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)

[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.

Comparison of the analgesic effects of a fixed-dose combination of orphenadrine and diclofenac (Neodolpasse) with its single active ingredients diclofenac and orphenadrine: a placebo-controlled study using laser-induced somatosensory-evoked potentials from capsaicin-induced hyperalgesic human skin. [2005]
OBJECTIVE: The aim of this study was to investigate the analgesic efficacy of Neodolpasse, a fixed-dose combination of orphenadrine and diclofenac, compared with those of its single active ingredients in a human pain model... CONCLUSION: This study demonstrated the efficacy of Neodolpasse in a human pain model. The observed effect was mainly caused by central mechanisms and was found to be superior for the fixed-dose combination of orphenadrine and diclofenac compared with the individual ingredients. Both components contributed to the effect of the combination in an additive fashion, which can be explained by the different molecular mechanisms of action of each drug.

Analgesic effects of low-dose intravenous orphenadrine in the state of capsaicin hyperalgesia. A randomised, placebo-controlled, double-blind cross-over study using laser somatosensory evoked potentials obtained from capsaicin-irritated skin in healthy volunteers. [2004]
The present investigation aimed to elucidate the analgesic efficacy of 30 mg of intravenous orphenadrine citrate (CAS 4682-36-4) in a human pain model. Eighteen healthy female and male subjects were enrolled and received single infusions of 30 mg orphenadrine citrate and matching placebo in two periods which were separated by a 1 week washout period...

Therapeutic response of benzodiazepine, orphenadrine citrate and occlusal splint association in TMD pain. [2003.04]
Loss of function, muscle inflammation, and pain are some of the signs and symptoms of temporomandibular dysfunction (TMD)... No significant difference was observed among association therapeutic protocols.

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