SENSORCAINE- bupivacaine hydrochloride injection, solution SENSORCAINE MPF- bupivacaine hydrochloride and epinephrine bitartrat

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

Composition:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS ). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS ). The routes of administration and indicated Sensorcaine concentrations are: - local infiltration - peripheral nerve block - retrobulbar block - sympathetic block - lumbar epidural - caudal - epidural test dose - dental blocks (See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the admini

Product summary:

These solutions are not for spinal anesthesia. Sensorcaine-MPF (methylparaben free) is available in the following forms: With Epinephrine: Product Code Unit of Sale Strength Each 460837 NDC 63323-468-37 Trays of 25 75 mg per 30 mL (2.5 mg per mL) 0.25% NDC 63323-468-02 30 mL Single-dose Vial 460817 NDC 63323-468-17 Trays of 25 25 mg per 10 mL (2.5 mg per mL) 0.25% NDC 63323-468-01 10 mL Single-dose Vial 460217 NDC 63323-462-17 Trays of 25 50 mg per 10 mL (5 mg per mL) 0.5% NDC 63323-462-04 10 mL Single-dose Vial 460237 NDC 63323-462-37 Trays of 25 150 mg per 30 mL (5 mg per mL) 0.5% NDC 63323-462-01 30 mL Single-dose Vial 460231 NDC 63323-462-31 Packaged in 5 150 mg per 30 mL (5 mg per mL) 0.5% NDC 63323-462-02 30 mL Single-dose Vial 461037 NDC 63323-460-37 Trays of 25 225 mg per 30 mL (7.5 mg per mL) 0.75% NDC 63323-460-01 30 mL Single-dose Vial Without Epinephrine: Product Code Unit of Sale Strength Each 460417 NDC 63323-464-17 Trays of 25 25 mg per 10 mL (2.5 mg per mL) 0.25% NDC 63323-464-01 10 mL Single-dose Vial 460437 NDC 63323-464-37 Trays of 25 75 mg per 30 mL (2.5 mg per mL) 0.25% NDC 63323-464-02 30 mL Single-dose Vial 460431 NDC 63323-464-31 Packaged in 5 75 mg per 30 mL (2.5 mg per mL) 0.25% NDC 63323-464-03 30 mL Single-dose Vial 460617 NDC 63323-466-17 Trays of 25 50 mg per 10 mL 5 mg per mL) 0.5% NDC 63323-466-03 10 mL Single-dose Vial 460637 NDC 63323-466-37 Trays of 25 150 mg per 30 mL (5 mg per mL) 0.5% NDC 63323-466-01 30 mL Single-dose Vial 460631 NDC 63323-466-31 Packaged in 5 150 mg per 30 mL (5 mg per mL) 0.5% NDC 63323-466-02 30 mL Single-dose Vial 470217 NDC 63323-472-17 Trays of 25 75 mg per 10 mL (7.5 mg per mL) 0.75% NDC 63323-472-03 10 mL Single-dose Vial 470237 NDC 63323-472-37 Trays of 25 225 mg per 30 mL (7.5 mg per mL) 0.75% NDC 63323-472-01 30 mL Single-dose Vial Sensorcaine (preserved with methylparaben) is available in the following forms: With Epinephrine: Product Code Unit of Sale Strength Each 460157 NDC 63323-461-57 Trays of 25 125 mg per 50 mL (2.5 mg per mL) 0.25% NDC 63323-461-01 50 mL Multiple-dose Vial 460357 NDC 63323-463-57 Trays of 25 250 mg per 50 mL (5 mg per mL) 0.5% NDC 63323-463-01 50 mL Multiple-dose Vial Without Epinephrine: Product Code Unit of Sale Strength Each 460557 NDC 63323-465-57 Trays of 25 125 mg per 50 mL (2.5 mg per mL) 0.25% NDC 63323-465-01 50 mL Multiple-dose Vial 460757 NDC 63323-467-57 Trays of 25 250 mg per 50 mL (5 mg per mL) 0.5% NDC 63323-467-01 50 mL Multiple-dose Vial For single dose vials: Discard unused portion. Solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Solutions containing epinephrine should be protected from light. The injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate. All trademarks are the property of Fresenius Kabi.

Authorization status:

New Drug Application

Summary of Product characteristics

SENSORCAINE - BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
SENSORCAINE MPF - BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
SENSORCAINE ® (BUPIVACAINE HCL INJECTION, USP)
SENSORCAINE ® -MPF (BUPIVACAINE HCL INJECTION, USP)
SENSORCAINE ® WITH EPINEPHRINE (BUPIVACAINE HCL AND EPINEPHRINE
INJECTION, USP) 1:200,000 (AS
BITARTRATE)
SENSORCAINE ® -MPF WITH EPINEPHRINE (BUPIVACAINE HCL AND EPINEPHRINE
INJECTION, USP)
1:200,000 (AS BITARTRATE)
Rx only
DESCRIPTION
Sensorcaine
(bupivacaine HCl) injections are sterile isotonic solutions that
contain a local anesthetic
agent with and without epinephrine (as bitartrate) 1:200,000 and are
administered parenterally by
injection. See INDICATIONS AND USAGE for specific uses. Solutions of
bupivacaine HCl may be
autoclaved if they do not contain epinephrine.
Sensorcaine injections contain bupivacaine HCl which is chemically
designated as 2-
piperidinecarboxamide, 1-butyl- _N_-(2,6-dimethylphenyl)-,
monohydrochloride, monohydrate and has the
following structure:
Epinephrine is (-)-3,4-Dihydroxy-α [(methylamino)methyl] benzyl
alcohol. It has the following
structural formula:
The pK
of bupivacaine (8.1) is similar to that of lidocaine (7.86). However,
bupivacaine possesses a
greater degree of lipid solubility and is protein bound to a greater
extent than lidocaine.
®
a
Bupivacaine is related chemically and pharmacologically to the
aminoacyl local anesthetics. It is a
homologue of mepivacaine and is chemically related to lidocaine. All
three of these anesthetics contain
an amide linkage between the aromatic nucleus and the amino, or
piperidine group. They differ in this
respect from the procaine-type local anesthetics, which have an ester
linkage.
DOSAGE FORMS LISTED AS SENSORCAINE-MPF INDICATES S INGLE DOSE
SOLUTIONS THAT ARE METHYL
PARABEN FREE (MPF).
Sensorcaine-MPF is a sterile isotonic solution containing sodium
chloride. Sensorcaine in multiple
dose vials, each mL also contains 1 mg methylparaben as antiseptic
pr