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Asenapine Maleate (Saphris)

Trade Name : SAPHRIS

Allergan, Inc.

TABLET

Strength 2.5 mg/1

ASENAPINE MALEATE Atypical Antipsychotic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Asenapine Maleate (Saphris) which is also known as SAPHRIS and Manufactured by Allergan, Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Asenapine Maleate (Saphris) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
  • See full prescribing information for complete boxed warning.
  • 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 is indicated for:n
  • SAPHRIS is an atypical antipsychotic indicated for ():n
  • Schizophrenia in adultsn
  • Bipolar I disordern
  • No data
  • Do not swallow tablet. SAPHRIS sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. (, )n
  • Sublingual tablets, black cherry flavor: 2.5 mg, 5 mg and 10 mg ()n
  • SAPHRIS is contraindicated in patients with:n
  • Severe hepatic impairment (Child-Pugh C). (, )n
  • Known hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation. (, , )n
  • No data
  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis:
  • Neuroleptic Malignant Syndrome:
  • Tardive Dyskinesia:
  • Metabolic Changes:
  • Orthostatic Hypotension:
  • Leukopenia, Neutropenia, and Agranulocytosis:
  • QT Prolongation:
  • Seizures:
  • Potential for Cognitive and Motor Impairment:
  • The following adverse reactions are discussed in more detail in other sections of the labeling:n
  • The most common adverse reactions (u22655% 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.n
  • The most common adverse reactions (u22655% 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.n
  • 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.n
  • In a 3-week monotherapy trial, the most common adverse reactions (u22655% 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.n
  • 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.n
  • 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.n
  • The most commonly observed adverse reactions (incidence u22655% and at least twice that for placebo) were ():n
  • Schizophrenia Adults:
  • Bipolar I Disorder Adults (Monotherapy):
  • Bipolar I Disorder Pediatric Patients (Monotherapy):
  • Bipolar I Disorder Adults (Adjunctive):
  • No data
  • Antihypertensive Drugs: SAPHRIS may cause hypotension. (, , )n
  • Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with SAPHRIS. (, )n
  • No data
  • Pregnancy:
  • Pediatric Use:
  • No data
  • No data
  • 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 CHClNOu00b7CHO and its molecular weight is 401.84 (free base: 285.8). The chemical structure is:n
  • Asenapine maleate is a white to off-white powder.n
  • 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.n
  • No data
  • No data
  • Efficacy of SAPHRIS was established in the following trials:n
  • SAPHRIS (asenapine) sublingual tablets are supplied as:n
  • 2.5 mg Tablets, black cherry flavor
  • Round, white to off-white sublingual tablets, with a hexagon on one side.n
  • Child-resistant packagingn
  • 5 mg Tablets, black cherry flavor
  • Round, white to off-white sublingual tablets, with u201c5u201d on one side within a circle.n
  • Child-resistant packagingn
  • 10 mg Tablets, black cherry flavor
  • Round, white to off-white sublingual tablets, with u201c10u201d on one side within a circle.n
  • Child-resistant packagingn
  • Storage
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling ().
  • INSTRUCTIONS FOR USE
  • SAPHRISu00ae (asenapine)sublingual tabletsn
  • Read these Instructions for Use before you start using SAPHRIS and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.n
  • IMPORTANT:
  • Your SAPHRIS tablets
  • Directions for Taking your SAPHRIS Tablets:
  • Step 1.n- Do not push tablet through the tablet pack. Do not cut or tear the tablet pack.
  • Step 2.
  • Step 3.n- Do not split, cut or crush the tablet.
  • Step 4.n- wholen- under
  • Do not chew or swallow the tablet.
  • Do not eat or drink for 10 minutes
  • Step 5.
  • Storing SAPHRIS tablets:
  • Store SAPHRIS tablets at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).n
  • These Instructions for Use have been approved by the U.S. Food and Drug Administration.n
  • Distributed by: Allergan USA, Inc.Irvine, CA 92612n
  • u00a9 2017 Merck Sharp & Dohme B. V.; used by Allergan under license.u00a9 2017 Allergan. All rights reserved.The trademark SAPHRIS is used by Allergan under license from Merck Sharp & Dohme B.V.n
  • Revised: January 2017n
  • Principal Display Panel - 2.5 mg 60 Count Blister Pack Label
  • NDC 0456-2402-06n
  • Rx only
  • 10 Tabletsn
  • Saphrisnn- Arrayn- 2.5 mg
  • (asenapine) sublingual tabletsn
  • Black Cherryn
  • Principal Display Panel - 2.5 mg 60 Count Carton Label
  • Rx onlyn
  • NDC 0456-2402-60n
  • Saphrisnn- Arrayn- 2.5 mg
  • (asenapine) sublinhual tabletsn
  • For sublingual use only.
  • Do not split, cut, or crush tablet.
  • Do not chew or swallow tablet.
  • Fragile: Do not push tablet throughtablet pack
  • 60 Tabletsn
  • Black Cherryn
  • Principal Display Panel - 5 mg 60 count Carton Label
  • Rx only
  • NDC 0456-2405-60n
  • Saphrisnn- Arrayn- 5mg
  • (asenapine) sublingual tabletsn
  • For sublingual use only.
  • Do not split, cut, or crush tablet.
  • Do not chew or swallow tablet.
  • Fragile: Do not push tablet throughtablet pack.
  • 60 Tablets
  • Black CherryFlavor
  • Principal Display Panel - 10 mg 60 count Carton Label
  • Rx only
  • NDC 0456-2410-60n
  • Saphrisnn- Arrayn- 10mg
  • (asenapine) sublingual tabletsn
  • For sublingual use only.
  • Do not split, cut, or crush tablet.
  • Do not chew or swallow tablet.
  • Fragile: Do not push tablet throughtablet pack.
  • 60 Tablets
  • Black CherryFlavor
  • Principal Display Panel - 5 mg Hospital Unit Dose
  • Saphrisnn- Arrayn- 5mg
  • (asenapine) sublingual tabletsn
  • Rx only
  • NDC 0456-2405-63n
  • Saphirisnn- Arrayn- 5mg
  • (asenapine) sublingual tabletsn
  • For sublingual use only.
  • Do not split, cut, or crush tablet.
  • Do not chew or swallow tablet.
  • Fragile: Do not push tablet throughtablet pack.
  • Black CherryFlavor
  • 100 Tablets
  • HOSPITAL UNIT DOSE
  • Principal Display Panel - 10 mg Hospital Unit Dose
  • Saphrisnn- Arrayn- 10mg
  • (asenapine) sublingual tabletsn
  • Rx only
  • NDC 0456-2410-63n
  • Saphirisnn- Arrayn- 10mg
  • (asenapine) sublingual tabletsn
  • For sublingual use only.
  • Do not split, cut, or crush tablet.
  • Do not chew or swallow tablet.
  • Fragile: Do not push tablet throughtablet pack.
  • Black CherryFlavor
  • 100 Tablets
  • HOSPITAL UNIT DOSE

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