Name: MLP A-1
MLP A-1 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:
Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following 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.
MARCAINESterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL 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 metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.
Indications and Usage for MLP A-1
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||0.25%|
|• peripheral nerve block||0.25% and 0.5%|
|• retrobulbar block||0.75%|
|• sympathetic block||0.25%|
|• lumbar epidural||0.25%, 0.5%, and 0.75% |
(0.75% not for obstetrical anesthesia)
|• caudal||0.25% and 0.5%|
|• epidural test dose||0.5% with epinephrine 1:200,000|
|• dental blocks||0.5% with epinephrine 1:200,000|
(See DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.
MARCAINE 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 MARCAINE solutions.
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
Plastic Multiple-dose Fliptop Vial
Glass Teartop Vial
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intramuscular or Intra-articular Use Only
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE
antiseptic skin preparation
Principal Display Panel - MLP A-1 Kit
2 Kenalog-40® Single Dose Vial (1mL)
1 Marcaine® 0.5% Single Dose Vial (5mg/mL) (10mL)
1 Lidocaine HCl Injection, USP 2% Single Dose Ampule (20mg/mL) (2mL)
1 Sterile Povidone-Iodine Swabsticks (3 Swabs)
1 Pair Nitrile Powder Free Sterile Gloves (Size 7.5)
1 Sterile Towel Drape
1 Fenestrated Sterile Towel Drape
1 Sterile Adhesive Bandage
1 Pack of Sterile 4x4 Gauze (2 Gauzes)
Needles and Syringes Not Included
DANEX INTERNATIONAL LLC
SPRING, TXl 77388
HAUPPAUGE, NY 11788
Kenalog-40® † (Bristol-Myers Squibb)*
Triamcinolone Acetonide Injectable Suspension, USP
Each mL Provides 40 mg triamcinolone acetonide with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol added as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension; sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0-7.5.
Marcaine® ‡ 0.5% (5mg/mL) (Hospira, Inc.)*
Each mL contains 5mg bupivacaine HCl, with NaCl to make isotonic, in Water for Injection. pH adjusted with NaOH or HCl.
Lidocaine HCl Injection, USP 2% (20mg/mL) (Hospira, Inc.)*
Each mL contains lidocaine hydrochloride, anhydrous 20mg; sodium chloride 6mg. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.5 (5.0 to 7.0). 0.31 mOsmol/mL (calc).
Sterile Povidone-lodine Swabsticks (Aplicare)*
Nitrile Powder Free Sterile Gloves (Dynarex) Size 7.5*
Sterile Towel Drape (Dynarex)*
Fenestrated Sterile Towel Drape (Dynarex)*
Sterile Adhesive Bandage (Dynarex)*
Sterile 4x4 Gauze (Dynarex)*
† Kenalog® (registered trademark of Bristol-Myers Squibb)
‡ Marcaine® (registered trademark of Hospira, Inc.)
* Internal package components remain sterile as long as items are unopened and undamaged
WARNING: KEEP THIS AND ALL MEDICATION OUT
OF THE REACH OF CHILDREN. IN CASE OF
ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL
ASSISTANCE OR CONTACT A POISON CONTROL
PROTECT FROM LIGHT I AVOID FREEZING
STORE AT CONTROLLED ROOM TEMPERATURE
20º-25ºC (68º-77º F) [SEE USP CONTROLLED
DO NOT REFRIGERATE.
Directions for Use: See enclosed inserts.
|MLP A-1 |
bupivacaine hydrochloride, lidocaine hydrochloride, triamcinolone acetonide, and povidone-iodine kit
|Labeler - RX PHARMA-PACK, INC. (962149634)|
|RX PHARMA-PACK, INC.||962149634||PACK(49836-740)|