WARNING

Taking Apadaz, which combines benzhydrocodone (an opioid) and acetaminophen, carries several risks due to its opioid content and the acetaminophen component. Here’s a detailed breakdown of these risks:

• Opioid Dependence: Benzhydrocodone, being an opioid, has a high potential for dependence. Regular use, especially at high doses or for extended periods, can lead to physical and psychological addiction.
• Abuse Potential: The euphoric effects of opioids can lead to misuse, where individuals might use the drug in ways not intended by a prescription, such as taking larger doses or using it more frequently.
• Respiratory Depression: Opioids like benzhydrocodone can cause severe respiratory depression, where breathing becomes dangerously slow or difficult. This can be life-threatening and requires immediate medical intervention.
• Overdose Symptoms: Signs of an overdose include extreme drowsiness, slow or shallow breathing, confusion, and loss of consciousness. In severe cases, overdose can be fatal.
• Liver Damage: Acetaminophen can cause significant liver damage if taken in doses higher than recommended or for prolonged periods. This risk is heightened in individuals with pre-existing liver conditions or those who consume alcohol regularly.
• Symptoms of Liver Damage: These may include yellowing of the skin or eyes (jaundice), dark urine, severe abdominal pain, nausea, and confusion.
• Constipation: Opioid medications commonly cause constipation. This can become severe and lead to complications such as bowel obstruction if not managed properly.
• Other Gastrointestinal Effects: Nausea and vomiting are also possible and can be uncomfortable and distressing.
• Breathing Problems: The sedative effects of Apadaz can impair breathing. Using Apadaz with other central nervous system depressants, such as alcohol or benzodiazepines, can exacerbate these effects.
• Drowsiness and Impairment: Apadaz can cause significant drowsiness, impairing the ability to perform tasks that require full attention, such as driving or operating machinery.
• Central Nervous System Depressants: Combining Apadaz with other CNS depressants can enhance sedative effects, increasing the risk of serious side effects.
• Interactions with Other Medications: It’s essential to inform your healthcare provider about all other medications you are taking, as interactions can alter the effectiveness of Apadaz or increase the risk of adverse effects.
• Severe Allergic Reactions: Although rare, Apadaz can cause severe allergic reactions such as rash, itching, swelling, severe dizziness, or difficulty breathing. Immediate medical attention is required if these symptoms occur.
• Pregnancy: Opioid use during pregnancy can harm the developing fetus and may lead to withdrawal symptoms in the newborn. Acetaminophen is generally considered safer during pregnancy, but its use should still be monitored by a healthcare provider.
• Breastfeeding: Benzhydrocodone can pass into breast milk and may affect the nursing infant. Consult your healthcare provider about the risks and benefits if you are breastfeeding.
• Discontinuation: Stopping Apadaz suddenly after prolonged use can lead to withdrawal symptoms, including anxiety, agitation, runny nose, yawning, muscle aches, and gastrointestinal upset. Tapering off the medication under medical supervision is recommended to minimize withdrawal effects.
• Children and Others: Accidental ingestion by children or individuals without a prescription can result in serious health issues, including overdose. Proper storage and disposal of Apadaz are crucial to prevent such accidents.
• Enzyme Interactions: Prolonged use of acetaminophen can affect liver enzyme levels, potentially interacting with other medications processed by the liver.

To manage these risks, use Apadaz exactly as prescribed. Do not alter the dosage or frequency without consulting your healthcare provider. Regular follow-ups with your healthcare provider can help monitor for side effects and adjust treatment as needed. Be aware of how to respond in case of an overdose and keep naloxone (if prescribed) accessible.

Always consult with your healthcare provider for advice tailored to your specific health situation and any concerns you may have about taking Apadaz.

Why is this medication prescribed?

Apadaz, which contains benzhydrocodone and acetaminophen, is prescribed primarily for the relief of moderate to severe pain. Hydrocodone is an opioid pain reliever that works by altering the way the brain and nervous system respond to pain, while acetaminophen enhances the effects of hydrocodone and provides additional pain relief. It’s typically used when pain relief from other medications is not sufficient.

How should this medicine be used?

Apadaz should be used exactly as prescribed by your healthcare provider. Here are some general guidelines:

• Dosage: Follow the dosage instructions provided by your doctor. Do not take more or less of the medication than prescribed, and do not take it more frequently than directed.
• Administration: Take the medication orally with a full glass of water. It can be taken with or without food.
• Avoid Crushing or Chewing: Swallow the tablets whole. Do not crush, chew, or break the tablets as this can release the medication too quickly and increase the risk of side effects.
• Avoid Alcohol and Other Sedatives: Do not consume alcohol or use other sedatives while taking Apadaz, as this can increase the risk of serious side effects like respiratory depression.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose; do not double up to make up for a missed dose.
• Storage: Store the medication in a secure place at room temperature, away from moisture and heat. Keep it out of reach of children and others who might misuse it.
• Disposal: Dispose of any unused medication properly. Check if there are any take-back programs in your area, or follow local guidelines for disposal of medications.
• Monitor for Side Effects: Be aware of potential side effects, including dizziness, drowsiness, constipation, and nausea. Contact your doctor if you experience severe side effects like difficulty breathing, severe drowsiness, or signs of an allergic reaction.

Always consult your healthcare provider for personalized instructions and to discuss any concerns you may have about the medication.

Other uses for this medicine

Apadaz is primarily prescribed for managing moderate to severe pain. However, the combination of hydrocodone and acetaminophen may also be used in specific cases such as:

• Post-Surgical Pain: It may be used to manage pain following surgical procedures.
• Injury-Related Pain: It can be prescribed for pain resulting from injuries or trauma.

What special precautions should I follow?

Special Precautions for Apadaz:

• Risk of Addiction, Abuse, and Misuse: Apadaz contains hydrocodone, which is an opioid and has a high potential for addiction, abuse, and misuse. Use the medication only as prescribed and discuss any concerns about dependence with your doctor.
• Respiratory Depression: Opioids can cause serious breathing problems. Seek medical help immediately if you experience symptoms such as severe drowsiness, slow or difficult breathing, or confusion.
• Liver Health: Acetaminophen can cause liver damage if taken in excessive amounts. Avoid consuming alcohol and follow the prescribed dosage to prevent liver toxicity.
• Drug Interactions: Inform your doctor of all other medications you are taking, including over-the-counter drugs, supplements, and other prescriptions. Certain drugs can interact with Apadaz, potentially leading to serious side effects.
• Medical Conditions: Notify your healthcare provider if you have a history of respiratory issues, liver disease, kidney problems, or a history of substance abuse.
• Avoid Operating Machinery: Apadaz can cause drowsiness and impair your ability to perform tasks that require alertness, such as driving or operating machinery.
• Pregnancy and Breastfeeding: If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the risks and benefits of using Apadaz with your healthcare provider.
• Proper Disposal: Dispose of any unused or expired medication properly to prevent misuse. Follow local disposal guidelines or use a drug take-back program.

Always consult your healthcare provider for advice tailored to your specific health needs and conditions.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Apadaz. However, maintaining a healthy diet can help manage any side effects such as constipation, which is a common issue with opioid medications. Drinking plenty of fluids and consuming a fiber-rich diet can help prevent constipation.

What should I do if I forget a dose?

• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose; do not double up to make up for a missed dose.
• Regular Schedule: Try to take Apadaz at the same times each day to help remember to take it and maintain consistent pain relief.

What side effects can this medication cause?

Apadaz can cause a range of side effects, some of which can be serious. Here’s a list of potential side effects:

Common Side Effects:

• Drowsiness or Dizziness: Feeling unusually tired or lightheaded.
• Nausea or Vomiting: Feeling sick to your stomach or throwing up.
• Constipation: Difficulty passing stools or reduced bowel movements.
• Dry Mouth: Reduced saliva production, leading to a dry mouth.

Serious Side Effects:

• Respiratory Depression: Slow or difficult breathing, which can be life-threatening.
• Severe Allergic Reactions: Symptoms such as rash, itching, swelling, severe dizziness, or trouble breathing.
• Severe Drowsiness: Excessive sleepiness or inability to stay awake.
• Liver Damage: Signs may include yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain, or unusual fatigue.
• Confusion or Difficulty Concentrating: Trouble thinking clearly or focusing.
• Mood Changes: Changes in mood, including depression or euphoria.
• Urinary Retention: Difficulty urinating or reduced urine output.

If you experience any severe side effects or symptoms of an overdose (such as extreme drowsiness, slow or difficult breathing, or loss of consciousness), seek emergency medical attention immediately.

Always report any side effects you experience to your healthcare provider, as they can help manage them and adjust your treatment if necessary.

What should I know about storage and disposal of this medication?

Storage and Disposal of Apadaz:

Storage:

• Store Apadaz at room temperature, typically between 68°F and 77°F (20°C and 25°C). Avoid exposure to extreme temperatures.
• Keep the medication in a dry place, away from moisture and heat sources.
• Store Apadaz in a secure location, out of reach of children and others who may misuse it.

Disposal:

• The best way to dispose of unused or expired medication is through a drug take-back program. Check with your local pharmacy, health department, or law enforcement for take-back locations.
• Some medications have specific disposal instructions. Check the FDA website or the medication’s patient information leaflet for any special disposal instructions.

In case of emergency/overdose

• Signs of Overdose: Symptoms may include extreme drowsiness, slow or difficult breathing, loss of consciousness, or pinpoint pupils.
• Immediate Action: Seek emergency medical attention immediately if you suspect an overdose. Contact your local emergency services or go to the nearest emergency room.
• Naloxone: If prescribed, use naloxone (an opioid overdose reversal medication) as directed. Naloxone can temporarily reverse the effects of an opioid overdose and provide time to seek emergency medical help.

What other information should I know?

• Regular Monitoring: Your doctor may need to monitor your response to Apadaz and adjust your dosage as necessary.
• Interactions: Inform your healthcare provider about all other medications, supplements, and health conditions to avoid potential drug interactions.
• Use Only as Prescribed: Use Apadaz only for the condition it was prescribed for and follow the prescribed dosage and frequency to minimize the risk of side effects and dependency.
• Medical History: Keep your healthcare provider informed about any changes in your medical history or health status that could affect your treatment with Apadaz.

Always consult your healthcare provider if you have any questions or concerns about using Apadaz, including questions about storage, disposal, or managing side effects.