Oxycodone 30 mg Hydrochloride Amneal, ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic.
Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP.
Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
The 5 mg Roxicodone (oxycodone hydrochloride) tablet contains inactive ingredients: microcrystalline cellulose and stearic acid. The 15 and 30 mg tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets).
The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.6 mg, 13.5 mg and 27.0 mg, respectively, of oxycodone free base.
INDICATIONS OXYCODONE 30 MG HYDROCHLORIDE AMNEAL
ROXICODONE (oxycodone hydrochloride) ® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
DOSAGE AND ADMINISTRATION
ROXICODONE (oxycodone hydrochloride) ® is intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.
Patients who have not been receiving opioid analgesics should be started on ROXICODONE (oxycodone hydrochloride) ® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient’s response to their initial dose of ROXICODONE (oxycodone hydrochloride) ®. Patients with chronic pain should have their dosage given on an aroundthe-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.
For control of severe chronic pain, ROXICODONE (oxycodone hydrochloride) ® should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia