Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

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Questions & Answers

Side Effects & Adverse Reactions

In performing ropivacaine hydrochloride 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 ropivacaine hydrochloride 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.

Ropivacaine hydrochloride 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 IV 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 insuring the immediate (without delay) 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 ADVERSE REACTIONS, PRECAUTIONS and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES).  Delay in proper management of dose-related toxicity, under ventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.  Solutions of ropivacaine hydrochloride 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.

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions.  The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours.  There is insufficient information to determine whether shorter infusion periods are not associated with these findings.  The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery.  Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.

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 not 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 ropivacaine hydrochloride 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.

Ropivacaine hydrochloride 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Ropivacaine Hydrochloride Injection 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 infiltration

Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration

History

There is currently no drug history available for this drug.

Other Information

Ropivacaine Hydrochloride Injection, USP contains ropivacaine hydrochloride which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride, USP for isotonicity and Water for Injection, USP.  Sodium hydroxide, NF and/or hydrochloric acid, NF may be used for pH adjustment.  It is administered parenterally.

Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride.  The drug substance is a white crystalline powder, with a molecular formula of C17H26N2O•HCl, molecular weight of 310.87 and the following structural formula:

ropivacaine-figure-1

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.

Ropivacaine Hydrochloride Injection, USP is preservative-free and is available in single dose containers in 5 mg/mL (0.5%) and 10 mg/mL (1%) concentrations.  The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C.

Ropivacaine Hydrochloride Manufacturers


  • Sandoz Inc
    Ropivacaine Hydrochloride Injection, Solution [Sandoz Inc]
  • Sagent Pharmaceuticals
    Ropivacaine Hydrochloride Injection, Solution [Sagent Pharmaceuticals]
  • Hospira, Inc.
    Ropivacaine Hydrochloride Injection, Solution [Hospira, Inc.]

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