Ultiva

IV Incompatibilities

Y-site: amphotericin B(?), ampho B cholesteryl SO4, cefoperazone(?), chlorpromazine(?), diazepam(?)

IV Compatibilities

Solution: D5/LR, D5/NS, D5W, NS, ½NS, SWI

Y-site: (partial list) acyclovir, aminophylline, ampicillin, ampicillin/sulbactam, Ca gluconate, ceftazidime, ceftriaxone, cimetidine, cistracurium, clindamycin, dexamethasone, digoxin, diphenhydramine, dobutamine, dopamine, epinephrine, famotidine, fentanyl, furosemide, heparin, hydrocortisone, hydromorphone, imepenem/cilastatin, inamrinone, lidocaine, linezolid, lorazepam, magnesium sulphate, meperidine, methylprednisolone, metoclopramide, metronidazole, midazolam, morphine, nitroglycerin, norepinephrine, ondansetron, KCl, procainamide, prochlorperazine, promethazine, propofol (do not administer in same tubing with blood), sodium bicarbonate, thiopental, sufentanil, trimethoprim/sulfamethoxazole, vancomycin, zidovudine

IV Preparation

Reconstitute solution with 1 mL of diluent per mg of remifentanil; shake well to dissolve; should be diluted to final concentration of 25, 50 or 250 mcg/mL prior to administration

IV Administration

IV injection over 30-60 sec

May also do IV infusion

Storage

Store intact vials at 2-25°C

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Remifentanil is an opioid medication. An opioid is sometimes called a narcotic.

Remifentanil is used to treat or prevent pain after surgery or other medical procedure.

Remifentanil may also be used for purposes not listed in this medication guide.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Remifentanil injection is used to relieve pain during and after surgery or other medical procedures. It is also used with other medicines (eg, isoflurane, propofol, midazolam, thiopental) just before or during an operation to help the anesthetic work better.

Remifentanil belongs to the group of medicines known as narcotic analgesics (pain medicines). It works by acting on the central nervous system (CNS) or brain to relieve pain.

Remifentanil is to be administered only by or under the immediate supervision of your doctor.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• muscle stiffness or tightness
• pale or blue lips, fingernails, or skin
• shortness of breath
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Less common

• Bluish lips or skin
• chills
• decrease in cardiac output
• fast, pounding, or heartbeat or pulse
• feeling of warmth
• fever
• headache
• nausea or vomiting
• nervousness
• not breathing
• pain after surgery
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• problems with bleeding or clotting
• redness of the face, neck, arms, and occasionally, upper chest
• shivering

Rare

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• congestion
• cough or hoarseness
• cough producing mucus
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• decreased frequency or amount of urine
• difficult, fast, or noisy breathing
• difficulty with swallowing
• disorientation
• dry mouth
• dryness or soreness of the throat
• dysphoria
• eye pain
• flushed, dry skin
• fruit-like breath odor
• general feeling of illness
• hiccups
• hives, itching, or skin rash
• increased blood pressure
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased sweating
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• muscle cramps or pain
• nervousness
• noisy breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid heartbeat
• red or black, tarry stools
• red or dark brown urine
• runny nose
• seizures
• shakiness in the legs, arms, hands, or feet
• small clicking, bubbling, or rattling sounds in the lungs when listening with a stethoscope
• stuffy nose
• swelling in the legs and ankles
• swelling of the face, fingers, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• voice changes
• vomiting
• weakness and heaviness of the legs
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Anxiety
• blurred or loss of vision
• difficulty having a bowel movement (stool)
• disturbed color perception
• double vision
• halos around lights
• hyperventilation
• night blindness
• overbright appearance of lights
• pain at the injection site
• restlessness
• trouble with sleeping
• tunnel vision

Rare

• Burning while urinating
• heartburn
• hives or welts
• loss of bladder control
• loss of memory
• nightmares
• problems with memory
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• trouble with urinating
• uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Avoid drinking alcohol for 24 hours after surgery.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking Ultiva.
• This medicine has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
• Many drugs interact with this medicine and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use Ultiva with all of your drugs.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ultiva while you are pregnant.
• Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Important Dosage and Administration Instructions

Monitor patients closely for respiratory depression when initiating therapy and following dosage increases with Ultiva and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

Ultiva is for IV use only. Continuous infusions of Ultiva should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion.

Ultiva should not be administered without dilution.

Consider an alternative to Ultiva for patients taking mixed agonist/antagonist and partial agonist opioid analgesics due to reduced analgesic effect or potential withdrawal symptoms. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Ultiva if patient is not responding appropriately to treatment.

General Anesthesia

Ultiva is not recommended as the sole agent in general anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Ultiva is synergistic with other anesthetics; therefore, clinicians may need to reduce doses of thiopental, propofol, isoflurane, and midazolam by up to 75% with the coadministration of Ultiva. The administration of Ultiva must be individualized based on the patient's response.

Induction of Anesthesia

Ultiva should be administered at an infusion rate of 0.5 to 1 mcg/kg/min with a hypnotic or volatile agent for the induction of anesthesia. If endotracheal intubation is to occur less than 8 minutes after the start of the infusion of Ultiva, then an initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.

Ultiva should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia.

Maintenance of Anesthesia

After endotracheal intubation, the infusion rate of Ultiva should be decreased in accordance with the dosing guidelines in Tables 1 (adults, predominately ASA physical status I, II, or III) and 2 (pediatric patients).

• Due to the fast onset and short duration of action of Ultiva, the rate of administration during anesthesia can be titrated upward in 25% to 100% increments in adult patients or up to 50% increments in pediatric patients, or downward in 25% to 50% decrements every 2 to 5 minutes to attain the desired level of µ-opioid effect. • In response to light anesthesia or transient episodes of intense surgical stress, supplemental bolus doses of 1 mcg/kg may be administered every 2 to 5 minutes. • At infusion rates > 1 mcg/kg/min, increases in the concomitant anesthetic agents should be considered to increase the depth of anesthesia. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Dosage and Administration, Table 2 (2.2).] Table 1: Dosing Guidelines in Adults – General Anesthesia and Continuing as an Analgesic into the Postoperative Care Unit or Intensive Care Setting*

* An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds.
Phase	Continuous IV Infusion of Ultiva (mcg/kg/min)	Range of Infusion Dose Ultiva (mcg/kg/min)	Supplemental IV Bolus Dose of Ultiva (mcg/kg)
Induction of Anesthesia (through intubation)	0.5 – 1*
Maintenance of anesthesia with:
Nitrous oxide (66%)	0.4	0.1 – 2	1
Isoflurane (0.4 to 1.5 MAC)	0.25	0.05 – 2	1
Propofol (100 to 200 mcg/kg/min)	0.25	0.05 – 2	1
Continuation as an analgesic into the immediate postoperative period	0.1	0.025 – 0.2	not recommended

Table 2 summarizes the recommended doses in pediatric patients, predominantly ASA physical status I, II, or III. In pediatric patients, remifentanil was administered with nitrous oxide or nitrous oxide in combination with halothane, sevoflurane, or isoflurane. The use of atropine may blunt the potential for bradycardia that can occur upon administration of Ultiva.

Table 2: Dosing Guidelines in Pediatric Patients – Maintenance of Anesthesia

* An initial dose of 1 mcg/kg may be administered over 30 to 60 seconds. † The clearance rate in neonates is highly variable, on average two times higher than in the young healthy adult population. Therefore, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The use of atropine may blunt the potential for bradycardia that can occur upon administration of Ultiva. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Clinical Studies (14.4).] ‡ Boluses of 1 mcg/kg were studied in ASA 1 and 2, full-term patients weighing at least 2500 gm, undergoing pyloromyotomy who received pretreatment with atropine. Neonates receiving supplementation with potent inhalation agents or neuraxial anesthesia, those with significant co-morbidities or undergoing significant fluid shifts, or those who have not been pretreated with atropine, may require smaller bolus doses to avoid hypotension and/or bradycardia.
Phase	Continuous IV Infusion of Ultiva (mcg/kg/min)	Range of Infusion Dose Ultiva (mcg/kg/min)	Supplemental IV Bolus Dose of Ultiva (mcg/kg)
Maintenance of anesthesia in patients aged 1 to 12 years old with*:
Halothane (0.3 to 1.5 MAC)	0.25	0.05 – 1.3	1
Sevoflurane (0.3 to 1.5 MAC)	0.25	0.05 – 1.3	1
Isoflurane (0.4 to 1.5 MAC)	0.25	0.05 – 1.3	1
Maintenance of anesthesia for patients from birth to 2 months of age with:
Nitrous oxide (70%)†	0.4	0.4 – 1.0	1‡

 

Continuation as an Analgesic into the Immediate Postoperative Period Under the Direct Supervision of an Anesthesia Practitioner

Infusions of Ultiva may be continued into the immediate postoperative period for select patients for whom later transition to longer acting analgesics may be desired.

• Ultiva has not been studied in pediatric patients for use in the immediate postoperative period. • The use of bolus injections of Ultiva to treat pain during the postoperative period is not recommended. • When used as an IV analgesic in the immediate postoperative period, Ultiva should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min. • The infusion rate may be adjusted every 5 minutes in 0.025 mcg/kg/min increments to balance the patient's level of analgesia and respiratory rate. • Infusion rates greater than 0.2 mcg/kg/min are associated with respiratory depression (respiratory rate less than 8 breaths/min).

Due to the rapid offset of action of Ultiva, no residual analgesic activity will be present within 5 to 10 minutes after discontinuation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, alternative analgesics should be administered prior to discontinuation of Ultiva. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of follow-up care [see Clinical Studies (14)].

Analgesic Component of Monitored Anesthesia Care

It is strongly recommended that supplemental oxygen be supplied to the patient whenever Ultiva is administered.

• Ultiva has not been studied for use in children in monitored anesthesia care.

Single Dose

A single IV dose of 0.5 to 1 mcg/kg over 30 to 60 seconds of Ultiva may be given 90 seconds before the placement of the local or regional anesthetic block [see Warnings and Precautions (5.6)].

Continuous Infusion

When used alone as an IV analgesic component of monitored anesthesia care, Ultiva should be initially administered by continuous infusion at a rate of 0.1 mcg/kg/min beginning 5 minutes before placement of the local or regional anesthetic block.

• Because of the risk for hypoventilation, the infusion rate of Ultiva should be decreased to 0.05 mcg/kg/min following placement of the block. • Thereafter, rate adjustments of 0.025 mcg/kg/min at 5 minute intervals may be used to balance the patient's level of analgesia and respiratory rate. • Rates greater than 0.2 mcg/kg/min are generally associated with respiratory depression (respiratory rates less than 8 breaths/min). • Bolus doses of Ultiva administered simultaneously with a continuous infusion of Ultiva to spontaneously breathing patients are not recommended.

Table 3 summarizes the recommended doses for monitored anesthesia care in adult patients, predominately ASA physical status I, II, or III.

Table 3: Dosing Guidelines in Adults – Monitored Anesthesia Care

Method	Timing	Ultiva Alone	Ultiva + 2 mg Midazolam
Single IV Dose	Given 90 seconds before local anesthetic	1 mcg/kg over 30 to 60 seconds	0.5 mcg/kg over 30 to 60 seconds
Continuous IV Infusion	Beginning 5 minutes before local anesthetic	0.1 mcg/kg/min	0.05 mcg/kg/min
	After local anesthetic	0.05 mcg/kg/min (Range: 0.025 to 0.2 mcg/kg/min)	0.025 mcg/kg/min (Range: 0.025 to 0.2 mcg/kg/min)

 

Discontinuation

Upon discontinuation of Ultiva, the IV tubing should be cleared to prevent the inadvertent administration of Ultiva at a later time.

For patients undergoing surgical procedures where postoperative pain is generally anticipated, alternative analgesics should be administered prior to discontinuation of Ultiva. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of follow-up care [see Clinical Studies (14)].

Dosage Modifications in Geriatric Patients

The starting doses of Ultiva should be decreased by 50% in elderly patients (> 65 years). Ultiva should then be cautiously titrated to effect [see Use in Specific Populations (8.5)].

Dosage Modifications in Pediatric Patients

See Table 2 for dosing recommendations for use of Ultiva in pediatric patients from birth to 12 years of age for maintenance of anesthesia. [See Clinical Pharmacology: Specific Populations: Pediatric Population (12.3) and Dosage and Administration, Table 2 and Maintenance of Anesthesia (2.2).]

Ultiva has not been studied in pediatric patients for use in the immediate postoperative period or for use as a component of monitored anesthesia care.

Dosage Modifications in Coronary Artery Bypass Surgery

Table 4 summarizes the recommended doses for induction, maintenance, and continuation as an analgesic into the ICU in adult patients, predominantly ASA physical status III or IV. To avoid hypotension during the induction phase, it is important to consider the concomitant medication regimens. [See Clinical Studies: Coronary Artery Bypass Surgery (14.5).]

Table 4: Dosing Recommendations* – Coronary Artery Bypass Surgery

Phase	Continuous IV Infusion of Ultiva (mcg/kg/min)	Range of Infusion Dose Ultiva (mcg/kg/min)	Supplemental IV Bolus Dose of Ultiva (mcg/kg)
* See Clinical Studies: Coronary Artery Bypass Surgery subsection (14.5) for concomitant medication regimens.
Induction of Anesthesia (through intubation)	1
Maintenance of Anesthesia	1	0.125 to 4	0.5 to 1
Continuation as an analgesic into ICU	1	0.05 to 1

 

Dosage Modifications in Obese Patients

The starting doses of Ultiva should be based on ideal body weight (IBW) in obese patients (greater than 30% over their IBW) [see Use in Specific Populations (8.6)].

Dosage Modifications in Preanesthetic Medication

The need for premedication and the choice of anesthetic agents must be individualized. In clinical studies, patients who received Ultiva frequently received a benzodiazepine premedication.

Preparation for Administration

To reconstitute solution, add 1 mL of diluent per mg of remifentanil. Shake well to dissolve. When reconstituted as directed, the solution contains approximately 1 mg of remifentanil activity per 1 mL.

• Ultiva should be diluted to a recommended final concentration of 20, 25, 50, or 250 mcg/mL prior to administration (see Table 5). Ultiva should not be administered without dilution. Table 5: Reconstitution and Dilution of Ultiva

Final Concentration	Amount of Ultiva in Each Vial	Final Volume After Reconstitution and Dilution
20 mcg/mL	1 mg	50 mL
	2 mg	100 mL
	5 mg	250 mL
25 mcg/mL	1 mg	40 mL
	2 mg	80 mL
	5 mg	200 mL
50 mcg/mL	1 mg	20 mL
	2 mg	40 mL
	5 mg	100 mL
250 mcg/mL	5 mg	20 mL

Continuous IV infusions of Ultiva should be administered only by an infusion device. Infusion rates of Ultiva can be individualized for each patient using Table 6:

Table 6: IV Infusion Rates of Ultiva (mL/kg/h)

Drug Delivery Rate (mcg/kg/min)	Infusion Delivery Rate (mL/kg/h)
	20 mcg/mL	25 mcg/mL	50 mcg/mL	250 mcg/mL
0.0125	0.038	0.03	0.015	not recommended
0.025	0.075	0.06	0.03	not recommended
0.05	0.15	0.12	0.06	0.012
0.075	0.23	0.18	0.09	0.018
0.1	0.3	0.24	0.12	0.024
0.15	0.45	0.36	0.18	0.036
0.2	0.6	0.48	0.24	0.048
0.25	0.75	0.6	0.3	0.06
0.5	1.5	1.2	0.6	0.12
0.75	2.25	1.8	0.9	0.18
1.0	3.0	2.4	1.2	0.24
1.25	3.75	3.0	1.5	0.3
1.5	4.5	3.6	1.8	0.36
1.75	5.25	4.2	2.1	0.42
2.0	6.0	4.8	2.4	0.48

When Ultiva is used as an analgesic component of monitored analgesia care, a final concentration of 25 mcg/mL is recommended. When Ultiva is used for pediatric patients 1 year of age and older, a final concentration of 20 or 25 mcg/mL is recommended. Table 7 is a guideline for milliliter-per-hour delivery for a solution of 20 mcg/mL with an infusion device.

Table 7: IV Infusion Rates of Ultiva (mL/h) for a 20 mcg/mL Solution

Infusion Rate (mcg/kg/min)	Patient Weight (kg)
	5	10	20	30	40	50	60
0.0125	0.188	0.375	0.75	1.125	1.5	1.875	2.25
0.025	0.375	0.75	1.5	2.25	3.0	3.75	4.5
0.05	0.75	1.5	3.0	4.5	6.0	7.5	9.0
0.075	1.125	2.25	4.5	6.75	9.0	11.25	13.5
0.1	1.5	3.0	6.0	9.0	12.0	15.0	18.0
0.15	2.25	4.5	9.0	13.5	18.0	22.5	27.0
0.2	3.0	6.0	12.0	18.0	24.0	30.0	36.0
0.25	3.75	7.5	15.0	22.5	30.0	37.5	45.0
0.3	4.5	9.0	18.0	27.0	36.0	45.0	54.0
0.35	5.25	10.5	21.0	31.5	42.0	52.5	63.0
0.4	6.0	12.0	24.0	36.0	48.0	60.0	72.0

Table 8 is a guideline for milliliter-per-hour delivery for a solution of 25 mcg/mL with an infusion device.

Table 8: IV Infusion Rates of Ultiva (mL/h) for a 25 mcg/mL Solution

Infusion Rate (mcg/kg/min)	Patient Weight (kg)
	10	20	30	40	50	60	70	80	90	100
0.0125	0.3	0.6	0.9	1.2	1.5	1.8	2.1	2.4	2.7	3.0
0.025	0.6	1.2	1.8	2.4	3.0	3.6	4.2	4.8	5.4	6.0
0.05	1.2	2.4	3.6	4.8	6.0	7.2	8.4	9.6	10.8	12.0
0.075	1.8	3.6	5.4	7.2	9.0	10.8	12.6	14.4	16.2	18.0
0.1	2.4	4.8	7.2	9.6	12.0	14.4	16.8	19.2	21.6	24.0
0.15	3.6	7.2	10.8	14.4	18.0	21.6	25.2	28.8	32.4	36.0
0.2	4.8	9.6	14.4	19.2	24.0	28.8	33.6	38.4	43.2	48.0

Table 9 is a guideline for milliliter-per-hour delivery for a solution of 50 mcg/mL with an infusion device.

Table 9: IV Infusion Rates of Ultiva (mL/h) for a 50 mcg/mL Solution

Infusion Rate (mcg/kg/min)	Patient Weight (kg)
	30	40	50	60	70	80	90	100
0.025					2.1	2.4	2.7	3.0
0.05		2.4	3.0	3.6	4.2	4.8	5.4	6.0
0.075	2.7	3.6	4.5	5.4	6.3	7.2	8.1	9.0
0.1	3.6	4.8	6.0	7.2	8.4	9.6	10.8	12.0
0.15	5.4	7.2	9.0	10.8	12.6	14.4	16.2	18.0
0.2	7.2	9.6	12.0	14.4	16.8	19.2	21.6	24.0
0.25	9.0	12.0	15.0	18.0	21.0	24.0	27.0	30.0
0.5	18.0	24.0	30.0	36.0	42.0	48.0	54.0	60.0
0.75	27.0	36.0	45.0	54.0	63.0	72.0	81.0	90.0
1.0	36.0	48.0	60.0	72.0	84.0	96.0	108.0	120.0
1.25	45.0	60.0	75.0	90.0	105.0	120.0	135.0	150.0
1.5	54.0	72.0	90.0	108.0	126.0	144.0	162.0	180.0
1.75	63.0	84.0	105.0	126.0	147.0	168.0	189.0	210.0
2.0	72.0	96.0	120.0	144.0	168.0	192.0	216.0	240.0

Table 10 is a guideline for milliliter-per-hour delivery for a solution of 250 mcg/mL with an infusion device.

Table 10: IV Infusion Rates of Ultiva (mL/h) for a 250 mcg/mL Solution

Infusion Rate (mcg/kg/min)	Patient Weight (kg)
	30	40	50	60	70	80	90	100
0.1	0.72	0.96	1.20	1.44	1.68	1.92	2.16	2.40
0.15	1.08	1.44	1.80	2.16	2.52	2.88	3.24	3.60
0.2	1.44	1.92	2.40	2.88	3.36	3.84	4.32	4.80
0.25	1.80	2.40	3.00	3.60	4.20	4.80	5.40	6.00
0.5	3.60	4.80	6.00	7.20	8.40	9.60	10.80	12.00
0.75	5.40	7.20	9.00	10.80	12.60	14.40	16.20	18.00
1.0	7.20	9.60	12.00	14.40	16.80	19.20	21.60	24.00
1.25	9.00	12.00	15.00	18.00	21.00	24.00	27.00	30.00
1.5	10.80	14.40	18.00	21.60	25.20	28.80	32.40	36.00
1.75	12.60	16.80	21.00	25.20	29.40	33.60	37.80	42.00
2.0	14.40	19.20	24.00	28.80	33.60	38.40	43.20	48.00

 

Compatibility and Stability

Reconstitution and Dilution Prior to Administration

Ultiva is stable for 24 hours at room temperature after reconstitution and further dilution to concentrations of 20 to 250 mcg/mL with the IV fluids listed below.

Sterile Water for Injection, USP
5% Dextrose Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
Lactated Ringer's and 5% Dextrose Injection, USP

Ultiva is stable for 4 hours at room temperature after reconstitution and further dilution to concentrations of 20 to 250 mcg/mL with Lactated Ringer's Injection, USP.

Ultiva has been shown to be compatible with these IV fluids when coadministered into a running IV administration set.

Compatibility with Other Therapeutic Agents

Ultiva has been shown to be compatible with Diprivan® (propofol) Injection when coadministered into a running IV administration set. The compatibility of Ultiva with other therapeutic agents has not been evaluated.

Incompatibilities

Nonspecific esterases in blood products may lead to the hydrolysis of remifentanil to its carboxylic acid metabolite. Therefore, administration of Ultiva into the same IV tubing with blood is not recommended.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product should be a clear, colorless liquid after reconstitution and free of visible particulate matter.

Ultiva does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions.

NDC 67457-198-03

Ultiva®
(remifentanil HCl)
for Injection

CII

1 mg
Equivalent to
1 mg of
remifentanil

For Intravenous Use Only

Rx only      10 x 1 mg Vials

Sterile.

Usual Dosage: See accompanying
prescribing information.

Store at 2° to 25°C (36° to 77°F).

To reconstitute solution, add 1 mL of diluent
per mg of remifentanil. Shake well to dissolve.
When reconstituted as directed, the solution
contains approximately 1 mg of remifentanil
activity per 1 mL.

Ultiva® should be diluted to a
recommended final concentration of 25,
50 or 250 mcg/mL prior to administration.

Ultiva® should not be administered
without dilution. See package insert.

Ultiva® is a registered trademark
of Glaxo Group Limited.

US Patent No. 5,866,591

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Made in U.S.A.

MI:19803:10C:R3

Mylan.com

Ultiva  remifentanil hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-198 Route of Administration INTRAVENOUS DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Remifentanil Hydrochloride (Remifentanil) Remifentanil 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Glycine 15 ug  in 1 mL Hydrochloric Acid

Packaging # Item Code Package Description 1 NDC:67457-198-03 10 VIAL, GLASS in 1 CARTON 1 NDC:67457-198-00 3 mL in 1 VIAL, GLASS 2 NDC:67457-198-05 10 VIAL, GLASS in 1 CARTON 2 NDC:67457-198-99 5 mL in 1 VIAL, GLASS 3 NDC:67457-198-10 10 VIAL, GLASS in 1 CARTON 3 NDC:67457-198-98 10 mL in 1 VIAL, GLASS

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020630 11/06/1996

Labeler - Mylan Institutional LLC (790384502)

Revised: 12/2016   Mylan Institutional LLC

Applies to remifentanil: intravenous powder for solution, intravenous solution

Along with its needed effects, remifentanil (the active ingredient contained in Ultiva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking remifentanil:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• difficult or troubled breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• muscle stiffness or tightness
• pale or blue lips, fingernails, or skin
• shortness of breath
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Less common

• Bluish lips or skin
• chills
• decrease in cardiac output
• fast, pounding, or heartbeat or pulse
• feeling of warmth
• fever
• headache
• nausea or vomiting
• nervousness
• not breathing
• pain after surgery
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• problems with bleeding or clotting
• redness of the face, neck, arms, and occasionally, upper chest
• shivering

Rare

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• congestion
• cough or hoarseness
• cough producing mucus
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• decreased frequency or amount of urine
• difficult, fast, or noisy breathing
• difficulty with swallowing
• disorientation
• dry mouth
• dryness or soreness of the throat
• dysphoria
• eye pain
• flushed, dry skin
• fruit-like breath odor
• general feeling of illness
• hiccups
• hives, itching, or skin rash
• increased blood pressure
• increased hunger
• increased menstrual flow or vaginal bleeding
• increased sweating
• increased thirst
• increased urination
• loss of appetite
• lower back or side pain
• muscle cramps or pain
• nervousness
• noisy breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid heartbeat
• red or black, tarry stools
• red or dark brown urine
• runny nose
• seizures
• shakiness in the legs, arms, hands, or feet
• small clicking, bubbling, or rattling sounds in the lungs when listening with a stethoscope
• stuffy nose
• swelling in the legs and ankles
• swelling of the face, fingers, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• voice changes
• vomiting
• weakness and heaviness of the legs
• weight gain

Some side effects of remifentanil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Anxiety
• blurred or loss of vision
• difficulty having a bowel movement (stool)
• disturbed color perception
• double vision
• halos around lights
• hyperventilation
• night blindness
• overbright appearance of lights
• pain at the injection site
• restlessness
• trouble with sleeping
• tunnel vision

Rare

• Burning while urinating
• heartburn
• hives or welts
• loss of bladder control
• loss of memory
• nightmares
• problems with memory
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• trouble with urinating
• uncontrolled eye movements