HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

AvKARE, Inc.

INN (International namn):

HYDROCODONE BITARTRATE

Sammansättning:

HYDROCODONE BITARTRATE 5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets is contraindicated in patients with: • Significant respiratory depression [see WARNINGS]. • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNI

Produktsammanfattning:

Hydrocodone bitartrate and acetaminophen tablets, USP 5 mg/325 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 109” on obverse and bisected on the reverse. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are available as follows: Bottles of 100:             NDC 42291-332-01 Storage:   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CII Narcotic. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 09-2016-04 AV Rev. 10/16

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

ACETAMINOPHEN TABLET
AvKARE, Inc.
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SPL MEDGUIDE SECTION
Medication Guide
Hydrocodone Bitartrate and Acetaminophen
(hye-droe-KOE-dohne bye-TAR-trate/a-SEET-a-MIN-oh-fen) Tablets, USP C
II
Hydrocodone bitartrate and acetaminophen tablets are:
• A strong prescription pain medicine that contains an opioid
(narcotic) that is used to manage moderate to
moderately severe pain, when other pain treatments such as non-opioid
pain medicines do not treat your pain
well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose
and death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about hydrocodone bitartrate and acetaminophen
tablets:
• Get emergency help right away if you take too much hydrocodone
bitartrate and acetaminophen tablets
(overdose). When you first start taking hydrocodone bitartrate and
acetaminophen tablets, when your dose is
changed, or if you take too much overdose), serious or
life-threatening breathing problems that can lead to
death may occur.
• Taking hydrocodone bitartrate and acetaminophen tablets with
other opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
• Never give anyone else your hydrocodone bitartrate and
acetaminophen tablets. They could die from
taking it. Store hydrocodone bitartrate and acetaminophen tablets away
from children and in a safe place to
prevent stealing or abuse. Selling or giving away hydrocodone
bitartrate and acetaminophen tablets is against
the law.
Do not take hydrocodone bitartrate and acetaminophen tablets if you
have:
• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or
intestines.
Before taking hydrocodone bitartrate and acetaminophen tablets, tell
your healthcare prov

Produktens egenskaper

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
AVKARE, INC.
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII
5 mg/325 mg
BOXED WARNING SECTION
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATIC
ENZYME WARNING, DRUG INTERACTION, HEPATOTOXICITY AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
Hydrocodone bitartrate and acetaminophen tablets expose patients and
other users to the risks of
opioid addiction, abuse, and misuse, which can lead to overdose and
death. Assess each patient’s
risk prior to prescribing hydrocodone bitartrate and acetaminophen
tablets and monitor all patients
regularly for the development of these behaviors or conditions [see
WARNINGS].
LIFE-THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening, or fatal respiratory depression may occur
with use of hydrocodone
bitartrate and acetaminophen tablets. Monitor for respiratory
depression, especially during
initiation of hydrocodone bitartrate and acetaminophen tablets or
following a dose increase [see
WARNINGS].
ACCIDENTAL INGESTION
Accidental ingestion of even one dose of hydrocodone bitartrate and
acetaminophen tablets,
especially by children, can result in a fatal overdose of hydrocodone
bitartrate and acetaminophen
tablets [see WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
Prolonged use of hydrocodone bitartrate and acetaminophen tablets
during pregnancy can result in
neonatal opioid withdrawal syndrome, which may be life-threatening if
not recognized and treated,
and requires management according to protocols developed by
neonatology experts. If opioid use
is required for a prolonged period in a pregnant woman, advise the
patient of the risk of neonatal
opioid withdrawal syndrome and ensure that appropriate treatment will
be available [see
WARNINGS].
CYTOCHROME P450 3A4 INTERA