Norco (Page 3 of 3)

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 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.

The toxic dose for acetaminophen for adults is 10 g.

DOSAGE AND ADMINISTRATION

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.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

are supplied as white with bright orange specks, capsule-shaped bisected, scored tablets, debossed “Watson”, on one side and debossed “3202” on the reverse side. The tablets are supplied in bottle of 30 and 90.

Storage:

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

A Schedule CIII Narcotic.

Manufactured for:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, Ms 39232


R4

PRINCIPAL DISPLAY PANEL

This is an image of the label for 5 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for 5 mg/325 mg Hydrocodone Bitartrate and Acetaminophen Tablets.
(click image for full-size original)
NORCO
hydrocodone bitartrate and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68387-236
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SUCROSE
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color WHITE (with orange specks) Score 2 pieces
Shape CAPSULE (capsule-shaped bisected) Size 17mm
Flavor Imprint Code Watson;3202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68387-236-30 30 TABLET (30 TABLET) in 1 BOTTLE None
2 NDC:68387-236-90 90 TABLET (500 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040099 02/01/2008
Labeler — Keltman Pharmaceuticals Inc. (362861077)
Establishment
Name Address ID/FEI Operations
Mikart, Inc. 030034847 MANUFACTURE

Revised: 02/2010 Keltman Pharmaceuticals Inc.

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