United States - English - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 0.05 mg in 1 ml - 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 analgesic

United States - English - NLM (National Library of Medicine)

akorn - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 50 ug in 1 ml - 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 analgesic

United States - English - NLM (National Library of Medicine)

hospira, inc. - sufentanil citrate (unii: s9zfx8403r) (sufentanil - unii:afe2yw0iiz) - sufentanil 50 ug in 1 ml - sufentanil citrate injection is indicated for intravenous administration in adults and pediatric patients: sufentanil citrate injection is indicated for epidural administration: sufentanil citrate injection is contraindicated in patients with: risk summary use of opioid analgesics for an extended period of time 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 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 use of opioid analgesics for an extended period of time 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 (5.4) ] . 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 monitor infants exposed to sufentanil citrate injection through breast milk 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 use of opioids for an extended period of time 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 (5.2) ] . 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 high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and ‎precautions (5.1)] . 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 sufentanil citrate 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 sufentanil citrate injection with alcohol and/or 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 sufentanil citrate injection abuse include those ‎with a history of prolonged use of any opioid, including products containing sufentanil, those ‎with a history of drug or alcohol abuse, or those who use sufentanil ‎citrate 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.‎ sufentanil citrate 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.‎ 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/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. sufentanil citrate injection should not be abruptly discontinued in a ‎physically-dependent patient. if sufentanil citrate 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 use in specific populations (8.1)] .‎

Canada - English - Health Canada

sandoz canada incorporated - sufentanil (sufentanil citrate) - solution - 50mcg - sufentanil (sufentanil citrate) 50mcg - opiate agonists

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - sufentanil citrate 7,48 µg/ml - eq. sufentanil 5 µg/ml - solution for injection - 5 µg/ml - sufentanil citrate 7.48 µg/ml - sufentanil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - sufentanil citrate 74,85 µg/ml - eq. sufentanil 50 µg/ml - solution for injection - 50 µg/ml - sufentanil citrate 74.85 µg/ml - sufentanil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - sufentanil citrate 7,48 µg/ml - eq. sufentanil 5 µg/ml - solution for injection - 5 µg/ml - sufentanil citrate 7.48 µg/ml - sufentanil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hameln pharma gmbh - sufentanil citrate 7,5 µg/ml - eq. sufentanil 5 µg/ml - solution for injection/infusion - 5 µg/ml - sufentanil citrate 7.5 µg/ml - sufentanil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hameln pharma gmbh - sufentanil citrate 7,5 µg/ml - eq. sufentanil 5 µg/ml - solution for injection/infusion - 5 µg/ml - sufentanil citrate 7.5 µg/ml - sufentanil

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hameln pharma gmbh - sufentanil citrate 75 µg/ml - eq. sufentanil 50 µg/ml - solution for injection/infusion - 50 µg/ml - sufentanil citrate 75 µg/ml - sufentanil