Bupivacaine Hydrochloride In Dextrose
Generic Name: bupivacaine hydrochloride in dextrose
Brand Names:
Marcaine Spinal
11 DESCRIPTION MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent.
Overview
11 DESCRIPTION MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent.
Uses
1 INDICATIONS AND USAGE MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). MARCAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The dosage of MARCAINE SPINAL administered varies with the anesthetic procedure, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Administer the smallest dosage and concentration required to produce the desired result. The following are general dosage guidelines: • MARCAINE SPINAL 6 mg is generally adequate for vaginal delivery. ( 2.2 ) • MARCAINE SPINAL 7.5 mg is generally adequate for spinal anesthesia for lower extremity and perineal procedures. ( 2.2 ) • MARCAINE SPINAL 12 mg is generally adequate for lower abdominal procedures.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in other sections of the labeling: • Allergic-Type Reactions [see Contraindications (4) ] • Dose-Related Toxicity [see Warnings and Precautions (5.3) ] • Systemic Toxicities with Unintended Intravascular Injection [see Warnings and Precautions (5.4) ] • Methemoglobinemia [see Warnings and Precautions (5.5) ] • Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.6) ] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.7) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.8) ] The following adverse reactions from voluntary reports or clinical studies have been reported with...
Interactions
7 DRUG INTERACTIONS • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. ( 7.1 ) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. ( 7.2 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive.
Warnings
5 WARNINGS AND PRECAUTIONS • Use of Spinal Anesthetics During Uterine Contractions : Spinal anesthetics, including MARCAINE SPINAL, should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. ( 5.1 ) • Patients with Hypertension : Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension. Monitor blood pressure frequently. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia frequently. 4 CONTRAINDICATIONS MARCAINE SPINAL is contraindicated in: • intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8) ] . • patients with septicemia. • patients with severe hemorrhage, severe hypotension or shock, due to a reduced cardiac output. • patients with clinically significant arrhythmias, such as complete heartblock, due a reduced cardiac output.
Pregnancy
8.1 Pregnancy Risk Summary The available data on the use of MARCAINE SPINAL in pregnant women do not establish the presence or absence of developmental toxicity related to the use of MARCAINE SPINAL. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning).
Storage
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.] MARCAINE SPINAL solution may be autoclaved once 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 contains particulate matter.
Frequently Asked Questions
What is Bupivacaine Hydrochloride In Dextrose used for?▼
1 INDICATIONS AND USAGE MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). MARCAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). ( 1 )
What are the side effects of Bupivacaine Hydrochloride In Dextrose?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in other sections of the labeling: • Allergic-Type Reactions [see Contraindications (4) ] • Dose-Related Toxicity [see Warnings and Precautions (5.3) ] • Systemic Toxicities with Unintended Intravascular Injection [see Warnings and Precautions (5.4) ] • Methemoglobinemia [see Warnings and Precautions (5.5) ] • Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.6) ] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.7) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.8) ] The following adverse reactions from voluntary reports or clinical studies have been reported with...
Can I take Bupivacaine Hydrochloride In Dextrose during pregnancy?▼
8.1 Pregnancy Risk Summary The available data on the use of MARCAINE SPINAL in pregnant women do not establish the presence or absence of developmental toxicity related to the use of MARCAINE SPINAL. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning).
What are the important warnings for Bupivacaine Hydrochloride In Dextrose?▼
5 WARNINGS AND PRECAUTIONS • Use of Spinal Anesthetics During Uterine Contractions : Spinal anesthetics, including MARCAINE SPINAL, should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. ( 5.1 ) • Patients with Hypertension : Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension. Monitor blood pressure frequently. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia frequently. 4 CONTRAINDICATIONS MARCAINE SPINAL is contraindicated in: • intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8) ] . • patients with septicemia. • patients with severe hemorrhage, severe hypotension or shock, due to a reduced cardiac output. • patients with clinically significant arrhythmias, such as complete heartblock, due a reduced cardiac output.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.