WARNING

Embeda is a prescription medication used to treat severe pain. It contains two active ingredients: morphine, an opioid pain reliever, and naltrexone, which is intended to help deter abuse of the medication. However, like all opioid medications, Embeda carries certain risks, including:

• Addiction: Opioids like morphine can be highly addictive, leading to physical and psychological dependence.
• Overdose: Taking too much Embeda can lead to respiratory depression, coma, and even death. This risk is heightened when the medication is misused or abused.
• Tolerance: Over time, individuals may develop a tolerance to Embeda, requiring higher doses to achieve the same level of pain relief.
• Withdrawal: Stopping Embeda suddenly can lead to withdrawal symptoms, which can be severe and include flu-like symptoms, anxiety, insomnia, and cravings.
• Respiratory depression: Embeda, like other opioids, can slow down breathing, especially at higher doses or when combined with other central nervous system depressants such as alcohol or benzodiazepines.
• Constipation: Opioids commonly cause constipation, which can be severe and require additional medication to manage.
• Drug interactions: Embeda can interact with other medications, including other opioids, sedatives, and certain antidepressants, potentially leading to dangerous side effects or reduced effectiveness.
• Misuse and abuse: Despite the addition of naltrexone to deter abuse, Embeda can still be misused or abused, especially by crushing or injecting the medication to bypass its extended-release mechanism.

It’s crucial for individuals prescribed Embeda to use it exactly as directed by their healthcare provider and to be aware of these risks. They should also discuss any concerns or potential side effects with their doctor.

Why is this medication prescribed?

Embeda is prescribed to manage severe pain that requires around-the-clock treatment and cannot be effectively managed with other pain medications. It is specifically indicated for long-term opioid treatment where alternative treatment options are inadequate. Embeda contains two active ingredients: morphine, which is an opioid pain reliever, and naltrexone, which is intended to help deter abuse of the medication. The morphine component provides pain relief, while the naltrexone component is designed to remain inactive unless the medication is tampered with (such as crushing or chewing), which is intended to deter abuse by making it less appealing to those seeking to misuse or abuse the medication. Embeda is typically prescribed for conditions such as chronic back pain, severe osteoarthritis pain, cancer pain, or other conditions causing severe and persistent pain.

How should this medicine be used?

Embeda should be used exactly as prescribed by a healthcare provider. Here are some general guidelines for its use:

• Dosage: The dosage of Embeda will be determined by a healthcare provider based on the severity of the pain, the patient’s medical history, and their response to opioid medications. It is important to take Embeda exactly as prescribed and not to change the dosage without consulting a healthcare professional.
• Administration: Embeda is usually taken orally, with or without food, every 12 hours. It is important to swallow the capsules whole and not to crush, chew, or dissolve them, as this can lead to a rapid release of the medication and increase the risk of overdose.
• Avoid alcohol: It is important to avoid alcohol while taking Embeda, as it can increase the risk of side effects such as drowsiness, dizziness, and respiratory depression.
• Monitor for side effects: Patients taking Embeda should be aware of potential side effects and contact their healthcare provider if they experience any unusual symptoms. Common side effects may include constipation, nausea, vomiting, dizziness, drowsiness, and headache.
• Avoid abrupt discontinuation: Embeda should not be stopped suddenly without consulting a healthcare provider, as this can lead to withdrawal symptoms. When discontinuing Embeda, the dosage should be gradually tapered under the guidance of a healthcare professional.
• Store properly: Embeda should be stored at room temperature away from moisture and heat. It should be kept out of reach of children and pets.
• Follow-up appointments: Patients taking Embeda should have regular follow-up appointments with their healthcare provider to monitor their response to the medication, adjust the dosage if necessary, and discuss any concerns or side effects.

It’s important for patients to communicate openly with their healthcare provider about their pain management and any concerns they may have about taking Embeda.

Other uses for this medicine

Embeda is primarily prescribed for the management of severe pain that requires around-the-clock treatment and cannot be effectively managed with other pain medications. It is not typically used for other conditions or purposes unless specifically directed by a healthcare provider.

What special precautions should I follow?

Special precautions should be taken when using Embeda, including:

• Medical history: Before taking Embeda, patients should inform their healthcare provider about their medical history, especially if they have a history of breathing problems, liver or kidney disease, mental/mood disorders, substance use disorder, or a personal or family history of substance abuse.
• Allergies: Patients should inform their healthcare provider about any allergies they have, particularly to opioids or naloxone (the active ingredient in Embeda).
• Pregnancy and breastfeeding: Embeda should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. It may also pass into breast milk and could have undesirable effects on a nursing infant. Patients should discuss the risks and benefits with their healthcare provider before using Embeda while pregnant or breastfeeding.
• Interactions: Patients should inform their healthcare provider about all the medications they are currently taking, including prescription and over-the-counter drugs, as well as any herbal supplements. Embeda can interact with certain medications, including other opioids, sedatives, tranquilizers, muscle relaxants, monoamine oxidase inhibitors (MAOIs), and certain antidepressants. These interactions can increase the risk of side effects or reduce the effectiveness of Embeda.
• Driving and operating machinery: Embeda may cause drowsiness, dizziness, or blurred vision, which can impair the ability to drive or operate machinery safely. Patients should avoid these activities until they know how Embeda affects them.
• Alcohol: Patients should avoid consuming alcohol while taking Embeda, as it can increase the risk of side effects, including drowsiness, dizziness, and respiratory depression.
• Overdose risk: Patients should be aware of the signs of opioid overdose, including slowed or shallow breathing, extreme drowsiness, difficulty waking up, and confusion. If overdose is suspected, medical attention should be sought immediately.
• Storage: Embeda should be stored securely out of reach of children and pets, at room temperature away from moisture and heat.

Patients should follow their healthcare provider’s instructions carefully and communicate openly about any concerns or side effects they experience while taking Embeda.

What special dietary instructions should I follow?

Regarding dietary instructions, there are no specific dietary restrictions associated with taking Embeda. However, patients should follow a balanced diet and maintain good hydration to support overall health and well-being.

What should I do if I forget a dose?

If a dose of Embeda is missed, patients should take it as soon as they remember, unless it is close to the time of their next scheduled dose. In that case, they should skip the missed dose and resume their regular dosing schedule. Patients should not double the dose to make up for a missed one. If they are unsure about what to do, they should consult their healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Embeda, like other opioid medications, can cause a range of side effects. Common side effects may include:

• Constipation: This is one of the most common side effects of opioid medications like Embeda. It can be managed with dietary changes, increased water intake, and over-the-counter medications if necessary.
• Nausea and vomiting: These gastrointestinal side effects are common when starting Embeda but may improve over time. Taking Embeda with food can help reduce the likelihood of experiencing nausea.
• Drowsiness: Embeda can cause drowsiness or sedation, which may impair the ability to perform tasks that require alertness, such as driving or operating machinery.
• Dizziness: Some people may experience dizziness or lightheadedness while taking Embeda, especially when standing up quickly. It’s important to get up slowly from a sitting or lying position to minimize the risk of falls.
• Headache: Headaches are a possible side effect of Embeda, though they are usually mild and temporary.
• Dry mouth: Opioids like Embeda can cause dry mouth, which may be alleviated by drinking water or chewing sugarless gum.
• Sweating: Some people may experience increased sweating while taking Embeda, particularly at higher doses.
• Itching: Itching or pruritus can occur with opioid use, though it is generally mild. If severe itching develops, patients should contact their healthcare provider.
• Difficulty urinating: Opioids can sometimes cause difficulty urinating, particularly in men with prostate enlargement. Patients experiencing this symptom should seek medical advice.
• Respiratory depression: In high doses or when combined with other respiratory depressants, Embeda can cause slowed or shallow breathing, which can be dangerous. This is more common in individuals who are opioid-naive or in those with pre-existing respiratory conditions.
• Allergic reactions: Rarely, Embeda can cause allergic reactions such as hives, rash, itching, difficulty breathing, or swelling of the face, lips, tongue, or throat. Patients experiencing these symptoms should seek immediate medical attention.

It’s important for patients to discuss any concerns or persistent side effects with their healthcare provider. Additionally, if any serious side effects or signs of overdose occur (such as extreme drowsiness, difficulty breathing, or loss of consciousness), emergency medical attention should be sought immediately.

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

Storage and disposal of Embeda:

• Storage: Embeda should be stored at room temperature (between 68-77°F or 20-25°C) away from moisture and heat. It should be kept in a secure location out of reach of children and pets.
• Disposal: Unused or expired Embeda should be disposed of properly to prevent accidental ingestion, misuse, or environmental contamination. The FDA recommends several methods for safe disposal:
  • Take-back programs: Many pharmacies, hospitals, and law enforcement agencies offer take-back programs or events for unused medications.
  • Drug disposal pouches: Drug deactivation systems such as drug disposal pouches or kits can be used to safely deactivate and dispose of medications at home.
  • Flush down the toilet: If no take-back options are available and immediate disposal is necessary to prevent accidental ingestion, the FDA recommends flushing certain medications, including Embeda, down the toilet. However, patients should first check local regulations and guidelines regarding medication disposal.

In case of emergency/overdose

• Seek medical attention: In case of an overdose or emergency related to Embeda, such as extreme drowsiness, difficulty breathing, or loss of consciousness, immediate medical attention should be sought. Call emergency services or go to the nearest emergency room.
• Naloxone: Naloxone is a medication used to rapidly reverse the effects of opioid overdose, including those caused by Embeda. Naloxone is available in various forms, including nasal spray and injectable formulations, and can be administered by bystanders or emergency responders.

What other information should I know?

• Avoid alcohol: Patients should avoid consuming alcohol while taking Embeda, as it can increase the risk of side effects such as drowsiness, dizziness, and respiratory depression.
• Follow-up appointments: Patients taking Embeda should have regular follow-up appointments with their healthcare provider to monitor their response to the medication, adjust the dosage if necessary, and discuss any concerns or side effects.
• Storage: Embeda should be stored securely out of reach of children and pets, at room temperature away from moisture and heat.
• Missed dose: If a dose of Embeda is missed, patients should take it as soon as they remember, unless it is close to the time of their next scheduled dose. In that case, they should skip the missed dose and resume their regular dosing schedule. Patients should not double the dose to make up for a missed one.
• Side effects: Patients should be aware of potential side effects of Embeda and contact their healthcare provider if they experience any unusual symptoms or concerns.
• Addiction and dependence: Patients should be aware of the risk of addiction and dependence associated with opioids like Embeda. It is important to take Embeda only as prescribed and to discuss any concerns about dependence or addiction with a healthcare provider.