PHARMACEUTICAL COMPOSITIONS
Pharmaceutical compositions are provided which comprise effective amounts of an analgesic to treat a subject, including to reduce or eliminate an adverse effect associated with the analgesic.
1 . A method for treating or preventing pain, and reducing or preventing nausea or vomiting associated with an opioid analgesic, the method comprising administering to a subject in need thereof an immediate-release bi-layered tablet, wherein the immediate-release bi-layered tablet comprises:
a first layer, wherein the first layer comprises an antiemetic that is promethazine or a pharmaceutically acceptable salt thereof; and
a second layer, wherein the second layer comprises: an opioid analgesic that is hydrocodone or a pharmaceutically acceptable salt thereof, and a non-opioid analgesic that is acetaminophen or a pharmaceutically acceptable salt thereof,
wherein the opioid analgesic, the non-opioid analgesic, and the antiemetic are present in a ratio by weight of (1 to 2):(40 to 45):(1 to 2), respectively, and
wherein the immediate-release bi-layered tablet provides an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or reduce or prevent vomiting associated with the opioid analgesic in the subject in need thereof, and an effective amount of the opioid analgesic and the non-opioid analgesic to treat or prevent pain in the subject in need thereof.
2 . The method of claim 1 , wherein the method treats pain and reduces vomiting associated with the opioid analgesic.
3 . The method of claim 1 , wherein the method treats pain and reduces nausea associated with the opioid analgesic.
4 . The method of claim 1 , wherein the method treats pain and reduces nausea and vomiting associated with the opioid analgesic.
5 . The method of claim 1 , wherein the pain is severe pain.
6 . The method of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount of about 1 mg to about 20 mg.
7 . The method of claim 6 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount of about 1 mg to about 15 mg.
8 . The method of claim 7 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount of about 7.5 mg.
9 . The method of claim 1 , wherein the opioid analgesic is hydrocodone bitartrate.
10 . The method of claim 9 , wherein the hydrocodone bitartrate is present in an amount of about 7.5 mg.
11 . The method of claim 1 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 0.5 to about 60 mg.
12 . The method of claim 11 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 12.5 mg.
13 . The method of claim 1 , wherein the promethazine is present in an amount of 11 mg.
14 . The method of claim 1 , wherein the antiemetic is promethazine hydrochloride.
15 . The method of claim 14 , wherein the promethazine hydrochloride is present in an amount of about 12.5 mg.
16 . The method of claim 1 , wherein the acetaminophen or the pharmaceutically acceptable salt thereof is present in an amount of about 200 mg to about 600 mg.
17 . The method of claim 16 , wherein the acetaminophen or a pharmaceutically acceptable salt thereof is present in an amount of about 325 mg.
18 . The method of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof, the acetaminophen or the pharmaceutically acceptable salt thereof, and the promethazine or the pharmaceutically acceptable salt thereof are present in a ratio by weight of 1:43.33:1.67, respectively.
19 . The method of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof, the acetaminophen or the pharmaceutically acceptable salt thereof, and the promethazine or the pharmaceutically acceptable salt thereof are present in an amount of 6 mg to 8 mg, 200 mg to 350 mg, and 5 mg to 13 mg, respectively.
20 . The method of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof, the acetaminophen or the pharmaceutically acceptable salt thereof, and the promethazine or the pharmaceutically acceptable salt thereof are present in an amount of about 7.5 mg, about 325 mg, and about 12.5 mg, respectively.
21 . The method of claim 1 , wherein the method treats pain and reduces nausea and vomiting associated with the opioid analgesic, wherein the antiemetic is promethazine hydrochloride, wherein the opioid analgesic is hydrocodone bitartrate, and wherein the non-opioid analgesic is acetaminophen.
22 . The method of claim 1 , wherein the method treats pain and reduces nausea and vomiting associated with the opioid analgesic, wherein the antiemetic is promethazine hydrochloride and present in an amount of about 12.5 mg, wherein the opioid analgesic is hydrocodone bitartrate and present in an amount of about 7.5 mg, and wherein the non-opioid analgesic is acetaminophen and present in an amount of about 325 mg.
23 . The method of claim 1 , wherein the immediate-release bi-layered tablet further comprises an opioid antagonist or an additional agent for reducing abuse and/or diversion.
24 . An immediate-release bi-layered tablet for treatment or prevention of pain, and reduction or prevention of nausea or vomiting associated with an opioid analgesic, wherein the immediate-release bi-layered tablet comprises:
a first layer, wherein the first layer comprises an antiemetic that is promethazine or a pharmaceutically acceptable salt thereof; and
a second layer, wherein the first layer comprises: an opioid analgesic that is hydrocodone or a pharmaceutically acceptable salt thereof, and a non-opioid analgesic that is acetaminophen or a pharmaceutically acceptable salt thereof,
wherein the opioid analgesic, the non-opioid analgesic, and the antiemetic are present in a ratio by weight of (1 to 2):(40 to 45):(1 to 2), respectively, and
wherein the immediate-release bi-layered tablet provides an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or reduce or prevent vomiting associated with the opioid analgesic, and an effective amount of the opioid analgesic and the non-opioid analgesic to treat or prevent pain.