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SAPHRIS

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Overview

What is SAPHRIS?

SAPHRIS contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3a,12b)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1dibenzo[2,3:6,7]oxepino[4,5-]pyrrole (2)-2-butenedioate (1:1). Its molecular formula is CHClNO·CHO and its molecular weight is 401.84 (free base: 285.8). The chemical structure is:

Asenapine maleate is a white to off-white powder.

SAPHRIS, black cherry flavor, is supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include gelatin, mannitol, sucralose, and black cherry flavor.



What does SAPHRIS look like?



What are the available doses of SAPHRIS?

Sublingual tablets, black cherry flavor: 2.5 mg, 5 mg and 10 mg ()

What should I talk to my health care provider before I take SAPHRIS?

How should I use SAPHRIS?

SAPHRIS is indicated for:

SAPHRIS is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. SAPHRIS sublingual tablets should not be split, crushed, chewed, or swallowed . Patients should be instructed to not eat or drink for 10 minutes after administration .


What interacts with SAPHRIS?

Sorry No Records found


What are the warnings of SAPHRIS?

Sorry No Records found


What are the precautions of SAPHRIS?

Sorry No Records found


What are the side effects of SAPHRIS?

Sorry No records found


What should I look out for while using SAPHRIS?

SAPHRIS is contraindicated in patients with:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS

(asenapine) is not approved for the treatment of patients with dementia-related psychosis

[see Warnings and Precautions (, )]

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Drug Interactions:


What might happen if I take too much SAPHRIS?


How should I store and handle SAPHRIS?

StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging 5 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging 10 mg Tablets, black cherry flavorRound, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination of antagonist activity at D and 5-HT receptors.

Non-Clinical Toxicology
SAPHRIS is contraindicated in patients with:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS

(asenapine) is not approved for the treatment of patients with dementia-related psychosis

[see Warnings and Precautions (, )]

Array

[see and Warnings and Precautions ()]

The following adverse reactions are discussed in more detail in other sections of the labeling:

The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in adults with schizophrenia were akathisia, oral hypoesthesia, and somnolence. The safety profile of SAPHRIS in the maintenance treatment of schizophrenia in adults was similar to that seen with acute treatment.

The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute monotherapy treatment of manic or mixed episodes associated with bipolar I disorder in adults were somnolence, oral hypoesthesia dizziness, extrapyramidal symptoms (excluding akathisia) and akathisia; and during the adjunctive therapy trial in bipolar I disorder in adults were somnolence and oral hypoesthesia. The rates were lower at the 5mg twice daily dose than the 10mg twice daily dose for all of these most common adverse reactions. The safety profile of SAPHRIS in the maintenance treatment of manic or mixed episodes associated with bipolar I disorder in adults was similar to that seen with acute treatment.

The adult information below is derived from a clinical trial database for SAPHRIS consisting of over 5355 patients and/or healthy subjects exposed to one or more sublingual doses of SAPHRIS. A total of 1427 SAPHRIS-treated patients were treated for at least 24 weeks and 785 SAPHRIS-treated patients had at least 52 weeks of exposure at therapeutic doses.

In a 3-week monotherapy trial, the most common adverse reactions (≥5% and at least twice the rate of placebo) reported in pediatric patients with bipolar I disorder treated with SAPHRIS were somnolence, dizziness, dysgeusia, oral hypoesthesia, nausea, increased appetite, fatigue, and increased weight. No new major safety findings were reported from a 50-week, open-label, uncontrolled safety trial.

A total of 651 pediatric patients were treated with SAPHRIS. Of these patients, 352 pediatric patients were treated with SAPHRIS for at least 180 days and 58 pediatric patients treated with SAPHRIS had at least 1 year of exposure. The safety of SAPHRIS was evaluated in 403 pediatric patients with bipolar I disorder who participated in a 3-week, placebo-controlled, double-blind trial, of whom 302 patients received SAPHRIS at fixed doses ranging from 2.5 mg to 10 mg twice daily.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced a treatment-emergent adverse event of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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