SENSORCAINE Solution for injection Ref.[27442] Active ingredients: Bupivacaine

Source: FDA, National Drug Code (US) Revision Year: 2020

Product 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_a 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-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 preservative. The pH of these solutions is adjusted to between 4.0 and 6.5 with sodium hydroxide and/or hydrochloric acid.

Sensorcaine-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 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).

How Supplied

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.

Drugs

Drug	Countries
SENSORCAINE	Canada, United States

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