Ropivacaine (Pf) In 0.9 % Nacl (ropivacaine HCl in 0.9 % sodium chloride/PF)

Dosage of ropivacaine hydrochloride is expressed in terms of ropivacaine hydrochloride. Dosage of ropivacaine hydrochloride varies with the anesthetic procedure, degree of anesthesia required, surgical site, and individual patient response. The smallest dose and lowest concentration required to produce the desired effect should be used. Rapid administration of a large single dose should be avoided. The manufacturer's dosage recommendations are based on the expected average dosage range necessary to produce a successful block in adults and should be used as a general guideline.

Ropivacaine hydrochloride may be administered by epidural block, peripheral nerve block (e.g., brachial plexus block), or local infiltration. The manufacturer states that ropivacaine should not be used for obstetrical paracervical block, retrobulbar block, or spinal anesthesia (subarachnoid block), and should not be administered using the Bier block technique (IV regional anesthesia).

Local anesthetics, including ropivacaine, have been administered by continuous intra-articular infusion+ (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis. (See Cautions: Musculoskeletal Effects in the Local Anesthetics, Parenteral, General Statement 72:00.)

To prevent intravascular or subarachnoid injection of a large epidural dose of ropivacaine hydrochloride, a test dose (e.g., 3-5 mL of a short-acting local anesthetic solution containing epinephrine) should be injected prior to administering the total dose. When clinical conditions permit, use of a test dose solution that contains epinephrine should be considered to detect inadvertent intravascular injection. The test dose should be repeated if the epidural catheter is displaced. An adequate time for onset of anesthesia should be allowed following administration of each test dose.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date with ropivacaine hydrochloride.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Local Anesthetics/Long-Acting Bupivacaine

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1)

PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Ropivacaine/Strong Cyp1a2 Inhibitors

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Strong CYP1A2 inhibitors may inhibit the metabolism of ropivacaine.

CLINICAL EFFECTS: Concurrent use of a strong CYP1A2 inhibitor may result in increased levels of and toxicity from ropivacaine.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: In patients receiving concurrent strong CYP1A2 inhibitors and ropivacaine, monitor patients closely for signs of toxicity.

DISCUSSION: In a double-blind, randomized, cross-over study in 9 healthy subjects, ciprofloxacin (500 mg twice daily) decreased the clearance of a single dose of ropivacaine (0.6 mg/kg) by 31%.(1) In a double-blind, randomized, cross-over study in 8 healthy subjects, fluvoxamine (100 mg daily) increased the area-under-curve (AUC) of a single dose of ropivacaine (0.6 mg/kg) by 3.7-fold.(2) In a randomized, cross-over study in 12 healthy subjects, fluvoxamine (25 mg daily) increased the clearance of a single dose of ropivacaine (40 mg) by 68%. Ropivacaine half-life almost doubled.(3) Strong inhibitors of CYP1A2 include angelica root (angelica dahurica radix), enasidenib, enoxacin, fluvoxamine, and rofecoxib.(4,5)

Known hypersensitivity to ropivacaine hydrochloride or other local anesthetics of the amide type.

• Methemoglobinemia

• Atrial fibrillation
• Bradycardia
• Butyrylcholinesterase deficiency
• Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
• Hemolytic anemia from pyruvate kinase and g6PD deficiencies
• Myasthenia gravis
• Structural disorder of heart

• Disease of liver
• Hypotension
• Kidney disease with reduction in glomerular filtration rate (GFr)

Adverse effects reported in 5% or more of patients receiving ropivacaine hydrochloride in clinical studies include hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

More Frequent

• Bradycardia
• Hypotension

Less Frequent

• Hypertension
• Hypokalemia

Rare or Very Rare

• Atrial fibrillation
• CNS toxicity
• Extrasystoles
• Hypersensitivity drug reaction
• Hypomagnesemia
• Jaundice
• Seizure disorder
• Thromboembolic disorder
• Tonic clonic seizure
• Unconsciousness
• Ventricular arrhythmias

More Frequent

• Anemia
• Back pain
• Fever
• Headache disorder
• Nausea
• Pain
• Paresthesia
• Pruritus of skin

Less Frequent

• Chest pain
• Chills
• Cramps
• Dizziness
• Dyspnea
• Hypoesthesia
• Oliguria
• Rhinitis
• Symptoms of anxiety
• Tachycardia
• Urinary retention
• Urinary tract infection
• Vomiting

Rare or Very Rare

• Acquired horner syndrome
• Acute bronchospasm
• Acute cognitive impairment
• Agitation
• Blepharoptosis
• Blurred vision
• Cough
• Drowsy
• Dysgeusia
• Dyskinesia
• Fecal incontinence
• General weakness
• Hallucinations
• Hearing loss
• Hypokinesia
• Hypothermia
• Hypotonia
• Injection site sequelae
• Insomnia
• Malaise
• Memory impairment
• Mood changes
• Muscle fasciculation
• Myalgia
• Nervousness
• Nightmares
• Oral hypoesthesia
• Orthostatic hypotension
• Peripheral sensory neuropathy
• Phlebitis
• Skin rash
• Slurred speech
• Stupor
• Syncope
• Tenesmus
• Tinnitus
• Tremor
• Urticaria
• Vertigo
• Visual changes

No enhanced messaging available.

The manufacturer states that efficacy and safety of ropivacaine have not been established in pediatric patients; however, the drug has been used in children for postoperative analgesia.

Category B.

There are no adequate and well-controlled studies of ropivacaine in pregnant women. Animal reproductive studies have not shown any evidence of teratogenicity or adverse developmental effects; however, maternal toxicity has been observed. Local anesthetics rapidly cross the placenta during epidural administration and can cause varying degrees of maternal, fetal, and neonatal toxicity. Ropivacaine should be used during pregnancy only if the benefits outweigh the risks.

Maternal hypotension has occurred with the use of ropivacaine for obstetrical pain relief. (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.)

Ropivacaine is distributed into milk in rats; it is not known whether the drug or its metabolites are distributed into human milk. Based on the milk to plasma concentration ratio and estimated exposures in rats, infant exposure to ropivacaine from breastfeeding is expected to be far less than the exposure in utero. Ropivacaine should be used with caution in nursing women.

In clinical studies of ropivacaine, 27% of patients receiving the drug were 65 years of age or older and 4% were 75 years of age or older. The drug was found to be safe and effective in these patients.

Differences in various pharmacodynamic measures of ropivacaine have been observed with increasing age. In one clinical study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure declined with age for the first hour following epidural administration, and the intensity of motor blockade increased with age.

Because ropivacaine and its metabolites are substantially excreted by the kidneys, the risk of toxic reactions to the drug may be greater in patients with renal impairment. Dosage should therefore be selected with caution in geriatric patients, usually starting at the lower end of the dosage range, since such patients are more likely to have decreased hepatic, renal, and/or cardiac function as well as concomitant illnesses. The manufacturer states that it may be useful to monitor renal function in geriatric patients.