البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Direct_Rx
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: • Significant respiratory depression [see WARNINGS] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] • Hypersensitivity to hydrocodone or
Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg is available as white to off-white, capsule shaped tablets, debossed with “U02” on one side and break-line on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 04/2019
Abbreviated New Drug Application
HYDROCODONE /APAP- HYDROCODONE /APAP TABLET Direct_Rx ---------- Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen Hydrocodone Bitartrate and Acetaminophen Tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Important information about Hydrocodone Bitartrate and Acetaminophen Tablets: Get emergency help right away if you take too much hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking hydrocodone bitartrate and acetaminophen tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Taking hydrocodone bitartrate and acetaminophen tablets with other opioid medicines,benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death. Never give anyone else your Hydrocodone Bitartrate and Acetaminophen Tablets. They could die from taking it. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets are against the law. Store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Hydrocodone Bitartrate and Acetaminophen Tablets if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines. known hypersensitivity to hydrocodone or acetaminophen ,or any ingredient in hydrocod اقرأ الوثيقة كاملة
HYDROCODONE /APAP- HYDROCODONE /APAP TABLET DIRECT_RX ---------- HYDROCODONE/APAP Hydrocodone bitartrate and acetaminophen is 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: [chemical structure] 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: [Chemical Structure] Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table. Each hydrocodone bitartrate and acetaminophen tablet contains: Strength Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg 7.5 mg/325 mg 10 mg/325 mg 5 mg 7.5 mg 10 mg 325 mg 325 mg 325 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1. Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effect اقرأ الوثيقة كاملة