Bupivacaine Hydrochloride

2 DOSAGE AND ADMINISTRATION 2.1 Important Dosage and Administration Information Visually inspect this product for particulate matter and discoloration prior to administration. Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter. Mixing or the prior or intercurrent use of any other local anesthetic with Bupivacaine Hydrochloride in Dextrose Injection, USP is not recommended because of insufficient data on the clinical use of such mixtures. Discard unused portions of Bupivacaine Hydrochloride in Dextrose Injection, USP following initial use. Administration Precautions Bupivacaine Hydrochloride in Dextrose Injection, USP is to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed. Use Bupivacaine Hydrochloride in Dextrose Injection, USP only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [ see Warnings and Precautions (5.3) , Adverse Reactions (6) , Overdosage (10) ]. The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with Bupivacaine Hydrochloride in Dextrose Injection, USP [ see Warnings and Precautions (5.3) , Drug Interactions (7.1) , Overdosage (10) ]. Aspirate for blood and cerebrospinal fluid prior to injecting Bupivacaine Hydrochloride in Dextrose Injection, USP, for both the initial dose and all subsequent doses (where applicable), to avoid intravascular injection and to confirm entry into the subarachnoid space. Aspiration of cerebrospinal fluid into a Bupivacaine Hydrochloride in Dextrose Injection, USP-filled syringe will result in an identifiable swirl in the solution. A negative aspiration for blood does not ensure against an intravascular injection [ see Warnings and Precautions (5.4) ]. Avoid rapid injection of Bupivacaine Hydrochloride in Dextrose Injection, USP. The patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of Bupivacaine Hydrochloride in Dextrose Injection, USP that results in effective spinal anesthesia should be used to avoid a high motor block and serious adverse reactions. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness during spinal anesthesia. Conditions Which May Preclude Use of Spinal Anesthesia The following conditions may preclude the use of spinal anesthesia, depending upon the physician’s evaluation of the patient: Pre-existing diseases of the central nervous system (CNS), such as those attributable to pernicious anemia, poliomyelitis, syphilis, or tumor. Hematological disorders predisposing to coagulopathies or patients on anticoagulant therapy. Trauma to a blood vessel during the conduct of spinal anesthesia may, in some instances, result in uncontrollable CNS hemorrhage, soft tissue hemorrhage, or development of a hematoma. Chronic backache and preoperative headache. Hypotension and hypertension. Technical problems (persistent paresthesias, persistent bloody tap). Arthritis or spinal deformity. Extremes of age. Psychosis, dementia, or other illnesses resulting in poor patient cooperation. 2.2 Recommended Dosages of Bupivacaine Hydrochloride in Dextrose Injection, USP The dosage of Bupivacaine Hydrochloride in Dextrose Injection, USP 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 extent and degree of spinal anesthesia depend upon several factors including dosage, baricity of the anesthetic solution, volume of solution, force of injection, level of puncture, and position of the patient during and immediately after injection. In recommended doses, Bupivacaine Hydrochloride in Dextrose Injection, USP produces complete motor and sensory block. The following table summarizes general dosage guidelines for adult patients for the procedures described: PROCEDURES DOSAGE GUIDELINES Vaginal Delivery Starting dose, 6 mg (0.8 mL) Lower Extremity and Perineal Procedures, such as: transurethral resection of the prostate (TURP) vaginal hysterectomy 7.5 mg (1 mL) Lower Abdominal Procedures, such as: abdominal hysterectomy tubal ligation appendectomy 12 mg (1.6 mL) Cesarean Section 7.5 mg to 10.5 mg (1 mL to 1.4 mL)

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1 INDICATIONS AND USAGE Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).