WARNING

Zohydro ER (extended-release) is a prescription medication that contains hydrocodone, an opioid analgesic used to manage severe pain. As with any medication, Zohydro ER carries certain risks and potential side effects. It’s important to note that only a qualified healthcare professional can provide personalized medical advice, so individuals considering this medication should consult with their healthcare provider. Here are some general risks associated with Zohydro ER:

• Opioid Addiction and Dependence: Zohydro ER belongs to the opioid class of drugs, and like other opioids, there is a risk of addiction and physical dependence. Individuals may develop tolerance over time, requiring higher doses to achieve the same pain-relieving effects.
• Respiratory Depression: Opioids can cause respiratory depression, a slowing or stopping of breathing. This risk is particularly relevant if the medication is misused, taken in excessive doses, or combined with other substances that depress the respiratory system, such as alcohol.
• Central Nervous System Effects: Zohydro ER may cause drowsiness, dizziness, and impaired mental or physical abilities. Patients are typically advised to avoid activities requiring mental alertness, such as driving, until they know how the medication affects them.
• Gastrointestinal Effects: Opioids, including Zohydro ER, can cause constipation. It’s important for individuals taking this medication to maintain adequate hydration, dietary fiber, and, if necessary, use laxatives as recommended by their healthcare provider.
• Interactions with Other Medications: Zohydro ER may interact with other medications, including those that depress the central nervous system (e.g., benzodiazepines, certain antidepressants). Combining these substances can increase the risk of adverse effects, including respiratory depression.
• Risk of Overdose: Taking too much Zohydro ER can lead to an overdose, which can be life-threatening. It’s crucial to follow the prescribed dosage and not to exceed recommended limits.
• Withdrawal Symptoms: Abruptly stopping Zohydro ER after prolonged use may lead to withdrawal symptoms. These can include irritability, anxiety, insomnia, and flu-like symptoms.
• Pregnancy and Breastfeeding: Zohydro ER may have risks during pregnancy and breastfeeding. It’s important for pregnant or breastfeeding individuals to discuss the potential risks and benefits with their healthcare provider.

Patients should communicate openly with their healthcare provider about their medical history, any existing conditions, and other medications they are taking to ensure safe and effective use of Zohydro ER. Additionally, healthcare providers may monitor patients closely while on this medication to manage risks and address any emerging concerns.

Why is this medication prescribed?

Zohydro ER (extended-release hydrocodone) is a prescription medication used for the management of severe pain that requires around-the-clock, long-term treatment and for which alternative treatment options are inadequate. It is an opioid analgesic and is classified as a Schedule II controlled substance due to its potential for abuse and dependence.

Zohydro ER is specifically indicated for the management of severe pain that is not effectively controlled with other treatments.

How should this medicine be used?

Zohydro ER (extended-release hydrocodone) should be used exactly as prescribed by a healthcare professional. It’s important to follow the prescribed dosage and administration instructions carefully. Here are general guidelines for using Zohydro ER:

• Prescription Only: Zohydro ER is a prescription medication and should only be used under the supervision and guidance of a qualified healthcare provider.
• Individualized Dosage: The dosage of Zohydro ER is individualized based on the severity of the pain, the patient’s response to opioids, and their previous opioid history. The healthcare provider will start with the lowest effective dose.
• Extended-Release Formulation: Zohydro ER is an extended-release formulation designed to provide pain relief over an extended period, typically every 12 hours. It is crucial not to crush, chew, or dissolve the capsules, as this can lead to the rapid release of a potentially fatal dose of hydrocodone.
• Swallow Whole: The capsules should be swallowed whole with a glass of water. They should not be broken, chewed, crushed, or dissolved.
• Timing of Administration: Zohydro ER is usually taken every 12 hours. Patients should follow the prescribed schedule consistently.
• With or Without Food: Zohydro ER can be taken with or without food. However, consistent administration with or without food is recommended.
• Avoid Alcohol: Patients are typically advised to avoid alcohol while taking Zohydro ER, as combining opioids with alcohol can increase the risk of central nervous system depression.
• Regular Monitoring: Patients should be regularly monitored for the effectiveness of pain management, the occurrence of side effects, signs of misuse or abuse, and the development of tolerance or dependence.
• Medical Assistance: If there are concerns about the medication or if side effects are experienced, it’s important to contact the healthcare provider promptly.

Patients should communicate openly with their healthcare provider about their pain levels, any side effects experienced, and any concerns or questions they may have about Zohydro ER. It’s crucial to use the medication exactly as prescribed to maximize the benefits and minimize the risks associated with opioid use.

Other uses for this medicine

Zohydro ER is not typically used for purposes other than pain management. It is not indicated for acute pain, postoperative pain, or mild to moderate pain. The formulation and extended-release nature of Zohydro ER make it suitable for long-term, around-the-clock pain management in opioid-tolerant individuals.

What special precautions should I follow?

As for special precautions when using Zohydro ER, consider the following:

• Opioid-Tolerant Patients: Zohydro ER is intended for use in patients who are already tolerant to opioid therapy of a comparable potency. Initiating therapy in opioid-naive patients can lead to life-threatening respiratory depression.
• Respiratory Depression: Zohydro ER can cause respiratory depression, especially during initiation or dose titration. Monitor patients closely, particularly those with chronic obstructive pulmonary disease (COPD) or other conditions that may compromise respiratory function.
• Abuse and Addiction: Zohydro ER has a high potential for abuse and addiction. Assess patients for their risk of substance abuse before prescribing. Caution is needed when prescribing opioids to patients with a history of substance abuse.
• Accidental Ingestion: Accidental ingestion, especially by children, can be fatal due to the high potency of hydrocodone. Store Zohydro ER securely and out of reach of children.
• Concurrent Use with Alcohol or other CNS Depressants: Concurrent use of Zohydro ER with alcohol or other central nervous system (CNS) depressants may result in respiratory depression, sedation, and death. Advise patients to avoid alcohol and other medications that may cause CNS depression.
• Hepatic Impairment: Use with caution in patients with hepatic impairment, as hydrocodone is metabolized in the liver. Adjust the dosage accordingly.
• Renal Impairment: Use with caution in patients with renal impairment. Adjust the dosage based on the severity of impairment.
• Head Injury and Increased Intracranial Pressure: Zohydro ER may obscure the clinical course in patients with head injuries. Avoid use in patients with impaired consciousness or coma.
• Pregnancy and Breastfeeding: Exercise caution when prescribing Zohydro ER to pregnant or breastfeeding women, considering the potential risks to the fetus or infant.
• Discontinuation and Withdrawal: Taper the dosage gradually when discontinuing Zohydro ER to avoid withdrawal symptoms. Monitor patients for signs of withdrawal if discontinuation is necessary.

Patients should always inform their healthcare provider about their medical history, existing conditions, medications they are currently taking, and any concerns or side effects experienced. It is crucial for patients to take Zohydro ER exactly as prescribed and not make adjustments to the dosage without consulting their healthcare provider. Regular follow-up appointments are essential for monitoring the ongoing need for opioid therapy and assessing any potential adverse effects.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Zohydro ER. However, it’s important to maintain a balanced and healthy diet to support overall well-being.

What should I do if I forget a dose?

If you miss a dose of Zohydro ER, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed one.

What side effects can this medication cause?

Zohydro ER (extended-release hydrocodone) can cause various side effects, and it’s important to be aware of them. Common side effects may occur, and there are also serious side effects that require immediate medical attention. Note that this is not an exhaustive list, and individuals may experience side effects differently. If you are prescribed Zohydro ER, it’s crucial to discuss potential side effects with your healthcare provider and report any unusual or severe reactions. Here are some possible side effects:

Common Side Effects:

• Constipation: Opioids, including Zohydro ER, can lead to constipation. Adequate fluid intake, dietary fiber, and exercise may help manage this side effect.
• Nausea and Vomiting: These gastrointestinal symptoms are common with opioid use and may improve with continued use.
• Drowsiness and Dizziness: Zohydro ER may cause drowsiness or dizziness. Avoid activities that require mental alertness, such as driving, until you know how the medication affects you.
• Headache: Some individuals may experience headaches as a side effect.
• Fatigue: Opioids can cause fatigue or feelings of tiredness.

Serious Side Effects:

• Respiratory Depression: This is a potentially life-threatening side effect characterized by slow or shallow breathing. Seek immediate medical attention if you experience difficulty breathing.
• Hypotension: Zohydro ER can cause low blood pressure, leading to dizziness or fainting.
• Adrenal Insufficiency: Prolonged use of opioids may affect the adrenal glands, resulting in symptoms such as nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.
• Severe Constipation: In some cases, constipation may become severe and require medical intervention.
• Paralytic Ileus: This is a condition where the intestines are unable to move, causing a blockage. Symptoms may include severe abdominal pain, vomiting, and bloating.
• Serotonin Syndrome: This is a potentially life-threatening condition that can occur when there is an excess of serotonin in the body. Symptoms include agitation, hallucinations, rapid heartbeat, fever, muscle stiffness, and coordination problems.
• Allergic Reactions: Seek immediate medical attention if you experience signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing.
• Risk of Addiction and Dependence: Long-term use of opioids, including Zohydro ER, can lead to physical dependence and addiction.

It’s important to take Zohydro ER exactly as prescribed and to report any side effects to your healthcare provider. If you experience severe or life-threatening symptoms, seek emergency medical attention. Additionally, discuss any concerns or questions about the medication with your healthcare provider, and attend regular follow-up appointments to monitor your response to the medication and adjust the treatment plan as needed.

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

Storage and Disposal of Zohydro ER:

• Storage:
  • Store Zohydro ER at room temperature away from light and moisture.
  • Keep it in a secure place out of reach of children and pets.
  • Do not share your medication with others.
• Disposal:
  • Dispose of unused or expired Zohydro ER properly to prevent accidental ingestion.
  • Follow local guidelines or regulations for medication disposal. Do not flush medications down the toilet unless instructed to do so.

In case of emergency/overdose

• Signs of Overdose:
  • Symptoms of opioid overdose may include extreme drowsiness, difficulty waking up, confusion, slow or shallow breathing, pinpoint pupils, and loss of consciousness.
• Emergency Action:
  • If you suspect an overdose, call emergency services (e.g., 911) immediately.
  • Stay with the person until help arrives.
  • If trained, administer naloxone if available and follow the instructions.

What other information should I know?

• Regular Follow-Up: Attend all scheduled appointments with your healthcare provider to assess the ongoing need for Zohydro ER and monitor for side effects.
• Communication: Inform your healthcare provider of any changes in your health status, new medications, or concerns about your pain management.
• Avoid Alcohol and Sedatives: Avoid consuming alcohol or using other medications that depress the central nervous system while taking Zohydro ER, as this can increase the risk of respiratory depression.
• Driving and Operating Machinery: Zohydro ER may cause drowsiness or dizziness. Avoid activities that require mental alertness until you know how the medication affects you.
• Avoid Abrupt Discontinuation: Do not stop taking Zohydro ER suddenly without consulting your healthcare provider. Abrupt discontinuation can lead to withdrawal symptoms.
• Allergy Information: Inform your healthcare provider of any allergies or sensitivities you may have, especially if you’ve had an allergic reaction to opioids in the past.
• Inform Other Healthcare Providers: Make sure to inform other healthcare providers, including dentists and emergency medical personnel, that you are taking Zohydro ER.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your healthcare provider. The risks and benefits of opioid use during pregnancy and breastfeeding should be carefully considered.
• Misuse and Addiction: Be aware of the potential for misuse, abuse, and addiction with opioids. Follow your healthcare provider’s instructions carefully and report any concerns promptly.

Always keep a list of your medications and share it with all your healthcare providers. In case of any uncertainties or questions, consult your healthcare provider for guidance. The information provided here is not a substitute for professional medical advice, diagnosis, or treatment.