Ropivacaine (PF) (ropivacaine HCl/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.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

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.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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.