País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)
Trigen Laboratories, LLC
HYDROMORPHONE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE 16 mg
ORAL
PRESCRIPTION DRUG
Hydromorphone hydrochloride extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, [see Warnings and Precautions (5.1 )] , reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immed
How Supplied Hydromorphone Hydrochloride Extended-Release Tablets Strengths Store at 25ºC (77ºF); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE Trigen Laboratories, LLC ---------- MEDICATION GUIDE Medication Guide Hydromorphone Hydrochloride Extended-Release Tablets, CII (hy-druh-mor-fon hy-druh-klawr-ahyd) Hydromorphone hydrochloride extended-release tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, 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 to be taken on an “as needed” basis. Important information about hydromorphone hydrochloride extended-release tablets: • Get emergency help or call 911 right away if you take too much hydromorphone hydrochloride extended-release tablets (overdose). When you first start taking hydromorphone hydrochloride extended-release 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking hydromorphone hydrochloride extended-release 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 hydromorphone hydrochloride extended-release tablets. They could die from taking it. Selling or giving away hydromorphone hydrochloride extended-release tablets is against the law. • Store hydromorphone hydrochloride extended-rele Llegiu el document complet
HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE TRIGEN LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1984 WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE 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) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL DOSE OF HYDROMORPHONE. (5.2) ACCIDENTAL INGESTION OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF HYDROMORPHONE. (5.4) CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. (5.3, 7) PROLONGED USE OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 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 Llegiu el document complet