Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
NALBUPHINE HYDROCHLORIDE (UNII: ZU4275277R) (NALBUPHINE - UNII:L2T84IQI2K)
Hospira, Inc.
NALBUPHINE HYDROCHLORIDE
NALBUPHINE HYDROCHLORIDE 10 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Nalbuphine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine Hydrochloride Injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Nalbuphine Hydrochloride Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Nalbuphine Hydrochloride Injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Nalbuphine Hydrochloride Injection is contraindicated in patients with: Nalbuphine Hydrochloride Injection contains nalbuphine, a substance which is subject to misuse and abuse, which can lead to the development of substance use disorder, including addiction [see WARNINGS ]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Nalbuphine Hydrochloride Injection increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of Nalbuphine Hydrochloride Injection with alcohol and other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of Nalbuphine Hydrochloride Injection abuse include those with a history of prolonged use of any opioid, including products containing nalbuphine, those with a history of drug or alcohol abuse, or those who use Nalbuphine Hydrochloride Injection in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Nalbuphine Hydrochloride Injection, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Abuse of Nalbuphine Hydrochloride Injection poses a risk of overdose and death. The risk is increased with concurrent use of Nalbuphine Hydrochloride Injection with alcohol and/or other CNS depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Nalbuphine Hydrochloride Injection should not be abruptly discontinued in a physically-dependent patient [see DOSAGE AND ADMINISTRATION ]. If Nalbuphine Hydrochloride Injection is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur, typically characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically‑dependent on opioids will also be physically‑dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy ].
Nalbuphine Hydrochloride Injection is supplied as a sterile solution in single-dose ampuls and multiple‑dose fliptop vials for intramuscular, subcutaneous, or intravenous administration, and available as follows: NDC 0409-1463-01 10 mg/ mL Tray of 10 – 1 mL Single-dose Ampuls NDC 0409-1465-01 20 mg/ mL Tray of 10 – 1 mL Single-dose Ampuls NDC 0409-1464-01 100 mg/10 mL Case of 25 – 10 mL Multiple-dose Fliptop Vials (10 mg/ mL) NDC 0409-1467-01 200 mg/10 mL Case of 25 – 10 mL Multiple-dose Fliptop Vials (20 mg/ mL) Store at 20℃ to 25°C (68℉ to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.
Abbreviated New Drug Application
NALBUPHINE HYDROCHLORIDE- NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- NALBUPHINE HYDROCHLORIDE INJECTION AMPUL FLIPTOP VIAL PROTECT FROM LIGHT. Rx only WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NALBUPHINE HYDROCHLORIDE INJECTION LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF NALBUPHINE HYDROCHLORIDE INJECTION, ESPECIALLY DURING INITIATION OR FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF NALBUPHINE HYDROCHLORIDE INJECTION ARE ESSENTIAL [SEE WARNINGS]. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS CONCOMITANT USE WITH BENZODIAZEPINES AND/OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING OF NALBUPHINE HYDROCHLORIDE INJECTION AND BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE [SEE WARNINGS; DRUG INTERACTIONS]. DESCRIPTION Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H O (35.5 mg/mL at 25ºC) and ethanol (0.8%); insoluble in CHCl and ether. Nalbuphine 2 3 hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C H NO ∙ HCl. The structural formula is: Nalbuphine Hydrochloride Injection is a sterile, nonpyrogenic solution of nalbuphine hydrochloride in water for injection. This product may be administered by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains nalbuphine hydrochloride 10 mg or 20 mg; sodium citrate, d সম্পূর্ণ নথি পড়ুন