Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)
RX PHARMA-PACK, INC.
BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
PRESCRIPTION DRUG
MARCAINE 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 0.75% concentration of MARCAINE in these patients. MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and indicated MARCAINE concentrations are: - local infiltration - peripheral nerve block - retrobulbar block - sympathetic block - lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) - 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 administration of MAR
These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. 0.5% Contains 5 mg bupivacaine hydrochloride per mL. 0.75% Contains 7.5 mg bupivacaine hydrochloride per mL. MARCAINE with epinephrine 1:200,000 (as bitartrate)―Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. 0 .25% with epinephrine 1:200,000 —Contains 2.5 mg bupivacaine hydrochloride per mL. 0.5% with epinephrine 1:200,000—Contains 5 mg bupivacaine hydrochloride per mL. For single-dose vials: Discard unused portion. Distributed by Hospira, Inc ., Lake Forest, IL 60045 USA Revised: 11/2018 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per mL) NDC 63323-186-04 2 mL, fill, in a 3mL Single-Dose vial 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-10 10 mL Single-Dose vial 63323-186-20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com 45764E Revised: October 2018 Aerosol Can Pain Ease 3.9 fl. oz. in Medium Stream P/N 0386-0008-03 Pain Ease 1.0 fl. oz. in Medium Stream P/N 0386-0008-04 Pain Ease 3.9 fl. oz. in Mist P/N 0386-0008-02 Pain Ease 1.0 fl. oz. in Mist P/N 0386-0008-01 Manufactured by: Gebauer Company Cleveland, OH 44128 1-800-321-9348 www.Gebauer.com ©2018 Gebauer Company
New Drug Application
P-CARE MG- BUPIVACAINE HYDROCHLORIDE, SODIUM CHLORIDE, POVIDONE-IODINE, ISOPROPYL ALCOHOL RX PHARMA-PACK, INC. ---------- P-CARE MG MARCAINE - BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION MARCAINE Bupivacaine Hydrochloride Injection, USP MARCAINE With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride and Epinephrine Injection, USP HOSPIRA, INC. Rx only DESCRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-_N_-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: MARCAINE STRUCTURAL FORMULA Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: EPINEPHRINE STRUCTURAL FORMULA MARCAINE is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of MARCAINE may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless. 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. _MARCAINE_—Sterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL TM TM also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4 and 6.5 with sodium hydroxide or hydrochloric acid. _MARCAINE with epinephrine 1:200,000 _(as bitartrate)—Sterile isotonic solutions containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabis Lesen Sie das vollständige Dokument