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indications:
Analgesic treatment used under general or local anesthesia.
Composition:
1 ml of solution contains 50 μg of fentanyl in the form of citrate.
Action:
A strong, narcotic analgesic. It makes it possible to keep the heart working normally, and at higher doses it reduces the hormonal changes caused by stress. After administration, the effect occurs very quickly, after about 2 min and usually takes 30 min after a single intravenous dose (100 μg). The maximum concentration after intravenous administration is achieved within 3-5 minutes. It can cause in addition to painkilling: increased muscle tone, euphoria, pupillary constriction, bradycardia, hypotension, contraction of the ureters and bile ducts, slowing down gastrointestinal motions. It can also affect the levels of hormones in the blood (growth hormone, antidiuretic hormone, prolactin, cortisol and catecholamines). The effects of fentanyl can be quickly and completely abolished by administering naloxone, an opioid antagonist. It binds about 84% with plasma proteins. T0,5 subsequent distribution phases is about 1 min and about 18 min, while the final one is0,5 the elimination is 475 min. It is metabolised quickly and predominantly by the liver. Fentanyl clearance is 0.5-1.2 l / h. About 75% of the administered dose is excreted within 24 hours. Only 10% is excreted unchanged in the urine.
Contraindications:
Hypersensitivity to fentanyl, other opioids or muscle relaxants or other components of the preparation. Limitation of respiratory function due to the opioid-specific respiratory depressant effect. Co-administration of MAO inhibitors, up to 2 weeks after discontinuation of their administration. Hypovolaemia and hypotension. Increased intracranial pressure, stroke. Myasthenia gravis.
Precautions:
The preparation may only be used by experienced medical personnel who have access to the resuscitation apparatus. Fentanyl may cause respiratory disorders and respiratory depression occurs after administration of a dose above 200 μg of fentanyl (4 ml). Administration of the naloxone antagonist (0.1-0.2 mg intravenously or intramuscularly) can eliminate these symptoms. Deep anesthesia exacerbates respiratory depression, this symptom may extend to the post-operative phase or re-occur in the postoperative phase - the patient should be closely observed and have a resuscitation apparatus and opioid antagonists. By hyperventilation during general anesthesia, the patient's carbon dioxide response may be altered and thus may affect respiration during the postoperative period. Fentanyl can lead to muscle stiffness, the frequency of which can be reduced by slow administration of intravenous injections. Bradycardia and asystole may occur if you have been given too low a dose of an anticholinergic medicine, or if fentanyl has been given in combination with non-blocking vagus nerve medication with a muscle relaxant. Bradycardia can be treated with atropine. Because opioids can cause hypotension, appropriate measures should be taken to maintain stable blood pressure. Fentanyl should be avoided as a rapid, single intravenous infusion in patients with cerebral dysfunction. These patients temporarily lower the blood pressure, sometimes accompanied by a short-term reduction in the brain's blood pressure. Patients who receive opioid therapy (also addicted to opioids) require higher doses. Caution should be exercised in the following cases: hypothyroidism, breathing disorders, chronic respiratory failure, alcoholism - long-term postoperative monitoring is recommended in these patients. Use with caution in patients with adrenal insufficiency, prostatic hypertrophy, porphyria and bradyarrhythmias. In patients with hepatic insufficiency, the preparation should be dispensed with caution due to the possibility of disruption of metabolic processes.In patients with renal insufficiency, particular attention should be paid to possible side effects as a result of increased fentanyl serum concentration. When used concomitantly with spideridosterone, the specific properties and side effects of both medicines should be considered.
Pregnancy and lactation:
The safety of fentanyl in pregnancy has not been established. Before using fentanyl in pregnant patients, possible benefits to potential risks should be considered. Fentanyl is not recommended during labor (including cesarean section) because fentanyl can cross the placenta and the fetal respiratory system is particularly sensitive to opioids. However, if fentanyl is given, a child with an antagonistic effect should be prepared for the child. Fentanyl may pass into the breast milk of the nursing mother, therefore patients who have been given fentanyl should discontinue breast-feeding for 24 hours.
Side effects:
Very common: drowsiness, postoperative depression or excessive agitation; muscle stiffness (including breathing muscles), myoclonic tremors, nervousness, weakness, dizziness; arrhythmias, bradycardia, hypotension or transient hypotonia; respiratory depression, apnea, urinary retention; nausea, vomiting, hiccups, spasm of Oddi's sphincter. Rare: allergic reactions (anaphylaxis, bronchospasm, pruritus, urticaria); asystole; laryngeal spasm, secondary respiratory depression after surgery; constipation; bile duct contraction; contraction of the ureters. In the case when a neuroleptic drug is administered simultaneously with fentanyl (eg droperidol), chills and convulsions may occur, anxiety may occur, postoperative hallucinations and extrapyramidal symptoms may occur. After a longer use of fentanyl, physical dependence may occur. During surgical procedures, tachycardia, hypertension may also occur.
Dosage:
The dose should be determined individually, taking into account the age, weight, mental state, general condition of the patient, simultaneous use of other drugs and the type of surgery and anesthesia. In order to avoid bradycardia, intravenous low dose anticholinergic therapy is recommended immediately before anesthesia. Adults. Initial anesthetic dose: 200-600 μg (4-12 ml); the dose above 200 μg is given only in the case of replacement ventilation. The maintenance dose of anesthesia: 50-200 μg (1-4 ml) can be given intravenously after 30-45 min. Children. Initial anesthetic dose: 1,25-2,5 μg / kg. (0.25-0.5 ml / 10 kg). Maintenance dose of anesthesia: 0.25 ml / 10 kg can be given intravenously after 30-45 min. There is no experience in children under 2 years of age. In patients who are weak and elderly, the dose for initiating anesthesia should be reduced. If the booster dose is set, the initial dose effect should be taken into account. The preparation should be administered slowly (over 1-2 minutes) intravenously.