SENSORCAINE 5 mg/mL
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
SENSORCAINE is a injection, solution containing bupivacaine hydrochloride and epinephrine bitartrate at 5 mg/mL, taken perineural. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- SENSORCAINE
- Generic Name
- BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
- NDC Code (Product)
63323-463- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERINEURAL
- Marketing Status
- Application #
- ANDA070968
- Marketing Start
- 11/19/2010
Recall History
Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Fresenius Kabi USA, LLC
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Fresenius Kabi USA, LLC
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Fresenius Kabi USA, LLC
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE 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: Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine. Table1.jpg
Dosage & Administration
DOSAGE & ADMINISTRATION The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Sensorcaine should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. For specific techniques and procedures, refer to standard textbooks. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Sensorcaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION). In recommended doses, Sensorcaine (bupivacaine HCl) produces complete sensory block, but the effect on mot…
Warnings
WARNINGS Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Sensorcaine and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydratio…
Contraindications
CONTRAINDICATIONS Sensorcaine (bupivacaine HCl) is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. Sensorcaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of bupivacaine solutions.
Adverse Reactions
ADVERSE REACTIONS Reactions to Sensorcaine (bupivacaine HCl) are characteristic of those associated with other amide- type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose related and due to high plasma levels which may result from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea (“Total or High Spinal”). Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the mot…
Frequently Asked Questions
What is SENSORCAINE used for?
SENSORCAINE contains BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE. It is a injection, solution taken perineural. Consult your doctor for specific uses.
Is SENSORCAINE a controlled substance?
SENSORCAINE is not classified as a controlled substance by the DEA.
What is the generic name for SENSORCAINE?
The generic name for SENSORCAINE is BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE. There are 10 other brand versions of BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE.
What is the NDC code for SENSORCAINE 5 mg/mL?
The NDC (National Drug Code) for SENSORCAINE 5 mg/mL is 63323-463, listed by Fresenius Kabi USA, LLC.
Other SENSORCAINE Dosages
Other Bupivacaine Brands
See all →- Marcaine with Epinephrine5 mg/mL0409-1749
- SENSORCAINE MPF5 mg/mL63323-462
- Marcaine5 mg/mL0362-0557
- Marcaine with Epinephrine5 mg/mL0409-1755
- SENSORCAINE MPF2.5 mg/mL63323-468
- Vivacaine5 mg/mL0362-9011
- SENSORCAINE MPF7.5 mg/mL63323-460
- MARCAINE WITH EPINEPHRINE2.5 mg/mL0404-9908
- Marcaine with Epinephrine2.5 mg/mL0409-1746
- Marcaine with Epinephrine2.5 mg/mL0409-1752
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)