Indications for: POSIMIR
For administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.
Limitations of Use:
Safety and efficacy have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.
For single-dose administration only. Confirm correct placement of the needle tip by direct arthroscopic visualization prior to injecting. ≥18yrs: Inject 660mg (5mL) into subacromial space at the end of surgery.
<18yrs: not established.
Obstetrical paracervical block anesthesia.
Risk of potential adverse embolic effects resulting from inadvertent intravascular injection.
Not interchangeable with other forms of bupivacaine. To be administered in a setting where trained personnel and equipment are immediately available. Avoid epidural, intrathecal, intravascular, intra-articular, regional nerve blocks, pre-incisional or pre-procedural locoregional anesthetic techniques that require deep and complete sensory block in the area of administration. Risk of joint cartilage necrosis after unapproved intra-articular injection. Risk of systemic toxicities (including CNS or cardiorespiratory depression, coma) with unintended intravascular injection. Monitor cardiovascular and respiratory vital signs, and patient's state of consciousness after administration. Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor closely and discontinue any oxidizing agents. Cardiovascular dysfunction (eg, hypotension, heart block); consider dose reduction and monitor closely for BP, HR, and ECG changes. Debilitated, elderly, acutely ill, renal or moderate to severe hepatic impairment: monitor for toxicity. Labor & delivery. Pregnancy. Nursing mothers.
Local anesthetic (amide-type).
Do not dilute or mix with local anesthetics, other drugs, or diluents. Avoid additional local anesthetics within 168hrs following Posimir administration. Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others (eg, acetaminophen, metoclopramide, quinine, sulfasalazine).
Dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, vomiting, anemia, bradycardia, constipation, increased C-reactive protein, diarrhea, nausea, post procedural contusion, procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising; CNS toxicity (eg, restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth/lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, drowsiness), chondrolysis (with unapproved intra-articular infusion).
Generic Drug Availability:
Single-dose vial (5mL)—10