Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3224
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ALFENTA (Injection)
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The dosage of ALFENTA (alfentanil hydrochloride) should be individualized and titrated to the desired effect in each patient according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of ALFENTA should be determined on the basis of lean body weight. The dose of ALFENTA shouldbe reduced in elderly or debilitated patients . Vital signs should be monitored routinely. See Dosage Guidelines for the use of ALFENTA: 1) by incremental injection as an analgesic adjunct to anesthesia with barbiturate/nitrous oxide/oxygen for short surgical procedures (expected duration of less than one hour); 2) by continuous infusion as a maintenance analgesic with nitrous oxide/oxygen for general surgical procedures; and 3) by intravenous injection in anesthetic doses for the induction of anesthesia for general surgical procedures with a minimum expected duration of 45 minutes; and 4) by intravenous injection as the analgesic component for monitored anesthesia care (MAC).<br/>Usage in Children: Clinical data to support the use of ALFENTA in patients under 12 years of age are not presently available. Therefore, such use is not recommended.<br/>Premedication: The selection of preanesthetic medications should be based upon the needs of the individual patient.<br/>Neuromuscular Blocking Agents: The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required . In patients administered anesthetic (induction) dosages of ALFENTA, it is essential that qualified personnel and adequate facilities are available for the management of intraoperative and postoperative respiratory depression. Also see WARNINGS and PRECAUTIONS sections. For purposes of administering small volumes of ALFENTA accurately, the use of a tuberculin syringe or equivalent is recommended. The physical and chemical compatibility of ALFENTA have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of ALFENTA infusion have been conducted with ALFENTA diluted to a concentration range of 25 mcg/mL to 80 mcg/mL. As an example of the preparation of ALFENTA for infusion, 20 mL of ALFENTA added to 230 mL of diluent provides 40 mcg/mL solution of ALFENTA. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.<br/>SAFETY AND HANDLING: ALFENTA (alfentanil hydrochloride) is supplied in individually sealed dosage forms which pose no known risk to health-care providers having incidental contact. Accidental dermal exposure to ALFENTA should be treated by rinsing the affected area with water. Protect from light. Storage: Store at 20��to 25��C (68��to 77��F). [See USP Controlled Room Temperature].
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ALFENTA (alfentanil hydrochloride) Injection is an opioid analgesic chemically designated as N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4-piperidinyl]-N-phenylpropanamide monohydrochloride (1:1) with a molecular weight of 452.98 and an n-octanol:water partition coefficient of 128:1 at pH 7.4. The structural formula of ALFENTA is: ALFENTA is a sterile, non-pyrogenic, preservative free aqueous solution containing alfentanil hydrochloride equivalent to 500��g per mL of alfentanil base for intravenous injection. The solution, which contains sodium chloride for isotonicity, has a pH range of 4-6. Each mL contains: Active: Alfentanil base 500 mcg. Inactive: Sodium Chloride 9 mg and Water for Injection Q.S.
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ALFENTA (alfentanil hydrochloride) is an opioid analgesic with a rapid onset of action. At doses of 8-40 mcg/kg for surgical procedures lasting up to 30 minutes, ALFENTA provides analgesic protection against hemodynamic responses to surgical stress with recovery times generally comparable to those seen with equipotent fentanyl dosages. For longer procedures, doses of up to 75 mcg/kg attenuate hemodynamic responses to laryngoscopy, intubation and incision, with recovery time comparable to fentanyl. At doses of 50-75 mcg/kg followed by a continuous infusion of 0.5-3 mcg/kg/min, ALFENTA attenuates the catecholamine response with more rapid recovery and reduced need for postoperative analgesics as compared to patients administered enflurane. At doses of 5 mcg/kg, ALFENTA provides analgesia for the conscious but sedated patient. Based on patient response, doses higher than 5 mcg/kg may be needed. Elderly or debilitated patients may require lower doses. High intrasubject and intersubject variability in the pharmacokinetic disposition of ALFENTA has been reported. The pharmacokinetics of ALFENTA can be described as a three-compartment model with sequential distribution half-lives of 1 and 14 minutes; and a terminal elimination half-life of 90-111 minutes (as compared to a terminal elimination half-life of approximately 475 minutes for fentanyl and approximately 265 minutes for sufentanil at doses of 250 mcg). The liver is the major site of biotransformation. ALFENTA has an apparent volume of distribution of 0.4-1 L/kg, which is approximately one-fourth to one-tenth that of fentanyl, with an average plasma clearance of 5 mL/kg/min as compared to approximately 8 mL/kg/min for fentanyl. Only 1.0% of the dose is excreted as unchanged drug; urinary excretion is the major route of elimination of metabolites. Plasma protein binding of ALFENTA is approximately 92%. In one study involving 15 patients administered ALFENTA with nitrous oxide/oxygen, a narrow range of plasma ALFENTA concentrations, approximately 310-340 ng/mL, was shown to provide adequate anesthesia for intra-abdominal surgery, while lower concentrations, approximately 190 ng/mL, blocked responses to skin closure. Plasma concentrations between 100-200 ng/mL provided adequate anesthesia for superficial surgery. ALFENTA has an immediate onset of action. At dosages of approximately 105 mcg/kg, ALFENTA produces hypnosis as determined by EEG patterns; an anesthetic EDof 182 mcg/kg for ALFENTA in unpremedicated patients has been determined, based upon the ability to block response to placement of a nasopharyngeal airway. Based on clinical trials, induction dosage requirements range from 130-245 mcg/kg. For procedures lasting 30-60 minutes, loading dosages of up to 50 mcg/kg produce the hemodynamic response to endotracheal intubation and skin incision as comparable to those from fentanyl. A pre-intubation loading dose of 50-75 mcg/kg prior to a continuous infusion attenuates the response to laryngoscopy, intubation and incision. Subsequent administration of ALFENTA infusion administeredat a rate of 0.5-3 mcg/kg/min with nitrous oxide/oxygen attenuates sympathetic responses to surgical stress with more rapid recovery than enflurane. Requirements for volatile inhalation anesthetics were reduced by thirty to fifty percent during the first 60 minutes of maintenance in patients administered anesthetic doses (above 130 mcg/kg) of ALFENTA as compared to patients given doses of 4-5 mg/kg thiopental for anesthetic induction. At anesthetic induction dosages, ALFENTA providesa deep level of anesthesia during the first hour of anesthetic maintenance and provides attenuation of the hemodynamic response during intubation and incision. Following an anesthetic induction dose of ALFENTA, requirements for ALFENTA infusion are reduced by 30 to 50% for the first hour of maintenance. Patients with compromised liver function and those over 65 years of age have been found to have reduced plasma clearance and extended terminal elimination for ALFENTA, which may prolong postoperative recovery. Repeated or continuous administration of ALFENTA produces increasing plasma concentrations and an accumulation of the drug, particularly in patients with reduced plasma clearance. Bradycardia may be seen in patients administered ALFENTA. The incidence and degree of bradycardia may be more pronounced when ALFENTA is administered in conjunction with non-vagolytic neuromuscular blocking agents or in the absence of anticholinergic agents such as atropine. Administration of intravenous diazepam immediately prior to or following high doses of ALFENTA has been shown to produce decreases in blood pressure that may be secondary to vasodilation; recovery may also be prolonged. Patients administered doses up to 200 mcg/kg of ALFENTA have shown no significant increase in histamine levels and no clinical evidence of histamine release. Skeletal muscle rigidity is related to the dose and speed of administration of ALFENTA. Muscular rigidity will occur with an immediate onset following anesthetic induction dosages. Preventative measures may reduce the rate and severity. The duration and degree of respiratory depression and increased airway resistance usually increase with dose, but have also been observed at lower doses. Although higher doses may produce apnea and a longer duration of respiratory depression, apnea may also occur at low doses. During monitored anesthesia care (MAC), attention must be given to the respiratory effects of ALFENTA Injection. Decreased oxygen saturation, apnea, decreased respiratory rate, and upper airway obstruction can occur.
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ALFENTA (alfentanil hydrochloride) is contraindicated in patients with known hypersensitivity to the drug or known intolerance to other opioid agonists.
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ALFENTA (alfentanil hydrochloride) Injection for intravenous use. Each mL Contains: Active: Alfentanil base 500 mcg. Inactives: Sodium Chloride 9 mg and WFI Q.S ALFENTA Injection is available as: NDC 11098-060-02, 2 mL Ampule in packages of 10NDC 11098-060-05, 5 mL Ampule in packages of 10NDC 11098-060-10, 10 mL Ampule in packages of 5NDC 11098-060-20, 20 mL Ampule in packages of 5
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Overdosage would be manifested by extension of the pharmacological actions of ALFENTA (alfentanil hydrochloride) as with other potent opioid analgesics. No experience of overdosage with ALFENTA was reported during clinical trials. The intravenous LDof ALFENTA is 43-51 mg/kg in rats, 72-74 mg/kg in mice, 72-82 mg/kg in guinea pigs and 60-88 mg/kg in dogs. Intravenous administration of an opioid antagonist such as naloxone should be employed as a specific antidote to manage respiratory depression. The duration of respiratory depression following overdosage with ALFENTA may be longer than the duration of action of the opioid antagonist. Administration of an opioid antagonist should not preclude immediate establishment of a patent airway, administration of oxygen, and assisted or controlled ventilation as indicated for hypoventilation or apnea. If respiratory depression is associated with muscular rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled ventilation. Intravenous fluids and vasoactive agents may be required to manage hemodynamic instability.
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Alfentanil Hydrochloride
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ALFENTA (Injection)
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The most common adverse reactions of opioids are respiratory depression and skeletal muscle rigidity, particularly of the truncal muscles. ALFENTA may produce muscular rigidity that involves the skeletal muscles of the neck and extremities. See CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS on the management of respiratory depression and skeletal muscle rigidity. The adverse experience profile from 696 patients receiving ALFENTA for Monitored Anesthesia Care (MAC) is similar to the profile established with ALFENTA during general anesthesia. Respiratory events reported during MAC included hypoxia, apnea, and bradypnea. Other adverse events reported by patients receiving ALFENTA for MAC, in order of decreasing frequency, were nausea, hypotension, vomiting, pruritus, confusion,somnolence and agitation. The following adverse reaction information is derived from controlled and open clinical trials in 785 patients who received intravenous ALFENTA during induction and maintenance of general anesthesia. The controlled trials included treatment comparisons with fentanyl, thiopental sodium, enflurane, saline placebo and halothane. The incidence of certain side effects is influenced by the type of use, e.g., chest wall rigidity has a higher reported incidence in clinical trials of alfentanil induction, and by the type of surgery, e.g., nausea and vomiting have a higher reported incidence in patients undergoing gynecologic surgery. The overall reports of nausea and vomiting with ALFENTA were comparable to fentanyl.<br/>Incidence Greater than 1% - Probably Causally Related (Derived from clinical trials):<br/>Incidence Less than 1% - Probably Causally Related (Derived from clinical trials): Adverse events reported in post-marketing surveillance, not seen in clinical trials, are italicized.
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ALFENTA (alfentanil hydrochloride) is indicated: SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OF ALFENTA.
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ALFENTA
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