"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(bupivacaine hydrochloride) Injection
SENSORCAINE MPF WITH EPINEPHRINE
(bupivacaine hydrochloride and epinephrine) Injection
(bupivacaine hydrochloride) Injection
Sensorcaine (bupivacaine hci injections) ® (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 (bupivacaine hci injections) 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 pKa 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.
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 (bupivacaine hci injections) -MPF indicates single dose solutions that are Methyl Paraben Free (MPF).
Sensorcaine (bupivacaine hci injections) -MPF is a sterile isotonic solution containing sodium chloride. Sensorcaine (bupivacaine hci injections) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/ or hydrochloric acid.
Sensorcaine (bupivacaine hci injections) -MPF with Epinephrine 1:200,000 (as bitartrate) is a sterile isotonic solution containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer. Sensorcaine (bupivacaine hci injections) with Epinephrine 1:200,000 (as bitartrate) in multiple dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.3 to 5.5 with sodium hydroxide and/ or hydrochloric acid. Filled under nitrogen.
Note: The user should have an appreciation and awareness of the formulations and their intended uses. (See DOSAGE AND ADMINISTRATION.)
What are the possible side effects of bupivacaine (Marcaine HCl, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have any of these serious side effects:
- feeling anxious, restless, confused, or like you might pass out;
- problems with speech or vision;
- ringing in the ears, metallic taste, numbness or tingling around your mouth, or...
Last reviewed on RxList: 5/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Sensorcaine Information
Report Problems to the Food and Drug Administration
Find out what women really need.