Ropivacaine Hydrochloride 5 mg/mL
Ropivacaine Hydrochloride · INJECTION, SOLUTION · Eugia US LLC
Ropivacaine Hydrochloride is a injection, solution containing ropivacaine hydrochloride at 5 mg/mL, taken epidural. Manufactured by Eugia US LLC.
Key Facts
- Brand Name
- Ropivacaine Hydrochloride
- Generic Name
- Ropivacaine Hydrochloride
- NDC Code (Product)
55150-198- Manufacturer
- Eugia US LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INFILTRATION, PERINEURAL
- Marketing Status
- Application #
- ANDA205612
- Marketing Start
- 09/15/2016
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Amneal Pharmaceuticals, LLC
Presence of Particulate Matter
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine Hydrochloride is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. ( 1 ) Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. ( 1 ) Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Table 1 for Dosage Recommendations. ( 2.2 ) 2.1 Important Administration Instructions There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Ropivacaine Hydrochloride Injection is not approved for this use [see Warnings and Precautions ( 5.3 )]. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special …
Contraindications
4 CONTRAINDICATIONS Ropivacaine Hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions ( 5.4 )]: Examples of Drugs Associated with Methemoglobinemia Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Ropivacaine Hydrochloride should be used with caution in patients receiving other local anesthetics or agents structurally related to amide- type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of rop…
Adverse Reactions
6 ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Ropivacaine Hydrochloride at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event. Because clinical trials are conducted under widely conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Incidence ≥ 5% For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the follo…
Frequently Asked Questions
What is Ropivacaine Hydrochloride used for?
Ropivacaine Hydrochloride contains Ropivacaine Hydrochloride. It is a injection, solution taken epidural. Consult your doctor for specific uses.
Is Ropivacaine Hydrochloride a controlled substance?
Ropivacaine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Ropivacaine Hydrochloride?
The generic name for Ropivacaine Hydrochloride is Ropivacaine Hydrochloride. There are 7 other brand versions of Ropivacaine Hydrochloride.
What is the NDC code for Ropivacaine Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Ropivacaine Hydrochloride 5 mg/mL is 55150-198, listed by Eugia US LLC.