Posimir

— THERAPEUTIC CATEGORIES —
  • Nonnarcotic analgesics

Posimir Generic Name & Formulations

General Description

Bupivacaine 132mg/mL; soln for infiltration use; contains benzyl alcohol.

Pharmacological Class

Local anesthetic (amide-type).

How Supplied

Single-dose vial (5mL)—10

Generic Availability

NO

Posimir Indications

Indications

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.

Posimir Dosage and Administration

Adult

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.

Children

<18yrs: not established.

Posimir Contraindications

Contraindications

Obstetrical paracervical block anesthesia.

Posimir Boxed Warnings

Boxed Warning

Risk of potential adverse embolic effects resulting from inadvertent intravascular injection.

Posimir Warnings/Precautions

Warnings/Precautions

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.

Posimir Pharmacokinetics

See Literature

Posimir Interactions

Interactions

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).

Posimir Adverse Reactions

Adverse Reactions

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).

Posimir Clinical Trials

See Literature

Posimir Note

Not Applicable

Posimir Patient Counseling

See Literature