HYDROCODONE BITATRATE AND ACETAMINOPHEN- hydrocodone bitatrate and acetaminophen tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mckesson Rxpak Inc

INN (Διεθνής Όνομα):

HYDROCODONE BITARTRATE

Σύνθεση:

HYDROCODONE BITARTRATE 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

NORCO® is indicated for the management 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 NORCO® 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 NORCO® 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 WARNINGS ] - Patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. - Known hypersensitivity to other opioids who may exhibit cross-sensitivity to hydrocodone. NORCO® contains hydrocodone, a Schedule II controlled s

Περίληψη προϊόντος:

NORCO® 5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100. NORCO® 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500. NORCO® 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Manufactured by: Warner Chilcott Company, LLC Manati, Puerto Rico 00674                                                                                                                                                                                    Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA                                                                                                           Revised: April 2016                                                                             

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

HYDROCODONE BITATRATE AND ACETAMINOPHEN- HYDROCODONE BITATRATE AND
ACETAMINOPHEN TABLET
Mckesson Rxpak Inc
----------
MEDICATION GUIDE
NORCO® (nor koe’)
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, CII
NORCO® is:
•
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 NORCO®:
•
Get emergency help right away if you take too much NORCO® (overdose).
When you first start
taking NORCO® 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.
•
Never give anyone else your NORCO® tablets. They could die from
taking it. Store NORCO®
away from children and in a safe place to prevent stealing or abuse.
Selling or giving away
NORCO® tablets is against the law.
Do not take NORCO® if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
signs or allergy such as a rash.
•
are allergic to any of its ingredients.
Before taking NORCO®, tell your healthcare provider if you have a
history of:
•
head injury, seizures ● liver, kidney, thyroid problems
•
problems urinating ● pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. Prolonged use of NORCO®
during pregnancy can
cause withdrawal symptoms in your newborn baby that could be
life-threatening if not recognized
and treated.
•
breastfeeding. NORCO® passes into breast milk and may har

Αρχείο Π.Χ.Π.

HYDROCODONE BITATRATE AND ACETAMINOPHEN- HYDROCODONE BITATRATE AND
ACETAMINOPHEN TABLET
MCKESSON RXPAK INC
----------
NORCO-5_325MG_7-5_325MG_10_325MG_NDCS_161 AND 162
NORCO C-II
(HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP)
Revised: April 2016
RX ONLY
®
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION AND
HEPATOTOXICITY
ADDICTION, ABUSE, AND MISUSE
NORCO
EXPOSES 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 NORCO
, 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 NORCO
.
MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF
NORCO
OR FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF NORCO
, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF NORCO
[SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF NORCO
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 INTERACTION
THE CONCOMITANT USE OF NORCO
WITH ALL CYTOCHROME P450 3A4 INHIBITORS MAY RESULT IN AN
INCREASE IN NORCO
PLASMA CONCENTRATIONS, WHICH COULD INCREASE OR PROLONG ADVERSE
REACTIONS AND MAY CAUSE POTENTIALLY FATAL RESPIRATORY DEPRESSION. IN
ADDITION,
DISCONTINUATION OF A CONCOMITANTLY USED CYTOCHROME P450 3A4 INDUCER
MAY RESULT IN AN
INCREASE IN NORCO
PLASMA CONC