Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
H.J. Harkins Company, Inc.
HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE 5 mg
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disea
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 109” on obverse and bisected on the reverse. They are available as follows: Bottles of 100: NDC 53746-109-01 Bottles of 500: NDC 53746-109-05 Bottles of 1000: NDC 53746-109-10 Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic.
Abbreviated New Drug Application
HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET H.J. HARKINS COMPANY, INC. ---------- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 mg/325 mg CS-III Rx only DESCRIPTION Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17- methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains: Hydrocodone Bitartrate, USP ........................... 5 mg Acetaminophen, USP .................................... 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose. Meets USP Dissolution Test 1. CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, t Lesen Sie das vollständige Dokument