Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)
Lake Erie Medical DBA Quality Care Products LLC
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
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. Oxycodone hydrochloride tablets are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. Oxycodone hydrochloride tablets contain oxycodone, a mu-agonist opioid of the morphine type and is a Schedule II controlled substance. Oxycodone hydrochloride tablets, like other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is characterized by compulsive use, use for non-medical purposes
Oxycodone Hydrochloride Tablets, USP are available as follows: 5 mg: White colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘223’ on one side and scored on the other side. 10 mg: Pink colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘370’ on one side and scored on the other side. NDC: 55700-020-30 Bottles of 30 NDC: 55700-020-60 Bottles of 60 NDC: 55700-020-90 Bottles of 90 15 mg: Green colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘187’ on one side and scored on the other side. 20 mg: Gray colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘371’ on one side and scored on the other side. 30 mg: Blue colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘224’ on one side and scored on the other side. DEA Order Form Required: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Store at 20 - 25°C (68 - 77°F). (See USP for Controlled Room Temperature). Protect from moisture. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6405T04 Rev. 11/2012
Abbreviated New Drug Application
OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- OXYCODONE HYDROCHLORIDE TABLETS, USP, 5 MG, 10 MG, 15 MG, 20 MG, 30 MG DESCRIPTION Oxycodone hydrochloride tablets USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 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). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17- methylmorphinan-6-one hydrochloride and has the following structural formula: The tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. In addition, the 10 mg tablet also contains D&C Red #27 aluminum lake and D&C Red # 30 aluminum lake, the 15 mg tablet contains D&C Yellow #10 aluminum lake and FD&C Blue #2 aluminum lake, the 20 mg tablet contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake and FD&C Red #40 aluminum lake and the 30 mg tablet contains FD&C Blue #2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 8.96 mg, 13.5 mg, 17.93 mg, and 27 mg, respectively, of oxycodone free base. CLINICAL PHARMACOLOGY PHARMACOLOGY The analgesic ingredient, oxycodone, is a semi-synthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involves the central nervous system and organs composed of smooth muscle. Oxycodone, as the hydrochloride salt, is a pure agonist opioid whose principal therapeutic action is analgesia and has been in clinical use since 1917. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as is seen wit Lestu allt skjalið