Ropivacaine

Ropivacaine is given as an injection through a needle placed into an area of your middle or lower back near your spine. You will receive this injection in a hospital or surgical setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving ropivacaine.

Some numbing medications can have long-lasting or delayed effects. Talk to your doctor if you have concerns about this risk. Call your doctor if you have joint pain or stiffness, or weakness in any part of your body that occurs after your surgery, even months later.

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Since ropivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.

Ropivacaine is available in the following forms:

• Injectable Solution
• Prefilled Syringe

Usual Adult Dose for Local Anesthesia:

Postoperative analgesia:
Lumbar epidural method:
Initial: 75 to 200 mg injected via lumbar epidural administration. The onset of action should occur within 10 to 30 minutes and should last approximately 2 to 6 hours.
Maintenance:
12 to 28 mg/hour administered via lumbar epidural continuous infusion.

Thoracic epidural:
Initial:
25 to 75 mg injected via thoracic epidural administration.
Maintenance:
12 to 28 mg/hour administered via thoracic epidural continuous infusion.
Cumulative epidural dosages up to 770 mg over a 24 hour period for postoperative pain have been well tolerated in adult patients.

Nerve block:
A major nerve block such as a brachial plexus block, may be established by injecting 175 to 250 mg of ropivacaine into the appropriate area of the nerve. The onset of action occurs in approximately 15 to 30 minutes with a duration of 5 to 8 hours.

A field block such as a minor nerve block or infiltration, may be established by injecting 5 to 200 mg of ropivacaine. The onset of action occurs within 1 to 15 minutes with an expected duration of 2 to 6 hours.

Usual Adult Dose for Cesarean Section:

Lumbar epidural method:
100 to 150 mg injected via lumbar epidural administration. The onset of action should occur within 15 to 25 minutes and should last approximately 2 to 4 hours. It is recommended that the 0.5% solution in doses not exceeding 150 mg be employed for cesarean sections.

Usual Adult Dose for Labor Pain:

Lumbar epidural method:
Initial: 20 to 40 mg injected via lumbar epidural administration. The onset of action should occur within 10 to 15 minutes and should last approximately 0.5 to 1.5 hours.
Maintenance:
12 to 28 mg/hour administered via lumbar epidural continuous infusion.

Incremental injections, also known as top- ups, may be made by administering a dose of 20 to 30 mg per hour.

Usual Pediatric Dose for Local Anesthesia:

Caudal Block:
2 to 8 years: 2 mg/kg

Epidural Block (other than caudal block):
1.7 mg/kg

Epidural continuous infusion:
4 months to 7 years: Loading dose of 1 mg/kg followed by 0.4 mg/kg/hr continuous epidural infusion

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will give ropivacaine.
• It is given as a shot into the skin.
• It is given into the spine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling very tired or weak.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• A burning, numbness, or tingling feeling that is not normal.
• Numbness or tingling in the mouth.
• Feeling confused.
• Restlessness.
• Anxiety.
• Trouble speaking.
• Metallic taste.
• Blurred eyesight.
• Ringing in ears.
• Dizziness or passing out.
• Shakiness.
• Twitching.
• Feeling sleepy.
• Low mood (depression).
• Seizures.
• Trouble breathing, slow breathing, or shallow breathing.
• Very upset stomach or throwing up.

• Ropivacaine Hydrochloride

Dose and route dependent: 3 to 15 hours

Half-Life Elimination

Children: Epidural: Terminal phase:4.9 hours (range: 3 to 6.7 hours) (Hansen 2000)

Adults: Epidural: 5 to 7 hours; IV: Terminal: 111 ± 62 minutes (Lee 1989)

Refer to adult dosing. Use with caution; initial dose reductions may be necessary.

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; ropivacaine undergoes hepatic metabolism and patients may be at a greater risk for developing toxic drug levels.

Concerns related to adverse effects:

• CNS toxicity: Careful and constant monitoring of the patient's state of consciousness should be done following each local anesthetic injection; at such times, restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of CNS toxicity. Treatment is primarily symptomatic and supportive.

• Intra-articular infusion related chondrolysis: Continuous intra-articular infusion of local anesthetics after arthroscopic or other surgical procedures is not an approved use; chondrolysis (primarily in the shoulder joint) has occurred following infusion, with some cases requiring arthroplasty or shoulder replacement.

• Respiratory arrest: Local anesthetics have been associated with rare occurrences of sudden respiratory arrest.

• Seizures: Convulsions due to systemic toxicity leading to cardiac arrest have also been reported, presumably following unintentional intravascular injection.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with hypotension, hypovolemia, heart block, or cardiovascular disease; may be at greater risk for toxicity.

• Hepatic impairment: Use with caution in patients with hepatic impairment; may be at greater risk for toxicity.

• Neurological disorders: Use with caution in patients with neurological disorders; may be at greater risk for toxicity.

• Porphyria: Use with caution in patients with acute porphyria; consider use of alternative agents.

• Psychiatric disorders: Use with caution in patients with psychiatric disorders; may be at greater risk for toxicity.

• Renal impairment: Use with caution in patients with severe renal impairment; may be at greater risk for toxicity.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Acutely ill patients: Use with caution in acutely ill; may be at greater risk for toxicity.

• Debilitated patients: Use with caution in debilitated patient; may be at greater risk for toxicity.

• Elderly: Use with caution in the elderly: may be at greater risk for toxicity. Cardiovascular adverse events (bradycardia, hypotension) may be age-related (more common in patients >61 years of age).

Other warnings/precautions:

• Administration: Intravascular injections should be avoided; aspiration should be performed prior to administration; the needle must be repositioned until no return of blood can be elicited by aspiration; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided.

• Rapid administration: Ropivacaine is not recommended for use in emergency situations where rapid administration is necessary.

• Trained personnel: Clinicians using local anesthetic agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

Heart rate, blood pressure, ECG monitoring (if used with antiarrhythmics)