HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 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): • 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 WARNINGS] • Hypersensitiv

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: 5 mg/325 mg: White to off-white, capsule-shaped, biconvex, uncoated tablets debossed with ‘126’ on one side and scored on the other side. Each tablet contains 5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-126-83 Bottles of 30 CRC NDC 57664-126-88 Bottles of 100 CRC NDC 57664-126-08 Bottles of 100 NDC 57664-126-13 Bottles of 500 NDC 57664-126-18 Bottles of 1000 7.5 mg/325 mg: Yellow colored, oval-shaped, biconvex, uncoated tablets debossed with ‘170’ on one side and scored on the other side. Each tablet contains 7.5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-170-83 Bottles of 30 CRC NDC 57664-170-88 Bottles of 100 CRC NDC 57664-170-08 Bottles of 100 NDC 57664-170-13 Bottles of 500 NDC 57664-170-18 Bottles of 1000 10 mg/325 mg: White to off-white, oval-shaped, biconvex, uncoated tablets debossed with ‘176’ on one side and scored on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-176-83 Bottles of 30 CRC NDC 57664-176-88 Bottles of 100 CRC NDC 57664-176-08 Bottles of 100 NDC 57664-176-13 Bottles of 500 NDC 57664-176-18 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at 20° - 25°C (68° - 77°F). (See USP for Controlled Room Temperature). A Schedule [hydrocodone3] Controlled Drug Substance. DEA ORDER FORM REQUIRED Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6100T08 Rev. 11/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACETAMINOPHEN TABLET
RedPharm Drug, Inc.
----------
SPL MEDGUIDE
Medication Guide
Hydrocodone Bitartrate and Acetaminophen (HIGH-droe-KOE-dohn
by-TAR-trate/ass-eet-ah-MEE-noe-
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 or acetaminophen, or any
ingredient in hydrocodone

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
BOXED WARNING
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
Tablets with all cytochrome
P450 3A4 inhibitors may result i