ROPIVACAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ROPIVACAINE HYDROCHLORIDE (UNII: V910P86109) (ROPIVACAINE - UNII:7IO5LYA57N)

Available from:

Sandoz Inc

INN (International Name):

ROPIVACAINE HYDROCHLORIDE

Composition:

ROPIVACAINE HYDROCHLORIDE 5 mg in 1 mL

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, eg, 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.

Product summary:

Ropivacaine Hydrochloride Injection, USP Single Dose Vials: The solubility of ropivacaine is limited at pH above 6.  Thus, care must be taken as precipitation may occur if Ropivacaine Hydrochloride Injection 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 ampule or vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. Glass containers may, as an alternative, be autoclaved once.  Stability has been demonstrated using a targeted F0 of 7 minutes at 121°C. Solutions should be stored at controlled room temperature 20 to 25°C (68 to 77°F) [see USP]. Excursions permitted to 15 to 30°C (59 to 86°F). These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly.  Manufactured by: Emcure Pharmaceuticals Ltd. Hinjwadi, Pune 411 057, INDIA. For Sandoz Inc. Princeton, NJ 08540

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPIVACAINE HYDROCHLORIDE- ROPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
SANDOZ INC
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ROPIVACAINE HYDROCHLORIDE INJECTION, USP
DESCRIPTION
Ropivacaine Hydrochloride Injection, USP contains ropivacaine
hydrochloride 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, USP for
isotonicity and Water for Injection, USP. Sodium hydroxide, NF and/or
hydrochloric acid, NF may be
used for pH adjustment. It is administered parenterally.
Ropivacaine HCl is chemically described as
S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride. The
drug substance is a white crystalline powder, with a molecular formula
of C
H N O•HCl, molecular
weight of 310.87 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.
Ropivacaine Hydrochloride Injection, USP is preservative-free and is
available in single dose
containers in 5 mg/mL (0.5%) 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 conduction