Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
ATLANTIC BIOLOGICALS COPR.
ACETAMINOPHEN
ACETAMINOPHEN 120 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain. Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Acetaminophen and codeine phosphate oral solution is classified as a Schedule V controlled substance. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.
NDC:17856-0079-1 in a CUP of 12.5 SOLUTIONS NDC:17856-0079-2 in a CUP of 10 SOLUTIONS NDC:17856-0079-4 in a CUP of 12 SOLUTIONS NDC:17856-0079-5 in a CUP of 5 SOLUTIONS
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION ATLANTIC BIOLOGICALS COPR. ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, USP 120 MG/12 MG PER 5 ML BOXED WARNING HEPATOTOXICITY Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING ULTRA-RAPID METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. DESCRIPTION Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, 7,8-didehydro- 4, 5α-epoxy-3- methoxy-17-methylmorphinan- 6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: Each 5 mL, for oral administration, contains: Acetaminophen 120 mg Codeine Phosphate 12 mg (Warning: May be habit forming) Alcohol 7% In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose. CLINICAL PHARMACOLOGY This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. PHARMACOKINETICS The behavior of the individual components is described below. Codeine Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intrava Կարդացեք ամբողջական փաստաթուղթը