দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: 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 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 in the absence of resuscitative equipment [see Warnings and Precautions (5.7)] - Known or suspected gastrointe
Hydromorphone Hydrochloride Tablets USP, 2 mg are available as a flat faced beveled edge white to off-white tablet with one side debossed “M”; other side debossed “2”. Bottles of 100................................... NDC 0406-3243-01 Hydromorphone Hydrochloride Tablets USP, 4 mg are available as a flat faced beveled edge white to off-white tablet with one side debossed “M”; other side debossed “4”. Bottles of 100................................... NDC 0406-3244-01 Hydromorphone Hydrochloride Tablets USP, 8 mg are available as a white to off-white arc triangle shaped tablet debossed with a bisected “M” on one side and a split “8” on the other side. Bottles of 100................................... NDC 0406-3249-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store hydromorphone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)] .
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 tablets: • Get emergency help right away if you take too many 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 them. Selling or giving away hydromorphone hydrochloride tablets is against the law. • Store hydromorphone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. 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 সম্পূর্ণ নথি পড়ুন
HYDROMORPHONE HYDROCHLORIDE- HYDROMORPHONE HYDROCHLORIDE TABLET REDPHARM DRUG, INC. ---------- HYDROMORPHONE HYDROCHLORIDE 2MG TABLETS BOXED WARNING SECTION WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning . Hydromorphone hydrochloride 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. ( 5.2) 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. ( 5.3) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ( 5.4) Accidental ingestion of hydromorphone hydrochloride tablets, especially by children, can result in a fatal overdose of hydromorphone. ( 5.4) Prolonged use of hydromorphone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening 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. ( 5.5) 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 d সম্পূর্ণ নথি পড়ুন