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FENTANYL 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 Injection BP is 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 Injection BP 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 Injection BP not be exceeded. Each patient should be assessed for their risk prior to prescribing Fentanyl Injection BP, 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 Injection BP (see DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage). Dosing Considerations Fentanyl Injection BP 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.
Adjunct to General Anesthesia:
See Dosage Range Chart (Table 1). 028 mL/kg) may be administered FENTANYL INJECTION BP Page 17 of 46 intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required.
As a General Anesthetic:
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 Injection BP. 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.
Adverse Drug Reaction Overview Adverse effects of Fentanyl Injection BP are similar to those of other opioid analgesics, and represent an extension of pharmacological effects of the drug class. The major hazards of opioids include respiratory and central nervous system depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.
The most frequently observed serious adverse effects of fentanyl are respiratory depression, apnea, muscle rigidity and bradycardia. If these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur.
Pruritus, occurring mainly in the face and chest area, is observed frequently following the administration of fentanyl by the epidural route. Other adverse reactions that have been reported are: cough, hypotension, dizziness, blurred vision, nausea, emesis, laryngospasm, diaphoresis, itching, drowsiness and urinary retention.
It has been reported that secondary rebound respiratory depression may occasionally occur postoperatively. Patients should be monitored for this possibility and appropriate countermeasures taken as necessary. When a neuroleptic such as droperidol is used with fentanyl, the following adverse reactions can occur: chills or shivering, restlessness, and postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression); extrapyramidal symptoms (dystonia, akathisia and oculogyric crisis) have been observed up to 24 hours postoperatively.
When they occur, extrapyramidal symptoms can usually be controlled with antiparkinson agents. Postoperative drowsiness is also frequently reported following the use of droperidol. Elevated blood pressure, with or without pre-existing hypertension, has been reported following administration of fentanyl combined with droperidol.
This might be due to unexplained alterations in sympathetic activity following large doses; however, it is also frequently attributed to anesthetic and surgical stimulation during light anesthesia. Although fentanyl has been reported to induce grand mal seizures with intravenous administration at doses of 100 mcg, there was no electroencephalographic documentation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 mL/kg) Fentanyl Injection BP. 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 Injection BP. 4 - 1 mL/kg) of Fentanyl Injection BP 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) Fentanyl Injection BP administered intravenously or intramuscularly when movement or changes in vital signs indicate surgical stress or lightening of analgesia.
5 mL) to one half the initial loading dose) Fentanyl Injection BP 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 has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is indicated, and for FENTANYL INJECTION BP Page 18 of 46 certain complicated neurological and orthopedic procedures.
1 mg, 2 mL). 9% sodium chloride resulting in a final concentration of 10 mcg/mL. If required, additional boluses of 100 mcg on demand or by continuous infusion at rate of 1 mcg/kg/hr.
Caution:
Such admixtures should be used within 24 hours because of the risk of microbial contamination during […]
Some authors suggest that rigidity is a more likely explanation for the myoclonic movements, since none of the patients showed any neurologic disorders after their reported seizures.
Clinical Trial Adverse Drug Reactions Sedation:
Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals. Sedation may also occur partly because patients often recuperate from prolonged fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within three to five days and, if the sedation is not severe, will not require any treatment except reassurance.
If excessive sedation persists beyond a few days, the dose of the opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and respiratory failure.
If FENTANYL INJECTION BP Page 14 of 46 it is necessary to reduce the dose, it can be carefully increased again after three or four days if it is obvious that the pain is not being well controlled. Dizziness and unsteadiness may be caused by postural hypotension, particularly in elderly or debilitated patients, and may be alleviated if the patient lies down.
Nausea and Vomiting:
Nausea is a common side effect on initiation of therapy with opioid analgesics and is thought to occur by activation of the chemoreceptor trigger zone, stimulation of the vestibular apparatus and through delayed gastric emptying. The prevalence of nausea declines following continued treatment with opioid analgesics.
When instituting therapy with an opioid for chronic pain, the routine prescription of an antiemetic should be considered. In the cancer patient, investigation of nausea should include such causes as constipation, bowel obstruction, uremia, hypercalcemia, hepatomegaly, tumor invasion of celiac plexus and concurrent use of drugs with emetogenic properties.
Persistent nausea which does not respond to dosage reduction may be caused by opioid-induced gastric stasis and may be accompanied by other symptoms including anorexia, early satiety, vomiting and abdominal fullness. These symptoms respond to chronic treatment with gastrointestinal prokinetic agents.
Constipation:
Practically all patients become constipated while taking opioids on a persistent basis. In some patients, particularly the elderly or bedridden, fecal impaction may result. It is essential to caution the patients in this regard and to institute an appropriate regimen of bowel management at the start of prolonged opioid therapy.
Stimulant laxatives, stool softeners, and other appropriate measures should be used as required. As fecal impaction may present as overflow diarrhea, the presence of constipation should be excluded in patients on opioid therapy prior to initiating treatment for diarrhea.
Post-Marketing Experience Serotonin Syndrome:
Post-marketing reports describe patients with symptoms suggestive of, or diagnostic of, serotonin syndrome following the concomitant use of fentanyl with a serotonergic drug, such as a Selective Serotonin Re-uptake Inhibitor or a Serotonin Norepinephrine Re-uptake Inhibitor (see DRUG INTERACTIONS).
Androgen deficiency:
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.
Patients presenting with symptoms of androgen deficiency should undergo […]