SUFENTANIL CITRATE injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SUFENTANIL CITRATE (UNII: S9ZFX8403R) (SUFENTANIL - UNII:AFE2YW0IIZ)

Tillgänglig från:

Hikma Pharmaceuticals USA Inc.

INN (International namn):

SUFENTANIL CITRATE

Sammansättning:

SUFENTANIL 0.05 mg in 1 mL

Administreringssätt:

EPIDURAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients: - as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. - as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. Sufentanil Citrate Injection is indicated for epidural administration: - as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery. Sufentanil Citrate Injection is contraindicated in patients with: - Hypersensitivity to sufentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2)] Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Sufentanil Citrate Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, embryolethality and maternal toxicity were noted in rabbits when sufentanil was administered intravenously at 0.9 times the human procedural dose of 30 mcg/kg during organogenesis. Decreased live fetuses and pup survival were noted in rats treated with sufentanil late in gestation and throughout lactation at doses below the human procedural dose. No malformations were observed in either rats or rabbits at doses below the human procedural dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.3)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Sufentanil Citrate Injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Sufentanil Citrate Injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. The use of epidurally administered sufentanil in combination with bupivacaine 0.125% with or without epinephrine is indicated for labor and delivery. Sufentanil is not recommended for intravenous use or for use of larger epidural doses during labor and delivery because of potential risks to the newborn infant after delivery. In clinical trials, one case of severe fetal bradycardia associated with maternal hypotension was reported within 8 minutes of maternal administration of sufentanil 15 mcg plus bupivacaine 0.125% (10 mL total volume). Data Animal Data Pregnant rats were treated with intravenous sufentanil doses of 0.005, 0.02, or 0.08 mg/kg/day (0.03, 0.1, or 0.4 times the human total procedural dose of 30 mcg/kg based on body surface area, respectively). No malformations or embryotoxic effects were noted despite maternal toxicity (increased mortality in the mid- and high-dose group). Pregnant rabbits were treated with intravenous sufentanil doses of 0.005, 0.02, or 0.08 mg/kg/day (0.05, 0.2, or 0.9 times the human total procedural dose of 30 mcg/kg based on body surface area, respectively). Decreased live fetuses per litter and decreased litter size in the high dose group were noted in the presence of maternal toxicity (decreased body weight gain and mortality in the high-dose group). No evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered 10, 50, or 100 mcg/kg/day sufentanil (0.05, 0.27, or 0.54 times the human procedural dose of 30 mcg/kg/day based on body surface area) continuously from Gestation Day 5 through Gestation Day 20 via subcutaneously implanted osmotic minipumps. Pregnant rats were treated intravenously with sufentanil 0.005, 0.02, or 0.08 mg/kg/day (0.03, 0.1, or 0.4 times the human total procedural dose of 30 mcg/day based on body surface area, respectively) from Gestation Day 16 through Lactation Day 21. Sufentanil reduced birth weights in the mid- and high-dose groups, decreased live fetuses in the high-dose group, and decreased pup survival in all groups in the presence of maternal toxicity (decreased weight gain and increased mortality in all groups). Risk Summary The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Sufentanil Citrate Injection and any potential adverse effects on the breastfed infant from Sufentanil Citrate Injection or from the underlying maternal condition. Clinical Considerations Infants exposed to Sufentanil Citrate Injection through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2)]. The safety and efficacy of intravenous sufentanil in pediatric patients as young as 1 day old undergoing cardiovascular surgery have been documented in a limited number of cases. The clearance of sufentanil in healthy neonates is approximately one-half that in adults and children. The clearance rate of sufentanil can be further reduced by up to a third in neonates with cardiovascular disease, resulting in an increase in the elimination half-life of the drug. Elderly patients (aged 65 years or older) may have increased sensitivity to sufentanil. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Sufentanil Citrate Injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.6)]. Sufentanil Citrate Injection should be administered with caution to patients with liver dysfunction because of the extensive hepatic metabolism. Reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. Sufentanil Citrate Injection should be administered with caution to patients with kidney dysfunction because of the renal excretion of sufentanil citrate and its metabolites. Reduce the dosage as needed and monitor for signs of respiratory depression, sedation, and hypotension. Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance. Sufentanil Citrate Injection contains sufentanil, a substance with a high potential for abuse similar to other opioids including hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Sufentanil Citrate Injection can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)]. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. Sufentanil Citrate Injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Risks Specific to Abuse of Sufentanil Citrate Injection Abuse of Sufentanil Citrate Injection poses a risk of overdose and death. The risk is increased with concurrent use of Sufentanil Citrate Injection with alcohol and other central nervous system 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 chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

Produktsammanfattning:

Sufentanil Citrate Injection, USP is a sterile aqueous, preservative-free solution, containing 50 mcg/mL eq. of sufentanil base, for intravenous and epidural use, supplied as:    1 mL (50 mcg) ampuls packaged in 10s (NDC 0641-6110-10)    2 mL (100 mcg) ampuls packaged in 10s (NDC 0641-6111-10)    5 mL (250 mcg) ampuls packaged in 10s (NDC 0641-6112-10) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised August 2018 462-303-02

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SUFENTANIL CITRATE- SUFENTANIL CITRATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUFENTANIL CITRATE
INJECTION, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SUFENTANIL CITRATE
INJECTION.
SUFENTANIL CITRATE INJECTION, FOR INTRAVENOUS AND EPIDURAL USE, CII
INITIAL U.S. APPROVAL: 1984
WARNING: ADDICTION, ABUSE, AND MISUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SUFENTANIL CITRATE INJECTION EXPOSES 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)
INDICATIONS AND USAGE
Sufentanil Citrate Injection is an opioid agonist indicated: (1)
as an analgesic adjunct in the maintenance of balanced general
anesthesia in patients who are
intubated and ventilated.
as a primary anesthetic agent for the induction and maintenance of
anesthesia with 100% oxygen in
patients undergoing major surgical procedures, in patients who are
intubated and ventilated, such as
cardiovascular surgery or neurosurgical procedures in the sitting
position, to provide favorable
myocardial and cerebral oxygen balance or when extended postoperative
ventilation is anticipated.
for epidural administration as an analgesic combined with low dose
(usually 12.5 mg per administration)
bupivacaine usually during labor and vaginal delivery.
DOSAGE AND ADMINISTRATION
Sufentanil Citrate Injection should be administered only by persons
specifically trained in the use of
intravenous anesthetics and management of the respiratory effects of
potent opioids.
Ensure that an opioid antagonist, resuscitative and intubation
equipment, and oxygen are readily
available (2.1).
Individualize dosing based on factors such as age, body weight,
physical status, underlying pathological
condition, use of other drugs, type of anesthesia to be used, and the
surgical procedure involved. (2.1)
Initiate