Xodol

Xodol® is indicated for the relief of moderate to moderately severe pain.

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.

Xodol® 5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg): The

usual adult dosage is one or two tablets every four to six hours as needed for pain.

Xodol® 7.5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg): The

usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage

should not exceed 6 tablets.

Xodol® 10/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg): The

usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage

should not exceed 6 tablets.

Patients receiving other narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined 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 the antidepressant or hydrocodone.

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of

the drug to the mother.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of hydrocodone bitartrate and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences 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, and of 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 toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may 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 of

hydrocodone bitartrate and acetaminophen tablets and observed closely.

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

Signs and Symptoms:

Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a

decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect.

Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Treatment: A single or multiple overdose with hydrocodone and acetaminophen is a potentially

lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug

absorption. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Vasopressors and other supportive

measures should be employed as indicated. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and, when necessary, to provide assisted respiration.

Meticulous attention should be given to maintaining adequate pulmonaryventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally.

Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratoryor cardiovascular depression.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen

levels should be obtained, since levels four or more hours following ingestion help

predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for acetaminophen is 10 g.

Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks 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 should be avoided.

Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Hydrocodone bitartrate and acetaminophen is supplied in tablet form

for oral administration.

[image: id_1b5ee93b-f6ac-4c0c-bbb7-1700e950d583]

Xodol® is supplied as follows:

5 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “5” score “300” on one side and “TP” on the other side.

7.5 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “7.5” score “300” on one side and “TP” on the

other side.

10 mg/300 mg

White, capsule-shaped, bisected tablets, debossed “10” score “300” on one side and “TP” on the other side.

STORAGE: Store at 20° to 25°C

(68° to 77°F). [See USP Controlled Room Temperature].

PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.

A Schedule III Narcotic

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Code 911C00 Rev. 12/06

Repackaged by:

REBEL DISTRIBUTORS CORP

Thousand Oaks, CA 91320