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Norflex (Orphenadrine Citrate) - Summary

 
 



NORFLEX SUMMARY

Norflex™
(orphenadrine citrate)
EXTENDED-RELEASE TABLETS AND INJECTION

Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.Each Norflex Extended-release Tablet contains 100 mg orphenadrine citrate. Norflex Extended-release Tablets also contain: calcium stearate, ethylcellulose, and lactose. Norflex Injection contains 60 mg of orphenadrine citrate in aqueous solution in each ampul. Norflex Injection also contains: sodium bisulfite NF, 2.0 mg; sodium chloride USP, 5.8 mg; sodium hydroxide, to adjust pH; and water for injection USP, q.s. to 2 mL.

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.


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NEWS HIGHLIGHTS

Published Studies Related to Norflex (Orphenadrine)

Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. [2010.11]
Multimodal pain management combines analgesics to improve analgesia and reduce side effects... This study demonstrates that Neodolpasse((R)) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. [2010.10.08]
Multimodal pain management combines analgesics to improve analgesia and reduce side effects... This study demonstrates that Neodolpasse((R)) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. [2010]
Multimodal pain management combines analgesics to improve analgesia and reduce side effects... This study demonstrates that Neodolpasse(®) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

[Diclofenac/orphenadrine as a combined analgetic in post-operative relief of pain] [2008.09.28]
The authors compared the potency, safety and tolerability of combined infusion containing non-steroid anti-inflammation diclofenac and central muscle relaxant orphenadrine, and those of tramadol HCl, during postoperative pain relief after low and middle category operations... Based on all this, diclofenac-orphenadrine infusion is considered an effective and safe analgesic which is easy to administer and to combine in pain relief after small and middle category operations.

Efficacy and safety of combined piroxicam, dexamethasone, orphenadrine, and cyanocobalamin treatment in mandibular molar surgery. [2006.09]
Third molar extraction is a common procedure frequently accompanied by moderate or severe pain, and involves sufficient numbers of patients to make studies relatively easy to perform. The aim of the present study was to determine the efficacy and safety of the therapeutic combination of 10 mg piroxicam, 1 mg dexamethasone, 35 mg orphenadrine citrate, and 2.5 mg cyanocobalamin (Rheumazin) when compared with 20 mg piroxicam alone (Feldene) in mandibular third molar surgery.

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Clinical Trials Related to Norflex (Orphenadrine)

A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis [Recruiting]
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee [Recruiting]
This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.

The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands [Not yet recruiting]
Osteoarthritis (OA) affects over 30 million people in the United States and represents our nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA raised overall health care costs by $185. 5 billion annually. Largely as a consequence of this disease, the number of patients undergoing joint replacement surgery will quadruple over the next 17 years. Importantly, several recent studies have demonstrated that OA is an independent risk factor for cardiovascular disease . Presently investigators have no medications that alter the natural history of OA. Weight control, exercise and some physical therapy measures are the only interventions short of total joint replacement that alter the course of this disease. To make matters worse, investigators have experienced only setbacks in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently available armamentarium for pain control in OA . Clearly OA is a major factor that demands better solutions as the health care system is redesigned. OA involving the hands represents a major part of the overall burden of this disease. In radiographic surveys about a quarter of the total US population has changes consistent with OA involving the hands. Among the elderly, radiographic hand OA has been found in over half of such individuals and as many as a quarter of them suffer from pain and functional incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint, the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints . Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and a variety of physical measures such as physical therapy, bracing, and heat and cold applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical therapies have been developed which either act as counter irritants, seek to reduce substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand function in a double blind controlled trial. However none of these measures have proven sufficiently effective to meet patient needs. Topical polytherapy will be employed in this study to see if it will be effective against the pain of OA.

Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients [Not yet recruiting]
The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients. The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain [Recruiting]
The purpose of the study is to examine if the hyposthesis of the preventive analgestic characteristic of diclofenac given preoperatively has any effect on postoperative thoracic wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption and the postoperative lung function test values.

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Page last updated: 2013-02-10

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