البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)
Zogenix, Inc.
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE 10 mg
ORAL
PRESCRIPTION DRUG
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
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) ].
New Drug Application
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة