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ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Overview
What is NAROPIN?
Naropin Injection contains ropivacaine HCl
which is a member of the amino amide class of local
anesthetics. Naropin Injection is a sterile, isotonic solution
that contains the enantiomerically pure drug substance, sodium chloride
for isotonicity and Water for Injection. Sodium hydroxide and/or
hydrochloric acid may be used for pH adjustment. It is
administered parenterally.Ropivacaine HCl is chemically described
as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride
monohydrate. The drug substance is a white crystalline powder,
with a molecular formula of
CHNO•HCl•HO,
molecular weight of 328.89 and the following structural formula:
At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL
in water, a distribution ratio between n-octanol and phosphate buffer at
pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The
pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is
similar to that of mepivacaine (7.7). However, ropivacaine has
an intermediate degree of lipid solubility compared to bupivacaine and
mepivacaine.Naropin Injection is preservative-free and is available
in single dose containers in 2 (0.2%), 5 (0.5%), 7.5
(0.75%) and 10 mg/mL (1%) concentrations. The
specific gravity of Naropin Injection solutions range from 1.002 to
1.005 at 25°C.
What does NAROPIN look like?
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What are the available doses of NAROPIN?
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What should I talk to my health care provider before I take NAROPIN?
Sorry No records found
How should I use NAROPIN?
Naropin is indicated for the production of local or regional
anesthesia for surgery and for acute pain management.
Surgical Anesthesia: epidural block for surgery
including cesarean section; major nerve block; local
infiltrationAcute Pain Management: epidural continuous
infusion or intermittent bolus, eg, postoperative or labor; local
infiltration
The rapid injection of a large volume of local anesthetic
solution should be avoided and fractional (incremental) doses should
always be used. The smallest dose and concentration required
to produce the desired result should be administered.
The dose of
any local anesthetic administered varies with the anesthetic procedure,
the area to be anesthetized, the vascularity of the tissues, the number
of neuronal segments to be blocked, the depth of anesthesia and degree
of muscle relaxation required, the duration of anesthesia desired,
individual tolerance, and the physical condition of the
patient. Patients in poor general condition due to aging or
other compromising factors such as partial or complete heart conduction
block, advanced liver disease or severe renal dysfunction require
special attention although regional anesthesia is frequently indicated
in these patients. To reduce the risk of potentially serious
adverse reactions, attempts should be made to optimize the
patient's condition before major blocks are performed, and the
dosage should be adjusted accordingly.
Use an adequate test dose (3
to 5 mL of a short acting local anesthetic solution containing
epinephrine) prior to induction of complete block. This test
dose should be repeated if the patient is moved in such a fashion as to
have displaced the epidural catheter. Allow adequate time for
onset of anesthesia following administration of each test
dose.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever
solution and container permit. Solutions which are discolored
or which contain particulate matter should not be administered.
The doses in the table are those considered to be necessary to
produce a successful block and should be regarded as guidelines for use
in adults. Individual variations in onset and duration
occur. The figures reflect the expected average dose range
needed. For other local anesthetic techniques standard current
textbooks should be consulted.
When prolonged blocks are used,
either through continuous infusion or through repeated bolus
administration, the risks of reaching a toxic plasma concentration or
inducing local neural injury must be considered. Experience to
date indicates that a cumulative dose of up to 770 mg Naropin
administered over 24 hours is well tolerated in adults when used for
postoperative pain management: ie, 2016 mg. Caution
should be exercised when administering Naropin for prolonged periods of
time, eg, > 70 hours in debilitated patients.
For treatment
of postoperative pain, the following technique can be recommended: If
regional anesthesia was not used intraoperatively, then an initial
epidural block with 5 to 7 mL Naropin is induced via an
epidural catheter. Analgesia is maintained with an infusion of
Naropin, 2 mg/mL (0.2%). Clinical studies have
demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour
provide adequate analgesia with nonprogressive motor block.
With this technique a significant reduction in the need for opioids was
demonstrated. Clinical experience supports the use of Naropin
epidural infusions for up to 72 hours.
What interacts with NAROPIN?
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What are the warnings of NAROPIN?
Sorry No Records found
What are the precautions of NAROPIN?
Sorry No Records found
What are the side effects of NAROPIN?
Reactions to ropivacaine are characteristic of those associated
with other amide-type local anesthetics. A major cause of
adverse reactions to this group of drugs may be associated with
excessive plasma levels, which may be due to overdosage, unintentional
intravascular injection or slow metabolic degradation.
The reported
adverse events are derived from clinical studies conducted in the U.S.
and other countries. The reference drug was usually
bupivacaine. The studies used a variety of premedications,
sedatives, and surgical procedures of varying length. A total
of 3,988 patients have been exposed to Naropin at concentrations up to
1% in clinical trials. Each patient was counted once
for each type of adverse event.
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Incidence 1 to
5%
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Incidence in Controlled Clinical
Trials
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Incidence
<1%
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Systemic Reactions
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Neurologic Reactions
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Cardiovascular System
Reactions
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Allergic Reactions
What should I look out for while using NAROPIN?
Naropin is contraindicated in patients with a known
hypersensitivity to ropivacaine or to any local anesthetic agent of the
amide type.
In performing Naropin blocks, unintended intravenous injection is
possible and may result in cardiac arrhythmia or cardiac
arrest. The potential for successful resuscitation has not
been studied in humans. There have been rare reports of
cardiac arrest during the use of Naropin for epidural anesthesia or
peripheral nerve blockade, the majority of which occurred after
unintentional accidental intravascular administration in elderly
patients and in patients with concomitant heart disease. In
some instances, resuscitation has been difficult. Should
cardiac arrest occur, prolonged resuscitative efforts may be required to
improve the probability of a successful outcome.
Naropin should be
administered in incremental doses. It is not recommended for
emergency situations, where a fast onset of surgical anesthesia is
necessary. Historically, pregnant patients were reported to
have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and
death when 0.75% bupivacaine (another member of the amino amide
class of local anesthetics) was inadvertently rapidly injected
intravenously.
Prior to receiving major blocks the general condition
of the patient should be optimized and the patient should have an i.v.
line inserted. All necessary precautions should be taken to
avoid intravascular injection. Local anesthetics should only
be administered by clinicians who are well versed in the diagnosis and
management of dose-related toxicity and other acute emergencies which
might arise from the block to be employed, and then only after ensuring
the availability of oxygen, other resuscitative drugs,
cardiopulmonary resuscitative equipment, and the personnel resources
needed for proper management of toxic reactions and related emergencies
(see also , , and ). Delay in proper management of dose-related
toxicity, underventilation from any cause, and/or altered sensitivity
may lead to the development of acidosis, cardiac arrest and, possibly,
death. Solutions of Naropin should not be used for the
production of obstetrical paracervical block anesthesia, retrobulbar
block, or spinal anesthesia (subarachnoid block) due to insufficient
data to support such use. Intravenous regional anesthesia
(bier block) should not be performed due to a lack of clinical
experience and the risk of attaining toxic blood levels of
ropivacaine.
It is essential that aspiration for blood, or
cerebrospinal fluid (where applicable), be done prior to injecting any
local anesthetic, both the original dose and all subsequent doses, to
avoid intravascular or subarachnoid injection. However, a
negative aspiration does ensure against an intravascular or subarachnoid
injection.
A well-known risk of epidural anesthesia may be an
unintentional subarachnoid injection of local anesthetic. Two
clinical studies have been performed to verify the safety of Naropin at
a volume of 3 mL injected into the subarachnoid space since this dose
represents an incremental epidural volume that could be unintentionally
injected. The 15 and 22.5 mg doses injected resulted in
sensory levels as high as T5 and T4, respectively. Anesthesia
to pinprick started in the sacral dermatomes in 2 to 3 minutes, extended
to the T10 level in 10 to 13 minutes and lasted for approximately 2
hours. The results of these two clinical studies showed that a
3 mL dose did not produce any serious adverse events when spinal
anesthesia blockade was achieved.
Naropin should be used with
caution in patients receiving other local anesthetics or agents
structurally related to amide-type local anesthetics, since the toxic
effects of these drugs are additive.
Patients treated with class III
antiarrhythmic drugs (eg, amiodarone) should be under close surveillance
and ECG monitoring considered, since cardiac effects may be
additive.
Metformin
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What might happen if I take too much NAROPIN?
Acute emergencies from local anesthetics are generally related to
high plasma levels encountered, or large doses administered, during
therapeutic use of local anesthetics or to unintended subarachnoid or
intravascular injection of local anesthetic solution (see , , and ).
How should I store and handle NAROPIN?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Naropin (ropivacaine HCl) Injection is supplied as follows: The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if Naropin is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. When a container is required to have a sterile outside, a Sterile-Pak should be chosen. Glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F of 7 minutes at 121°C. Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. NAROPIN is a trademark of APP Pharmaceuticals, LLC.Distributed by: Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.451114/Issued: March 2009Naropin (ropivacaine HCl) Injection is supplied as follows: The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if Naropin is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. When a container is required to have a sterile outside, a Sterile-Pak should be chosen. Glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F of 7 minutes at 121°C. Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. NAROPIN is a trademark of APP Pharmaceuticals, LLC.Distributed by: Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.451114/Issued: March 2009Naropin (ropivacaine HCl) Injection is supplied as follows: The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if Naropin is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. When a container is required to have a sterile outside, a Sterile-Pak should be chosen. Glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F of 7 minutes at 121°C. Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. NAROPIN is a trademark of APP Pharmaceuticals, LLC.Distributed by: Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.451114/Issued: March 2009Naropin (ropivacaine HCl) Injection is supplied as follows: The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if Naropin is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. When a container is required to have a sterile outside, a Sterile-Pak should be chosen. Glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F of 7 minutes at 121°C. Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. NAROPIN is a trademark of APP Pharmaceuticals, LLC.Distributed by: Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.451114/Issued: March 2009
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after ensuring the availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (see also , , and ). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2 to 3 minutes, extended to the T10 level in 10 to 13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
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The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use (see and ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient's state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available.
Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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