LORTAB

LORTAB Elixir (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain.

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 for adults 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 LORTAB Elixir (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

BODY WEIGHT	APPROXIMATE AGE	DOSE every 4 to 6 hours	MAXIMUM TOTAL DAILY DOSE (6 doses per day)
12 to 15 kg 27 to 34 lbs.	2 to 3 years	¾ teaspoonful = 3.75 mL	4 ½ teaspoonfuls = 22.5 mL
16 to 22 kg 35 to 50 lbs.	4 to 6 years	1 teaspoonful = 5 mL	6 teaspoonfuls = 30 mL
23 to 31 kg 51 to 69 lbs.	7 to 9 years	1 ½ teaspoonfuls = 7.5 mL	9 teaspoonfuls = 45 mL
32 to 45 kg 70 to 100 lbs.	10 to 13 years	2 teaspoonfuls = 10 mL	12 teaspoonfuls = 60 mL
46 kg and up 101 lbs. and up	14 years to adult	1 Tablespoonful = 15 mL	6 Tablespoonfuls = 90 mL

The total daily dosage for children should not exceed 6 doses per day.

It is of utmost importance that the dose of LORTAB Elixir 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 care givers 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 care givers to use extreme caution in measuring the dosage.

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

Signs and Symptoms

Toxicity from hydrocodone poisoning includes the opioid triad of loss of consciousness, pinpoint pupils, and respiratory depression (Cheyne-Stokes respiration, cyanosis, decrease in respiratory rate and/or tidal volume). Convulsions may occur.

The toxic dose of acetaminophen for adults is 10 grams. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Early symptoms following a potentially hepatotoxic overdose of acetaminophen may include diaphoresis, general malaise, nausea, and vomiting. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Other signs and symptoms of overdose of this product include bradycardia, cold and clammy skin, extreme somnolence progressing to stupor or coma, hypoglycemic coma, hypotension, renal tubular necrosis, skeletal muscle flaccidity, thrombocytopenia.

In severe overdosage, apnea; circulatory collapse; cardiac arrest; dose-dependent, potentially fatal hepatic necrosis; and death may occur.

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 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 endo-tracheal 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 pulmonary ventilation. 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 respiratory or 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.

Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.

WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

[image: MM1]

C₁₈H₂₁NO₃ ● C₄H₆O₆ ● 2 ½ H₂0

M.W. 494.490

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:

[image: MM2]

C₈H₉NO₂     

MW = 151.16     

                                                                                                           

LORTAB Elixir contains:                                   Per               Per 

                                                                   5   mL              15 mL

Hydrocodone Bitartrate.............................2.5 mg                7.5 mg

Acetaminophen.........................................167 mg              500 mg

Alcohol......................................................7%                         7%

In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow #10 and FD&C Yellow #6 as coloring and natural and artificial flavoring.

LORTAB  Elixir (hydrocodone bitartrate and acetaminophen oral solution)

1 pint / 16 ounces / 473 mL

NDC 54868-2908-0

[image: MM3]

LORTAB  Elixir (hydrocodone bitartrate and acetaminophen oral solution) is a yellow-colored tropical fruit punch flavored liquid containing hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg per 15 mL, with 7% alcohol. It is supplied in containers of 1 pint (473 mL)   NDC 54868-2908-0.

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.

For Medical Information

Contact: Medical Affairs Department

Phone: (866) 822-0068

Fax: (770) 970-8859

A Schedule CIII Narcotic

Manufactured for
UCB Pharma, Inc.
Smyrna, GA 30080

Manufactured by
Mikart Inc.
Atlanta, GA 30318

Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK       74146