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NORCO (HYDROCODONE/ACETAMINOPHEN) TABLETS: INFORMATION FOR PATIENTS

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse, and Misuse

Inform patients that the use of Norco (Hydrocodone Bitartrate and Acetaminophen) tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death. Instruct patients not to share Norco with others and to take steps to protect this medication from theft or misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Norco (Hydrocodone Bitartrate with Acetaminophen) tablets or when the dosage is increased, and that it can occur even at recommended dosages. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death. Instruct patients to take steps to store Norco (Hydrocodone Bitartrate and Acetaminophen) tablets securely and to dispose of unused Norco by flushing down the toilet.

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Norco is used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider.

Serotonin Syndrome

Inform patients that Norco (Hydrocodone Bitartrate and Acetaminophen) could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications.

Monoamine Oxidase Inhibitor (MAOI) Interaction

Inform patients to avoid taking Norco (Hydrocodone Bitartrate and Paracetamol) tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Norco.

Adrenal Insufficiency

Inform patients that Norco (Hydrocodone Bitartrate with Acetaminophen) tablets could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as vomiting, nausea, anorexia, fatigue, dizziness, weakness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms.

Important Administration Instructions

Instruct patients how to properly take Norco.

Maximum Daily Dose of Acetaminophen

Inform patients not to take more than 4,000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose.

Hypotension

Inform patients that Norco (Hydrocodone Bitartrate with Acetaminophen) may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position).

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in Norco tablets. Advise patients how to recognize such a reaction and when to seek medical attention.

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