Reducing Side Effects of Tramadol
The invention provides methods of reducing the side effects of tramadol. Accordingly, in one embodiment, the invention provides a method of reducing the incidence of newly-discovered side effects related to sexual function in human males taking a tramadol material. The method comprises administering a phosphodiesterase inhibitor to a male taking the tramadol material. The invention also provides pharmaceutical compositions. In one embodiment, the composition comprises a tramadol material and a phosphodiesterase inhibitor. The invention further provides kits. In one embodiment, the kit comprises a tramadol material and a phosphodiesterase inhibitor.
1 .- 18 . (canceled)
19 . A pharmaceutical composition comprising a pharmaceutically-acceptable carrier, and a tramadol material, a phosphodiesterase (PDE) inhibitor and a second side-effect-reducing agent.
20 . (canceled)
21 . The composition of claim 19 wherein the second side-effect-reducing agent is an opioid antagonist.
22 . The composition of claim 20 wherein the second side-effect-reducing agent is naltrexone.
23 . The composition of claim 19 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
24 . The composition of claim 23 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
25 . The composition of claim 24 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
26 . The composition of claim 25 wherein the PDE5 inhibitor is sildenafil citrate.
27 - 32 . (canceled)
33 . A kit comprising one or more containers, each of which holds a tramadol material, a phosphodiesterase (PDE) inhibitor, a second side-effect-reducing agent or a combination of two or more of the foregoing.
34 . The kit of claim 33 wherein the second side-effect-reducing agent is an opioid antagonist.
35 . The kit of claim 33 wherein the second side-effect-reducing agent is naltrexone.
36 . The kit of claim 33 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
37 . The kit of claim 36 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
38 . The kit of claim 37 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
39 . The kit of claim 38 wherein the PDE5 inhibitor is sildenafil citrate.
40 .- 50 . (canceled)
51 . The composition of claim 21 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
52 . The composition of claim 51 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
53 . The composition of claim 52 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
54 . The composition of claim 53 wherein the PDE5 inhibitor is sildenafil citrate.
55 . The composition of claim 22 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
56 . The composition of claim 55 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
57 . The composition of claim 56 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
58 . The composition of claim 57 wherein the PDE5 inhibitor is sildenafil citrate.
59 . The kit of claim 34 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
60 . The kit of claim 59 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
61 . The kit of claim 60 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
62 . The kit of claim 61 wherein the PDE5 inhibitor is sildenafil citrate.
63 . The kit of claim 35 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE5 inhibitor.
64 . The kit of claim 63 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
65 . The kit of claim 64 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
66 . The kit of claim 65 wherein the PDE5 inhibitor is sildenafil citrate.