Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/958
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Hydrocodone Bitartrate and Acetaminophen (Solution)
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Dosage should be adjusted according to the severity of the pain and the 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 (15 mL) every four to six 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 on weight 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. Health care 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.
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| dailymed-instance:descripti... |
Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration. Warning: May be habit forming . Hydrocodone bitartrate is an opioid analgesic and antitussive which occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5��-epoxy-3-methoxy-17-methyl-morphinan-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: Hydrocodone Bitartrate and Acetaminophen Oral Solution contains: In addition Hydrocodone Bitartrate and Acetaminophen Oral Solution contains the following inactive ingredients: citric acid, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.
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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-��-hydroxy-metabolites. 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 and unchanged drug. See OVERDOSAGE for toxicity information.
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| dailymed-instance:supply |
Hydrocodone Bitartrate and Acetaminophen Oral Solution is a yellow-colored, fruit flavored liquid containing 7.5 mg hydrocodone bitartrate and 500 mg acetaminophen per 15 mL, with 7% alcohol. It is supplied in bottles of 4 fl oz (118 mL), NDC 0121-0655-04, in bottles of 16 fl oz (473 mL), NDC 0121-0655-16, 5 mL unit dose cups packaged in trays of 10, NDC 0121-4655-05, 10 mL unit dose cups packaged in trays of 10, NDC 0121-4655-10, 15 mL unit dose cups packaged in trays of 10, NDC 0121-4655-15.<br/>Storage:: Store at 20��-25��C (68��-77��F). [See USP Controlled Room Temperature] Dispense in a tight, light-resistant container with a child-resistant closure. A Schedule CIII Narcotic Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 R11/03
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dailymed-ingredient:Alcohol,
dailymed-ingredient:Citric_Acid,
dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:Glycerin,
dailymed-ingredient:Methylparaben,
dailymed-ingredient:Natural_and_Artificial_Flavoring,
dailymed-ingredient:Propylene_Glycol,
dailymed-ingredient:Saccharin_Sodium,
dailymed-ingredient:Sorbitol_Solution,
dailymed-ingredient:Sucrose,
dailymed-ingredient:Water
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| dailymed-instance:genericMe... |
Hydrocodone Bitartrate and Acetaminophen
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| dailymed-instance:fullName |
Hydrocodone Bitartrate and Acetaminophen (Solution)
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| dailymed-instance:adverseRe... |
Potential effects of high dosage are also listed in the OVERDOSAGE section.<br/>Cardio-renal:: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.<br/>Central Nervous System/Psychiatric:: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.<br/>Endocrine:: Hypoglycemic coma.<br/>Gastrointestinal System:: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.<br/>Genitourinary System:: Spasm of vesical sphincters, ureteral spasm, and urinary retention.<br/>Hematologic:: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.<br/>Hypersensitivity:: Allergic reactions.<br/>Musculoskeletal:: Skeletal muscle flaccidity.<br/>Respiratory Depression:: Acute airway obstruction, apnea, dose-related respiratory depression , shortness of breath.<br/>Special Senses:: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.<br/>Skin:: Cold and clammy skin, diaphoresis, pruritus, rash.
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| dailymed-instance:indicatio... |
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the relief of moderate to moderately severe pain.
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Hydrocodone Bitartrate and Acetaminophen
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