Hydrocodone Bitartrate and Acetaminophen Tablets USP

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Major Pharmaceuticals

INN (Mezinárodní Name):

HYDROCODONE BITARTRATE

Složení:

HYDROCODONE BITARTRATE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hydrocodone bitartrate and acetaminophen tablets are 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 hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]  Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: Controlled Substance Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids used in analgesia. Hydrocodone bitartrate and acetaminophen tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. 

Přehled produktů:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are available in the following strengths: 5 mg/325 mg             5 mg hydrocodone bitartrate and 325 mg acetaminophen, capsule shaped,                                   white tablets bisected on one side and debossed with 2172 on the other side,                                   supplied in bottles of 100 and 500.  Available in cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6567-61 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 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Refer to package label for Distributor's NDC Number Revised:  April 2016

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
MAJOR PHARMACEUTICALS
REFERENCE LABEL SET ID: A3FFF41B-9EAB-43B2-8E7F-CB1EAF9042BC
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HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP
HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLETS, USP
CII
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
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 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 INTERACTION
THE C