Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
OXYCODONE (UNII: CD35PMG570) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Blenheim Pharmacal, Inc.
OXYCODONE
OXYCODONE 5 mg
ORAL
PRESCRIPTION DRUG
Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain. Oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including 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 is contraindicated in the setting of suspected or known paralytic ileus. Oxycodone and acetaminophen tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical
Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed “IP203” on obverse and bisect on reverse. They are available as follows: Bottles of 100: NDC 53746-203-01 Bottles of 500: NDC 53746-203-05 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. DEA Order Form Required
Abbreviated New Drug Application
OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET BLENHEIM PHARMACAL, INC. ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 MG / 325 MG CII RX ONLY DESCRIPTION Each tablet for oral administration contains: Oxycodone Hydrochloride, USP……………. 5 mg* Acetaminophen, USP………………………325 mg *5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C H NO •HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula: Acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C H NO and the molecular weight is 151.16. It may be represented by the following structural formula: CLINICAL PHARMACOLOGY CENTRAL NERVOUS SYSTEM Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably μ and k) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the 18 21 4 8 9 2 analgesic effect of Прочитајте комплетан документ