"The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease "...
(ropivacaine HCl) Injection
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:
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, numbness or tingling around your mouth, or tremors;
Last reviewed on RxList: 3/8/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Naropin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.