Remifentanil Hydrochloride Interactions

Brand names: Remifentanil Hydrochloride

Route: Intravenous

FDA Black Box Warning

WARNING: ADDICTION, ABUSE, AND MISUSE WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF REMIFENTANIL HYDROCHLORIDE FOR INJECTION Addiction, Abuse, and Misuse Because the use of Remifentanil Hydrochloride for 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 and Precautions ( 5.1 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Remifentanil Hydrochloride for injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Remifentanil Hydrochloride for injection are essential [see Warnings and Precautions ( 5.2 )] . 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 Remifentanil Hydrochloride for injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )] . WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF REMIFENTANIL HYDROCHLORIDE FOR INJECTION See full prescribing information for complete boxed warning. Remifentanil Hydrochloride for injection exposes users to the risks of addiction, abuse, and misuse. Assess patient’s risk before prescribing and reassess regularly for the development of these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur with use of Remifentanil Hydrochloride for injection, especially during initiation or following

Contraindications

4 CONTRAINDICATIONS Remifentanil Hydrochloride for injection is contraindicated: For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13) ] . In patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2 )] . Remifentanil Hydrochloride for injection is contraindicated: For epidural or intrathecal administration due to the presence of glycine in the formulation. ( 4 ) In patients with hypersensitivity to remifentanil (e.g., anaphylaxis). ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced fetal rat body weight and pup weights were reported at 2.2 times a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours. There were no malformations noted when remifentanil was administered via bolus injection to pregnant rats or rabbits during organogenesis at doses approximately 5 times and approximately equal, respectively, to a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours [ 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 2-4% and 15-20%, respectively. Clinical Considerations 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. Remifentanil Hydrochloride for 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 Remifentanil Hydrochloride for 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 b

18 interactions on record

Remifentanil Hydrochloride + Monoamine Oxidase Inhibitors (Maois)Contraindicated

May manifest as serotonin syndrome or opioid toxicity. Not recommended for patients taking MAOIs or within 14 days of stopping treatment.