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Drug overview for NAROPIN (PF) (ropivacaine hcl/pf):
Generic name: ropivacaine HCl/PF
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Anesthetics
Ropivacaine hydrochloride is a long-acting local anesthetic of the amide type.
No enhanced Uses information available for this drug.
Generic name: ropivacaine HCl/PF
Drug class: Local Anesthetics - Parenteral
Therapeutic class: Anesthetics
Ropivacaine hydrochloride is a long-acting local anesthetic of the amide type.
No enhanced Uses information available for this drug.
DRUG IMAGES
NAROPIN 0.2% 400 MG/200 ML BTL
NAROPIN 0.2% 200 MG/100 ML BTL
The following indications for NAROPIN (PF) (ropivacaine hcl/pf) have been approved by the FDA:
Indications:
Administration of local anesthesia
Local anesthesia for procedure
Major nerve block for surgery
Regional anesthesia for cesarean section
Regional anesthesia for labor pain
Regional anesthesia for postoperative pain
Regional anesthesia for surgery
Professional Synonyms:
Epidural block for cesarean section
Epidural block for surgery
Indications:
Administration of local anesthesia
Local anesthesia for procedure
Major nerve block for surgery
Regional anesthesia for cesarean section
Regional anesthesia for labor pain
Regional anesthesia for postoperative pain
Regional anesthesia for surgery
Professional Synonyms:
Epidural block for cesarean section
Epidural block for surgery
The following dosing information is available for NAROPIN (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.
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.
(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 available.
No generic dosing information available.
The following drug interaction information is available for NAROPIN (PF) (ropivacaine hcl/pf):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics 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) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER, IDHIFA |
The following contraindication information is available for NAROPIN (PF) (ropivacaine hcl/pf):
Drug contraindication overview.
Known hypersensitivity to ropivacaine hydrochloride or other local anesthetics of the amide type.
Known hypersensitivity to ropivacaine hydrochloride or other local anesthetics of the amide type.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Methemoglobinemia |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 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 |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for NAROPIN (PF) (ropivacaine hcl/pf):
Adverse reaction overview.
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.
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 28 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypotension Nausea |
Back pain Bradycardia Fever Headache disorder Pain Paresthesia Vomiting |
| Rare/Very Rare |
|---|
|
Blurred vision Chills Chondrolysis of articular cartilage Dizziness Drowsy Dysgeusia Head sensation disturbance Hemiparesis Hypertension Muscle fasciculation Nervousness Pruritus of skin Seizure disorder Slurred speech Tachycardia Tremor Unconsciousness Urinary retention Ventricular arrhythmias |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acquired horner syndrome Injection site sequelae Oral hypoesthesia Symptoms of anxiety Tinnitus Visual changes |
The following precautions are available for NAROPIN (PF) (ropivacaine hcl/pf):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.)
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.
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.
The following prioritized warning is available for NAROPIN (PF) (ropivacaine hcl/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NAROPIN (PF) (ropivacaine hcl/pf)'s list of indications:
| Regional anesthesia for c-section | |
| O82 | Encounter for cesarean delivery without indication |
| Regional anesthesia for postoperative pain | |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute postprocedural pain |
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