Saphris

1 What is Saphris?

Brand: Saphris

Generic: Asenapine

Brand name:

Saphris is an antipsychotic drug prescribed to adult patients with schizophrenia and bipolar disorder. Saphris is also used to treat children with bipolar disorder.

This medication is not recommended for elderly patients with dementia-related psychosis. Asenapine can be used alone or in combination with lithium or valproate.

2 What to Know Before Using

Saphris must be used with care and only according to doctor’s prescription. Before you use Saphris, tell your doctor if any of the following applies to you:

  • If you are allergic to medications, foods, dyes, preservatives, or animals.
  • If you are a nursing mother, planning to get pregnant, or expecting a baby.

Taking any of the following medicines with Saphrisis not recommended. Your doctor may decide not to treat you with this medication or change some of your other medication.

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Taking any of the following medicines with Saphris is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Acecainide
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Arsenic Trioxide
  • Artemether
  • Astemizole
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bretylium
  • Bromazepam
  • Bunazosin
  • Buprenorphine
  • Buserelin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxazosin
  • Droperidol
  • Duloxetine
  • Eliglustat
  • Enoxacin
  • Erythromycin
  • Escitalopram
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluconazole
  • Fluoxetine
  • Fluvoxamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydroquinidine
  • Hydroxychloroquine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Moxisylyte
  • Nafarelin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Phenoxybenzamine
  • Phentolamine
  • Pirmenol
  • Posaconazole
  • Prajmaline
  • Prazosin
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Risperidone
  • Salmeterol
  • Sematilide
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sultopride
  • Sunitinib
  • Suvorexant
  • Tacrolimus
  • Tapentadol
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Terazosin
  • Tetrabenazine
  • Tizanidine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Urapidil
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zotepine

Taking Asenapine with Paroxetine may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Some medical conditions can interact with this medication.

Tell your doctor if you have any of the following conditions:

3 Proper Usage

Only take Saphris as prescribed by the doctor, and do not change doses or stop using it without permission. Ask your doctor if you have any questions.

To use the sublingual tablet:

  • Open the blister pack once you are ready to take it.
  • Handle the tablet with clean and dry hands
  • Take away the tablet carefully from the blister pack by tearing the aluminum foil and take the tablet out. Do not push the tablet through the pack.
  • Put the tablet under your tongue and allow it to dissolve completely. Do not split, crush, chew, or swallow the tablet.
  • After taking Saphris, do not eat or drink anything for at least 10 minutes.

Below are the recommended dosages for certain age groups. However, some doses may have modification depending on your doctor’s evaluation.

For patients with bipolar disorder:

Monotherapy

  • Adults - starting dose is 10 milligrams two times a day.
  • Children 10 to 17 years of age - 2.5 to 10 mg two times a day for.
  • Children younger than 10 years of age - Use and dosage must be determined by your physician.

Adjunctive Therapy (for patients taking Saphris in combination with lithium or valproate)

  • Adults - starting dose is 5 milligrams two times a day. Your doctor may adjust your dose to 10 mg two times a day if necessary.
  • Children - Use and dose must be determined by your physician.

For patients with schizophrenia:

  • Adults – starting dose is 5 milligrams two times a day. Your doctor may increase your dose as needed.
  • Children - Use and dose must be determined by your physician.

If you miss a dose of this medicine, take it as soon as possible. However, if it is near for your next dose, skip the missed dose and start again to your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store the medication in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of reach of children. Do not keep expired medications.

4 Precautions to Take

It is very important that you visit your doctor regularly while using Saphris. This is to ensure your progress is monitored and and check for early signs of side effects.

Check with your doctor immediately if you developed any sores or blisters in the mouth, inflammation, or numbness or tingling of the mouth or throat after using Saphris.

Neuroleptic malignant syndrome is a serious side effect of Saphris. Check with your doctor right away if you experience any of the following symptoms of NMS: convulsions, breathing problems, high fever, high or low blood pressure, fast heartbeat, increased sweating, severe muscle stiffness, unusually pale skin, tiredness, and loss of bladder control.

Saphris may also cause tardive dyskinesia. Check with your doctor immediately if you experience any of the following symptoms: lip smacking or puckering, uncontrolled chewing movements, rapid or worm-like movements of the tongue, puffing of the cheeks, or uncontrolled movements of the arms and legs.

For diabetic patient, monitor your blood sugar regularly since this medication may affect your blood sugar. Check with your doctor right away if you have increased thirst or increased urination as well as change in the results of your urine or blood sugar tests.

You may gain weight when taking this medication. Talk to your doctor to give you advises on how to prevent weight gain.

Call your doctor or go to hospital emergency immediately if you experience any allergic reaction to this medication.

Slowly get up from a lying or sitting position since this medication may cause dizziness, lightheadedness, or fainting. Check with your doctor if this problem continues or gets worse.

Saphris can lower your body’s resistance temporarily. Avoid people with infections. Check with your doctor right away if you think you are getting an infection.

This medicine can cause QT prolongation (changes in the heart rhythm) which can change the way your heart beats and cause fainting or serious side effects. Call your doctor as soon as possible if you have any symptoms of heart rhythm problems.

This medicine may cause dizziness, difficulty concentrating, drowsiness, or uncontrollable body movements. Avoid driving or performing risky task until you know how you react to this medicine.

This medicine might reduce perspiration. If you do not sweat, your body cannot cool itself and is prone to overheat. Call your doctor if you are too hot and cannot cool down. Avoid places that are very hot.

Some people may become agitated, irritable, or display other abnormal behaviors due to this medicine. They might as well have suicidal thoughts and tendencies. If you or your caregiver noticed any of these side effects, tell your doctor right away.
This medicine will add to the effects of alcohol and other CNS depressants. Check with your doctor before taking any of those medications while you are using asenapine.

Discuss with your doctor if you are taking any other medication.

5 Potential Side Effects

Saphris may cause side effects, some of which require immediate medical attention. 

If any of the following side effects occur, check with your doctor right away:

  • Abnormal or decreased touch sensation
  • Inability to move the eyes
  • Inability to sit still
  • Increase in body movements
  • Increased blinking or spasms of the eyelid
  • Lip smacking or puckering
  • Need to keep moving
  • Puffing of the cheeks
  • Rapid or worm-like movements of the tongue
  • Restlessness
  • Shakiness in the legs, arms, hands, or feet
  • Sticking out of tongue
  • Trembling or shaking of the hands or feet
  • Trouble with breathing, speaking, or swallowing
  • Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • Uncontrolled chewing movements
  • Uncontrolled twisting movements of the neck, trunk, arms, or legs
  • Unusual facial expressions
  • Weakness of the arms and legs
  • Blurred vision
  • Dizziness
  • Headache
  • Nervousness
  • Pounding in the ears
  • Slow or fast heartbeat
  • Black, tarry stools
  • Bleeding gums
  • Blood in the urine or stools
  • Burning, crawling, itching, numbness, prickling, ""pins and needles"", or tingling feelings
  • Changes in patterns and rhythms of speech
  • Coma
  • Confusion
  • Convulsions
  • Decreased urine output
  • Fast, pounding, or irregular heartbeat or pulse
  • Increased thirst
  • Muscle pain or cramps
  • Nausea or vomiting
  • Pale skin
  • Pinpoint red spots on the skin
  • Slurred speech
  • Swelling of the face, ankles, or hands
  • Troubled breathing with exertion
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness

Less serious side effects:

  • Constipation
  • Sleepiness or unusual drowsiness
  • Trouble sleeping
  • Unusually deep sleep
  • Unusually long duration of sleep
  • Acid or sour stomach
  • Belching
  • Depression
  • Difficulty with moving
  • Dry mouth
  • Fear or nervousness
  • Heartburn
  • Increased appetite
  • Increased watering of the mouth
  • Increased weight
  • Indigestion
  • Irritability
  • Muscle pain or stiffness
  • Pain in the arms or legs
  • Pain in the joints
  • Stomach discomfort, upset, or pain
  • Toothache

Not all side effects are listed above. If you notice any other effects, check with your healthcare professional.

6 Related Clinical Trials

Top