Bupivacaine Hci Injection, Solution
Product Images NDC 51662-1581

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Bupivacaine Hci (NDC 51662-1581). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Boxed Warning (Boxed Warning)

The text describes a warning not to use a 0.75% concentration of bupivacaine hydrochloride for obstetrical anesthesia due to reports of cardiac arrest and death among obstetrical patients. The use of this concentration has resulted in resuscitation difficulties even in cases where adequate preparation and management were taken. The cardiac arrests have occurred after systemic toxicity resulting from unintentional intravascular injection. The 0.75% concentration should only be used for surgical procedures that require a high degree of muscle relaxation and prolonged effect.*

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Case Labeling (Case U)

This text describes a medication known as 0.25% Bupivacaine HCI Injection, USP. The medication is delivered via a 50mL vial with a concentration of 2.5mg/mL. The vial is designed for spinal anesthesia and infiltrations. It includes Bupivacaine Hydrochloride and can be adjusted with Sodium H. Dosage instructions must be followed from the package insert, and the medication should be stored within a certain temperature range. The medication is manufactured by a company in Mukilteo, WA 98275.*

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Dosage (Dosage)

The text provides a table displaying the recommended concentrations and doses of Bupivacaine Hydrochloride Injection for various procedures including local infiltration, epidural, caudal, peripheral nerves, Retrobulbar, and Sympathetic procedures. The table recommends different percentages for different procedures with varying doses to ensure a desired level of moderate to complete effectiveness. The Test Dose is also mentioned with the recommended amount of 10 to 15 micrograms of epinephrine.*

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Pouch (Pouch U)

This is a description of a bupivacaine HCI injection, with specifications on its concentration per mL and volume. It is sterile and non-pyrogenic, and contains 2.5mg of bupivacaine hydrochloride USP per mL, with methylparaben and sodium chloride as preservatives. The injection is intended for infiltration and nerve block, and not for caudal, epidural, or spinal anesthesia. The usual dosage and storage temperature are provided, but for more information, the user should refer to the manufacturer's package insert. The product was manufactured by HFAcquisitionCo., LLC in Mukilteo, WA.*

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Precautions (Precautions)

This text provides a list of drugs that are associated with a condition called Methemoglobinemia. It categorizes the entire list according to various drug classes like nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. The text enumerates examples of drugs associated with each class of drugs. Methemoglobinemia is a condition caused due to elevated levels of methemoglobin in an individual's blood, which reduces the blood's oxygen-carrying capacity.*

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Rfid Labeling (Rfid U)

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Structure (Structure)

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Vial (Vial)

A2 AUROME is a sterile and nonpyrogenic Bupivacaine HCI Injection in a 50 mL multiple dose vial manufactured in India by AuroMedics Pharma LLC. Each mL of this injection contains 2.5 mg bupivacaine hydrochloride USP, which is equivalent to 2.2 mg bupivacaine, with 1 mg methylparaben as preservative and sodium chloride to make isotonic in water for injection. It is not recommended for caudal, epidural, or spinal anesthesia. The normal dosage should refer to the package insert. The injection should be stored at a temperature between 20°C and 25°C (68°F to 77°F).*

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Warnings (Warning)

The 0.75% concentration of bupivacaine hydrochloride is not recommended for obstetrical anesthesia due to reports of cardiac arrest and death in obstetrical patients. The use of this concentration has resulted in difficult or impossible resuscitation despite adequate preparation and management. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, possibly due to unintentional intravascular injection. The 0.75% concentration should only be used for surgical procedures that require high muscle relaxation and prolonged effect.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.