MARCAINE- bupivacaine hydrochloride injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO)

Beschikbaar vanaf:

Henry Schein, Inc.

Toedieningsweg:

EPIDURAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

MARCAINE / MARCAINE 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 MARCAINE / MARCAINE 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 MARCAINE / MARCAINE 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)]. MARCAINE / MARCAINE 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 MARCAINE / MARCAINE WITH EPINEPHRINE. 8.1 Pregnancy Risk Summary MARCAINE / MARCAINE WITH EPINEPHRINE is contraindicated for obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1)]. There are no available data on use of MARCAINE / MARCAINE WITH EPINEPHRINE in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. Decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (MRHD) on a body surface area (BSA) basis. Based on animal data, advise pregnant women of the potential risks to a fetus (see DATA). Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see CLINICAL PHARMACOLOGY (12.3)]. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the CNS, peripheral vascular tone, and cardiac function. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Maternal Adverse Reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. Labor or Delivery Epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. Epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. The use of obstetrical anesthesia may increase the need for forceps assistance. The use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. This has not been reported with bupivacaine. It is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. To do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. Data Animal Data Bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). The high doses are comparable to the daily MRHD of 400 mg/day on a mg/m2 BSA basis. No embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal No Observed Adverse Effect Level representing approximately 0.3 times the MRHD on a BSA basis. In a rat pre- and post-natal developmental study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg, decreased pup survival was observed at the high dose. The high dose is comparable to the daily MRHD of 400 mg/day on a BSA basis. 8.2 Lactation Risk Summary Lactation studies have not been conducted with bupivacaine. Bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. MARCAINE / MARCAINE WITH EPINEPHRINE should be administered to lactating women only if clearly indicated. Studies assessing the effects of MARCAINE / MARCAINE WITH EPINEPHRINE in breastfed children have not been performed. Studies to assess the effect of MARCAINE / MARCAINE WITH EPINEPHRINE on milk production or excretion have not been performed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. 8.4 Pediatric Use MARCAINE / MARCAINE WITH EPINEPHRINE is approved for use in adults. Administration of MARCAINE / MARCAINE WITH EPINEPHRINE in pediatric patients younger than 12 years is not recommended. Continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities. 8.5 Geriatric Use Patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with MARCAINE / MARCAINE WITH EPINEPHRINE. In clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. Differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see CLINICAL PHARMACOLOGY (12.3)]. This product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Elderly patients may require lower doses of MARCAINE / MARCAINE WITH EPINEPHRINE. 8.6 Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with MARCAINE / MARCAINE WITH EPINEPHRINE, especially with repeat doses [see WARNINGS AND PRECAUTIONS (5.10)]. 8.7 Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. This should be considered when selecting the MARCAINE / MARCAINE WITH EPINEPHRINE dosage [see USE IN SPECIFIC POPULATIONS (8.5)].

Product samenvatting:

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room Temperature.] MARCAINESolutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121 °C (250 °F) for 15 minutes. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion. MARCAINE with epinephrine 1:200,000 (as bitartrate)Do not autoclave solutions of MARCAINE that contain epinephrine and protect from light. This product is clear and colorless. Do not use the solution if it is discolored or if it contains a precipitate. For single-dose vials: Discard unused portion.

Autorisatie-status:

New Drug Application

Productkenmerken

MARCAINE- BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
HENRY SCHEIN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE HIGHLIGHTS DO NOT INCLUDE
ALL THE
INFORMATION NEEDED TO USE MARCAINE™ AND MARCAINE™ WITH EPINEPHRINE
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARCAINE™ AND
MARCAINE™ WITH
EPINEPHRINE. MARCAINE™ (BUPIVACAINE HYDROCHLORIDE) INJECTION, FOR
INFILTRATION, PERINEURAL,
CAUDAL, EPIDURAL, OR RETROBULBAR USE
MARCAINE™ WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND
EPINEPHRINE) INJECTION, FOR
INFILTRATION, PERINEURAL, CAUDAL, OR EPIDURAL USE
INITIAL U.S. APPROVAL: 1972
INDICATIONS AND USAGE
MARCAINE contains bupivacaine, an amide local anesthetic, and MARCAINE
WITH EPINEPHRINE is a
combination of bupivacaine, an amide local anesthetic, and
epinephrine, an alpha and beta-adrenergic
agonist. MARCAINE / MARCAINE 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. For each type
of block indicated to produce local
or regional anesthesia or analgesia, specific concentrations and
presentations are recommended. (1, 2.2)
(2)
Limitations of Use (2)
Not all blocks are indicated for use with MARCAINE / MARCAINE WITH
EPINEPHRINE given clinically
significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7,
5.9) (2)
DOSAGE AND ADMINISTRATION
Not for intrathecal use. (2.1)
Avoid use of solutions containing antimicrobial preservatives (i.e.,
multiple-dose vials) for epidural or
caudal anesthesia. (2.1, 5.4)
Three mL of MARCAINE WITH EPINEPHRINE without antimicrobial
preservative (0.5% bupivacaine with
1:200,000 epinephrine ) is recommended for use as a test dose prior to
caudal and lumbar epidural
blocks when clinical conditions permit. (2.4)
See full prescribing information for:
–
Recommended concentrations and dosages of MARCAINE / MARCAINE WITH
EPINEPHRINE acco