Hydrocodone Bitartrate and Acetaminophen (Liquid)

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Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based onweight whenever possible. The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Healthcare providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.

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, toxic doses may cause circulatory failure and rapid, shallow breathing.<br/>Pharmacokinetics: The behavior of the individual components is described below.<br/>Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6��5.2 ng/mL. Maximum serum levels were achieved at 1.3��0.3 hours and the half-life was determined to be 3.8��0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-��- and 6-��-hydroxymetabolites. See OVERDOSAGE for toxicity information.<br/>Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates andunchanged drug. See OVERDOSAGE for toxicity information.

Hydrocodone bitartrate and acetaminophen oral solution is a clear, yellow-colored liquid with a fruity aroma containing hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg per 15 mL, with 7% alcohol, packaged as follows: NDC 58177-909-07 16 fl oz (473 mL) bottles.<br/>STORAGE: Store at 20��to 25��C (68��to 77��F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic. Manufactured byKV Pharmaceutical Co. forETHEX CorporationSt. Louis, MO 63044

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Hydrocodone Bitartrate and Acetaminophen (Liquid)

Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain.

http://www4.wiwiss.fu-berlin.de/dailymed/resource/routeOfAdministration/Oral