TYLENOL with Codeine (Page 5 of 11)

Hypersensitivity/Anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue TYLENOL® with Codeine immediately and seek medical care if they experience these symptoms. Do not prescribe TYLENOL® with Codeine tablets for patients with acetaminophen allergy (see PRECAUTIONS; Information for Patients/Caregivers).

Risks of Use in Patients with Gastrointestinal Conditions

TYLENOL® with Codeine tablets are contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.

The administration of TYLENOL® with Codeine tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

TYLENOL® with Codeine tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Sulfite Sensitivity

TYLENOL® with Codeine tablets contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Increased Risk of Seizures in Patients with Seizure Disorders

The codeine in TYLENOL® with Codeine tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during TYLENOL® with Codeine tablets therapy.

Withdrawal

Avoid the use of mixed agonist/antagonist (e.g, pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including TYLENOL® with Codeine tablets. In these patients, mixed agonist/antagonist and partial analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms.

When discontinuing TYLENOL® with Codeine, gradually taper the dosage (see DOSAGE AND ADMINISTRATION). Do not abruptly discontinue TYLENOL® with Codeine tablets (see DRUG ABUSE AND DEPENDENCE).

PRECAUTIONS

Risks of Driving and Operating Machinery

TYLENOL® with Codeine tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of TYLENOL® with Codeine tablets and know how they will react to the medication (see PRECAUTIONS; Information for Patients/Caregivers).

Information for Patients/Caregivers

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

Addiction, Abuse and Misuse

Inform patients that the use of TYLENOL® with Codeine tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death (see WARNINGS). Instruct patients not to share TYLENOL® with Codeine tablets with others and to take steps to protect TYLENOL® with Codeine tablets 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 TYLENOL® with Codeine tablets or when the dosage is increased, and that it can occur even at recommended dosages (see WARNINGS). 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 (see WARNINGS). Instruct patients to take steps to store TYLENOL® with Codeine tablets securely. Advise patients to properly dispose of TYLENOL® with Codeine tablets in accordance with local state guidelines and/or regulations.

Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children

Advise caregivers that TYLENOL® with Codeine is contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children 12 to 18 years of age receiving TYLENOL® with Codeine to monitor for signs of respiratory depression (see WARNINGS).

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if TYLENOL® with Codeine is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these drugs concomitantly unless supervised by a healthcare provider (see WARNINGS, PRECAUTIONS; Drug Interactions).

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome and to seek medical attention right away if symptoms develop.

Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications (see PRECAUTIONS; Drug Interactions).

MAOI Interaction

Inform patients not to take TYLENOL® with Codeine tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking TYLENOL® with Codeine tablets (see WARNINGS, Drug Interactions).

Adrenal Insufficiency

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

Important Administration Instructions

Instruct patients how to properly take TYLENOL® with Codeine tablets (see DOSAGE AND ADMINISTRATION).

  • Advise patients not to adjust the dose of TYLENOL® with Codeine without consulting a physician or other healthcare professional.
  • If patients have been receiving treatment with TYLENOL® with Codeine tablets for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication (see WARNINGS).

Maximum Daily Dose of Acetaminophen

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

Hypotension

Inform patients that TYLENOL® with Codeine 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) (see WARNINGS; Hypotension).

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in TYLENOL® with Codeine. Advise patients how to recognize such a reaction, and if they develop signs of allergy such as a rash or difficulty breathing to stop taking TYLENOL® with Codeine and seek medical attention. (see CONTRAINDICATIONS, ADVERSE REACTIONS).

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