Apadaz

Apadaz is:

• a strong prescription pain medicine that contains an opioid (narcotic) and the medicine acetaminophen. It is used to manage short-term pain (no more than 14 days), when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

• Get emergency help right away if you take too much Apadaz, or overdose. When you first start taking Apadaz, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking Apadaz with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your Apadaz. They could die from taking it. Store this medicine away from children and in a safe place to prevent stealing or abuse. Selling or giving away Apadaz is against the law.
• Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking Apadaz with other products that contain acetaminophen can lead to serious liver problems and death.

• Do not change your dose. Take this medicine exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Apadaz regularly, do not stop abruptly without talking to your healthcare provider.
• After you stop taking Apadaz, flush any unused tablets down the toilet or contact the Drug Enforcement Agency (DEA) at 1­ 800—882-9539 for an authorized collector.
• Do not drive or operate heavy machinery, until you know how Apadaz affects you. Apadaz can make you sleepy, dizzy, or lightheaded.
• Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Apadaz may cause you to overdose and die.
• Do not take other products that contain acetaminophen.

Applies to acetaminophen / benzhydrocodone: oral tablet

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• chest pain, fast heartbeats, shallow breathing;

• extreme drowsiness;

• a light-headed feeling, like you might pass out;

• confusion; or

• liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common side effects include:

• nausea, vomiting, constipation.

• dizziness, drowsiness;

• headache; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Applies to acetaminophen / benzhydrocodone: oral tablet

General

The most commonly reported adverse reactions have included nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.[Ref]

Respiratory

Rhinitis has been reported in less than 1% of patients.

Frequency not reported: Rhinitis

Opioids:
Frequency not reported: Respiratory depression

Dermatologic

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) have been associated with acetaminophen use.

Common (1% to 10%): Pruritus

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions

Hepatic

Acetaminophen:
Frequency not reported: Hepatotoxicity

Gastrointestinal

Very common (10% or more): Nausea (21.5%), vomiting (13%), constipation (12%)
Common (1% to 10%): Abdominal distension, abdominal pain, flatulence
Frequency not reported: Diarrhea, gastroesophageal reflux disease, hematemesis

Diarrhea, gastroesophageal reflux disease, and hematemesis have been reported in less than 1% of patients.

Psychiatric

Frequency not reported: Agitation, euphoric mood, nightmare

Agitation, euphoric mood, and nightmare have been reported in less than 1% of patients.

Nervous system

Very common (10% or more): Somnolence (18.5%)
Common (1% to 10%): Dizziness, headache, asthenia, presyncope, tremor
Frequency not reported: Syncope, hypoesthesia
Postmarketing reports: Serotonin syndrome

Syncope and hypoesthesia have been reported in less than 1% of patients. Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.

Cardiovascular

Chest discomfort has been reported in less than 1% of patients.

Common (1% to 10%): Hypotension, hot flush
Frequency not reported: Chest discomfort

Ocular

Eye pruritus has been reported in less than 1% of patients.

Frequency not reported: Eye pruritus

Endocrine

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of adrenal insufficiency and androgen deficiency have been reported with opioid use, more often following greater chronic use.

Hypersensitivity

Postmarketing reports: Anaphylaxis

Anaphylaxis has been reported with ingredients contained in this product.

Applies to acetaminophen / benzhydrocodone: oral tablet

General

The most commonly reported adverse reactions have included nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.[Ref]

Respiratory

Rhinitis has been reported in less than 1% of patients.

Frequency not reported: Rhinitis

Opioids:
Frequency not reported: Respiratory depression

Dermatologic

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) have been associated with acetaminophen use.

Common (1% to 10%): Pruritus

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions

Hepatic

Acetaminophen:
Frequency not reported: Hepatotoxicity

Gastrointestinal

Very common (10% or more): Nausea (21.5%), vomiting (13%), constipation (12%)
Common (1% to 10%): Abdominal distension, abdominal pain, flatulence
Frequency not reported: Diarrhea, gastroesophageal reflux disease, hematemesis

Diarrhea, gastroesophageal reflux disease, and hematemesis have been reported in less than 1% of patients.

Psychiatric

Frequency not reported: Agitation, euphoric mood, nightmare

Agitation, euphoric mood, and nightmare have been reported in less than 1% of patients.

Nervous system

Very common (10% or more): Somnolence (18.5%)
Common (1% to 10%): Dizziness, headache, asthenia, presyncope, tremor
Frequency not reported: Syncope, hypoesthesia
Postmarketing reports: Serotonin syndrome

Syncope and hypoesthesia have been reported in less than 1% of patients. Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.

Cardiovascular

Chest discomfort has been reported in less than 1% of patients.

Common (1% to 10%): Hypotension, hot flush
Frequency not reported: Chest discomfort

Ocular

Eye pruritus has been reported in less than 1% of patients.

Frequency not reported: Eye pruritus

Endocrine

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of adrenal insufficiency and androgen deficiency have been reported with opioid use, more often following greater chronic use.

Hypersensitivity

Postmarketing reports: Anaphylaxis

Anaphylaxis has been reported with ingredients contained in this product.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer