Remikaf Side Effects

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see PRECAUTIONS].
Respiratory Depression in Spontaneously Breathing Patients [see PRECAUTIONS].
Interactions with Benzodiazepines or other CNS Depressants [see PRECAUTIONS].
Serotonin Syndrome [see PRECAUTIONS].
Skeletal Muscle Rigidity [see PRECAUTIONS].
Bradycardia [see PRECAUTIONS].
Hypotension [see PRECAUTIONS].
Biliary Tract Disease [see PRECAUTIONS].
Seizures [see PRECAUTIONS].
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse event information is derived from controlled clinical studies that were conducted in a variety of surgical procedures of varying duration, using a variety of premedications and other anesthetics, and in patient populations with diverse characteristics including underlying disease.
Adults: Approximately 2,770 adult patients were exposed to REMIKAF in controlled clinical studies. The frequencies of adverse events during general anesthesia with the recommended doses of REMIKAF are given in Table 13. Each patient was counted once for each type of adverse event. (See Table 13.)


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In the elderly population ( > 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. (See Table 14.)


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The frequencies of adverse events from the clinical studies at the recommended doses of REMIKAF in monitored anesthesia care are given in Table 15. (See Table 15.)


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Other Adverse Events In Adult Patients: The frequencies of less commonly reported adverse clinical events from all controlled general anesthesia and monitored anesthesia care studies are presented as follows.
Event frequencies are calculated as the number of patients who were administered REMIKAF and reported an event divided by the total number of patients exposed to REMIKAF in all controlled studies including cardiac dose-ranging and neurosurgery studies (n = 1,883 general anesthesia, n = 609 monitored anesthesia care).
Incidence Less than 1%: Digestive: constipation, abdominal discomfort, xerostomia, gastro-esophageal reflux, dysphagia, diarrhea, ileus.
Cardiovascular: various atrial and ventricular arrhythmias, heart block, ECG change consistent with myocardial ischemia, elevated CPK-MB level, syncope.
Musculoskeletal: muscle stiffness, musculoskeletal chest pain.
Respiratory: cough, dyspnea, bronchospasm, laryngospasm, rhonchi, stridor, nasal congestion, pharyngitis, pleural effusion, hiccup(s), pulmonary edema, rales, bronchitis, rhinorrhea.
Nervous: anxiety, involuntary movement, prolonged emergence from anesthesia, confusion, awareness under anesthesia without pain, rapid awakening from anesthesia, tremors, disorientation, dysphoria, nightmare(s), hallucinations, paresthesia, nystagmus, twitch, seizure, amnesia.
Body as a Whole: decreased body temperature, anaphylactic reaction, delayed recovery from neuromuscular block.
Skin: rash, urticaria.
Urogenital: urine retention, oliguria, dysuria, urine incontinence.
Infusion Site Reaction: erythema, pruritus, rash.
Metabolic and Nutrition: abnormal liver function, hyperglycemia, electrolyte disorders, increased CPK level.
Hematologic and Lymphatic: anemia, lymphopenia, leukocytosis, thrombocytopenia.
The frequencies of adverse events from the clinical studies at the recommended doses of REMIKAF in cardiac surgery are given in Tables 16, 17, and 18. These tables represent adverse events collected during discrete phases of cardiac surgery. Any event should be viewed as temporally associated with drug administration and the phase indicated should not be perceived as the only time the event might occur. (See Table 16, Table 17 and Table 18.)


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Pediatrics: REMIKAF has been studied in 342 pediatric patients in controlled clinical studies for maintenance of general anesthesia. In the pediatric population (birth to 12 years), the most commonly reported events were nausea, vomiting, and shivering.
The frequencies of adverse events during general anesthesia with the recommended doses of REMIKAF are given in Table 19. Each patient was counted once for each type of adverse event.
There were no adverse events ≥ 1% for any treatment group during the maintenance period in the pediatric patient general anesthesia studies. (See Table 19.)


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Postmarketing Experience: The following adverse reactions have been identified during post approval use of remifentanil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Asystole.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in REMIKAF.