Norco - Dosage Hydrocodone Bitartrate and Acetaminophen
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Acute overdosage with NORCO® can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects 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.
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to NORCO® overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to NORCO® overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of NORCO® in NORCO® tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.
Dosage & Administration
important dosage & administration instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS ].
Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with NORCO® and adjust the dosage accordingly [see WARNINGS ].
Initiating Treatment with NORCO ®
|NORCO ® 5/325||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.|
| NORCO ® 7.5/325 |
NORCO ® 10/325
|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.|
Conversion from Other Opioids to NORCO ®
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of NORCO®. It is safer to underestimate a patient’s 24-hour NORCO® dosage than to overestimate the 24-hour NORCO® dosage and manage an adverse reaction due to overdose.
Conversion from NORCO ® to Extended-Release Hydrocodone
The relative bioavailability of hydrocodone from NORCO® compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression.
titration & maintenance of therapy
Individually titrate NORCO® to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NORCO® to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the NORCO® dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
discontinuation of norco ®
When a patient who has been taking NORCO® regularly and may be physically dependent no longer requires therapy with NORCO®, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue NORCO® in a physically-dependent patient [see WARNINGS , DRUG ABUSE AND DEPENDENCE ].
norco ® is supplied as:
|NORCO® 5/325||capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 0023-6002-01). |
|NORCO® 7.5/325||capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 0023-6021-01) and 500 (NDC 0023-6021-05). |
|NORCO® 10/325||capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 (NDC 0023-6022-01) and 500 (NDC 0023-6022-05). |
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Allergan USA, Inc.
Madison, NJ 07940
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NORCO® is a registered trademark of Allergan Sales, LLC