July 7, 2015
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Saphris

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Saphris




Indications
Dosage
How Supplied

INDICATIONS

SAPHRIS is indicated for

DOSAGE AND ADMINISTRATION

Administration Instructions

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 [see CLINICAL PHARMACOLOGY]. Patients should be instructed to not eat or drink for 10 minutes after administration [see CLINICAL PHARMACOLOGY and PATIENT INFORMATION].

Schizophrenia

The recommended dose of SAPHRIS is 5 mg given twice daily. In short term controlled trials, there was no suggestion of added benefit with a 10 mg twice daily dose, but there was a clear increase in certain adverse reactions. If tolerated, daily dosage can be increased to 10 mg twice daily after one week. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies [see Clinical Studies].

Bipolar I Disorder

Acute Treatment of Manic or Mixed Episodes

Monotherapy in Adults: The recommended starting dose of SAPHRIS is 10 mg twice daily. The dose can be decreased to 5 mg twice daily if warranted by adverse effects. The safety of doses above 10 mg twice daily has not been evaluated in clinical trials [see Clinical Studies].

Monotherapy in Pediatric Patients: The recommended dose of SAPHRIS is 2.5 mg to 10 mg twice daily in pediatric patients 10 to 17 years of age, and dose may be adjusted for individual response and tolerability. The starting dose of SAPHRIS is 2.5 mg twice daily. After 3 days, the dose can be increased to 5 mg twice daily, and from 5 mg to 10 mg twice daily after 3 additional days. Pediatric patients aged 10 to 17 years appear to be more sensitive to dystonia with initial dosing with SAPHRIS when the recommended escalation schedule is not followed [see Use in Specific Populations]. The safety of doses greater than 10 mg twice daily has not been evaluated in clinical trials [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

Adjunctive Therapy in Adults: The recommended starting dose of SAPHRIS is 5 mg twice daily when administered as adjunctive therapy with either lithium or valproate. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. The safety of doses above 10 mg twice daily as adjunctive therapy with lithium or valproate has not been evaluated in clinical trials.

If SAPHRIS is used for extended periods in bipolar disorder, the health care provider should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

HOW SUPPLIED

Dosage Forms And Strengths

  • SAPHRIS 2.5 mg tablets, black cherry flavor, are round, white to off-white sublingual tablets, with a hexagon on one side.
  • SAPHRIS 5 mg tablets, black cherry flavor, are round, white to off-white sublingual tablets, with “5” on one side within a circle.
  • SAPHRIS 10 mg tablets, black cherry flavor, are round, white to off-white sublingual tablets, with “10” on one side within a circle.

Storage And Handling

SAPHRIS (asenapine) sublingual tablets are supplied as:

2.5 mg Tablets, Black Cherry Flavor

Round, white to off-white sublingual tablets, with a hexagon on one side.

Child-resistant Packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2402-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2402-63

5 mg Tablets, Black Cherry Flavor

Round, white to off-white sublingual tablets, with “5” on one side within a circle.

Child-resistant Packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2405-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2405-63

10 mg Tablets, Black Cherry Flavor

Round, white to off-white sublingual tablets, with “10” on one side within a circle.

Child-resistant Packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2410-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2410-63

Storage

Store at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufactured by: Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK Distributed by: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, LLC, St. Louis, MO 63045, USA. Revised: March 2015

Last reviewed on RxList: 3/26/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Saphris - User Reviews

Saphris User Reviews

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