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on :

Drug Name: VICTANYL

Legal Class:CD

Drug Class: OpiatesHow

Supplied:Fentanyl

Price:

25 microgram/hr, 5=25.89.50 microgram/hr, 5=48.36.75 microgram/hr, 5=67.41.100 microgram/hr, 5=83.09.Transparent and colourless transdermal patches with blue imprint on the

backing foil and marked with name and strength.Indications: Severe chronic pain.

Adults:

Opioid-naive patients: Initially, patch with release rate of 12.5 microgram/hr.Opioid-tolerant patients: Apply strength of patch according to previousanalgesics. See SPC.Apply patch to non-hairy area of chest or upper arm, remove and replace withnew patch every 72 hrs using a different site. Titrate in 12.5 or 25microgram/hr increments until pain controlled. Consider other analgesics ifdose exceeds 300 microgram/hr.

Children:

Under 2 years, not recommended. 2 16 years, opioid tolerant patients only:

apply strength of patch according to previous analgesics. See SPC.In young children, apply patch to upper back to minimise potential for removaland monitor adhesion. Remove and replace with new patch every 72 hrs usinga different site. Titrate in 12 microgram/hr increments until pain controlled.

General Warnings for Fentanyl

Contraindications:Severe respiratory depression, severe obstructive lung conditions, severeCNS impairment, bradycardia. Lactation.Fencino, Mezolar Matrix: soya/peanut allergy.Instanyl: previous facial radiotherapy, recurrent epistaxis.

Precautions:

COPD, raised intracranial pressure, impaired consciousness, head injury,

brain tumour, renal or hepatic impairment, hypovolaemia, hypotension.Monitor for signs of respiratory depression. Myasthenia gravis. Risk oftolerance and dependence (esp in patients with history of drug or alcoholdependence); withdraw gradually. Elderly or debilitated patients.Opioid-naive patients. Pregnancy. Dispose of patches and oral units withcare. Patches: fever, avoid exposure of application site to direct heat. Donot cut patches. Avoid touching adhesive side, wash hands after use.Abstral: mouth wounds or mucositis.

Interactions:MAOIs, SSRIs, SNRIs, other serotonergic drugs, CNS depressants,inducers or inhibitors of CYP3A4, grapefruit juice, buprenorphine,

pentazocine. Instanyl, PecFent: other intranasal drugs.Side Effects: Hypotension, hypertension, somnolence, sedation, dizziness,
http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/search/Drugs/phrase/Opiates/


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General Warnings for Fentanylhallucinations, pruritus, sweating, bradycardia, tachycardia, palpitations,GI upset, urinary retention, headache, confusion, asthenia, fatigue,dyspnoea, respiratory depression, anxiety, anorexia, insomnia,depression, tremor, paraesthesia, muscle spasm, oedema. Oral use:mouth ulceration, dry mouth, flushing. Nasal spray: epistaxis,rhinorrhoea, nasal discomfort, flushing, hot flushes, throat irritation,dysgeusia. Patches: application site reactions.

Additional Notes: Effentora, PecFent: Report any adverse reaction to CHM.

Section:Pain

Sub Section:Pain, fever (View Prescribing Notes )

Drug Class:

Opiates Manufacturer:

Zentiva Drug Name: OSMANIL

Legal Class: CD


Supplied:Fentanyl

Price:

12 microgram/hr (releases 12.5 microgram/hr), 5=18.11.25 microgram/hr, 5=26.94.50 microgram/hr, 5=50.32.75 microgram/hr, 5=70.15.100 microgram/hr, 5=86.46.Transparent and colourless transdermal patches with blue imprint on the

backing foil and marked with name and strength.Indications: Severe chronic pain which can be adequately managed only with opioid

analgesics.

Adults:

Opioid-naive patients: Initially 12.5 microgram/hr.

Opioid-tolerant patients: Apply strength of patch according to previousanalgesics. See SPC.Apply patch to non-hairy area of chest or upper arm, remove and replace withnew patch every 72 hrs using a different site. Titrate in 12.5 or25 microgram/hr increments until pain controlled.Consider other analgesics if dose exceeds 300 microgram/hr.

Children:2 16 years; opioid-tolerant patients only, receiving at least 30mg oralmorphine equivalents per day: Apply strength of patch according to previousanalgesics. See SPC. Apply patch to upper back.


Contraindications: Severe respiratory depression, severe obstructive lung conditions, severeCNS impairment, bradycardia. Lactation.
http://www.mims.co.uk/Drugs/pain/http://www.mims.co.uk/Drugs/pain/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Manufacturers/zentiva/http://www.mims.co.uk/Manufacturers/zentiva/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Manufacturers/zentiva/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/


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General Warnings for FentanylFencino, Mezolar Matrix: soya/peanut allergy.Instanyl: previous facial radiotherapy, recurrent epistaxis.

Precautions:

COPD, raised intracranial pressure, impaired consciousness, head injury,

brain tumour, renal or hepatic impairment, hypovolaemia, hypotension.Monitor for signs of respiratory depression. Myasthenia gravis. Risk oftolerance and dependence (esp in patients with history of drug or alcoholdependence); withdraw gradually. Elderly or debilitated patients.Opioid-naive patients. Pregnancy. Dispose of patches and oral units withcare. Patches: fever, avoid exposure of application site to direct heat. Donot cut patches. Avoid touching adhesive side, wash hands after use.Abstral: mouth wounds or mucositis.


pentazocine. Instanyl, PecFent: other intranasal drugs.

Side Effects:

Hypotension, hypertension, somnolence, sedation, dizziness,hallucinations, pruritus, sweating, bradycardia, tachycardia, palpitations,GI upset, urinary retention, headache, confusion, asthenia, fatigue,dyspnoea, respiratory depression, anxiety, anorexia, insomnia,depression, tremor, paraesthesia, muscle spasm, oedema. Oral use:mouth ulceration, dry mouth, flushing. Nasal spray: epistaxis,rhinorrhoea, nasal discomfort, flushing, hot flushes, throat irritation,dysgeusia. Patches: application site reactions.

Additional Notes: Effentora, PecFent: Report any adverse reaction to CHM.

Mezolar Matrix (CD)

Section:Pain

Sub Section:Pain, fever (View Prescribing Notes )

Drug Class:Opiates

Manufacturer:

Sandoz Ltd Drug Name: MEZOLAR MATRIX

Legal Class: CD


Supplied:Fentanyl

Price:12 microgram/hr, 5=8.87.25 microgram/hr, 5=12.68.

50 microgram/hr, 5=23.69.75 microgram/hr, 5=33.03.
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Drug Name: MEZOLAR MATRIX

100 microgram/hr, 5=40.71.Transdermal, rounded oblong transparent matrix patches.

Indications: Severe chronic pain.

Adults:

Strong opioid-naive patients: Initially 12 25 microgram/hr.Opioid tolerant patients: Apply strength of patch according to previousanalgesics. See SPC.Apply patch to non-hairy area of chest or upper arm, remove and replace withnew patch every 72 hrs using a different site. Titrate in 12 or 25 microgram/hrincrements until pain controlled. Consider other analgesics if dose exceeds 300microgram/hr.

Children:

Under 2 years, not recommended. 2 16 years, opioid tolerant patients only:apply strength of patch according to previous analgesics. See SPC.In young children, apply patch to upper back to minimise potential for removaland monitor adhesion. Remove and replace with new patch every 72 hrs usinga different site. Titrate in 12 microgram/hr increments until pain controlled.


Contraindications:Severe respiratory depression, severe obstructive lung conditions, severeCNS impairment, bradycardia. Lactation.Fencino, Mezolar Matrix: soya/peanut allergy.Instanyl: previous facial radiotherapy, recurrent epistaxis.

Precautions:

COPD, raised intracranial pressure, impaired consciousness, head injury, brain tumour, renal or hepatic impairment, hypovolaemia, hypotension.Monitor for signs of respiratory depression. Myasthenia gravis. Risk oftolerance and dependence (esp in patients with history of drug or alcoholdependence); withdraw gradually. Elderly or debilitated patients.Opioid-naive patients. Pregnancy. Dispose of patches and oral units withcare. Patches: fever, avoid exposure of application site to direct heat. Donot cut patches. Avoid touching adhesive side, wash hands after use.Abstral: mouth wounds or mucositis.


pentazocine. Instanyl, PecFent: other intranasal drugs.

Side Effects:

Hypotension, hypertension, somnolence, sedation, dizziness,hallucinations, pruritus, sweating, bradycardia, tachycardia, palpitations,GI upset, urinary retention, headache, confusion, asthenia, fatigue,dyspnoea, respiratory depression, anxiety, anorexia, insomnia,depression, tremor, paraesthesia, muscle spasm, oedema. Oral use:mouth ulceration, dry mouth, flushing. Nasal spray: epistaxis,rhinorrhoea, nasal discomfort, flushing, hot flushes, throat irritation,dysgeusia. Patches: application site reactions.

Additional Notes:

Effentora, PecFent: Report any adverse reaction to CHM.

Cyclimorph (CD)


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General Warnings for FentanylSection:

Pain Sub Section:

Pain, fever (View Prescribing Notes ) Drug Class:

Opiates Manufacturer:

Amdipharm Mercury Company Ltd Drug Name:

CYCLIMORPH

Legal Class: CD

Drug Class: Opiates

HowSupplied:

Cyclimorph 10 morphine tartrate 10mg, cyclizinetartrate 50mg/ml.Cyclimorph 15 morphine tartrate 15mg, cyclizinetartrate 50mg/ml

Price: Cyclimorph 10, 5 x 1ml amp=8.77.Cyclimorph 15, 5 x 1ml amp=9.12.

Indications: Moderate to severe pain where reduction of nausea isrequired.

Adults: 10 20mg morphine tartrate by sc, im or iv inj not morefrequently than every four hrs. Max 3 doses in 24 hrs.

Children: Not recommended.

General Warnings for Morphine + cyclizine

Contraindications:

Respiratory depression, obstructed airways, heartfailure secondary to chronic lung disease, moderateto severe renal impairment, severe hepaticimpairment, ulcerative colitis, acute alcoholintoxication, head injury, raised intracranial

pressure.

Precautions:

Hypothyroidism, adrenocortical insufficiency,hypopituitarism, prostatic hypertrophy, shock,diabetes, phaeochromocytoma, severe heart failure,glaucoma, obstructive disease of GI tract. Risk oftolerance and dependence. Elderly, debilitated.Pregnancy, labour, lactation.

Interactions: MAOIs, CNS depressants, phenothiazines,diuretics, propranolol, anticholinergics.

Side Effects:Drowsiness, dry mouth, blurred vision,constipation, respiratory depression, orthostatichypotension.

Alfenta
http://www.mims.co.uk/Drugs/pain/http://www.mims.co.uk/Drugs/pain/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Manufacturers/amdipharm-mercury-company-ltd/http://www.mims.co.uk/Manufacturers/amdipharm-mercury-company-ltd/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Manufacturers/amdipharm-mercury-company-ltd/http://www.mims.co.uk/search/Drugs/phrase/Opiates/http://www.mims.co.uk/Drugs/pain/pain-fever/PrescribingNotes/http://www.mims.co.uk/Drugs/pain/pain-fever/http://www.mims.co.uk/Drugs/pain/


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CII

Rx only

Alfenta Description

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 amolecular weight of 452.98 and an n-octanol:water partition coefficient of 128:1 at pH 7.4.The structural formula of Alfenta is:

Slideshow: Psoriasis: Treatment Options to Manage Your Symptoms

Alfenta is a sterile, non-pyrogenic, preservative free aqueous solution containing Alfentanilhydrochloride equivalent to 500 g per mL of Alfentanil base for intravenous injection. Thesolution, which contains sodium chloride for isotonicity, has a pH range of 4-6. Each mLcontains: Active: Alfentanil base 500 mcg. Inactive: Sodium Chloride 9 mg and Water forInjection Q.S.

Alfenta - Clinical Pharmacology

Alfenta (Alfentanil hydrochloride) is an opioid analgesic with a rapid onset of action.
http://www.drugs.com/slideshow/psoriasis-treatment-options-1049http://www.drugs.com/slideshow/psoriasis-treatment-options-1049


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At doses of 8-40 mcg/kg for surgical procedures lasting up to 30 minutes, Alfenta providesanalgesic protection against hemodynamic responses to surgical stress with recovery timesgenerally 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 dosesof 50-75 mcg/kg followed by a continuous infusion of 0.5-3 mcg/kg/min, Alfenta attenuatesthe catecholamine response with more rapid recovery and reduced need for postoperativeanalgesics 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, doseshigher 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 Alfentahas been reported.

The pharmacokinetics of Alfenta can be described as a three-compartment model withsequential distribution half-lives of 1 and 14 minutes; and a terminal elimination half-life of90-111 minutes (as compared to a terminal elimination half-life of approximately 475minutes for fentanyl and approximately 265 minutes for sufentanil at doses of 250 mcg). Theliver 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 ascompared 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 ofelimination of metabolites. Plasma protein binding of Alfenta is approximately 92%.

In one study involving 15 patients administered Alfenta with nitrous oxide/oxygen, a narrowrange 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 between100-200 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 ED90 of 182 mcg/kg forAlfenta in unpremedicated patients has been determined, based upon the ability to blockresponse 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, loadingdosages of up to 50 mcg/kg produce the hemodynamic response to endotracheal intubationand 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, intubationand incision. Subsequent administration of Alfenta infusion administered at a rate of 0.5-3mcg/kg/min with nitrous oxide/oxygen attenuates sympathetic responses to surgical stresswith more rapid recovery than enflurane.

Requirements for volatile inhalation anesthetics were reduced by thirty to fifty percent duringthe first 60 minutes of maintenance in patients administered anesthetic doses (above 130mcg/kg) of Alfenta as compared to patients given doses of 4-5 mg/kg thiopental for

anesthetic induction. At anesthetic induction dosages, Alfenta provides a deep level of


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anesthesia during the first hour of anesthetic maintenance and provides attenuation of thehemodynamic response during intubation and incision.

Following an anesthetic induction dose of Alfenta, requirements for Alfenta infusion arereduced 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 tohave reduced plasma clearance and extended terminal elimination for Alfenta, which may

prolong postoperative recovery. Repeated or continuous administration of Alfenta producesincreasing plasma concentrations and an accumulation of the drug, particularly in patientswith 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 asatropine.

Administration of intravenous diazepam immediately prior to or following high doses ofAlfenta has been shown to produce decreases in blood pressure that may be secondary tovasodilation; recovery may also be prolonged.

Patients administered doses up to 200 mcg/kg of Alfenta have shown no significant increasein 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 (see WARNINGS ) may reduce the rate and severity.

The duration and degree of respiratory depression and increased airway resistance usuallyincrease 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 lowdoses.

During monitored anesthesia care (MAC), attention must be given to the respiratory effects ofAlfenta Injection. Decreased oxygen saturation, apnea, decreased respiratory rate, and upperairway obstruction can occur. (See WARNINGS )

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Indications and Usage for Alfenta

Alfenta (Alfentanil hydrochloride) is indicated:

as an analgesic adjunct given in incremental doses in the maintenance of anesthesia withbarbiturate/nitrous oxide/oxygen.

as an analgesic administered by continuous infusion with nitrous oxide/oxygen in themaintenance of general anesthesia.

as a primary anesthetic agent for the induction of anesthesia in patients undergoing generalsurgery in which endotracheal intubation and mechanical ventilation are required.

as the analgesic component for monitored anesthesia care (MAC).

SEE DOSAGE CHART FOR MORE COMPLETE INFORMATION ON THE USE OFAlfenta.

ContraindicationsAlfenta (Alfentanil hydrochloride) is contraindicated in patients with known hypersensitivityto the drug or known intolerance to other opioid agonists.

Warnings

Alfenta SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLYTRAINED IN THE USE OF INTRAVENOUS AND GENERAL ANESTHETIC AGENTSAND IN THE MANAGEMENT OF RESPIRATORY EFFECTS OF POTENT OPIOIDS.

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

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

Alfenta (Alfentanil hydrochloride) administered in initial dosages up to 20 mcg/kg may causeskeletal muscle rigidity, particularly of the truncal muscles. The incidence and severity ofmuscle rigidity is usually dose-related. Administration of Alfenta at anesthetic inductiondosages (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 may produce muscular rigidity that involves all skeletal muscles, including those of the neck and
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extremities. The incidence may be reduced by: 1) routine methods of administration ofneuromuscular blocking agents for balanced opioid anesthesia; 2) administration of up to 1/4of the full paralyzing dose of a neuromuscular blocking agent just prior to administration ofAlfenta at dosages up to 130 mcg/kg; following loss of consciousness, a full paralyzing doseof a neuromuscular blocking agent should be administered; or 3) simultaneous administration

of Alfenta and a full paralyzing dose of a neuromuscular blocking agent when Alfenta is usedin rapidly administered anesthetic dosages (above 130 mcg/kg).

The neuromuscular blocking agent used should be appropriate for the patient's cardiovascularstatus. Adequate facilities should be available for postoperative monitoring and ventilation of

patients administered Alfenta. It is essential that these facilities be fully equipped to handleall degrees of respiratory depression.

PATIENTS RECEIVING MONITORED ANESTHESIA CARE (MAC) SHOULD BECONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCTOF THE SURGICAL OR DIAGNOSTIC PROCEDURE; OXYGEN SUPPLEMENTATIONSHOULD BE IMMEDIATELY AVAILABLE AND PROVIDED WHERE CLINICALLYINDICATED; 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 beenreported for other opioid analgesics, and rarely with Alfentanil. Therefore when Alfentanil isadministered to patients who have received MAO inhibitors within 14 days, appropriatemonitoring and ready availability of vasodilators and beta-blockers for the treatment ofhypertension is recommended.

Precautions

DELAYED RESPIRATORY DEPRESSION, RESPIRATORY ARREST,BRADYCARDIA, ASYSTOLE, ARRHYTHMIAS AND HYPOTENSION HAVE ALSOBEEN REPORTED. THEREFORE, VITAL SIGNS MUST BE MONITOREDCONTINUOUSLY.

General

The initial dose of Alfenta (Alfentanil hydrochloride) should be appropriately reduced inelderly and debilitated patients. The effect of the initial dose should be considered indetermining supplemental doses. In obese patients (more than 20% above ideal total bodyweight), the dosage of Alfenta should be determined on the basis of lean body weight.

In one clinical trial, the dose of Alfenta required to produce anesthesia, as determined byappearance of delta waves in EEG, was 40% lower in geriatric patients than that needed inhealthy young patients.

In patients with compromised liver function and in geriatric patients, the plasma clearance ofAlfenta may be reduced and postoperative recovery may be prolonged.


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Induction doses of Alfenta should be administered slowly (over three minutes).Administration may produce loss of vascular tone and hypotension. Consideration should begiven to fluid replacement prior to induction.

Diazepam administered immediately prior to or in conjunction with high doses of Alfenta

may produce vasodilation, hypotension and result in delayed recovery.

Bradycardia produced by Alfenta may be treated with atropine. Severe bradycardia andasystole have been successfully treated with atropine and conventional resuscitative methods.

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

Following an anesthetic induction dose of Alfenta, requirements for volatile inhalationanesthetics or Alfenta infusion are reduced by 30 to 50% for the first hour of maintenance.

Alfenta infusions should be discontinued at least 10-15 minutes prior to the end of surgeryduring general anesthesia. During administration of Alfenta 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 antagonistssuch as naloxone. Because the duration of respiratory depression produced by Alfenta maylast longer than the duration of the opioid antagonist action, appropriate surveillance should

be maintained. As with all potent opioids, profound analgesia is accompanied by respiratorydepression and diminished sensitivity to CO2 stimulation which may persist into or recur inthe postoperative period. Intraoperative hyperventilation may further alter postoperativeresponse to CO2. Appropriate postoperative monitoring should be employed, particularlyafter infusions and large doses of Alfenta, to ensure that adequate spontaneous breathing isestablished and maintained in the absence of stimulation prior to discharging the patient fromthe recovery area.

Head Injuries

Alfenta 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 mayobscure the clinical course of patients with head injuries and should be used only if clinicallyindicated.

Impaired Respiration

Alfenta should be used with caution in patients with pulmonary disease, decreased respiratoryreserve or potentially compromised respiration. In such patients, opioids may additionallydecrease respiratory drive and increase airway resistance. During anesthesia, this can bemanaged by assisted or controlled respiration.

Impaired Hepatic or Renal Function

In patients with liver or kidney dysfunction, Alfenta should be administered with caution dueto the importance of these organs in the metabolism and excretion of Alfenta.


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Drug Interactions

Both the magnitude and duration of central nervous system and cardiovascular effects may beenhanced when Alfenta is administered in combination with other CNS depressants such as

barbiturates, tranquilizers, opioids, or inhalation general anesthetics. Postoperative respiratory

depression may be enhanced or prolonged by these agents. In such cases of combinedtreatment, the dose of one or both agents should be reduced. Limited clinical experienceindicates that requirements for volatile inhalation anesthetics are reduced by 30 to 50% forthe first sixty (60) minutes following Alfenta induction.

The concomitant use of erythromycin with Alfenta can significantly inhibit Alfenta clearanceand may increase the risk of prolonged or delayed respiratory depression.

Cimetidine reduces the clearance of Alfenta. Therefore smaller Alfenta doses will be requiredwith prolonged administration and the duration of action of Alfenta may be extended.

Perioperative administration of drugs affecting hepatic blood flow or enzyme function mayreduce plasma clearance and prolong recovery.

Carcinogenesis, Mutagenesis and Impairment of Fertility

No long-term animal studies of Alfenta have been performed to evaluate carcinogenic potential. No structural chromosome mutations were produced in the in vivo micronucleustest in female rats at single intravenous doses of Alfenta as high as 20 mg/kg body weight(approximately 40 times the upper human dose), equivalent to a dose of 103 mg/m2 bodysurface 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). Nomutagenic activity was revealed in the in vitro Ames Salmonella typhimurium test, with andwithout metabolic activation.

Pregnancy Category C

Alfenta has been shown to have an embryocidal effect in rats and rabbits when given in doses2.5 times the upper human dose for a period of 10 days to over 30 days. These effects couldhave 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 in rats orrabbits.

There are no adequate and well-controlled studies in pregnant women. Alfenta should be usedduring 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 in labor and delivery. Placentaltransfer of the drug has been reported; therefore, use in labor and delivery is notrecommended.


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Nursing Mothers

In one study of nine women undergoing postpartum tubal ligation, significant levels ofAlfenta were detected in colostrum four hours after administration of 60 mcg/kg of Alfenta,with no detectable levels present after 28 hours. Caution should be exercised when Alfenta is

administered to a nursing woman.

Pediatric Use

Adequate data to support the use of Alfenta in children under 12 years of age are not presently available.

Adverse Reactions

The most common adverse reactions of opioids are respiratory depression and skeletal muscle

rigidity, particularly of the truncal muscles. Alfenta may produce muscular rigidity thatinvolves the skeletal muscles of the neck and extremities. See CLINICALPHARMACOLOGY , WARNINGS , and PRECAUTIONS on the management of respiratorydepression and skeletal muscle rigidity.

The adverse experience profile from 696 patients receiving Alfenta for Monitored AnesthesiaCare (MAC) is similar to the profile established with Alfenta during general anesthesia.Respiratory events reported during MAC included hypoxia, apnea, and bradypnea. Otheradverse events reported by patients receiving Alfenta for MAC, in order of decreasingfrequency, were nausea, hypotension, vomiting, pruritus, confusion, somnolence andagitation.

The following adverse reaction information is derived from controlled and open clinical trialsin 785 patients who received intravenous Alfenta during induction and maintenance ofgeneral anesthesia. The controlled trials included treatment comparisons with fentanyl,thiopental sodium, enflurane, saline placebo and halothane. The incidence of certain sideeffects is influenced by the type of use, e.g., chest wall rigidity has a higher reportedincidence in clinical trials of Alfentanil induction, and by the type of surgery, e.g., nausea andvomiting have a higher reported incidence in patients undergoing gynecologic surgery. Theoverall reports of nausea and vomiting with Alfenta were comparable to fentanyl.

Incidence Greater than 1% - Probably Causally Related (Derived from clinical trials)

*

Incidence 3% to 9%All others 1% to 3%

Gastrointestinal: nausea (28%),vomiting (18%)

Cardiovascular: arrhythmia, bradycardia (14%),hypertension (18%),hypotension (10%),
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tachycardia (12%)

Musculoskeletal: chest wall rigidity (17%),skeletal muscle movement s*

Respiratory: apne a*, postoperative respiratory depression

Central NervousSystem:

blurred vision, dizzines s*, sleepiness/postoperativesedation

Incidence Less than 1% - Probably Causally Related (Derived from clinical trials)

Adverse events reported in post-marketing surveillance, not seen in clinical trials, areitalicized.

*

Incidence 0.3% to 1%

Body as a whole: anaphylaxis

Central NervousSystem:

headach e*, myoclonic movements, postoperativeconfusion *, postoperative euphori a*, shiverin g*

Dermatological: itchin g*, urticaria*

Injection Site: pai n*

Musculoskeletal: skeletal muscle rigidity of neck and extremities

Respiratory: bronchospasm, hypercarbi a*, laryngospasm *

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Drug Abuse and Dependence
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Alfenta (Alfentanil hydrochloride) is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and therefore has the potential for beingabused.

Opioid analgesics have been associated with abuse and dependence in health care providers

and others with ready access to such drugs. Alfenta should be handled accordingly.

Overdosage

Overdosage would be manifested by extension of the pharmacological actions of Alfenta(Alfentanil hydrochloride) (see CLINICAL PHARMACOLOGY ) as with other potent opioidanalgesics. No experience of overdosage with Alfenta was reported during clinical trials. Theintravenous LD50 of Alfenta is 43-51 mg/kg in rats, 72-74 mg/kg in mice, 72-82 mg/kg inguinea pigs and 60-88 mg/kg in dogs. Intravenous administration of an opioid antagonist suchas naloxone should be employed as a specific antidote to manage respiratory depression.

The duration of respiratory depression following overdosage with Alfenta may be longer thanthe duration of action of the opioid antagonist. Administration of an opioid antagonist shouldnot preclude immediate establishment of a patent airway, administration of oxygen, andassisted or controlled ventilation as indicated for hypoventilation or apnea. If respiratorydepression is associated with muscular rigidity, a neuromuscular blocking agent may berequired to facilitate assisted or controlled ventilation. Intravenous fluids and vasoactiveagents may be required to manage hemodynamic instability.

Alfenta Dosage and Administration

The dosage of Alfenta (Alfentanil hydrochloride) should be individualized and titrated to thedesired effect in each patient according to body weight, physical status, underlying

pathological condition, use of other drugs, and type and duration of surgical procedure andanesthesia. In obese patients (more than 20% above ideal total body weight), the dosage ofAlfenta should be determined on the basis of lean body weight. The dose of Alfenta should

be reduced in elderly or debilitated patients (see PRECAUTIONS ).

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 maintenanceanalgesic with nitrous oxide/oxygen for general surgical procedures; and 3) by intravenousinjection in anesthetic doses for the induction of anesthesia for general surgical procedureswith a minimum expected duration of 45 minutes; and 4) by intravenous injection as theanalgesic component for monitored anesthesia care (MAC).

DOSAGE GUIDELINES

DOSAGE SHOULD BE INDIVIDUALIZED AND TITRATED

FOR USE DURING GENERAL ANESTHESIA
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DOSAGE GUIDELINES

DOSAGE SHOULD BE INDIVIDUALIZED AND TITRATED

FOR USE DURING GENERAL ANESTHESIA

SPONTANEOUSLYBREATHING/ASSISTED VENTILATION

Induction of Analgesia: 8-20 mcg/kgMaintenance of Analgesia: 3-5 mcg/kg q 5-20min or 0.5 to 1 mcg/kg/minTotal dose: 8-40 mcg/kg

ASSISTED OR CONTROLLEDVENTILATION

Incremental Injection(To attenuate response tolaryngoscopy and intubation)

Induction of Analgesia: 20-50 mcg/kg

Maintenance of Analgesia: 5-15 mcg/kg q 5-20 minTotal dose: Up to 75 mcg/kg

Continuous Infusion(To provide attenuation of response tointubation and incision)

Infusion rates are variable and should betitrated to the desired clinical effect.SEE INFUSION DOSAGE GUIDELINES BELOW.Induction of Analgesia: 50-75 mcg/kgMaintenance of Analgesia: 0.5 to 3mcg/kg/min (Average rate 1 to 1.5mcg/kg/min)Total dose: Dependent on duration ofprocedure

Anesthetic Induction

Induction of Anesthesia: 130-245 mcg/kgMaintenance of Anesthesia: 0.5 to 1.5mcg/kg/min or general anestheticTotal dose: Dependent on duration ofprocedureAt these doses, truncal rigidity should beexpected and a muscle relaxant should beutilized.Administer slowly (over 3 minutes).Concentration of inhalation agents reducedby 30-50% for initial hour.

MONITORED ANESTHESIA CARE (MAC)(For sedated and responsive,spontaneously breathing patients)

Induction of MAC: 3-8 mcg/kgMaintenance of MAC: 3-5 mcg/kg q 5-20 minor 0.25 to 1 mcg/kg/min

Total dose: 3-40 mcg/kg
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INFUSION DOSAGE

Continuous Infusion: 0.5-3 mcg/kg/min administered with nitrous oxide/oxygen inpatients undergoing general surgery. Following an anesthetic induction dose ofAlfenta, infusion rate requirements are reduced by 30-50% for the first hour ofmaintenance.

Changes in vital signs that indicate a response to surgical stress or lightening ofanesthesia may be controlled by increasing the Alfentanil to a maximum of 4mcg/kg/min and/or administration of bolus doses of 7 mcg/kg. If changes are notcontrolled after three bolus doses given over a five minute period, a barbiturate,vasodilator, and/or inhalation agent should be used. Infusion rates should always beadjusted downward in the absence of these signs until there is some response tosurgical stimulation.

Rather than an increase in infusion rate, 7 mcg/kg bolus doses of Alfenta or a potentinhalation agent should be administered in response to signs of lightening ofanesthesia within the last 15 minutes of surgery. Alfenta infusion should bediscontinued at least 10-15 minutes prior to the end of surgery.

Usage in Children

Clinical data to support the use of Alfenta in patients under 12 years of age are not presentlyavailable. Therefore, such use is not recommended.

Premedication

The selection of preanesthetic medications should be based upon the needs of the individual patient.

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 ofskeletal muscle relaxation required (see CLINICAL PHARMACOLOGY , WARNINGS andPRECAUTIONS sections).

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 tuberculinsyringe or equivalent is recommended.
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The physical and chemical compatibility of Alfenta have been demonstrated in solution withnormal 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 aconcentration 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 mLof 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.

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 dermalexposure to Alfenta should be treated by rinsing the affected area with water.

Protect from light. Storage: Store at 20 to 25C (68 to 77F). [See USP Controlled RoomTemperature].

How is Alfenta Supplied

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 isavailable as:

NDC 11098-060-02, 2 mL Ampule in packages of 10 NDC 11098-060-05, 5 mL Ampule in packages of 10 NDC 11098-060-10, 10 mL Ampule in packages of 5 NDC 11098-060-20, 20 mL Ampule in packages of 5

U.S. Patent No. 4,167,574May 1995, November 1995

TAYLOR PHARMACEUTICALSAN AKORN COMPANY

Decatur, IL 62522

AFA0N Rev. 06/05

Alfenta

Alfentanil hydrochloride injection

Product Information

Product Type HUMAN PRESCRIPTIONDRUG LABEL Item Code (Source)

NDC:11098-060


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Route of Administration INTRAVENOUS DEA Schedule CII

Indications and Usage for Ionsys

Ionsys is indicated for the short -term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to anacceptable level of analgesia before initiating treatment with Ionsys. Ionsys is notintended for home use and is, therefore, inappropriate for use in patients once they have beendischarged from the hospital. It is not recommended for patients under the age of 18 years(see WARNINGS and PRECAUTIONS )

Numorphan

Generic Name: oxymorphone (OX-i-MOR-fone)Brand Name: Opana

Overview Side Effects Dosage Interactions For Professionals More...

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Numorphan is used for:

Treating moderate to severe pain. It may be used before surgery to cause sedation and reduceanxiety. It may also be used for other conditions as determined by your doctor.

Numorphan is a narcotic pain reliever. It works in the brain and nervous system to reduce pain. It may also affect other body systems (eg, respiratory, circulatory) at higher doses.

Do NOT use Numorphan if: you are allergic to any ingredient in Numorphan or any other codeine- or morphine-related

medicine (eg, oxycodone) you have known or suspected stomach or bowel blockage (eg, paralytic ileus) you have slow or difficult breathing, fluid in the lungs due to chemical irritation, high levels

of carbon dioxide in the blood (hypercapnia or hypercarbia), or severe asthma, or you arehaving an asthma attack

you have moderate to severe liver problems you are taking mixed agonist/antagonist analgesic medicines (eg, buprenorphine,
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butorphanol, pentazocine) or sodium oxybate (GHB) you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within

the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doingright away.

Before using Numorphan:

Some medical conditions may interact with Numorphan. Tell your doctor or pharmacist if

you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary

supplement if you have allergies to medicines, foods, or other substances if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or

breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of thespine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), hypercapnia or hypercarbia,low levels of oxygen in the blood (hypoxia), low blood pressure, dehydration, or low bloodvolume

if you have severe drowsiness, a recent head injury, increased pressure in the brain, growthsin the brain (eg, tumors), or a history of seizures

if you have liver or kidney problems, thyroid problems, adrenal gland problems (eg, Addisondisease), stomach pain, stomach or bowel problems (eg, inflammation), gallbladder orpancreas problems, a blockage of the bladder, trouble urinating, constipation, or anenlarged prostate, or if you have had recent stomach or bowel surgery

if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidalthoughts or attempts

if you or a member of your family has a history of mood or mental problems (eg, anxiety,depression, hallucinations), or alcohol or other substance abuse or dependence

if you have poor health or are in shock, are very overweight, or have recently had or will be

having surgery


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if you are taking carisoprodol

Some MEDICINES MAY INTERACT with Numorphan. Tell your health care provider ifyou are taking any other medicines, especially any of the following:

Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may beincreased

Cimetidine or sodium oxybate (GHB) because the risk of side effects, such as severedrowsiness, slow or difficult breathing, coma, or confusion, may be increased

Anticholinergics (eg, scopolamine, benztropine) because the risk of severe constipation ortrouble urinating may be increased

MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, andcoma, may be increased

Mixed agonist/antagonist analgesics (eg, buprenorphine, butorphanol, nalbuphine,pentazocine) or naltrexone because they may decrease Numorphan's effectiveness andwithdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Numorphan may interact with other medicines that you take. Check with yourhealth care provider before you start, stop, or change the dose of any medicine.

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How to use Numorphan:

Use Numorphan as directed by your doctor. Check the label on the medicine for exact dosinginstructions.

Numorphan is usually administered as an injection at your doctor's office, hospital, or clinic.If you will be using Numorphan at home, a health care provider will teach you how to use it.Be sure you understand how to use Numorphan. Follow the procedures you are taughtwhen you use a dose. Contact your health care provider if you have any questions.

Do not use Numorphan if it contains particles, is cloudy or discolored, or if the vial is crackedor damaged.

Keep this product, as well as syringes and needles, out of the reach of children and awayfrom pets. Do not reuse needles, syringes, or other materials. Ask your health care providerhow to dispose of these materials after use. Follow all local rules for disposal.

If you have been taking Numorphan regularly, do not suddenly stop taking Numorphan. You
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