Naropin SDV Side Effects
Generic Name: ropivacaine
Note: This document contains side effect information about ropivacaine. Some of the dosage forms listed on this page may not apply to the brand name Naropin SDV.
For the Consumer
Applies to ropivacaine: injection solution
Along with its needed effects, ropivacaine (the active ingredient contained in Naropin SDV) 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 immediately if any of the following side effects occur while taking ropivacaine:Less common or rare
- Burning or prickling sensation
Check with your doctor as soon as possible if any of the following side effects occur while taking ropivacaine:Less common or rare
- Back pain
- difficulty urinating
For Healthcare Professionals
Applies to ropivacaine: injectable solution
Cardiovascular side effects have included hypotension (37%), bradycardia (9.3%), hypertension, and tachycardia. Vasovagal reaction, syncope, postural hypotension, ECG abnormalities, extrasystoles, arrhythmias, atrial fibrillation, deep vein thrombosis, phlebitis, pulmonary embolism, ST segment changes, and myocardial infarction have been reported rarely (less than 1%). Decreased cardiac output, heart block, hypotension, and cardiac arrest have also been reported.
The incidence of hypotension is increased in patients 65 years of age or older. The incidence of hypotension following the epidural administration of a 5 mg/mL, 7.5 mg/mL and 10 mg/mL solutions of ropivacaine (the active ingredient contained in Naropin SDV) were 32.2%, 43.2%, 51.5%, respectively, in patients under 65 years of age, and 68.9%, 69.1%, 68.4%, respectively, in patients 65 years of age or older.[Ref]
High doses or unintentional intravascular injection may lead to decreased cardiac output, heart block, hypotension, bradycardia, cardiac arrhythmias, and cardiac arrest. In comparative studies, ropivacaine has been shown to be less cardiotoxic and arrhythmogenic than bupivacaine.
The incidence of hypotension is dose related. In patients under 65- years- old the incidence of hypotension following administration of 5 mg/mL, 7.5 mg/mL, and 10 mg/mL ropivacaine solutions was 38.7%, 49.2% and 54.6%, respectively.
Hypotension occurs at a higher incident rate in females as compared to males. It was reported, following epidural administration, in 54.3% of females versus 38.9% of males.[Ref]
Seizure activity in an obstetrical patient who had been treated with ropivacaine (the active ingredient contained in Naropin SDV) has been reported. One case involved a 26- year- old female who received an aggregate dose of 279 mg of ropivacaine. She developed oculogyric movements and slurred speech that proceeded to twitching of the face and arms. The seizure was successfully treated with thiopental sodium 400 mg, the patient was given general anesthesia, and the child was delivered without further incident.
A 38- year- old woman was reported to have developed Transient Neurologic Symptom (TNS) following intrathecal administration of 10 mg at the L2-L3 while in the right lateral decubitus position. The patient gradually recovered over a 6- week period.
Clinicians should be aware that restlessness, anxiety, incoherent speech, lightheadedness, paresthesias, dizziness, blurred vision, tremors, twitching, depression, and drowsiness may be early warning signs of central nervous system toxicity. The mean (min - max) maximum tolerated total and free arterial plasma concentrations following intravenous administration in humans were 4.3 (3.4 - 5.3) and 0.6 (0.3 - 0.9) respectively, at which time twitching (representative of moderate central nervous system toxicity) was noted.
Headache, dizziness, and hypoesthesia occur at a higher incident rate in females as compared to males. Headache was reported, following epidural administration, in 8.1% of females versus 4.8% of males. Dizziness was reported, following epidural administration, in 2,2% of females versus 1.1% of males. Hypoesthesia was reported, following epidural administration, in 2% of females versus 0.6% of males.[Ref]
Nervous system side effects have frequently included paraesthesia (5.6%), dizziness (2.5%), hypoesthesia (1.6%), and anxiety (1.3%). Tremor, Horner's syndrome, paresis, dyskinesia, neuropathy, vertigo, coma, convulsion, hypokinesia, hypotonia, ptosis, stupor, confusion, somnolence, nervousness, amnesia, insomnia and asthenia have occurred rarely. Restlessness, incoherent speech, lightheadedness, twitching and drowsiness have also been reported. Seizures have been reported in patients receiving local anesthetics. There is a single case report of Transient Neurologic Symptom (TNS).[Ref]
Gastrointestinal side effects have frequently included nausea (24.8%) and vomiting (11.6%). Fecal incontinence and tenesmus have been reported rarely.[Ref]
Nausea and vomiting may have resulted from other concomitant surgical anesthetics.
Nausea and vomiting occur at a higher incident rate in females as compared to males. Nausea was reported, following epidural administration, in 39.4% of females versus 6.5% of males. Vomiting was reported, following epidural administration, in 14.6% of females versus 2.3% of males.[Ref]
Other side effects have frequently included fever (9.2%), pain (8%), postoperative complications (7.1%), headache (5.1%), pruritus (5.1%), back pain (5%), rigors (2.5%), breast-feeding disorder (1.3%), poor/failed progression of labor (1.4%), and cramps (1 to 5%). Hypothermia, malaise, accident and/or injury, uterine atony, tinnitus, and hearing abnormalities have been reported rarely. Metallic taste has also been reported, but may also be an early sign of central nervous system toxicity. Transient increases in body temperature (>38.5 C) have been reported rarely following epidural administration. This effect occurred more frequently at doses exceeding 16 mg/hr.[Ref]
Back pain, chills, fever, pruritus, and pain occur at a higher incident rate in females as compared to males. Back pain was reported, following epidural administration, in 10.1% of females versus 6.5% of males. Chills was reported, following epidural administration, in 4.4% of females versus 1.4% of males. Fever was reported, following epidural administration, in 4% of females versus 0.8% of males. Pruritus was reported, following epidural administration, in 4% of females versus 0.3% of males. Pain was reported, following epidural administration, in 3% of females versus 1.1% of males.[Ref]
Other side effects reported in >= 1% of fetuses or neonates given birth by mothers who received administration prior to cesarean section and/or labor have included fetal bradycardia (12.1%), neonatal jaundice (7.7%), neonatal complications (6.6%), low Apgar score (2.8%), neonatal respiratory disorder (2.7%), neonatal tachypnea (2.2%), neonatal fever (2%), fetal tachycardia (2%), fetal distress (1.7%), neonatal infection (1.6%), and neonatal hypoglycemia (1.3%). Neonatal vomiting has been reported rarely.[Ref]
Genitourinary side effects, occurring in 1% to 5% of patients, have included urinary retention, urinary tract infection, and oliguria. Urinary incontinence and micturition disorder have been reported rarely.[Ref]
Dermatologic side effects have rarely included rash and urticaria.[Ref]
Hematologic side effects have included anemia (6.1%).[Ref]
Hepatic side effects have rarely included jaundice.[Ref]
Local side effects have rarely included injection site pain.[Ref]
Metabolic side effects have included hypokalemia (1% to 5%) and hypomagnesemia.[Ref]
Musculoskeletal side effects have rarely included myalgia.[Ref]
Ocular side effects have rarely included vision abnormalities.[Ref]
Psychiatric side effects have rarely included agitation, hallucination, emotional lability, and nightmares.[Ref]
Respiratory side effects have rarely included rhinitis (1.1%), bronchospasm, and coughing.[Ref]
Hypersensitivity side effects have rarely included life-threatening anaphylaxis. Allergic cross-sensitivity between amide-type anesthetics has been reported. A delayed hypersensitivity reaction to epidural ropivacaine (the active ingredient contained in Naropin SDV) has been reported.[Ref]
Allergic reactions may manifest themselves as urticaria, pruritus, erythema, angioneurotic edema, tachycardia, sneezing, nausea, syncope, dizziness, and fever.[Ref]
In general, most side effects due to ropivacaine (the active ingredient contained in Naropin SDV) are transient and mild. Most effects are similar to the type and frequency of those seen with bupivacaine and tend to be dose related.[Ref]
1. Stienstra R, Jonker TA, Bourdrez P, Kuijpers JC, van Kleef JW, Lundberg U "Ropivacaine 0.25% versus bupivacaine 0.25% for continuous epidural analgesia in labor: a double-blind comparison." Anesth Analg 80 (1995): 285-9
2. Kerkkamp HE, Gielen MJ "Cardiovascular effects of epidural local anaesthetics. Comparison of 0.75% bupivacaine and 0.75% ropivacaine, both with adrenaline." Anaesthesia 46 (1991): 361-5
3. Cederholm I, Anskar S, Bengtsson M "Sensory, motor, and sympathetic block during epidural analgesia with 0.5% and 0.75% ropivacaine with and without epinephrine." Reg Anesth 19 (1994): 18-33
4. Katz JA, Knarr D, Bridenbaugh PO "A double-blind comparison of 0.5% bupivacaine and 0.75% ropivacaine administered epidurally in humans." Reg Anesth 15 (1990): 250-2
5. Stewart J, Kellett N, Castro D "The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers." Anesth Analg 97 (2003): 412-6
6. Morrison LM, Emanuelsson BM, McClure JH, Pollok AJ, McKeown DW, Brockway M, Jozwiak H, Wildsmith JA "Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine." Br J Anaesth 72 (1994): 164-9
7. Griffin RP, Reynolds F "Extradural anaesthesia for caesarean section: a double-blind comparison of 0.5% ropivacaine with 0.5% bupivacaine." Br J Anaesth 74 (1995): 512-6
8. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.
9. Ganapathy S, Sandhu HB, Stockall CA, Hurley D "Transient neurologic symptom (TNS) following intrathecal ropivacaine." Anesthesiology 93 (2000): 1537-9
10. Borgeat A, Ruetsch YA, Jorg M "Convulsions induced by ropivacaine during interscalene brachial plexus block." Anesth Analg 87 (1998): 497
11. Abouleish EI, Elias M, Nelson C "Ropivacaine-induced seizure after extradural anaesthesia." Br J Anaesth 80 (1998): 843-4
12. Marri S, Coventry D "Convulsions associated with ropivacaine 300 mg for brachial plexus block." Br J Anaesth 102 (2009): 562-3; author reply 563
13. Owen MD, Gautier P, Hood DD "Can ropivacaine and levobupivacaine be used as test doses during regional anesthesia?" Anesthesiology 100 (2004): 922-5
14. Bisschop DY, Alardo JP, Razgallah B, Just BY, Germain ML, Millart HG, Trenque TC "Seizure induced by ropivacaine." Ann Pharmacother 35 (2001): 311-3
15. Wildsmith JA "Delayed hypersensitivity due to epidural block with ropivacaine: report raises several issues." BMJ 330 (2005): 966; author reply 966
16. Concepcion M, Arthur GR, Steele SM, Bader AM, Covino BG "A new local anesthetic, ropivacaine. Its epidural effects in humans." Anesth Analg 70 (1990): 80-5
17. Moller R, Covino BG "Cardiac electrophysiologic properties of bupivacaine and lidocaine compared with those of ropivacaine, a new amide local anesthetic." Anesthesiology 72 (1990): 322-9
18. de Jong RH "1995 Gaston Labat Lecture. Ropivacaine. White knight or dark horse?" Reg Anesth 20 (1995): 474-81
Some side effects of Naropin SDV may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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