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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Secuado
Generic Name
Asenapine
Active Ingredient
AsenapineCategory
Atypical Antipsychotic [EPC]
Variants
3
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 5.7 mg/d | FILM, EXTENDED RELEASE | TRANSDERMAL | 68968-0173 |
| 3.8 mg/d | FILM, EXTENDED RELEASE | TRANSDERMAL | 68968-0172 |
| 7.6 mg/d | FILM, EXTENDED RELEASE | TRANSDERMAL |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Secuado, you must consult a qualified healthcare professional.
Detailed information about Secuado
Asenapine is an atypical antipsychotic medication used to treat schizophrenia and manic or mixed episodes associated with Bipolar I disorder. It works by modulating dopamine and serotonin receptors in the brain.
The dosage of asenapine is highly individualized based on the condition being treated and the patient's clinical response.
Asenapine is approved for use in pediatric patients (ages 10-17) specifically for Bipolar I disorder.
No dosage adjustment is typically required for patients with renal impairment, as the kidneys are not the primary route for the clearance of the parent drug.
Asenapine is not recommended for patients with severe hepatic impairment (Child-Pugh Class C). For patients with mild to moderate hepatic impairment, no specific dose adjustment is mandated, but clinical monitoring is advised as drug exposure may be increased.
While specific dose adjustments are not always required based solely on age, elderly patients should generally start at the lower end of the dosing range due to a higher frequency of decreased hepatic, renal, or cardiac function and concomitant diseases.
Proper administration is critical for asenapine's efficacy. If the sublingual tablet is swallowed, it will not work.
For the Secuado patch, apply to clean, dry, intact skin on the upper arm, chest, or back. Rotate application sites daily to avoid skin irritation.
If you miss a dose, 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 schedule. Never double the dose to catch up, as this increases the risk of serious side effects like extreme sedation or movement disorders.
Signs of asenapine overdose may include severe drowsiness, rapid heart rate (tachycardia), low blood pressure (hypotension), and extrapyramidal symptoms (involuntary muscle movements). In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment is generally supportive, focusing on maintaining an open airway and monitoring cardiac function.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without medical guidance, as sudden discontinuation can lead to a relapse of psychiatric symptoms.
Asenapine is generally well-tolerated, but like all antipsychotics, it can cause side effects. The most frequently reported adverse reactions include:
Asenapine is a potent psychiatric medication that requires careful medical supervision. Patients should be aware that this medication can impair judgment, thinking, and motor skills. It is essential to avoid activities requiring mental alertness, such as operating heavy machinery or driving a car, until you are certain that asenapine does not adversely affect your ability to perform these tasks safely.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Asenapine is not approved for the treatment of patients with dementia-related psychosis.
While there are few absolute contraindications for drug combinations with asenapine, it should never be used with other medications that cause a severe prolongation of the QT interval, such as certain anti-arrhythmics (e.g., sotalol, amiodarone) or certain antibiotics (e.g., moxifloxacin), as this can lead to fatal heart rhythms.
There are specific circumstances where asenapine must never be used due to the risk of life-threatening complications:
These are conditions where the drug should be used only if the benefits clearly outweigh the risks, and with extreme caution:
Asenapine is categorized under the newer FDA labeling system which provides a descriptive risk summary. Data on the use of asenapine in pregnant women are limited. However, there are risks to the newborn if antipsychotics are taken during the third trimester. These include Extrapyramidal Symptoms (EPS) and withdrawal symptoms after birth, such as agitation, hypertonia (increased muscle tone), hypotonia (decreased muscle tone), tremor, somnolence, and respiratory distress.
Pregnant women are encouraged to enroll in the National Pregnancy Registry for Atypical Antipsychotics to help monitor the safety of these drugs during pregnancy. The decision to use asenapine during pregnancy must involve a careful discussion between the patient and doctor regarding the risk of untreated psychiatric illness versus the potential risk to the fetus.
Studies in animals have shown that asenapine is excreted in milk. It is not known if asenapine is excreted in human breast milk, but because many drugs are, there is a potential for serious adverse reactions in nursing infants. A risk-benefit analysis is required; often, providers recommend either discontinuing nursing or discontinuing the drug, taking into account the importance of the drug to the mother's mental health.
Asenapine is an atypical antipsychotic that acts as a potent antagonist at several key neurotransmitter receptors. Its primary clinical efficacy in schizophrenia and bipolar disorder is attributed to its high affinity for Dopamine D2 and Serotonin 5-HT2A receptors. By blocking D2 receptors in the mesolimbic pathway, asenapine reduces the 'positive' symptoms of psychosis. Its potent antagonism of 5-HT2A receptors is believed to modulate dopamine release in the prefrontal cortex, which may help with 'negative' symptoms and reduce the risk of extrapyramidal side effects.
Additionally, asenapine has high affinity for 5-HT2C, 5-HT6, and 5-HT7 receptors. Antagonism at 5-HT2C is often linked to antidepressant effects but also weight gain. It also acts as an antagonist at Alpha-1 and Alpha-2 adrenergic receptors and Histamine H1 receptors, which explains its side effects of hypotension and sedation, respectively. Notably, asenapine has virtually no affinity for muscarinic cholinergic receptors, which means it lacks common 'anticholinergic' side effects like blurred vision or severe constipation.
Asenapine shows a rapid onset of receptor binding, but the full therapeutic effect on psychiatric symptoms usually takes several weeks. The dose-response relationship is well-characterized for bipolar mania, where higher doses (10 mg BID) may be more effective than lower doses. Tolerance to the sedative effects may develop over several weeks, but the antipsychotic effects remain stable with long-term use.
Common questions about Secuado
Asenapine is primarily used to treat schizophrenia in adults and Bipolar I disorder in both adults and children aged 10 to 17. In Bipolar I disorder, it is specifically indicated for the acute treatment of manic or mixed episodes, where it can be used alone or in combination with other mood stabilizers like lithium. It helps to reduce symptoms such as hallucinations, delusions, racing thoughts, and extreme mood swings. Your doctor may also prescribe it for long-term maintenance to prevent the recurrence of these symptoms. It is not approved for use in elderly patients with dementia-related psychosis.
The most common side effects reported by patients taking asenapine include extreme sleepiness (somnolence), dizziness, and a temporary numbing or tingling sensation in the mouth or tongue (oral hypoesthesia). Many patients also experience akathisia, which is a distressing feeling of inner restlessness and the need to move constantly. Other frequent side effects include weight gain, increased appetite, and fatigue. While the oral numbness usually fades within an hour, the sleepiness may persist for several days or weeks as your body adjusts to the medication. Always report persistent or worsening side effects to your healthcare provider.
No, you should avoid drinking alcohol while taking asenapine. Asenapine is a central nervous system (CNS) depressant, meaning it slows down brain activity to help manage psychiatric symptoms. Alcohol is also a CNS depressant, and combining the two can lead to dangerous levels of sedation, impaired motor coordination, and respiratory depression. This combination significantly increases the risk of falls, accidents, and severe respiratory distress. Furthermore, alcohol can worsen the underlying symptoms of bipolar disorder and schizophrenia, making the medication less effective overall.
The safety of asenapine during pregnancy has not been fully established in humans, as there are no large-scale, controlled studies in pregnant women. However, using antipsychotics during the third trimester carries a risk of the baby experiencing extrapyramidal symptoms (involuntary movements) or withdrawal symptoms after birth. These symptoms can include agitation, tremors, and difficulty breathing or feeding. If you are pregnant or planning to become pregnant, you must weigh the risks of the medication against the risks of leaving your psychiatric condition untreated. Many doctors recommend joining a pregnancy registry to monitor the health of both the mother and the baby.
While some patients may feel a sedative effect within the first few days of starting asenapine, the full antipsychotic or anti-manic effects typically take longer to manifest. For acute manic episodes, improvement may be noticed within 1 to 2 weeks. For schizophrenia, it often takes 4 to 6 weeks of consistent use to see a significant reduction in hallucinations or delusions. It is vital to continue taking the medication exactly as prescribed, even if you do not feel better immediately. Do not stop taking the drug without consulting your doctor, as the full benefits require steady-state levels in your bloodstream.
No, you should never stop taking asenapine suddenly unless specifically instructed by your doctor in an emergency (such as a severe allergic reaction). Abruptly stopping an antipsychotic can lead to a rapid return of psychiatric symptoms, known as a relapse. You may also experience withdrawal-like symptoms, including extreme nausea, vomiting, insomnia, and irritability. If you and your doctor decide to discontinue the medication, they will provide a tapering schedule to slowly lower your dose over several weeks. This allows your brain chemistry to adjust safely and minimizes the risk of a symptom flare-up.
If you miss a dose of asenapine, take it as soon as you remember, provided it is not almost time for your next scheduled dose. If your next dose is only a few hours away, skip the missed dose and return to your regular twice-daily schedule. Never take two doses at once to make up for a missed one, as this can lead to excessive sedation or movement disorders. Because asenapine must be taken sublingually and requires a 10-minute wait before eating or drinking, try to link your doses to a routine part of your morning and evening that does not involve immediate meals.
Yes, asenapine can cause weight gain, although it is generally considered to have a more moderate effect on weight compared to some other atypical antipsychotics like olanzapine or clozapine. In clinical trials, a percentage of patients experienced an increase in body weight of 7% or more. This weight gain is often linked to an increase in appetite. To manage this, healthcare providers recommend monitoring your weight regularly and maintaining a balanced diet and exercise routine. Your doctor will also monitor your blood sugar and cholesterol levels, as weight gain from antipsychotics can sometimes lead to metabolic changes.
Asenapine can interact with several other medications, so it is crucial to provide your doctor with a full list of everything you take. It should be used with caution alongside drugs that affect the heart's rhythm (QT prolonging drugs) or medications that inhibit the CYP1A2 enzyme, such as fluvoxamine, which can increase asenapine levels. It may also interact with blood pressure medications and other drugs that cause drowsiness. However, it is frequently and safely used as an 'adjunct' therapy with mood stabilizers like lithium or valproate for Bipolar I disorder. Always consult your pharmacist before starting any new over-the-counter supplements.
Yes, asenapine is available as a generic medication in the form of sublingual tablets. The generic version became available after the patent for the brand-name drug, Saphris, expired. Generic medications are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name product. Choosing the generic version can significantly reduce the cost of treatment for many patients. The transdermal patch version (Secuado) may still be under patent protection and might only be available as a brand-name product depending on your location and current year.
Other drugs with the same active ingredient (Asenapine)
> Warning: Stop taking Asenapine and call your doctor immediately if you experience any of these serious reactions:
Prolonged use of asenapine requires monitoring for metabolic changes. This includes the development of Type 2 diabetes, significant elevations in cholesterol and triglycerides (dyslipidemia), and the aforementioned risk of Tardive Dyskinesia. Regular blood work and physical exams are necessary to mitigate these risks. Additionally, long-term use of antipsychotics has been associated with a slight increase in the hormone prolactin, which can lead to menstrual irregularities or breast enlargement in both men and women, though asenapine's effect on prolactin is generally mild.
Asenapine carries a Black Box Warning regarding its use in elderly patients with dementia-related psychosis. Clinical trials have shown that elderly patients treated with antipsychotic drugs for dementia-related psychosis are at an increased risk of death, often from cardiovascular causes (like heart failure or sudden death) or infectious causes (like pneumonia). Asenapine is not FDA-approved for the treatment of patients with dementia-related psychosis.
Report any unusual symptoms to your healthcare provider. Early detection of side effects often allows for dose adjustments that can make the medication more tolerable.
Healthcare providers will typically order the following tests to ensure safety:
Asenapine commonly causes somnolence (drowsiness). Patients should not drive or operate dangerous machinery until they know how the medication affects them. The sedative effect may be more pronounced in the first few weeks of treatment.
Alcohol should be avoided while taking asenapine. Alcohol can significantly increase the sedative effects of the drug, leading to dangerous levels of respiratory depression, impaired coordination, and extreme drowsiness.
Do not stop taking asenapine abruptly. Sudden discontinuation can lead to 'rebound' psychosis or withdrawal-like symptoms, including insomnia, irritability, and return of manic symptoms. If the drug must be stopped, your doctor will provide a tapering schedule to gradually reduce the dose.
> Important: Discuss all your medical conditions, especially heart problems, diabetes, or a history of seizures, with your healthcare provider before starting Asenapine.
Asenapine does not typically interfere with standard laboratory tests, but it can cause physiological changes that appear on tests, such as elevated blood glucose, increased liver enzymes (ALT/AST), or decreased white blood cell counts. It is important to inform the laboratory that you are taking an antipsychotic if you are undergoing a drug screening, as some antipsychotics can occasionally cause false positives for other substances on rapid urine screens.
To manage these interactions, your doctor may:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers and cold medications.
While asenapine is chemically unique, patients who have had severe 'Type I' hypersensitivity reactions (like immediate swelling or hives) to other atypical antipsychotics should be monitored closely during their first dose of asenapine, as there is a theoretical risk of cross-reactivity in the body's immune response to this class of medications.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of liver disease or heart rhythm problems, before prescribing Asenapine.
Asenapine is FDA-approved for the treatment of manic or mixed episodes associated with Bipolar I disorder in children and adolescents aged 10 to 17 years. It has not been established as safe or effective for schizophrenia in patients under 18. Pediatric patients may be more prone to certain side effects, such as weight gain and sedation, compared to adults. Long-term effects on growth and maturation have not been extensively studied.
Clinical studies of asenapine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, geriatric patients are at a higher risk for orthostatic hypotension (falls) and are more sensitive to the sedative effects of the drug. Most importantly, the Black Box Warning regarding increased mortality in dementia-related psychosis applies specifically to this population.
The pharmacokinetics of asenapine are not significantly altered by renal impairment. Therefore, no dosage adjustment is necessary for patients with varying degrees of kidney disease, including those on dialysis. However, as with any medication, the lowest effective dose should be used.
> Important: Special populations require individualized medical assessment and more frequent monitoring of vital signs and metabolic health.
| Parameter | Value |
|---|---|
| Bioavailability | 35% (Sublingual), <2% (Oral) |
| Protein Binding | 95% (Albumin and AAG) |
| Half-life | ~24 hours |
| Tmax | 0.5 to 1.5 hours |
| Metabolism | Direct glucuronidation (UGT1A4), Oxidation (CYP1A2) |
| Excretion | Renal 50%, Fecal 40% |
Asenapine is classified as an Atypical Antipsychotic (also known as a Second-Generation Antipsychotic). It belongs to the dibenzo-oxepino pyrrole chemical class. Related medications in the atypical class include Clozapine, Olanzapine, and Quetiapine, though asenapine’s receptor profile and sublingual delivery make it unique within this group.