness, changes in mood and mental clouding.
The analgesic action of acetaminophen involves peripheral influences,
but the specific mechanism is as
yet undetermined. Antipyretic activity is m