Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)
Rebel Distributors Corp.
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. 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.
Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0504-04 (4 fl. oz. bottles).
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION REBEL DISTRIBUTORS CORP. ---------- RX ONLY 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, non-salicylate 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 Alcohol 7% INACTIVE INGREDIENTS Glycerin, propylene glycol, sodium saccharin, and sucrose, NF. Also FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, and purified water USP. 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 intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), n Baca dokumen lengkap