ZOHYDRO- hydrocodone bitartrate capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Available from:

Zogenix, Inc.

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZOHYDRO® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - ZOHYDRO ER is not indicated as an as-needed (prn) analgesic. ZOHYDRO ER is contraindicated in patients with: - Significant respiratory depression - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - Known or suspected paralytic ileus - Hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartr

Product summary:

ZOHYDRO ER extended-release capsules are supplied in 100-count bottles with a child-resistant closure as follows: ZOHYDRO ER contains hydrocodone bitartrate which is a controlled substance and is controlled under Schedule II of the Controlled Substances Act. Hydrocodone, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to dispose of any ZOHYDRO ER capsules that are no longer needed. ZOHYDRO ER may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product. Healthcare professionals should advise patients to store ZOHYDRO ER in a secure place, preferably locked and out of the reach of children and other non-caregivers. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure. Advise patients to dispose of any unused capsules from a prescription as soon as they are no longer needed in accordance with local State guidelines and/or regulations [see  Patient Counseling Information (17) ].

Authorization status:

New Drug Application

Patient Information leaflet

Zogenix, Inc.
----------
Medication Guide
ZOHYDRO® ER (zoh-hye-droh)
(hydrocodone bitartrate) extended-release capsules, CII
ZOHYDRO ER is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is
used to treat pain severe enough to require daily, around-the-clock,
long-
term treatment with an opioid, when other pain treatments such as non-
opioid pain medicines or immediate-release opioid medicines do not
treat
your pain well enough or you cannot tolerate them.
•
A long acting (extended-release) 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.
•
Not for use to treat pain that is not around-the-clock.
Important information about ZOHYDRO ER:
•
Get emergency help right away if you take too much ZOHYDRO ER
(overdose). When you first start taking ZOHYDRO ER, 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.
•
Never give anyone else your ZOHYDRO ER. They could die from taking it.
Store ZOHYDRO ER away from children and in a safe place to prevent
stealing or abuse. Selling or giving away ZOHYDRO ER is against the
law.
Do not take ZOHYDRO ER if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or narrowing of the stomach or intestines.
Before taking ZOHYDRO ER, 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, or
mental health problems.
Tell your healthcare provider if you are:
•
pregnant or planning to become pregnant. Prolonged use of ZOHYDRO ER
during pregnancy can cause withdrawal symptoms in your newborn baby
that could be life-threatening if not recognized and treated.
•
breastfeeding. ZOHYDRO ER passes i

Summary of Product characteristics

ZOHYDRO- HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE
ZOGENIX, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOHYDRO ER SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ZOHYDRO ER.
ZOHYDRO ER (HYDROCODONE BITARTRATE) EXTENDED RELEASE CAPSULES, FOR
ORAL USE, CII
INITIAL U.S. APPROVAL: 1943
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION
WITH
ALCOHOL; AND CYTOCHROME P450 3A4 INTERACTION_ _
_ _
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ZOHYDRO ER EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS EACH PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR
REGULARLY FOR DEVELOPMENT OF THESE
BEHAVIORS OR CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
ZOHYDRO ER WHOLE TO AVOID
EXPOSURE TO A POTENTIALLY FATAL DOSE OF HYDROCODONE. (5.2)
ACCIDENTAL INGESTION OF ZOHYDRO ER, ESPECIALLY IN CHILDREN, CAN RESULT
IN A FATAL OVERDOSE OF
HYDROCODONE. (5.2)
PROLONGED USE OF ZOHYDRO ER DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME,
WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. 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. (5.3)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCTS CONTAINING
ALCOHOL WHILE TAKING ZOHYDRO
ER BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA HYDROCODONE LEVELS.
(5.4)
INITIATION OF CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL OVERDOSE
OF HYDROCODONE FROM ZOHYDRO ER. (5.13)
INDICATIONS AND USAGE
ZOHYDRO ER is an opioid agonist indicated for the management of pain
severe enough to require da