Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ROPIVACAINE HYDROCHLORIDE (UNII: V910P86109) (ropivacaine - UNII:7IO5LYA57N)
Mylan Institutional LLC
INFILTRATION
PRESCRIPTION DRUG
Ropivacaine hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.
Ropivacaine Hydrochloride Injection, USP is supplied as: NDC Ropivacaine Hydrochloride Injection, USP (0.2%) (2 mg per mL) Package Factor 67457-875-20 40 mg per 20 mL Single-Dose Vial 5 vials per carton NDC Ropivacaine Hydrochloride Injection, USP (0.5%) (5 mg per mL) Package Factor 67457-876-30 150 mg per 30 mL Single-Dose Vial 1 vial per carton 67457-876-99 150 mg per 30 mL Single-Dose Vial 5 vials per carton NDC Ropivacaine Hydrochloride Injection, USP (0.75%) (7.5 mg per mL) Package Factor 67457-878-20 150 mg per 20 mL Single-Dose Vial 5 vials per carton NDC Ropivacaine Hydrochloride Injection, USP (1%) (10 mg per mL) Package Factor 67457-877-20 200 mg per 20 mL Single-Dose Vial 5 vials per carton Ropivacaine Hydrochloride Injection, USP is a clear, colorless solution free from visible particles. The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if ropivacaine hydrochloride injection, USP is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema. When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] The container closure is not made with natural rubber latex. Discard unused portion promptly. Sterile, Nonpyrogenic, Preservative-free. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India MARCH 2019
Abbreviated New Drug Application
ROPIVACAINE HYDROCHLORIDE- ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- ROPIVACAINE HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION Ropivacaine Hydrochloride Injection, USP contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection, USP 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 the following structural formula: C H N O•HCL•H O M.W. 328.89 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. Ropivacaine Hydrochloride Injection, USP is preservative-free and is available in single dose containers in 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) and 10 mg/mL (1%) concentrations. The specific gravity of Ropivacaine Hydrochloride Injection, USP solutions range from 1.002 to 1.005 at 25°C. CLINICAL PHARMACOLOGY _MECHANISM OF ACTION_ Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)- enantiomer. Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and condu Läs hela dokumentet