MARBETA 25 KIT- betamethasone sodium phosphate and betamethasone acetate, bupivacaine hydrochloride, povidine iodine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE SODIUM PHOSPHATE (UNII: 7BK02SCL3W) (BETAMETHASONE - UNII:9842X06Q6M), BETAMETHASONE ACETATE (UNII: TI05AO53L7) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Asclemed USA, Inc.

INN (International Name):

Betamethasone Sodium Phosphate

Composition:

Betamethasone 3 mg in 1 mL

Administration route:

INTRA-ARTICULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupivacaine Hydrochloride Injection 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 Bupivacaine Hydrochloride Injection 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 Bupivacaine Hydrochloride Injection 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)] . Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is contraindicated

Product summary:

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.] Bupivacaine Hydrochloride Injection, USP ─ Solutions of bupivacaine hydrochloride 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. NDC 0517-0720-01: Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, 5 mL multiple dose vial; box of one. Inactive ingredients per mL: 7.1 mg dibasic sodium phosphate anhydrous; 3.4 mg monobasic sodium phosphate monohydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative. SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx only AMERICAN REGENT, INC. SHIRLEY, NY 11967 Revised July 2018

Authorization status:

unapproved drug other

Summary of Product characteristics

MARBETA 25 KIT- BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE
ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPIVACAINE
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BUPIVACAINE HYDROCHLORIDE INJECTION.
BUPIVACAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION, PERINEURAL,
CAUDAL, EPIDURAL, OR
RETROBULBAR USE
INITIAL U.S. APPROVAL: 1972
WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE
INJECTION IN OBSTETRICAL ANESTHESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION
OR DEATH DURING
USE OF BUPIVACAINE HYDROCHLORIDE INJECTION FOR EPIDURAL ANESTHESIA IN
OBSTETRICAL
PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% (7.5
MG/ML) CONCENTRATION.
RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY
ADEQUATE
PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED
AFTER
CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING
UNINTENTIONAL
INTRAVASCULAR INJECTION. THE 0.75% (7.5 MG/ML) CONCENTRATION OF
BUPIVACAINE
HYDROCHLORIDE INJECTION IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA
AND SHOULD BE
RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE
RELAXATION AND
PROLONGED EFFECT ARE NECESSARY ( 5.1).
INDICATIONS AND USAGE
Bupivacaine Hydrochloride Injection contains bupivacaine, an amide
local anesthetic. Bupivacaine
Hydrochloride Injection 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