SAPHRIS (ASENAPINE)

Saphris is a brand name for a generic antipsychotic, sublingual tablet called Asenapine. It is a prescription medication that got FDA approval in 2009 to provide relief from symptoms of certain mood/mental disorders. Doctors prescribe Saphris as monotherapy to treat schizophrenia in adults and acute manic or mixed episodes of bipolar I disorder in patients aged 10 to 17 years. For adults suffering from bipolar 1 disorder, Saphris may be given by the doctor in combination with lithium and valproate.

Saphris tablets contain Asenapine maleate as its active ingredient and the following inactive ingredients: sucralose, gelatin, black cherry flavor, and mannitol. Asenapine maleate is a white to off-white powder that is a member of class dibenzo-oxepino pyrroles. It is chemically designated as (3aRS,12bRS)-5Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo [2,3:6,7] oxepino [4,5-c] pyrrole (2Z)-2-butenedioate (1:1).

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Saphris belongs to the pharmacological class: Second generation Antipsychotics (Atypical antipsychotics).

Antipsychotics are a class of medications known to be effective in treating mental illnesses that affect one’s thoughts, moods, and behavior. They are of two kinds: First generation or typical antipsychotics and Second generation or atypical antipsychotics. The latter type is a safer and more effective antipsychotic. It works to alter the activities of brain chemicals: serotonin and dopamine.

Glyxambi comes in various different strengths, including:

Saphris tablets come in three strengths. All of the tablets are white to off-white, round, and have a black cherry flavor.

• 2.5 mg: This strength tablet has a hexagon on one side.
• 5 mg: This strength tablet is imprinted with “5” on one side within a circle.
• 10 mg: This strength tablet is imprinted with “10” on one side within a circle.

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• Schizophrenia: It is a chronic mental illness that can affect emotions, behavior, and thinking. This condition features delusions, hallucinations, disordered speech and thinking, lack of initiative/drive, and/or extremely disorganized or unusual movement. Saphris tablets can be taken for the short term to treat schizophrenia symptoms or as maintenance therapy. Clinical drug research studies reveal Saphris as an effective medication in improving all symptoms of Schizophrenia in adults.
• Bipolar 1 disorder: It is another mental illness/mood disorder caused by a prolonged imbalance in brain chemicals having a role in mood and behavior. High mood is known as mania and low mood is depression. Bipolar 1 disorder patients experience episodes of mania, depression, or both. The intake of Saphris tablets can help treat manic or mixed episodes of Bipolar 1 disorder.

Doctors recommend the specific dosage of Saphris to patients based on their medical condition, tolerability to the drug, personal needs, and other medications that they might be taking.

• The suggested initial dose for schizophrenia patients is 5 mg daily, twice a day. In certain cases, the dose may be increased to 10 mg twice daily.
• The suggested dose for adults having Bipolar 1 disorder is 5 to 10 mg twice daily. 5 mg is the recommended initial dose in case of adjunct therapy while 10 mg is the suggested initial dose for monotherapy.
• The suggested initial dose for 10–17-year-old patients having Bipolar 1 disorder is 2.5 mg twice a day.
• The maximum prescribed dose to treat schizophrenia or Bipolar 1 disorder is 20 mg per day.

Saphris is available in the form of sublingual tablets. Place the Saphris tablet underneath the tongue and the saliva will dissolve the tablet in the mouth. Avoid eating and drinking anything for a minimum of 10 minutes after taking the medication.

Common side effects of Saphris include:

• Restlessness or agitated feeling
• Increase in appetite, and weight gain
• Muscle stiffness or jerky muscle movements
• Drowsiness, dizziness, and tiredness
• Upset stomach, constipation
• Tingling or numbness of the mouth
• Dry mouth or altered taste sense

Some of the serious side effects that call for prompt medical attention are:

• Tremors or uncontrollable shaking
• A constant need to move
• Difficulty swallowing or drooling
• Feeling of anxiety or agitation
• Stiff muscles
• Sleep apnea
• Effects of low white blood counts
• Ulcers, swelling, blisters, or peeling in the mouth
• Breast pain or swelling, nipple discharge
• Shuffling walk

The intake of Saphris tablets with certain drugs, supplements, or substances, may make Saphris less effective and cause serious or fatal side effects. Some drugs known to interact with Saphris include:

• Antihypertensive medications
• Strong CYP1A2 inhibitors like Fluvoxamine
• CYP2D6 substrates and inhibitors like Paroxetine
• Antihistamines
• Anticholinergic/antispasmodic drugs
• Antidepressants
• Alpha-blockers
• Muscle relaxants
• Narcotic drugs
• Drugs for sleep or anxiety
• Antibiotics
• Quinidine
• Procainamide
• Dofetilide
• Theophylline
• Tramadol

Saphris tablets are not meant for use or be safe for consumption by:

• Older patients suffering from dementia-related psychosis
• Woman who is in her last three months of pregnancy
• Patients suffering from severe hepatic impairment
• People who are allergic to asenapine or other ingredients of Saphris.
• Anyone suffering from cardiac problems, hypertension, arrhythmia, stroke, or heart attack
• Diabetic individuals
• Breast cancer patients
• People having low WBC count or low QT syndrome
• People facing difficulty in swallowing
• People suffering from seizures or Parkinson’s disease
• Lactating mothers
• Children aged below 10 years

While on treatment course with Saphris:

• Consult a doctor about whether it's right to take Risperdal tablets in your pregnancy or while breastfeeding.
• Avoid drug/disease interactions with Saphris by sharing information about your current intake of drugs, and illnesses (if any) with your doctor.
• Avoid any activities like driving that require an alert mind, as Saphris may impair thinking abilities, judgment, and reactions.
• Do not consume alcohol.
• Avoid sudden changes in postures, as Saphris can cause dizziness or drowsiness.
• Avoid getting your body overheated or severely dehydrated in hot weather or while working out.
• Drink adequate water daily.

• Store Saphris tablets at controlled room temperature, preferably at 20-25℃.
• Dispense them in a tightly closed, light-resistant container and keep the container in a cool, dry place away from the reach of children and pets.
• The tablets may get spoiled or their efficacy may become low below 15℃ and above 30℃.

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