TREATMENT OF PAIN WITH TOPICAL DICLOFENAC
The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
1 .- 20 . (canceled)
21 . A method for treating a patient with a combination therapy, said combination comprising:
administering a therapeutically effective amount of an oral NSAID; and
applying a topical diclofenac preparation to a knee of said patient to treat osteoarthritis of the knee of said patient, wherein said topical diclofenac preparation consists essentially of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; about 23-29% w/w ethanol; about 10-12% w/w propylene glycol; about 0-6% w/w hydroxypropylcellulose; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise;
wherein the therapeutically effective amount of oral NSAID is the amount required to achieve a therapeutic effect in the absence of applying a topical diclofenac preparation.
22 . The method according to claim 21 , wherein the patient is treated for severe knee pain.
23 . The method according to claim 21 , wherein the patient is treated for breakthrough knee pain.
24 . The method according to claim 21 , further comprising: conducting periodic laboratory evaluations regarding said patient and the combination therapy.
25 . The method according to claim 21 , wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.
26 . The method according to claim 21 , wherein said oral NSAID is a member selected from the group consisting of a COX-2 selective NSAID, diclofenac, tenoxicam, meloxicam, celecoxib, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, and tolmetin.
27 . A method for applying topical agents to a knee of a patient with pain, said method comprising:
applying a first medication consisting of a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation consists essentially of 2% w/w diclofenac sodium; about 40% to about 50% w/w dimethyl sulfoxide; about 23-29% w/w ethanol; about 10-12% w/w propylene glycol; about 0-6% w/w hydroxypropylcellulose; and water to make 100% w/w; and wherein the topical diclofenac preparation has a viscosity of 500-5000 centipoise.
waiting for the treated area to dry;
subsequently applying a sunscreen, or an insect repellant to said treated area after said treated area is dry, wherein said step of applying a first medication does not enhance the systemic absorption of the subsequently applied sunscreen, or insect repellant; and
wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation.
28 . The method according to claim 27 , wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.
29 . The method according to claim 27 , wherein said step of subsequently applying comprises subsequently applying said sunscreen.
30 . The method according to claim 29 , wherein said sunscreen comprises oxybenzone.
31 . The method according to claim 27 , wherein said step of subsequently applying comprises subsequently applying said insect repellant.
32 . The method of claim 31 , wherein said insect repellant comprises N,N-diethyl-m-toluamide (DEET).
33 . The method of claim 31 , wherein said insect repellant comprises 2,4 D dimethylamine salt (2,4 D).