What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Saphris (Asenapine)
Also Known as Sycrest
Prescription Required
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Product Details
Description
Saphris is an atypical antipsychotic medication used to treat schizophrenia in adults and bipolar I disorder in adults and pediatric patients ages 10-17 years.
The generic name for Saphris is Asenapine.
Fact Table
Formula
C17H16ClNO
License
EU EMA, US DailyMed, US FDA
Bioavailability
35%
Legal status
Rx-Only
Chemical Name
Asenapine
Elimination half-life
24 hours
Dosage (Strength)
5mg Sublingual, 10mg Sublingual, 10mg (Tablets)
Pregnancy
Consult Doctor
Brands
Saphris
Protein binding
95%
PubChem CID
163091
MedlinePlus
a610015
ChEBI
71253
ATC code
N05AH05
DrugBank
DB06216
KEGG
D11769
Routes of administration
Sublingual, by mouth
Directions
Once you are prescribed and buy Saphris medication (asenapine) or Saphris generic, it is a sublingual tablet that should be placed under the tongue to dissolve. You should not eat or drink for 10 minutes after taking the medication.
Saphris (asenapine) sublingual tablets come in 2.5 mg, 5 mg, and 10 mg strengths.
The dosage for schizophrenia ranges from 5 mg sublingually twice a day to 10 mg sublingually twice a day.
The dosage for bipolar I disorder in adults ranges from 5 mg sublingually twice a day to 10 mg sublingually twice a day.
The dosage for bipolar I disorder in pediatric patients who are 10 to 17 years old ranges from 2.5 mg sublingually twice a day to 10 mg sublingually twice a day.
Ingredients
The active ingredient in Saphris is asenapine, an Atypical antipsychotic.
Contraindications
Do not take Saphris if you have severe liver problems.
Tell your doctor about any allergies you may have. Do not take Saphris if you are allergic to asenapine or any of the other ingredients in Saphris.
Cautions
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warnings.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis.
Saphris (asenapine) may interact with certain medications. Be sure to tell your doctor about any medications you take, including prescription, over-the-counter, vitamins, and herbal supplements.
Saphris (asenapine) may not be right for everyone. Tell your doctor if you:
- Have dementia-related psychosis as your risk of cerebrovascular events such as stroke or heart disease is increased with the use of Saphris.
- Have diabetes or dyslipidemia. You should monitor for changes in blood sugar levels and weight while taking Saphris.
- Experience fever, rigid muscles, confusion, rapid heart rate, or sweating while taking Saphris as these could be signs of neuroleptic malignant syndrome (NMS). If NMS is suspected, stop taking Saphris immediately and seek medical care right away.
- Experience tardive dyskinesia, or uncontrollable movements of the face, neck, or tongue, Saphris may be stopped if clinically appropriate.
- Have blood pressure problems. You should monitor your heart rate and blood pressure while taking Saphris as it can cause a sudden drop in blood pressure when you stand up from lying down or sitting.
- Have a low white blood cell count (WBC) or have had leukopenia or neutropenia. If your WBC count declines significantly without any other cause, your doctor may discontinue Saphris.
- Have risk factors for QT prolongation.Do not take Saphris with drugs that may also increase the QT interval.
- Have a history of seizures or if you have a condition(s) that increases your risk for seizures.
- Have problems sleeping. Saphris may cause sleepiness or drowsiness. Use caution when driving or operating machinery.
- Are pregnant or plan to become pregnant. Taking Saphris while pregnant may increase the risk of extrapyramidal symptoms and/or symptoms of withdrawal in neonates. Women should be advised of the possible risk to the fetus. Please note that there is a pregnancy exposure registry. This registry monitors the health of mom and baby while taking Saphris during pregnancy.
- Are breastfeeding or plan to start breastfeeding. The effects of Saphris (asenapine) while breastfeeding are unknown. Benefits versus risks must be considered.
Side Effects
Like any medication, Saphris can cause side effects. Tell your doctor if you experience any adverse effects while taking Saphris (asenapine). Saphris (asenapine) side effects that are common include:
- Restlessness, unable to sit still
- Reduced sensation in your mouth
- Sleepiness, drowsiness
- Dizziness
- Extrapyramidal symptoms (problems with movement)
- Altered taste
- Nausea
- Fatigue
- Weight gain
- Increase in appetite
References:
SAPHRIS Prescribing Information. Madison, NJ: Allergan USA, 2021.
Tardive Dyskinesia. National Alliance of Mental Illness. Last updated January 2016.
Accessed November 1, 2021.
Frequently Asked Questions about Asenapine
What is Asenapine and what does it treat?
Asenapine is a second-generation antipsychotic medication used to treat schizophrenia, including symptoms like hallucinations, delusions, and disorganized thinking. It also treats acute manic or mixed episodes of bipolar I disorder in adults and children aged 10-17, and is used for the maintenance treatment of bipolar I disorder.
What is the most important information I should know about Asenapine?
Asenapine requires long-term treatment for schizophrenia. It's crucial not to stop taking it even when feeling better, as missing doses can increase the risk of relapse. The medication should be taken exactly as prescribed by a healthcare provider.
Are there specific concerns about Asenapine and pregnancy?
If planning to become pregnant, it's important to consult with a healthcare provider. Antipsychotic use during the third trimester can risk abnormal muscle movements or withdrawal symptoms in newborns. Breastfeeding is not recommended while taking Asenapine.
What should I discuss with my healthcare provider before taking Asenapine?
Discuss symptoms, previous medication responses, any history of muscle stiffness, shaking, tardive dyskinesia, neuroleptic malignant syndrome, or weight gain caused by medications, psychiatric or medical problems, family history of diabetes or heart disease, other medications being taken, and if you are pregnant, planning to become pregnant, or breastfeeding.
How should I take Asenapine?
Asenapine comes in sublingual tablets and a transdermal system. The sublingual tablet should be placed under the tongue and not swallowed or chewed. The transdermal system is applied every 24 hours to different areas such as the hip, abdomen, upper arm, or upper back. The dosage varies and should be determined by a healthcare provider.
What happens if I miss a dose of Asenapine?
If a dose is missed, take it as soon as possible unless it's close to the time of the next dose. Do not double the next dose or take more than prescribed. Keep a regular dosing schedule and consult a healthcare provider for guidance.
What should I avoid while taking Asenapine?
Avoid consuming alcohol or using illegal drugs, as they can decrease the benefits and increase adverse effects of the medication. If using the skin patch, avoid using heating pads or other heating devices on the treated area.
What happens if I overdose with Asenapine?
In case of an overdose, seek urgent medical care or call poison control. There is no specific treatment to reverse the effects of Asenapine overdose.
What are the possible side effects of Asenapine?
Common side effects include drowsiness, insomnia, restlessness, fatigue, headache, weight gain, increased glucose, and cholesterol abnormalities. Serious side effects can include increased prolactin levels, muscle-related side effects, impaired temperature regulation, and metabolic syndrome.
Are there any risks for taking Asenapine for long periods of time?
Long-term use of antipsychotics like Asenapine can lead to tardive dyskinesia, a condition involving involuntary movements. It also increases the risk of diabetes, weight gain, high cholesterol, and high triglycerides.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 10363
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