Naropin 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.

Some side effects of Naropin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ropivacaine: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ropivacaine (the active ingredient contained in Naropin) hives or red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• feeling anxious, restless, confused, or like you might pass out;

• problems with speech or vision;

• ringing in the ears, metallic taste, numbness or tingling around your mouth, or tremors;

• seizure (convulsions);

• weak or shallow breathing;

• slow heart rate, weak pulse; or

• fast heart rate, gasping, feeling unusually hot.

Less serious side effects include:

• nausea, vomiting;

• headache, back pain;

• fever;

• itching;

• numbness or tingly feeling; or

• problems with urination or sexual function.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ropivacaine: injectable solution

Cardiovascular

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) 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.

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.

Nervous system

Seizure activity in an obstetrical patient who had been treated with ropivacaine (the active ingredient contained in Naropin) 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.

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).

Gastrointestinal

Gastrointestinal side effects have frequently included nausea (24.8%) and vomiting (11.6%). Fecal incontinence and tenesmus have been reported rarely.

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.

Other

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.

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.

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.

Genitourinary

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.

Dermatologic

Dermatologic side effects have rarely included rash and urticaria.

Hematologic

Hematologic side effects have included anemia (6.1%).

Hepatic

Hepatic side effects have rarely included jaundice.

Local

Local side effects have rarely included injection site pain.

Metabolic

Metabolic side effects have included hypokalemia (1% to 5%) and hypomagnesemia.

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia.

Ocular

Ocular side effects have rarely included vision abnormalities.

Psychiatric

Psychiatric side effects have rarely included agitation, hallucination, emotional lability, and nightmares.

Respiratory

Respiratory side effects have rarely included rhinitis (1.1%), bronchospasm, and coughing.

Hypersensitivity

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) has been reported.

Allergic reactions may manifest themselves as urticaria, pruritus, erythema, angioneurotic edema, tachycardia, sneezing, nausea, syncope, dizziness, and fever.

General

In general, most side effects due to ropivacaine (the active ingredient contained in Naropin) are transient and mild. Most effects are similar to the type and frequency of those seen with bupivacaine and tend to be dose related.

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