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FENTANYL CITRATE is a brand name for Fentanyl, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
, non- opioid analgesics). Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP are administered by intravenous, intramuscular, or epidural injection. Dosage should be individualized. Some of the factors to be considered in determining the dose are: age, body weight, physical status, underlying pathological condition, use of other drugs and the surgical procedure involved.
Vital signs should be monitored routinely. For acute pain, it is recommended that Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP be used for a maximum of 7 days at the lowest dose that provides adequate pain relief.
All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. 9 mg (90 morphine milligram equivalent) of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP not be exceeded.
Each patient should be assessed for their risk prior to prescribing Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient’s own level of tolerance.
In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP (see DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage).
Dosing Considerations Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP should be used with caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively (see WARNINGS AND PRECAUTIONS, Peri-operative Considerations).
Rapid intravenous injection of opioid analgesics increases the possibility of hypotension and respiratory depression. 028 mL/kg) may be administered intramuscularly 30 to 60 minutes prior to surgery. Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP Page 18 of 46 Adjunct to General Anesthesia: See Dosage Range Chart (Table 1).
028 mL/kg) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required.
As a General Anesthetic:
SERIOUS WARNINGS AND PRECAUTIONS
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). As with other CNS depressants, patients who have received fentanyl should have appropriate surveillance.
Resuscitative equipment and a narcotic antagonist such as naloxone should be readily available to manage apnea. Addiction, Abuse, and Misuse Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP pose risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient’s risk should be assessed prior to prescribing Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS, Abuse and Misuse).
Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP or following a dose increase. Further, instruct patients of the hazards related to taking opioids including fatal overdose.
Accidental Exposure Accidental exposure of even one dose of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP, especially by children, can result in a fatal overdose of fentanyl (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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When attenuation of responses to surgical stress is especially important, fentanyl in doses of 50 to 100 mcg/kg (1 to 2 mL/kg) may be administered with oxygen and a muscle relaxant to produce anesthesia without the use of additional anesthetic agents.
In certain cases, doses up to 150 mcg/kg (3 mL/kg) may be necessary to produce the anesthetic effects. Table 1. 04 mL/kg) Fentanyl Citrate Injection SDZ or Fentanyl Citrate injection USP. Fentanyl in small doses is useful for minor but painful surgical procedures.
In addition to the analgesia during surgery, fentanyl may also provide some pain relief in the immediate postoperative period. 4 mL/kg) Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP. Where surgery becomes more major, a larger dose is required.
With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary, and careful observation of ventilation postoperatively is essential.
4 mL - 1 mL/kg) Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP. 4 - 1 mL/kg) of Fentanyl Citrate Injection SDZ with nitrous oxide oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH, and prolactin.
When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce "stress free" anesthesia.
Additional doses are infrequently needed in these minor procedures. 5 mL) to one half the initial loading dose) Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP will be dictated by changes in vital signs which indicate stress and lightening of analgesia.
However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short. Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP Page 19 of 46 Low Dose Moderate Dose High Dose intramuscularly when movement or changes in vital signs indicate surgical stress or lightening of analgesia.
Fentanyl has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from […]
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP Page 6 of 46 Syndrome (NOWS)).
Interaction with Alcohol The co-ingestion of alcohol with Fentanyl Citrate Injection SDZ or with Fentanyl Citrate Injection USP should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS, General, and DRUG INTERACTIONS, Drug-Lifestyle Interactions).
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 (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
Reserve concomitant prescribing of Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation. General Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP should be stored securely to avoid theft or misuse. Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP should only be prescribed by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
If fentanyl is administered with a tranquilizer such as droperidol, the user should familiarize himself with the special properties of each drug, particularly the widely differing durations of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available (see DRUG INTERACTIONS).
Patients should be cautioned not to consume alcohol while taking Fentanyl Citrate Injection SDZ or Fentanyl Citrate Injection USP as it may increase the chance of experiencing serious adverse events, including death. Hyperalgesia that will not respond to a further dose increase of fentanyl can occur at particularly high doses.
A fentanyl dose reduction or change in opioid may be required. Abuse and Misuse Like all opioids, Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP are potential drugs of abuse and misuse, which can lead to overdose and death.
Therefore, Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP should be prescribed and handled with Fentanyl Citrate Injection SDZ / Fentanyl Citrate Injection USP Page 7 of 46 caution. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids, such as Fentanyl Citrate Injection SDZ and Fentanyl Citrate Injection USP, should be used with particular care in patients with a history of alcohol and illicit/prescription drug abuse.
However, concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Cardiovascular Fentanyl administration may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of drugs such as phenothiazines and other tranquilizers, sedative/hypnotics, […]