Pharmaceutical compositions for treating or preventing pain

摘要

Methods and compositions are provided which comprise effective amounts of one or more analgesics, such as hydrocodone or acetaminophen, and an antiemetic, such as promethazine, to treat or prevent pain in a subject, and to reduce or prevent an adverse effect associated with the analgesics.

主权项

1. A method for treating or preventing pain, and reducing or preventing an adverse effect associated with an opioid analgesic, comprising administering to a subject in need thereof an immediate-release bi-layered tablet that comprises:
(1) a first layer that comprises:
(a) 5 mg to 30 mg of an antiemetic that is promethazine or a pharmaceutically acceptable salt thereof;(b) about 75 mg to about 150 mg of silicified microcrystalline cellulose;(c) about 10 mg to about 20 mg of croscarmellose sodium; and(d) about 0.5 mg to 2 mg of magnesium stearate; and (2) a second layer that comprises:
(a) about 200 mg to about 1000 mg of a non-opioid analgesic that is acetaminophen or a pharmaceutically acceptable salt thereof;(b) about 0.5 mg to about 20 mg of the opioid analgesic that is hydrocodone or a pharmaceutically acceptable salt thereof;(c) about 75 mg to about 250 mg of silicified microcrystalline cellulose;(d) about 10 mg to about 40 mg of hydroxypropyl methylcellulose;(e) about 0.5 mg to 5 mg of magnesium stearate; and(f) about 0.5 mg to about 5 mg of stearic acid, wherein the immediate-release bi-layered tablet provides an effective amount of the opioid analgesic and the non-opioid analgesic to treat or prevent pain in the subject in need thereof, and an effective amount of the antiemetic to reduce or prevent an adverse effect associated with the opioid analgesic in the subject in need thereof.