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:

Akorn

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, 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, 0.2% (2 mg/mL) is a clear, colorless solution supplied in 100 mL and 200 mL infusion bottles packaged individually as follows: 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 bottle 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 121ºC. Solutions should be stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. Rx only AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 RPA0N        Rev. 12/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPIVACAINE HYDROCHLORIDE- ROPIVACAINE HYDROCHLORIDE INJECTION,
SOLUTION
AKORN
----------
ROPIVACAINE HYDROCHLORIDE INJECTION USP, 0.2%
Rx only
DESCRIPTION
Ropivacaine Hydrochloride Injection contains ropivacaine HCl which is
a member of the
amino amide class of local anesthetics. Ropivacaine Hydrochloride
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 the
following molecular formula of C
H
N O•HCl•H O, 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.
Ropivacaine Hydrochloride Injection is preservative-free and is
available in a single dose
container in 2 mg/mL (0.2%) concentration. The specific gravity of
Ropivacaine
Hydrochloride Injection solutions range from 1.00 to 1.01 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 affected nerve
fibe