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Rebel Distributors Corp
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Manufacturer
Rebel Distributors Corp
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
CONTRAINDICATIONSThis product should not be administered to patients who have previously exhibited Hypersensitivity to hydrocodone oracetaminophen.Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
Drug interactionsPatients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (includingalcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. Whencombined therapy is contemplated, the dose of one or both agents should be reduced.The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either theantidepressant or hydrocodone.Drug/Laboratory Test InteractionsAcetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.Carcinogenesis, Mutagenesis, Impairment of FertilityNo adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential forcarcinogenesis, mutagenesis, or impairment of fertility.
adverse reactions which may obscure the clinical course of patients with head injuries.Acute Abdominal Conditions:The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Pregnancy
Nursing MothersAcetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is notknown whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of thepotential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether todiscontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.
Geriatric Use
OVERDOSAGE for toxicity information.Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-lifeis 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally byliver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urinewithin 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.See OVERDOSAGE for toxicity information.INDICATIONS AND USAGEHydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
Information for PatientsHydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardoustasks such as driving a car or operating machinery; patients should be cautioned accordingly.Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and shouldbe avoided.Hydrocodone may be habit forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, andno more frequently than prescribed.Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate andacetaminophen tablets are used postoperatively and in patients with pulmonary disease.
DESCRIPTIONHydrocodone 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 affectedby light. The chemical name is 4,5a-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the followingstructural formula: Acetaminophen, 4-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesicand antipyretic. It has the following structural formula: Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration are available in a variety of strengths as described inthe following table. Hydrocodone Strength Bitartrate Acetaminophen 2.5 mg/500mg 2.5 mg 500 mg 5 mg/500 mg 5 mg 500 mg 7.5 mg/325 mg 7.5 mg 325 mg 7.5 mg/500 mg 7.5 mg 500 mg 7.5 mg/650 mg 7.5 mg 650 mg 7.5 mg/750 mg 7.5 mg 750 mg 10 mg/325 mg 10 mg 325 mg 10 mg/500 mg 10 mg 500 mg 10 mg/650 mg 10 mg 650 mg 10 mg/660 mg 10 mg 660 mg 10 mg/750 mg 10 mg 750 mg In addition, each tablet contains the following
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HOW SUPPLIEDHydrocodone Bitartrate and Acetaminophen Tablets USP are available in10 mg/500 mg 10 mg hydrocodone bitartrate and 500 mg acetaminophen, capsule-shaped, blue tablets bisected on one side anddebossed with WATSON 540 on the other side, supplied in unit dose packages of :
120 NDC 21695-273-72
90 NDC 21695-273-90
60 NDC 21695-273-60
45 NDC 21695-273-45
30 NDC 21695-273-30
28 NDC 21695-273-28
12 NDC 21695-273-12
8 NDC 21695-273-08
Store at 20260-25260C (68260-77260F). [See USP controlled room temperature].Rx onlyManufactured by:Watson Laboratories, Inc.Corona, CA 92880 USADistributed by:Watson Pharma, Inc.Corona, CA 92880 USA
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Photos of the product and/or packaging supplied by the manufacturer.
inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone,magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid; except the 7.5 mg/325 mg, 10 mg/325 mg and 10 page 2 of 7 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake; the 7.5mg/650 mg tablets include FD&C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D&C Yellow #10Aluminum Lake; the 10 mg/500 mg tablets include FD&C Blue #2 Aluminum Lake; and the 10 mg/650 mg tablets include FD&CBlue #1 Aluminum Lake and D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGYHydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Mostof these involve the central nervous system and smooth muscle. The precise
mechanism of action of hydrocodone and other opiates isnot 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. Antipyreticactivity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeuticdoses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may causecirculatory failure and rapid, shallow breathing.
Pharmacokinetics:The behavior of the individual components is described below.Hydrocodone: Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 261 5.2ng/mL. Maximum serum levels were achieved at 1.3 261 0.3 hours and the half-life was determined to be 3.8 261 0.3 hours. Hydrocodoneexhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-ketoreduction to the corresponding 6-aand 6-337 -hydroxymetabolites. See
Clinical studies of hydrocodone bitartrate 5 mg and acetaminophen 500 mg did not include sufficient numbers of subjects aged 65and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identifieddifferences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious,usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, andof concomitant disease or other drug therapy.Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxicreactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites page 4 of 7 in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and itmay be useful to monitor renal function.Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses ofhydrocodone bitartrate and acetaminophen tablets and observed closely.ADVERSE REACTIONSThe most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem tobe more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patientlies down.Other adverse reactions include:Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear,dysphoria, psychic
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