APADAZ- benzhydrocodone and acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZHYDROCODONE HYDROCHLORIDE (UNII: I894QAU7FJ) (BENZHYDROCODONE - UNII:75MS0AAZ9I), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

KVK-Tech, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

APADAZ is indicated for the short-term (no more than 14 days) management of acute 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 and Precautions (5.1) ], reserve APADAZ 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. APADAZ is contraindicated in patients with: - Significant respiratory depression [ see Warnings and Precautions (5.3) ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.8) ] - Known or suspected gastrointestinal obstruction, including pa

Product summary:

APADAZ (benzhydrocodone and acetaminophen) tablets are available as follows: Capsule-shaped, white tablets debossed with “KP201” on one side and “445” on the opposite side, containing 4.08 mg benzhydrocodone (equivalent to 4.45 mg benzhydrocodone hydrochloride) and 325 mg acetaminophen supplied as: Capsule-shaped, white tablets debossed with “KP201” on one side and blank on the opposite side, containing 6.12 mg benzhydrocodone (equivalent to 6.67 mg benzhydrocodone hydrochloride) and 325 mg acetaminophen supplied as: Capsule-shaped, white tablets debossed with “KP201” on one side and “890” on the opposite side containing 8.16 mg benzhydrocodone (equivalent to 8.90 mg benzhydrocodone hydrochloride) and 325 mg acetaminophen supplied as: Flush expired or unused APADAZ tablets that are no longer needed down the toilet or contact the Drug Enforcement Administration (DEA) to find the location of an authorized collector (1-800-882- 9539). Storage Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store APADAZ securely and dispose of properly [see Patient Counseling Information (17)].

Authorization status:

New Drug Application

Patient Information leaflet

KVK-Tech, Inc.
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MEDICATION GUIDE
APADAZ® (AP’ AH DAZ)
(BENZHYDROCODONE AND
ACETAMINOPHEN) TABLET, CII
APADAZ is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
and the medicine
acetaminophen. APADAZ is used to manage short-term pain (no more than
14 days), 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 APADAZ:
•
Get emergency help or call 911 right away if you take too much APADAZ
(overdose). When you
first start taking APADAZ, 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. Talk to your
healthcare provider about naloxone, a medicine for the emergency
treatment of an opioid
overdose.
•
Never give anyone else your APADAZ. They could die from taking it.
Selling or giving away
APADAZ is against the law.
•
Store APADAZ securely, out of sight and reach of children, and in a
location not accessible by
others, including visitors to the home.
•
Get emergency help right away if you take more than 4,000 mg of
acetaminophen in 1 day.
Taking APADAZ with other products that contain acetaminophen can lead
to serious liver
problems and death.
Do not take APADAZ if you have:
• severe asthma, trouble breathing, or other lung problems.
• an allergy to hydrocodone or acetaminophen.
• a bowel blockage or have narrowing of the stomach or intestines.
• severe liver problems.
Before taking APADAZ, 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, opioid
overdose, or mental health problems.
T

Summary of Product characteristics

APADAZ- BENZHYDROCODONE AND ACETAMINOPHEN TABLET
KVK-TECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APADAZ® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APADAZ.
APADAZ (BENZHYDROCODONE AND ACETAMINOPHEN) TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1982
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFETHREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P450 3A4 INTERACTION; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE
WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
APADAZ EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO
OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND
MONITOR REGULARLY
FOR THESE BEHAVIORS AND CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF APADAZ, ESPECIALLY BY CHILDREN, CAN RESULT IN
A FATAL
OVERDOSE OF HYDROCODONE. (5.3)
PROLONGED USE OF APADAZ DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFETHREATENING IF NOT RECOGNIZED
AND TREATED. IF
PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE
RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT
APPROPRIATE TREATMENT
WILL BE AVAILABLE. (5.4)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF HYDROCODONE FROM APADAZ. (5.5, 7, 12.3)
APADAZ CONTAINS ACETAMINOPHEN. ACETAMINOPHEN HAS BEEN ASSOCIATED WITH
CASES
OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TR