ROPIVACAINE HYDROCHLORIDE- 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:

Sagent Pharmaceuticals

INN (International Name):

ropivacaine hydrochloride

Composition:

ropivacaine hydrochloride 2 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropivacaine hydrochloride 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 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 is supplied as: 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 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. 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.] Discard unused portion promptly. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT™ Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2014 Sagent Pharmaceuticals, Inc. August 2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPIVACAINE HYDROCHLORIDE- ROPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
SAGENT PHARMACEUTICALS
----------
ROPIVACAINE HYDROCHLORIDE INJECTION, USP
SAGENT™
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:
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 conduction
velocity of affecte