HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

H.J Harkins Co., Inc

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, 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 are 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] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNING

Ringkasan produk:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. 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 Revised: 12/2016

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
H.J Harkins Co., Inc
----------
MEDICATION GUIDE
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-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 to manage pain severe
enough to require an opioid pain medicine, 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.
known hypersensitivity to hydrocodone or acetaminophen ,or any
in

Karakteristik produk

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLET
H.J HARKINS CO., INC
----------
0737 HYDRO/APAP 5/325MG
BOXED WARNING
_WARNING_
_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 _
_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’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 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 INTERACTION _
_THE CONCOMITANT USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN_
_TABLETS WITH ALL CYTOCHROME P450 3A