Bupivacaine hydrochloride 0.5%, dextrose 8%.
Bupivacaine Hydrochloride in 8% Dextrose 5 mg/mL Solution for Spinal Injection is a sterile, non-pyrogenic solution of Bupivacaine Hydrochloride and Dextrose (as Monohydrate) in Water for Injection. It contains no preservative. The solution is clear and colorless.
Each mL contains 5 mg of Bupivacaine Hydrochloride and 80 mg of Dextrose (as Monohydrate).
It is indicated for the production of local or regional anesthesia or analgesia for surgical procedures, for diagnostic and therapeutic, and for obstetrical procedures.
See Table 1.
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Treatment of a patient with toxic manifestations consists of ensuring adequate ventilation and arresting convulsions. Ventilation should be maintained with supplemental oxygen, by assisted or controlled respiration, if necessary. Assessment of circulation immediately should follow and support given when necessary. Convulsions may be aborted by administration of drugs such as succinylcholine, diazepam or thiopental. If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation must be instituted.
Bupivacaine HCl is contraindicated in obstetrical paracervical block anesthesia. Its use by technique has resulted in fetal bradycardia and death. It is contraindicated in patients who have known sensitivity to it or to any local anesthesia of amide-type. The use of bupivacaine is contraindicated in children under the age of 12 years and should be used with caution in debilitated, elderly, or acutely ill patients. It is not also recommended for intravenous regional anesthesia.
Local anesthetics should be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and personnel resources needed for proper management of toxic reaction and related emergencies. Delay in the proper management of dose-related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and possibly death.
Use During Pregnancy: Bupivacaine easily crosses the placenta and should be used with caution during pregnancy. Excessive dose can result in high fetal blood concentration and fetal depression.
The most commonly encountered acute adverse reactions which demand immediate counter-measures are related to the central nervous system and the cardiovascular system. These are generally dose-related and due to high plasma levels which may result from the injection site, diminished tolerance or from unintentional intravascular injection of the local anesthetic solution. (See Table 2.)
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Drugs that have interactions with bupivacaine includes: Beta-adrenergic blockers: May enhanced sympathomimetic effects when used with bupivacaine.
Chloroprocaine: May lessen bupivacaine's action with Chloroprocaine.
Cyclic antidepressants and MAOIs: Can cause severe sustained hypertension when used with bupivacaine.
Enflurane, halothane, Isoflurane and related drugs: It can cause arrhythmias when used with bupivacine.
Stores at temperatures not exceeding 30°C.
N01BB51 - bupivacaine, combinations ; Belongs to the class of amides. Used as local anesthetics.
Euro-Med 0.5% Bupivacaine Hydrochloride in 8% Dextrose soln for inj
4 mL x 10 × 1's (P550.48/ampoule)
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