Dosing & Uses
Dosage Forms & Strengths
surgical implant
- 100mg/implant
- Each single-dose package (pouch) contains 3 implants totaling 300 mg
Postsurgical Analgesia
Indicated for management of postsurgical pain after open inguinal hernia surgery
Single dose of 300 mg (3 x 100-mg implants)
Doses >300 mg not studied in clinical trials
Dosage Modifications
Renal impairment
- Bupivacaine is substantially excreted by the kidneys
- Consider increased monitoring for local anesthetic systemic toxicity
Hepatic impairment
- Amide-type local anesthetics (eg, bupivacaine) are metabolized by the liver
- Moderate-to-severe: Consider increased monitoring for local anesthetic systemic toxicity
Dosing Considerations
Safety and efficacy not established in other surgical procedures (eg, orthopedic and boney procedures)
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (16)
- benzocaine
benzocaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- benzydamine
benzydamine, bupivacaine implant. Either increases effects of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- bupivacaine
bupivacaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
bupivacaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - bupivacaine liposome
bupivacaine liposome, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
bupivacaine liposome, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - chloroprocaine
chloroprocaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
chloroprocaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - cocaine
cocaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- dibucaine topical ointment
dibucaine topical ointment, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- lidocaine anesthetic
lidocaine anesthetic, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
lidocaine anesthetic, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - lidocaine rectal
lidocaine rectal, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- lidocaine topical
lidocaine topical, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- lidocaine transdermal
lidocaine transdermal, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- mepivacaine
mepivacaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
mepivacaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - phenol oropharyngeal
phenol oropharyngeal, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- prilocaine
prilocaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
- ropivacaine
ropivacaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
ropivacaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia. - tetracaine
tetracaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.
Monitor Closely (59)
- acetaminophen
acetaminophen, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- amobarbital
amobarbital, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- amyl nitrite
amyl nitrite, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- artemether
artemether, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- artemether/lumefantrine
artemether/lumefantrine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- artesunate
artesunate, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- atovaquone
atovaquone, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- benzocaine
benzocaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- benzydamine
benzydamine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- chloroquine
chloroquine, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- cocaine
cocaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- cyclophosphamide
cyclophosphamide, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- dapsone
dapsone, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- dibucaine topical ointment
dibucaine topical ointment, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- flutamide
flutamide, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- hydroxyurea
hydroxyurea, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- ifosfamide
ifosfamide, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- isosorbide dinitrate
isosorbide dinitrate, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- isosorbide mononitrate
isosorbide mononitrate, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- lidocaine rectal
lidocaine rectal, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- lidocaine topical
lidocaine topical, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- lidocaine transdermal
lidocaine transdermal, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- mefloquine
mefloquine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- methohexital
methohexital, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- metoclopramide
metoclopramide, bupivacaine implant. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitric oxide gas
nitric oxide gas, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitrofurantoin
nitrofurantoin, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin IV
nitroglycerin IV, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin PO
nitroglycerin PO, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin sublingual
nitroglycerin sublingual, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin topical
nitroglycerin topical, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin transdermal
nitroglycerin transdermal, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin translingual
nitroglycerin translingual, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroglycerin transmucosal
nitroglycerin transmucosal, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitroprusside sodium
nitroprusside sodium, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- nitrous oxide
nitrous oxide, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- pentaerythritol tetranitrate
pentaerythritol tetranitrate, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- pentobarbital
pentobarbital, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- phenelzine
phenelzine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- phenobarbital
phenobarbital, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- phenol oropharyngeal
phenol oropharyngeal, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- prilocaine
prilocaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- primaquine
primaquine, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- primidone
primidone, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- proguanil
proguanil, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- pyrimethamine
pyrimethamine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- pyrimethamine/sulfadoxine
pyrimethamine/sulfadoxine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- quinidine
quinidine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- quinine
quinine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- rasburicase
rasburicase, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- riluzole
riluzole, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- secobarbital
secobarbital, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- sulfadiazine
sulfadiazine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- sulfasalazine
sulfasalazine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- sulfisoxazole
sulfisoxazole, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- tafenoquine
tafenoquine, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- tetracaine
tetracaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
- trazodone
trazodone, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.
Minor (0)
Adverse Effects
>10%
Incision site swelling (14.6%)
1-10%
Dysgeusia (7.5%)
Postprocedural discharge (4.9%)
Headache (4.1%)
Tremor (3.6%)
Blurred vision (3.6%)
Seroma (2.9%)
Scrotal swelling (2.9%)
Pyrexia (2.4%)
Oral hypoesthesia (2.2%)
Postmarketing Reports
Nervous system disorders: Restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, pupillary constriction
Neurological effects following routes of administration other than epidural or caudal have included persistent anesthesia, paresthesia, weakness, and paralysis, all with slow, incomplete, or no recovery
Cardiovascular (high doses): Myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest
Immune system disorders: Urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and severe hypotension; cross-sensitivity among members of amide-type local anesthetic group reported
Warnings
Contraindications
Hypersensitivity to any amide-type local anesthetic or any component of the implant
Obstetrical paracervical block anesthesia; use of bupivacaine in this technique has resulted in fetal bradycardia and death
Cautions
Caution with hepatic impairment; amide local anesthetics are metabolized by the liver; monitor for systemic toxicity with moderate-to-severe liver impairment
Patients with impaired cardiovascular function (eg, hypotension, heart block) may be less able to compensate for functional changes associated with prolonged atrioventricular conduction produced by bupivacaine; monitor blood pressure, heart rate, and ECG
Safety and efficacy in surgical procedures other than open inguinal hernia repair are not established; not approved for other surgical procedures (eg, orthopedic procedures); a study evaluating osteotomy in rats demonstrated inhibition of bone healing
Methemoglobinemia
- Local anesthetics may cause methemoglobinemia; signs may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood; immediate treatment is required to avert more serious CNS and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death
- Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are at higher risk; if local anesthetics must be used in these patients, monitor closely for signs and symptoms
- Methemoglobin levels may continue to rise; initiate treatment immediately
- Depending on severity of signs and symptoms, patients may respond to supportive care, including oxygen therapy, hydration; a severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen
Dose-related toxicity
- Avoid additional local anesthetics within 96 hr after bupivacaine implant placement
- Monitor for neurological, cardiovascular, and respiratory symptoms related to local anesthetic systemic toxicity
- Early warning signs of CNS toxicity may include restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness
- Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to acidosis, cardiac arrest, and, possibly, death
- Consider surgically removing implant depending on clinical situation
Drug interaction overview
-
Local anesthetics
- Avoid additional local anesthetic administration within 96 hr after bupivacaine implant placement
- Toxic effects of local anesthetics are additive
- If additional local anesthetic administration cannot be avoided, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity
-
Drugs associated with methemoglobinemia
- Additive risk of methemoglobinemia if coadministered with other drugs that increase risk
- Local anesthetics may increase risk of methemoglobinemia
Pregnancy & Lactation
Pregnancy
Data are not available
Based on animal data, advise pregnant females of potential risks to fetus
Animal studies
- Embryofetal lethality was noted when bupivacaine was administered SC to pregnant rabbits during organogenesis at clinically relevant doses
- Decreased pup survival observed in a rat prenatal and postnatal developmental study (dosing from implantation through weaning) at dose level comparable to the daily maximum recommended human dose
Labor or delivery
- Local anesthetics rapidly cross the placenta
- Incidence and degree of toxicity depend on procedure performed, type and amount of drug used, and technique of drug administration
- Adverse reactions in parturient, fetus, and neonate can involve alterations of the CNS, peripheral vascular tone, and cardiac function
Lactation
Excreted in human milk
Data are not available on effects in breastfed infants or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Collagen-matrix implant that delivers bupivacaine to the surgical site
Local anesthetic; blocks generation and conduction of nerve impulses presumably by increasing the electrical excitation threshold in the nerve, slowing nerve impulse propagation, and reducing the rate of action potential rise
Absorption
Peak plasma time: 3 hr
Peak plasma concentration: 663 ng/mL
AUC: 19,493-20,368 hr⋅ngmL
Distribution
Protein bound: 95%
Crosses placenta by passive diffusion
Metabolism
Primarily in liver via conjugation with glucuronic acid
Metabolite: Pipecoloxylidine
Elimination
Half-life: 19 hr
Excretion: Primarily via kidneys (6% unchanged)
Administration
Compatibility
Administration of additional local anesthetics, including bupivacaine, into surgical site with implant has not been studied
Studies conducted demonstrated that commonly used surgical materials (nonabsorbable surgical suture, delayed absorbable surgical suture, and surgical mesh) are not affected by bupivacaine implant
Allow surgical site to dry before placing bupivacaine implants if topical antiseptic (eg, povidone iodine) applied
Implant Preparation
Administered by or under supervision of experienced clinicians versed in the diagnosis and management of dose-related toxicity and other acute emergencies arising from bupivacaine exposure
Local anesthetic effects are additive; avoid additional local anesthetic administration within 96 hr after implantation; if additional local anesthetic administration cannot be avoided based on clinical need, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity
Immediate availability of oxygen, other resuscitative drugs, CPR equipment, and personnel needed for proper management of toxic reactions and related emergencies
Inspect outer pouch and inner blister before use; do not use if packaging compromised
Aseptically peel open package to remove the 3 inner blister packages containing the implant; to avoid cutting implants before placement, do not open the blister packaging using scissors or a scalpel
Carefully remove from inner blister packages and inspect each implant before use
Implant is white to off-white in color, has uniform thickness, and is ~5-cm x 5-cm x 0.5-cm in size
Do not use if implant appears discolored, contains foreign particulates, or is collapsed, compressed, or misshapen
Avoid excessive handling and compression
Using aseptic technique, cut each implant in half before placement into the surgical site
Implant Administration
Place halved implants into the surgical site dry; avoid contact of implant with liquids before placement; premoistening may result in premature release of bupivacaine from implant
Place 3 halves below site of mesh placement and 3 halves just below the skin closure
Implant may become difficult to move once placed in surgical site and moistened; use care when moving implant after placement
Storage
Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)
Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized
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- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
