HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Proficient Rx LP

INN (nume internaţional):

HYDROCODONE BITARTRATE

Compoziție:

HYDROCODONE BITARTRATE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Hydrocodone bitartrate and acetaminophentablets are indicated for the management of relief of moderate to moderatelysevere pain, pain severe enough to require an opioid analgesic and for whichalternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, andmisuse, with opioids, even at recommended doses [see WARNINGS ], reserve hydrocodonebitartrate and acetaminophen tablets for use in patients for whom alternativetreatment options [e.g., non-opioid analgesics] Hydrocodonebitartrate and acetaminophen tablets are contraindicated in patients with: Controlled  Substance Hydrocodone  bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, aSchedule CII controlled substance. Abuse Hydrocodone  bitartrate and acetaminophen tablets contains hydrocodone and acetaminophen, asubstance with a high potential for abuse similar to other opioids including  withdrawal also may be precipitated through the administration of drugs withopioid antagonist activity

Rezumat produs:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen.          Bottles of 12                 NDC 63187-778-12          Bottles of 15                NDC 63187-778-15          Bottles of 20                NDC 63187-778-20          Bottles of 30                NDC 63187-778-30          Bottles of 60              NDC 63187-778-60          Bottles of 90                NDC 63187-778-90 Storage: 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 with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides  Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810  Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810  Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320  Revised: 09/2016

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
Proficient Rx LP
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MEDICATION GUIDE
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohnby-TAR-trate/ass-eet-ah-MEE-noe-fen
Hydrocodone Bitartrate and Acetaminophen Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the management
of relief of moderate to moderately severe pain, pain severe enough to
require an opioid analgesic and
for which alternative treatments are inadequate or when 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:
•
acute or severe bronchial asthma, trouble breathing, or other lung
problems.
•
a bowel bl

Caracteristicilor produsului

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
PROFICIENT RX LP
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
WARNING
WARNING:ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION;ACCIDENTAL INGESTION; NEONATAL OPIOID;
WITHDRAWAL SYNDROME; AND HEPATOTOXICITY
ADDICTION, ABUSE, AND MISUSE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS EXPOSES PATIENTS
AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’SRISK
PRIOR
TO PRESCRIBING HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS,
ANDMONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE
BEHAVIORS
ORCONDITIONS [SEE WARNINGS].
LIFE-THREATENINGRESPIRATORY 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 ADOSE 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 ANDTREATED, AND
REQUIRES
MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS.
IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN APREGNANT WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE [SEEWARNINGS].
HEPATOTOXICITY
ACETAMINOPHENHAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT
TIMES RESULTING INLIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF
LIVER
INJURY ARE ASSOCIATEDWITH THE USE OF ACETAMINOPHEN AT DOSES THA