BUTORPHANOL TARTRATE injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D)

Pieejams no:

Hospira, Inc.

SNN (starptautisko nepatentēto nosaukumu):

BUTORPHANOL TARTRATE

Kompozīcija:

BUTORPHANOL TARTRATE 2 mg in 1 mL

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Butorphanol Tartrate Injection is indicated Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve butorphanol tartrate for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Butorphanol Tartrate 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.‎ Butorphanol Tartrate Injection is contraindicated in: Butorphanol Tartrate Injection contains butorphanol, a Schedule IV controlled substance. Butorphanol Tartrate Injection contains butorphanol, a substance with high potential ‎for 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 Butorphanol Tartrate 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 Butorphanol Tartrate 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 Butorphanol Tartrate Injection abuse include those with a history ‎of prolonged use of any opioid, including products containing butorphanol, those with a ‎history of drug or alcohol abuse, or those who use Butorphanol Tartrate 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. Butorphanol Tartrate 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 Butorphanol Tartrate Injection poses a risk of overdose and death. The risk is increased with concurrent use of Butorphanol Tartrate 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. Butorphanol Tartrate Injection should not be abruptly discontinued in a physically-dependent patient‎ [see DOSAGE AND ADMINISTRATION ]. If butorphanol tartrate 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 physical-dependent on opioids will also be physically-dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy ].

Produktu pārskats:

Butorphanol Tartrate Injection, USP is supplied as single-dose glass fliptop vials, and available as follows: NDC 0409-1623-01 Carton of 10 – 1 mL Single-Dose Glass Fliptop Vials 1 mg/mL NDC 0409-1626-01 Carton of 10 – 1 mL Single-Dose Glass Fliptop Vials 2 mg/mL NDC 0409-1626-02 Carton of 10 – 2 mL Single-Dose Glass Fliptop Vials 4 mg/2 mL (2 mg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

BUTORPHANOL TARTRATE- BUTORPHANOL TARTRATE INJECTION, SOLUTION
HOSPIRA, INC.
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BUTORPHANOL TARTRATE INJECTION, USP CIV
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL
TARTRATE
INJECTION
ADDICTION, ABUSE, AND MISUSE
BECAUSE THE USE OF BUTORPHANOL TARTRATE INJECTION EXPOSES 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 AND REASSESS ALL PATIENTS
REGULARLY FOR THE
DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS_ [SEE WARNINGS]._
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE OF BUTORPHANOL
TARTRATE INJECTION, ESPECIALLY DURING INITIATION OR FOLLOWING A DOSAGE
INCREASE. TO REDUCE THE
RISK OF RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION ​
OF BUTORPHANOL TARTRATE INJECTION
ARE ESSENTIAL [_SEE WARNINGS_].
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 OF BUTORPHANOL
TARTRATE INJECTION AND
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT
OPTIONS ARE INADEQUATE [_SEE WARNINGS, PRECAUTIONS; DRUG
INTERACTIONS_].
NEONATAL OPIOID WITHDRAWAL SYNDROME (NOWS)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN, ADVISE THE
PATIENT OF THE RISK OF NOWS, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED.
ENSURE THAT MANAGEMENT BY NEONATOLOGY EXPERTS​ WILL BE AVAILABLE AT DELIVERY [_SEE_
_WARNINGS_].
DESCRIPTION
Butorphanol tartrate is a synthetically derived opioid
agonist-antagonist analgesic of the phenanthrene series.
The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol
D-(-)- tartrate (1:1) (salt). The molecular
formula is C
H
NO ∙ C H O , which corresponds to a mole