WARNING

Studies have shown that older adults who take antipsychotics (medications for mental illness) like olanzapine have an increased risk of dying while receiving treatment. Dementia is a brain disorder that affects memory, thinking clearly, communication, and daily activities as well as possibly causing changes in mood and personality. Additionally, older people with dementia may be more likely to get a stroke or mini-stroke while receiving treatment.

The Food and Drug Administration (FDA) has not given its approval for the use of olanzapine and samidorphan together to treat behavioral issues in dementia-affected older individuals. If you, a loved one, or a person you care for has dementia and is taking olanzapine and samidorphan, speak with the doctor who recommended it.

Why is this medication prescribed?

Olanzapine and samidorphan are used in conjunction to treat the symptoms of schizophrenia in adults. Schizophrenia is a mental condition that results in disturbed or strange thinking, loss of interest in life, and strong or inappropriate emotions. Adults with bipolar disorder (manic depressive disorder; a condition that produces episodes of depression, episodes of mania, and other aberrant moods) may take it by itself or in combination with other drugs to treat episodes of mania (a frenetic, unusually excited, or irritable mood). In adults with bipolar disorder, olanzapine and samidorphan are also used to avoid manic episodes. Olanzapine belongs to a group of drugs known as atypical antipsychotics. It functions by altering the way that some organic brain chemicals behave. An opioid antagonist is samidorphan. It aims to lessen potential negative effects from olanzapine, such as weight gain.

How should this medicine be used?

Samidorphan and olanzapine are available as a tablet for oral use. The normal dosage is one dose per day, with or without food. Take samidorphan and olanzapine at roughly the same time each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. As prescribed, take olanzapine and samidorphan. Never take it in quantities or frequencies other than those recommended by your doctor.

Do not break the tablets; swallow them whole.

Your doctor may begin treating you with a low dose of olanzapine and samidorphan and then gradually increase it.

Olanzapine and samidorphan together may help you manage your symptoms, but they won’t make you better. Even if you feel fine, keep taking samidorphan and olanzapine. Without consulting your doctor, do not discontinue taking olanzapine and/or samidorphan. Your doctor will likely want to progressively reduce your dose.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug may be recommended for another purpose.

What special precautions should I follow?

Olanzapine and samidorphan, whether taken separately or in combination as olanzapine/samidorphan, may have specific precautions that need to be considered. It’s important to note that the following information is not exhaustive, and it’s crucial to consult with your healthcare provider or pharmacist for comprehensive guidance based on your specific medical situation. Here are some general precautions associated with these medications:

• Allergies and Sensitivities: Inform your healthcare provider if you have any known allergies or sensitivities to olanzapine, samidorphan, or any other medications. It’s essential to disclose any previous adverse reactions or allergies to help prevent potential complications.
• Medical History: Provide your healthcare provider with a comprehensive medical history, including any pre-existing conditions or previous adverse reactions to medications. Certain medical conditions, such as liver problems, diabetes, heart diseases, seizures, low blood pressure, or a history of neuroleptic malignant syndrome, may require special consideration or monitoring when taking olanzapine or samidorphan.
• Medication Interactions: Olanzapine and samidorphan can interact with other medications, including prescription, over-the-counter, and herbal supplements. Some medications, such as certain antidepressants, antifungal drugs, or medications affecting liver enzymes, may interact with olanzapine/samidorphan. Inform your healthcare provider about all the medications you are taking to avoid potential interactions.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, it’s essential to discuss the potential risks and benefits of taking olanzapine or samidorphan with your healthcare provider. These medications may have varying effects on the developing fetus or newborn, and a careful evaluation of the situation is necessary.
• Driving and Operating Machinery: Olanzapine and samidorphan may cause drowsiness, dizziness, or impaired judgment. If you experience these side effects, it’s important to exercise caution while driving or operating heavy machinery. It’s recommended to avoid alcohol or other central nervous system depressants that may increase these effects.
• Monitoring: Regular check-ups and monitoring may be necessary while taking olanzapine or samidorphan. This can include assessments of weight, blood pressure, blood sugar levels, lipid profiles, and other relevant parameters. Your healthcare provider will determine the appropriate monitoring schedule based on your individual needs.

Remember, these precautions are not exhaustive, and individual circumstances can vary. Always consult your healthcare provider or pharmacist for personalized advice, taking into account your specific medical history and any other medications you may be taking.

What special dietary instructions should I follow?

Regarding dietary instructions for olanzapine and samidorphan, there are no specific dietary restrictions associated with these medications. However, it’s generally recommended to maintain a balanced and healthy diet while taking any medication. This means consuming a variety of nutritious foods, including fruits, vegetables, whole grains, lean proteins, and healthy fats.

What should I do if I forget a dose?

If you happen to forget a dose of your medication, it’s best to follow the instructions provided by your healthcare provider or the medication’s packaging. In general, if you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. It’s important not to double up on doses unless specifically instructed by your healthcare provider.

What side effects can this medication cause?

Olanzapine and samidorphan are two different medications that are sometimes combined in a single formulation called olanzapine/samidorphan. Each of these medications can cause their own set of side effects. Here’s a breakdown of the potential side effects associated with each medication:

Olanzapine:

• Common side effects: drowsiness, weight gain, increased appetite, dizziness, constipation, dry mouth, and low blood pressure upon standing.
• Less common side effects: blurred vision, increased heart rate, difficulty sleeping, restlessness, tremors, muscle stiffness, difficulty swallowing, and increased levels of cholesterol and triglycerides in the blood.
• Rare but serious side effects: Neuroleptic Malignant Syndrome (a potentially life-threatening condition characterized by fever, muscle rigidity, and altered mental status), tardive dyskinesia (involuntary movements of the face and body), and agranulocytosis (a severe drop in white blood cells).

Samidorphan:

• Common side effects: nausea, vomiting, constipation, headache, and dizziness.
• Less common side effects: sleepiness, dry mouth, increased heart rate, and abnormal liver function tests.

Olanzapine/samidorphan combination: The combination of olanzapine and samidorphan may have similar side effects to those listed above, as well as additional or modified side effects. It’s important to note that combining medications can sometimes alter the side effect profile compared to each medication taken separately.

It’s essential to discuss any concerns or potential side effects with your healthcare provider, as they can provide more specific and up-to-date information based on your individual health situation.

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

Storage and Disposal of Olanzapine and Samidorphan:

1. Storage: Both medications should be stored at room temperature, away from moisture, heat, and light. Follow the specific storage instructions provided by your pharmacist or as indicated on the medication packaging.
2. Disposal: It is important to dispose of medications properly to prevent accidental ingestion or environmental contamination. Follow these guidelines for safe disposal:
   • Check if there are any specific instructions for disposal provided by your healthcare provider or pharmacist.
   • If no specific instructions are given, you can mix the medication with an undesirable substance like coffee grounds or kitty litter in a sealable bag or container and discard it in the household trash.
   • It is advisable not to flush the medication down the toilet unless specifically instructed to do so, as it can contribute to water pollution.

In case of emergency/overdose

In case of an emergency or overdose, it is crucial to seek immediate medical attention. Contact your local emergency services or call your poison control center. Be prepared to provide them with information such as the name of the medication ingested, the dosage if known, and the time of ingestion.

What other information should I know?

• Dosage and Administration: Always take these medications exactly as prescribed by your healthcare provider. Do not alter the dosage or stop taking the medication without consulting your doctor.
• Side Effects: Olanzapine and samidorphan can both cause side effects. Common side effects may include drowsiness, dizziness, weight gain, constipation, and dry mouth. It is important to discuss any concerning or persistent side effects with your doctor.
• Precautions and Warnings: Inform your healthcare provider about any existing medical conditions, allergies, or medications you are currently taking before starting these medications. Olanzapine and samidorphan may not be suitable for everyone and may have interactions with certain medications.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, it is important to discuss the risks and benefits of taking these medications with your doctor.
• Regular Monitoring: Your doctor may require regular check-ups and monitoring to assess the effectiveness of the treatment and monitor for any potential side effects.

Remember, this information is not exhaustive, and it is always important to consult with your healthcare provider or pharmacist for personalized advice and guidance regarding the storage, disposal, and usage of specific medications.