Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06)
RedPharm Drug, Inc.
ORAL
PRESCRIPTION DRUG
Hydromorphone hydrochloride 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 and Precautions ( 5.2)] , reserve hydromorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.7)] - Acute or severe bronchial asthma in an unmonitored setting or i
Hydromorphone Hydrochloride Tablets USP, 2 mg are white, round, flat-faced beveled edge tablets debossed with “LCI” over “1353” on one side and “2” on the other side. Available in bottles of 100 (NDC 0527-1353-01). Hydromorphone Hydrochloride Tablets USP, 4 mg are white, round, flat-faced beveled edge tablets debossed with “LCI” over “1354” on one side and “4” on the other side. Available in bottles of 100 (NDC 0527-1354-01). Hydromorphone Hydrochloride Tablets USP, 8 mg are white, round, flat-faced beveled edge, scored, tablets debossed with “LCI” over “1355” on one side and plain on the other side. Available in bottles of 100 (NDC 0527-1355-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
RedPharm Drug, Inc. ---------- MEDICATION GUIDE Hydromorphone Hydrochloride (hy-dro-MOR-fone hy-dro-KLOR-īd) Tablets, CII Hydromorphone hydrochloride tablets are: • Strong prescription pain medicines that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid analgesic, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • Opioid pain medicines 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 hydromorphone hydrochloride: • Get emergency help right away if you take too much hydromorphone hydrochloride tablets (overdose). When you first start taking hydromorphone hydrochloride 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 hydromorphone hydrochloride 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 tablets. They could die from taking it. Store hydromorphone hydrochloride tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away hydromorphone hydrochloride tablets is against the law. Do not take hydromorphone hydrochloride tablets if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines. Before taking hydromorphone hydrochloride tablets, tell your healthcare provider if you have a history of: • head injury, seizures • problems urinating • liver, kidney, thyroid problems • pancreas or gallbladder problems • abuse of street or prescription drugs, alcohol addiction, or m Preberite celoten dokument
HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET REDPHARM DRUG, INC. ---------- HYDROMORPHONE 2MG BOXED WARNING ADDICTION, ABUSE, AND MISUSE HYDROMORPHONE HYDROCHLORIDE 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 HYDROMORPHONE HYDROCHLORIDE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS _[SEE WARNINGS AND_ _PRECAUTIONS ( 5.2)] _. OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) 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 REMS FOR THESE PRODUCTS _[SEE WARNINGS AND PRECAUTIONS ( 5.3)]. _UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM, COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS, EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY SAFETY. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF HYDROMORPHONE HYDROCHLORIDE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF HYDROMORPHONE HYDROCHLORIDE TABLETS OR FOLLOWING A DOSE INCREASE _[SEE_ _WARNINGS AND PRECAUTIONS ( 5.4)]._ ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF EVEN ONE DOSE OF HYDROMORPHONE HYDROCHLORIDE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROMORPHONE _[SEE WARNINGS AND PRECAUTIONS (_ _5.4)] _. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF HYDROMORPHONE Preberite celoten dokument