Note: This document contains side effect information about ropivacaine. Some dosage forms listed on this page may not apply to the brand name Naropin Polyamp.

Applies to ropivacaine: injection solution.

Serious side effects of Naropin Polyamp

Along with its needed effects, ropivacaine (the active ingredient contained in Naropin Polyamp) 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 ropivacaine:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• decrease in frequency or amount of urine
• difficulty in passing urine (dribbling)
• fever
• painful urination

Rare

• Absence of or decrease in body movement
• agitation
• anxiety
• bluish color of the skin or changes in skin color
• changes in vision
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• decreased awareness or responsiveness
• difficulty breathing
• drooping upper eyelids
• drowsiness
• fast or irregular heartbeat
• general feeling of discomfort or illness
• hearing loss
• loss of appetite
• loss of consciousness
• low body temperature
• mood or mental changes
• muscle aches
• muscle spasms (tetany) or twitching seizures
• muscle weakness
• nausea
• nervousness
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• problems with memory
• seeing or hearing things that are not there
• seizures
• severe sleepiness
• severe, unusual tiredness or weakness
• shivering
• slow heartbeat
• swelling of the foot or leg tenderness
• tightness in the chest
• trembling
• trouble sleeping
• vomiting
• weak or feeble pulse
• weight gain
• yellow skin or eyes

Incidence not known

• Anxiety
• depression
• difficulty swallowing
• excitation
• fast, irregular, pounding, or racing heartbeat or pulse
• hives, itching, skin rash
• inability to breathe without assistance
• paralysis of the arms
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• slow heartbeat
• tremors

Other side effects of Naropin Polyamp

Some side effects of ropivacaine 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:

More common

• Headache

Less common

• Anxiety
• runny or stuffy nose
• sneezing

Rare

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• difficulty in moving
• frequent urge to defecate
• joint pain or swelling
• lack or loss of strength
• loss of bowel control
• muscle pain, cramps, or stiffness
• straining while passing stool

For Healthcare Professionals

Applies to ropivacaine: injectable solution.

General

Reactions to this drug are characteristic of those associated with other amide-type local anesthetics. A major cause of side effects can me associated with excessive plasma levels which may be due to overdose, unintentional intravascular injection, or slow metabolic degradation.^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (up to 54.6%), bradycardia (up to 19.5%), fetal bradycardia (12.1%)

Common (1% to 10%): Hypertension, tachycardia, chest pain, fetal tachycardia, fetal distress

Uncommon (0.1% to 1%): Syncope, severe hypotension

Rare (less than 0.1%): Cardiac arrest, cardiac arrhythmia

Frequency not reported: Vasovagal reaction, postural hypotension, non-specific ECG abnormalities, extrasystole, nonspecific arrhythmia, atrial fibrillation, ST segment changes, myocardial infarction, deep vein thrombosis, phlebitis, pulmonary embolism^[Ref]

Nervous system

Common (1% to 10%): Paresthesia, headache, dizziness, hypoesthesia

Uncommon (0.1% to 1%): CNS toxicity, convulsion, grand mal convulsions, seizure, lightheadedness, circumoral paresthesia, numbness of the tongue, hyperacusis, dysarthria, tremor

Frequency not reported: Horner's syndrome, paresis, dyskinesia, neuropathy, coma, convulsion, hypokinesia, hypotonia, ptosis, stupor, spinal cord dysfunction, anterior spinal artery syndrome, arachnoiditis, cauda equine, total spinal block, persistent anesthesia, weakness, paralysis of lower extremities, loss of sphincter control, septic meningitis^[Ref]

Local

Frequency not reported: Injection site pain^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 29.4%), vomiting (up to 14.6%)

Common (1% to 10%): Neonatal vomiting

Frequency not reported: Fecal incontinence, tenesmus^[Ref]

Other

Common (1% to 10%): Fever, pain, postoperative complication, rigors, neonatal complication, Apgar score low, neonatal fever, neonatal infection, temperature elevation, chills

Uncommon (0.1% to 1%): Tinnitus, hypothermia, neonatal sepsis

Frequency not reported: Malaise, asthenia, accident/injury, hearing abnormal, vertigo^[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, oliguria, urinary tract infection, progression of labor poor/failed

Frequency not reported: Uterine atony, urinary incontinence, micturition disorder^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Rare (less than 0.1%): Angioedema, urticaria

Frequency not reported: Rash^[Ref]

Hematologic

Common (1% to 10%): Anemia^[Ref]

Hepatic

Common (1% to 10%): Neonatal jaundice

Frequency not reported: Jaundice^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, neonatal hypoglycemia

Uncommon (0.1% to 1%): Fetal acidosis

Frequency not reported: Hypomagnesemia^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 16.4%)

Common (1% to 10%): Cramps

Uncommon (0.1% to 1%): Muscular twitch, muscular rigidity, hypotonia

Frequency not reported: Myalgia^[Ref]

Ocular

Frequency not reported: Vision abnormal, vision blurred, pupil constriction^[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia

Frequency not reported: Agitation, confusion, somnolence, nervousness, amnesia, hallucination, emotional lability, nightmares, restlessness, drowsiness, unconsciousness^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, rhinitis, neonatal respiratory disorder, neonatal tachypnea, hypoxia, hypercapnia, apnea

Frequency not reported: Bronchospasm, coughing, underventilation, apnea, respiratory paralysis^[Ref]

Endocrine

Common (1% to 10%): Breast disorder/breastfeeding disorder^[Ref]

Immunologic

Rare (less than 0.1%): Allergic reaction, anaphylactic reaction^[Ref]