SENSORCAINE MPF 2.5 mg/mL
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
SENSORCAINE MPF is a injection, solution containing bupivacaine hydrochloride and epinephrine bitartrate at 2.5 mg/mL, taken epidural. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- SENSORCAINE MPF
- Generic Name
- BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
- NDC Code (Product)
63323-468- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 2.5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
- Marketing Status
- Application #
- ANDA070966
- Marketing Start
- 11/19/2010
Recall History
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
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
1 INDICATIONS AND USAGE SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults 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. Specific concentrations and presentations of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)]. Limitations of Use Not all blocks are indicated for use with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE given clinically significant risks associated with use [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1, 5.4, 5.5, 5.7, 5.9)]. SENSORCAINE contains bupivacaine, an amide local anesthetic, and SENSORCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Important Dosage and Administration Information SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is not for intrathecal use. Avoid use of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE solutions containing antimicrobial preservatives (i.e., multiple dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.4)]. Discard unused portions of solution not containing preservatives, i.e., those supplied in single dose vials, following initial use. Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. SENSORCAINE are clear, colorless solutions. Do not administer solutions which are discolored or contain particulate matter. SENSORCAINE WITH EPINEPHRINE are clear, colorless to slightly yellow solutions. Do not administer solutions which are pinkish or darker than slightly yellow or contain particulate matter. Mixing or the prior or intercurrent use of any other local anesthetic with SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions SENSORCAINE / SENSORCAINE WITH EPI…
Contraindications
4 CONTRAINDICATIONS SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7)]. patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE. Obstetrical paracervical block anesthesia. (4) Intravenous regional anesthesia (Bier Block). (4) Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE. (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with SENSORCAINE/ SENSORCAINE WITH EPINEPHRINE cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1), Warnings and Precautions (5.2)]. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of SENSORCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors, or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Warnings and Precautions (5.6)]. 7.3 Ergot-Type Oxytocic Drugs Concurrent administration of SENSORCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of SENSORCAINE WITH EPINEPHRINE concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions (5.6)]. 7.4 Nonselective Beta-Adrenergic Antagonists…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.1)] Dose-Related Toxicity [see Warnings and Precautions (5.2)] Methemoglobinemia [see Warnings and Precautions (5.3)] Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.5)] Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.6)] Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4), Warnings and Precautions (5.7)] Allergic-Type Reactions [see Warnings and Precautions (5.8)] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9)] Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15)] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not alw…
Frequently Asked Questions
What is SENSORCAINE MPF used for?
SENSORCAINE MPF contains BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE. It is a injection, solution taken epidural. Consult your doctor for specific uses.
Is SENSORCAINE MPF a controlled substance?
SENSORCAINE MPF is not classified as a controlled substance by the DEA.
What is the generic name for SENSORCAINE MPF?
The generic name for SENSORCAINE MPF is BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE. There are 9 other brand versions of BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE.
What is the NDC code for SENSORCAINE MPF 2.5 mg/mL?
The NDC (National Drug Code) for SENSORCAINE MPF 2.5 mg/mL is 63323-468, listed by Fresenius Kabi USA, LLC.
Other SENSORCAINE MPF Dosages
Other Bupivacaine Brands
See all →- Marcaine with Epinephrine5 mg/mL0409-1749
- SENSORCAINE2.5 mg/mL63323-461
- SENSORCAINE5 mg/mL63323-463
- Marcaine5 mg/mL0362-0557
- Marcaine with Epinephrine5 mg/mL0409-1755
- Vivacaine5 mg/mL0362-9011
- 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)