Naropin

DRUG DESCRIPTION

Naropin® Injection contains ropivacaine HCl, which is a member of the amino amide class of local anesthetics. Naropin (ropivacaine hcl) Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally.

Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with a molecular formula of C17H26N2O•HCl•H2O, molecular weight of 328.89 and the following structural formula:

NAROPIN®
  (ropivacaine HCl) Structural Formula Illustration

At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine.

Naropin (ropivacaine hcl) Injection is preservative-free and is available in single dose containers in 2 (0.2%), 5 (0.5%), 7.5 (0.75%) and 10 mg/mL (1%) concentrations. The specific gravity of Naropin (ropivacaine hcl) Injection solutions range from 1.002 to 1.005 at 25°C.

What are the possible side effects of ropivacaine (Naropin, Naropin Polyamp, Naropin SDV)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives or red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling anxious, restless, confused, or like you might pass out;
  • problems with speech or vision;
  • ringing in the ears, metallic taste, vision problems, numbness or tingling...

Read All Potential Side Effects and See Pictures of Naropin »


Naropin Patient Information Including Side Effects

Brand Names: Naropin, Naropin Polyamp, Naropin SDV

Generic Name: ropivacaine (Pronunciation: roe PIV a kane)

  • What is ropivacaine (Naropin)?
  • What are the possible side effects of ropivacaine (Naropin)?
  • What is the most important information I should know about ropivacaine (Naropin)?
  • What should I discuss with my health care provider before receiving ropivacaine (Naropin)?
  • How is ropivacaine given (Naropin)?
  • What happens if I miss a dose (Naropin)?
  • What happens if I overdose (Naropin)?
  • What should I avoid after receiving ropivacaine (Naropin)?
  • What other drugs will affect ropivacaine (Naropin)?
  • Where can I get more information?

What is ropivacaine (Naropin)?

Ropivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain.

Ropivacaine is used as a local (in only one area) anesthesia for a spinal block, also called an epidural. The medication is used to provide anesthesia during a surgery or C-section, or to ease labor pains.

Ropivacaine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ropivacaine (Naropin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives or red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • feeling anxious, restless, confused, or like you might pass out;
  • problems with speech or vision;
  • ringing in the ears, metallic taste, vision problems, numbness or tingling around your mouth, or tremors;
  • seizure (convulsions);
  • weak or shallow breathing;
  • slow heart rate, weak pulse; or
  • fast heart rate, gasping, feeling unusually hot.

Less serious side effects include:

  • nausea, vomiting;
  • headache, back pain;
  • fever;
  • itching;
  • numbness or tingly feeling; or
  • problems with urination or sexual function.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ropivacaine (Naropin)?

You should not receive ropivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving ropivacaine, tell your doctor if you are allergic to any drugs, or if you have liver disease, heart disease, or kidney disease.

Tell your caregivers at once if you have a serious side effect such as: confusion, feeling like you might pass out, problems with speech or vision, ringing in your ears, numbness or tingling around your mouth, seizure, weak or shallow breathing, fast or slow heart rate, weak pulse, gasping, or feeling unusually hot.

This medication can cause numbness over a large portion of your body. Take care to avoid injury before the feeling has returned completely.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from ropivacaine.

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