HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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): Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with: Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance. Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with o

Product summary:

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, USP and 325 mg acetaminophen, USP. They are available as follows: Bottle of 12 - 68788-9250-1 Bottle of 15 - 68788-9250-5 Bottle of 20 - 68788-9250-2 Bottle of 30 - 68788-9250-3 Bottle of 40 - 68788-9250-4 Bottle of 60 - 68788-9250-6 Bottle of 90 - 68788-9250-9 Bottle of 120 - 68788-9250-8 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. A Schedule II Narcotic DEA Order Form Required. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Rev. 02-2017-07 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN TABLET
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Acetaminophen (a seet” a min’ oh fen)
Tablets CII
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 bitartrate or acetaminophen, or
any ingr

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG CII
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 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 AND
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
TAB