Naropin 2 mg/mL

ROPIVACAINE HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC

No Recall HistoryCurrently in Shortage

Plain English

Naropin is a injection, solution containing ropivacaine hydrochloride at 2 mg/mL, taken epidural. Manufactured by Fresenius Kabi USA, LLC.

Key Facts

Brand Name: Naropin
Generic Name: ROPIVACAINE HYDROCHLORIDE
NDC Code (Product): 63323-285
Manufacturer: Fresenius Kabi USA, LLC
Strength: 2 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: EPIDURAL, INFILTRATION
Marketing Status
Application #: NDA020533
Marketing Start: 08/04/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea536 reports

vomiting535 reports

drug hypersensitivity522 reports

pneumonia518 reports

oedema513 reports

asthma497 reports

wheezing488 reports

pain231 reports

malaise206 reports

respiratory tract infection187 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NAROPIN 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 NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesi a: 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

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. NAROPIN 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 attention although regional an…

Contraindications

4 CONTRAINDICATIONS NAROPIN 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 NAROPIN 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 ropivacaine was redu…

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 NAROPIN 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 following treatment-eme…

Frequently Asked Questions

What is Naropin used for?

Naropin contains ROPIVACAINE HYDROCHLORIDE. It is a injection, solution taken epidural. Consult your doctor for specific uses.

Is Naropin a controlled substance?

Naropin is not classified as a controlled substance by the DEA.

What is the generic name for Naropin?

The generic name for Naropin is ROPIVACAINE HYDROCHLORIDE. There are 12 other brand versions of ROPIVACAINE HYDROCHLORIDE.

What is the NDC code for Naropin 2 mg/mL?

The NDC (National Drug Code) for Naropin 2 mg/mL is 63323-285, listed by Fresenius Kabi USA, LLC.

Product NDC

63323-285

Package NDC

63323-285-67

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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