PHARMACEUTICAL COMPOSITIONS
Pharmaceutical compositions are provided which comprise effective amounts of analgesic to treat a subject, including to reduce or eliminate an adverse effect associated with the analgesic.
1 - 22 . (canceled)
23 . A method for reducing or preventing opioid-induced nausea or vomiting, the method comprising administering a solid oral dosage form to a subject in need thereof, wherein the solid oral dosage form comprises an immediate-release layer and a controlled-release layer, wherein the immediate-release layer comprises an antiemetic and the controlled-release layer comprises an opioid analgesic and a non-opioid analgesic, and wherein the opioid analgesic, the non-opioid analgesic, and the antiemetic are present in a ratio by weight of about (1 to 2):(40 to 45):(1 to 2), respectively.
24 . The method of claim 23 , wherein the opioid analgesic is hydrocodone, oxycodone, or a pharmaceutically acceptable salt thereof.
25 . The method of claim 24 , wherein the hydrocodone, oxycodone, or a pharmaceutically acceptable salt thereof is present in an amount of about 1-20 mg.
26 . The method of claim 25 , wherein the hydrocodone, oxycodone, or a pharmaceutically acceptable salt thereof is present in an amount of about 1-15 mg.
27 . The method of claim 26 , wherein the hydrocodone or a pharmaceutically acceptable salt thereof is present in an amount of about 7.5 mg.
28 . The method of claim 26 , wherein the hydrocodone is present in an amount of about 5 mg.
29 . The method of claim 27 , wherein the pharmaceutically acceptable salt of the hydrocodone is hydrocodone bitartrate and is present in an amount of about 7.5 mg.
30 . The method of claim 26 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is present in an amount of about 7.5 mg.
31 . The method of claim 26 , wherein the oxycodone or a pharmaceutically acceptable salt thereof is present in an amount of about 10 mg.
32 . The method of claim 24 , wherein the opioid analgesic is hydrocodone bitartrate.
33 . The method of claim 24 , wherein the opioid analgesic is oxycodone hydrochloride.
34 . The method of claim 23 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof.
35 . The method of claim 34 , wherein the antiemetic is promethazine hydrochloride.
36 . The method of claim 34 , wherein the promethazine or a pharmaceutically acceptable salt thereof is present in an amount of about 0.5-60 mg.
37 . The method of claim 36 , wherein the promethazine is present in an amount of about 11 mg.
38 . The method of claim 36 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride and is present in an amount of about 12.5 mg.
39 . The method of claim 36 , wherein the promethazine or a pharmaceutically acceptable salt thereof is present in an amount of about 12.5 mg.
40 . The method of claim 23 , wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof.
41 . The method of claim 40 , wherein the acetaminophen or a pharmaceutically acceptable salt thereof is present in an amount of about 200-600 mg.
42 . The method of claim 41 , wherein the acetaminophen or a pharmaceutically acceptable salt thereof is present in an amount of about 325 mg.
43 . The method of claim 23 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in a ratio by weight of about 1:43:2, respectively.
44 . The method of claim 23 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in a ratio by weight of about 1:43:1.7, respectively.
45 . The method of claim 23 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of 6-8 mg, 310-330 mg, and 5-13 mg, respectively.
46 . The method of claim 23 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of 7.5 mg, 325 mg, and 12.5 mg, respectively.
47 . The method of claim 23 , wherein the opioid analgesic is hydrocodone bitartrate, the non-opioid analgesic is acetaminophen, and the antiemetic is promethazine hydrochloride, which are present in an amount of 7.5 mg, 325 mg, and 12.5 mg, respectively.
48 . The method of claim 23 , wherein the opioid analgesic oxycodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of 7.5 mg, 325 mg, and 12.5 mg, respectively.
49 . The method of claim 23 , wherein the opioid analgesic is oxycodone hydrochloride, the non-opioid analgesic is acetaminophen, and the antiemetic is promethazine hydrochloride, which are present in an amount of 7.5 mg, 325 mg, and 12.5 mg, respectively.
50 . The method of claim 23 , wherein the solid oral dosage form is a tablet.
51 . The method of claim 50 , wherein the tablet is a bi-layer tablet.