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Alfenta

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Alfenta

WARNINGS

ALFENTA (alfenta (alfenta (alfentanil) nil) nil) SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF INTRAVENOUS AND GENERAL ANESTHETIC AGENTS AND IN THE MANAGEMENT OF RESPIRATORY EFFECTS OF POTENT OPIOIDS.

AN OPIOID ANTAGONIST, RESUSCITATIVE AND INTUBATION EQUIPMENT AND OXYGEN SHOULD BE READILY AVAILABLE.

BECAUSE OF THE POSSIBILITY OF DELAYED RESPIRATORY DEPRESSION, MONITORING OF THE PATIENT MUST CONTINUE WELL AFTER SURGERY.

ALFENTA (alfenta (alfenta (alfenta (alfentanil) nil) nil) nil hydrochloride) administered in initial dosages up to 20 mcg/kg may cause skeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity of muscle rigidity is usually dose-related. Administration of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) at anesthetic induction dosages (above 130 mcg/kg) will consistently produce muscular rigidity with an immediate onset. The onset of muscular rigidity occurs earlier than with other opioids. ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may produce muscular rigidity that involves all skeletal muscles, including those of the neck and extremities. The incidence may be reduced by: 1) routine methods of administration of neuromuscular blocking agents for balanced opioid anesthesia; 2) administration of up to 1/4 of the full paralyzing dose of a neuromuscular blocking agent just prior to administration of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) at dosages up to 130 mcg/kg; following loss of consciousness, a full paralyzing dose of a neuromuscular blocking agent should be administered; or 3) simultaneous administration of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) and a full paralyzing dose of a neuromuscular blocking agent when ALFENTA (alfenta (alfenta (alfentanil) nil) nil) is used in rapidly administered anesthetic dosages (above 130 mcg/kg).

The neuromuscular blocking agent used should be appropriate for the patient's cardiovascular status. Adequate facilities should be available for postoperative monitoring and ventilation of patients administered ALFENTA (alfenta (alfenta (alfentanil) nil) nil) . It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.

PATIENTS RECEIVING MONITORED ANESTHESIA CARE (MAC) SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE; OXYGEN SUPPLEMENTATION SHOULD BE IMMEDIATELY AVAILABLE AND PROVIDED WHERE CLINICALLY INDICATED; OXYGEN SATURATION SHOULD BE CONTINUOUSLY MONITORED; THE PATIENT SHOULD BE OBSERVED FOR EARLY SIGNS OF HYPOTENSION, APNEA, UPPER AIRWAY OBSTRUCTION AND/OR OXYGEN DESATURATION.

Severe and unpredictable potentiation of monoamine oxidase (MAO) inhibitors has been reported for other opioid analgesics, and rarely with alfentanil. Therefore when alfenta (alfenta (alfenta (alfentanil) nil) nil) nil is administered to patients who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and betablockers for the treatment of hypertension is recommended.

PRECAUTIONS

DELAYED RESPIRATORY DEPRESSION, RESPIRATORY ARREST, BRADYCARDIA, ASYSTOLE, ARRHYTHMIAS AND HYPOTENSION HAVE ALSO BEEN REPORTED. THEREFORE, VITAL SIGNS MUST BE MONITORED CONTINUOUSLY.

General: The initial dose of ALFENTA (alfenta (alfenta (alfenta (alfentanil) nil) nil) nil hydrochloride) should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining supplemental doses. In obese patients (more than 20% above ideal total body weight), the dosage of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be determined on the basis of lean body weight.

In one clinical trial, the dose of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) required to produce anesthesia, as determined by appearance of delta waves in EEG, was 40% lower in geriatric patients than that needed in healthy young patients.

In patients with compromised liver function and in geriatric patients, the plasma clearance of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may be reduced and postoperative recovery may be prolonged.

Induction doses of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be administered slowly (over three minutes). Administration may produce loss of vascular tone and hypotension. Consideration should be given to fluid replacement prior to induction.

Diazepam administered immediately prior to or in conjunction with high doses of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may produce vasodilation, hypotension and result in delayed recovery.

Bradycardia produced by ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may be treated with atropine. Severe bradycardia and asystole have been successfully treated with atropine and conventional resuscitative methods.

The hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required should be considered in the selection of a neuromuscular blocking agent.

Following an anesthetic induction dose of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) , requirements for volatile inhalation anesthetics or ALFENTA (alfenta (alfenta (alfentanil) nil) nil) infusion are reduced by 30 to 50% for the first hour of maintenance.

ALFENTA (alfenta (alfenta (alfentanil) nil) nil) infusions should be discontinued at least 10-15 minutes prior to the end of surgery during general anesthesia. During administration of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) for Monitored Anesthesia Care (MAC), infusions may be continued to the end of the procedure.

Respiratory depression caused by opioid analgesics can be reversed by opioid antagonists such as naloxone. Because the duration of respiratory depression produced by ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may last longer than the duration of the opioid antagonist action, appropriate surveillance should be maintained. As with all potent opioids, profound analgesia is accompanied by respiratory depression and diminished sensitivity to CO2 stimulation which may persist into or recur in the postoperative period. Intraoperative hyperventilation may further alter postoperative response to CO2. Appropriate postoperative monitoring should be employed, particularly after infusions and large doses of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) , to ensure that adequate spontaneous breathing is established and maintained in the absence of stimulation prior to discharging the patient from the recovery area.

Head Injuries: ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be used with caution in patients with head injury or increased intracranial pressure, due to the increased risk of respiratory depression. As with all opioids, ALFENTA (alfenta (alfenta (alfentanil) nil) nil) may obscure the clinical course of patients with head injuries and should be used only if clinically indicated.

Impaired Respiration: ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be used with caution in patients with pulmonary disease, decreased respiratory reserve or potentially compromised respiration. In such patients, opioids may additionally decrease respiratory drive and increase airway resistance. During anesthesia, this can be managed by assisted or controlled respiration.

Impaired Hepatic or Renal Function: In patients with liver or kidney dysfunction, ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be administered with caution due to the importance of these organs in the metabolism and excretion of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) .

Carcinogenesis, Mutagenesis and Impairment of Fertility: No long-term animal studies of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) have been performed to evaluate carcinogenic potential. No structural chromosome mutations were produced in the in vivo micronucleus test in female rats at single intravenous doses of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) as high as 20 mg/kg body weight (approximately 40 times the upper human dose), equivalent to a dose of 103 mg/m² body surface area. No dominant lethal mutations were produced in the in vivo dominant lethal test in male and female mice at the maximum intravenous dose of 20 mg/kg (60 mg/m²). No mutagenic activity was revealed in the in vitro Ames Salmonella typhimurium test, with and without metabolic activation.

Pregnancy Category C: ALFENTA (alfenta (alfenta (alfentanil) nil) nil) has been shown to have an embryocidal effect in rats and rabbits when given in doses 2.5 times the upper human dose for a period of 10 days to over 30 days. These effects could have been due to maternal toxicity (decreased food consumption with increased mortality) following prolonged administration of the drug.

No evidence of teratogenic effects has been observed after administration of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) in rats or rabbits.

There are no adequate and well-controlled studies in pregnant women. ALFENTA (alfenta (alfenta (alfentanil) nil) nil) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: There are insufficient data to support the use of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) in labor and delivery. Placental transfer of the drug has been reported; therefore, use in labor and delivery is not recommended.

Nursing Mothers: In one study of nine women undergoing postpartum tubal ligation, significant levels of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) were detected in colostrum four hours after administration of 60 mcg/kg of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) , with no detectable levels present after 28 hours. Caution should be exercised when ALFENTA (alfenta (alfenta (alfentanil) nil) nil) is administered to a nursing woman.

Pediatric Use: Adequate data to support the use of ALFENTA (alfenta (alfenta (alfentanil) nil) nil) in children under 12 years of age are not presently available.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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Additional Alfenta Information

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