NAROPIN- ropivacaine hydrochloride injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

APP Pharmaceuticals, LLC

INN (Nama Internasional):

ROPIVACAINE HYDROCHLORIDE

Komposisi:

ROPIVACAINE HYDROCHLORIDE 10 mg in 1 mL

Rute administrasi :

EPIDURAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Naropin 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 Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

Ringkasan produk:

Naropin ® Plastic Ampule Sterile-Pak: Boxes of 5 polypropylene ampules fitting both Luer-lock and Luer-slip (tapered syringes) Product No. NDC No. Strength Ampule Size 278510* 63323-285-10 2 mg/mL (0.2%) 10 mL 278520* 63323-285-20 2 mg/mL (0.2%) 20 mL 278620* 63323-286-20 5 mg/mL (0.5%) 20 mL 278720* 63323-287-20 7.5 mg/mL (0.75%) 20 mL 278810* 63323-288-10 10 mg/mL (1%) 10 mL 278820* 63323-288-20 10 mg/mL (1%) 20 mL *Product manufactured for APP Pharmaceuticals, LLC.   Product No. NDC No. Strength Size 278630 63323-286-30 5 mg/mL (0.5%) 30 mL single dose vial packaged individually. 278631 63323-286-31 5 mg/mL (0.5%) 30 mL single dose vials Sterile-Pak in boxes of 5. Naropin ® Single Dose Infusion Bottles Product No. NDC No. Strength Size 278565 63323-285-65 2 mg/mL (0.2%) 100 mL Infusion Bottle. 278564 63323-285-64 2 mg/mL (0.2%) 200 mL Infusion Bottle. The solubility of ropivacaine is limited at pH above 6.  Thus, care must be taken as precipitation may occur if Naropin 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.  When a container is required to have a sterile outside, a Sterile-Pak should be chosen.  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 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. 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. NAROPIN is a trademark of APP Pharmaceuticals, LLC.

Status otorisasi:

New Drug Application

Karakteristik produk

NAROPIN- ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
APP PHARMACEUTICALS, LLC
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NAROPIN® (ROPIVACAINE HCL) INJECTION
Rx only
DESCRIPTION
Naropin Injection contains ropivacaine HCl which is a member of the
amino amide class of local
anesthetics. Naropin 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 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.
Naropin 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 Injection 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 affected nerve fibers.
Clinically, the order of loss of nerve function is as follows: (1)
pain, (2) temperature, (