Pain Management

Endura-KT™ Injectable For Postsurgical Non-Opioid Pain Management. Brought to you by InfuBLOCK™.

Endura-KT is an opioid and preservative-free local anesthetic compound. Endura-KT contains three components, which, when combined, mix into a Lidocaine, Tetracaine and Epinephrine injection for postoperative pain relief. This combination of three well-known, extremely safe, low-toxic drugs provides an anesthetic designed to deliver an opioid-free postoperative solution.

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Endura-KT provides a long-lasting pain management solution for various pain management applications. The local anesthetic compound may be suitable for a variety of surgical procedures and plane blocks, longer-acting local infiltration anesthesia, and local or regional pain management.

Due to the dilute concentration of the components, the combined product has low toxicity. This allows higher volume dosing for volume/plane blocks to ensure full coverage of the affected nerves.^2,3

Pain-Control Applications: Use for incisional infiltration, major and minor regional nerve blocks, soft tissue infiltration, subcutaneous, epidural and intra-articular injection.

What is Endura-KT Injectable?

(Tetracaine 0.2%, Lidocaine 0.4%, Epinephrine 1:1000)

Endura-KT is a local anesthesia compound that offers a solution for non-opioid pain relief. Endura-KT provides ultra-long acting, safe pain relief for post-operative care.
Endura-KT contains two components, which, when combined, mixes into a preservative-free, patented local anesthetic compound.

Endura-KT consists of one preloaded Luer-Lock syringe with an 18g mixing needle containing 0.2mL of Epinephrine 1:1000, and one vial containing 50mL of Tetracaine and Lidocaine. Combining these two components results in a solution of 0.2% Tetracaine and 0.4% Lidocaine with Epinephrine 1:250,000.
The maximum recommended dose is 1.5mL/kg IBW.¹

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Benefits

Opioid-Free Pain Relief
A Versatile Post-Operative Pain Relief Solution

Low-Toxicity Formula
Increased Comfort With Minimal Side Effects

Potential Reduced Need for Narcotic Prescriptions
Long-Lasting Pain Relief

Cost Efficient and Available Throughout the U.S. to Improve the Quality of Life for All Patients

Increase Patients' Level of Comfort with Fewer Side Effects.

Enhanced Recovery After Surgery

Endura-KT Injectable addresses the demand for non-opioid pain control by providing safe and effective pain relief for patients after surgery.

Endura-KT includes:

One Pre-Loaded Luer-Lock Syringe Containing 0.2mL of Preservative-Free Epinephrine 1:1000, USP (0.2mg/0.2mL)

One Sterile Injection Vial Containing 50mL Preservative-Free 0.4% Lidocaine HCI with 0.2% Tetracaine HCI

Combining these two components results in a solution of 0.2% Tetracain and 0.4% Lidocaine with Epinephrine 1:250,000. A maximum recommended dose is 1.5mL/kg IBW.

Alcohol Prep Pad
18G 1” Blunt Needle
Green Transfer Label Sticker
Directions for Use Insert

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Disclaimer:
*Endura-KT is not recommended for topical use or for spinal anesthesia. This product is an off-label use of three long-available and extremely safe anesthetics. Medications may only be ordered by health care providers when it is determined that the product is clinically significant over other commercially available products.

FDA Disclaimer:
This product has not been evaluated or approved by the FDA. Nubratori RX Products are produced and lawfully sold in the USA, under the FDA Structured Product Listing Marketing Category #Cl81659 “Outsourcing Facility Compounded Human Drug Product” (Exempt from Approval Requirements). Under the Drug Quality and Security Act of 2013 enacted by Congress, human drug products compounded by an outsourcing facility, such as Nubratori RX, are exempt from the following three sections of the FD&C Act: section 505 (21 U.S.C. 355).

A. Concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(l) (21 U.S.C. 352(f)(l).
B. Concerning the labeling of drugs with adequate directions for use.
C. Concerning Drug Supply Chain Security Requirements: section 582 (21 U.S.C. 360eee-1).

References:
1. Local Anesthetics. Ian K McLeod, MD; Chief Editor: Arlen D Meyers, MD, MBA et al. Updated: Mar 18, 2015. http://emedicine.medscape.com/article/873879-overview#a5.
2. Epinephrine prolongs duration of subcutaneous infiltration of local anesthesia in a dose-related manner. Correlation with magnitude of vasoconstriction. S Liu, R L Carpenter, A A Chiu, T J McGill, S A Mantell. Regional Anesth. Sep-Oct 1995; 20(5):378-84.
3. Laparoscopic-Guided Transversus Abdominis Plane Block for Colorectal Surgery, Joanne Favuzza, D.O., Conor P. Delaney, M.D. Dis Colon Rectum 2013; 56: 389–391DOI: 10.1097/DCR.0b013e318280549b © The ASCRS 2013.
4. The Opioid Epidemic: By the Numbers. http://www.hhs.gov/opioids/.
5. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. Chad M. Brummett, MD, et al. JAMA Surg. Published online April 12, 2017. doi:10.1001/jamasurg.2017.0504.
6. Benefit and risks of local anesthetics in infants and children. Gunter JB. Paediatric Drugs. 2002;4(10):649-72.
7. Evidence-based practice supports adopting ERAS protocols. OR Manager Vol. 33 No. 5 May 2017. Brydges G.
8. On the Mechanism by Which Epinephrine Potentiates Lidocaine’s Peripheral Nerve Block. Catherine J. Sinnott, B.A.; Lawrence P. Cogswell, Ph.D.; Anthony Johnson, B.S.; Gary R. Strichartz, Ph.D. Anesthesiology January 2003, Vol. 98, 181–188. https://doi.org/10.1097/00000542-200301000-00028.
9. Anesthesiology. 1981 Mar; 54(3):177-81. Mixtures of local anesthetics are no more toxic than the parent drugs. de Jong RH, Bonin JD.

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InfuSystem is a leading national health care service provider, facilitating outpatient care for durable medical equipment manufacturers and health care providers by delivering ambulatory pumps and supplies, along with related clinical, biomedical and billing services, to practices and patients nationwide. With a comprehensive suite of services, InfuSystem improves clinician access to quality medical equipment and promotes patient wellness and safety while reducing the overall cost of infusion care.

InfuSystem offers Oncology, Pain Management and Wound Care therapies, including Negative Pressure Wound Therapy. The company’s Durable Medical Equipment (DME) Services are composed of direct payer rentals, pump and consumable sales, and biomedical services and repair, including on-site and depot services. InfuSystem provides the sale, rental, lease and associated supplies, including infusion pumps, nerve blocks for acute pain, nerve block catheters, postoperative pain pumps, central venous catheters, IV pumps, pole-mounted pumps, syringe pumps, enteral pumps, Huber needles, clean room supplies, IV extension tubing, pump tubing, ambulatory pumps, replacement pumps, disposable products, central venous access devices, closed system transfer devices, negative pressure wound therapy vacs, wound vac, and chemotherapy and oncology infusion pumps. Biomedical services include both on-site and depot preventive maintenance, repair and warranty services, ranging from equipment inspections to extensive repairs, including compression device systems, defibrillators, EKG machines, electrosurgical units, external pacemakers, humidifiers, infusion pumps, LCDs, light sources, modules, patient monitors, printers, pulse oximeters, telemetry transmitters and tourniquets – all completed to factory specifications.

Headquartered in Rochester Hills, Michigan, InfuSystem delivers local, field-based customer support and operates Centers of Excellence in Michigan, Kansas, California, Massachusetts, Texas and Ontario, Canada.