Asenapine is an atypical antipsychotic sold in the U.S. under 3 brand and generic names, for bipolar disorder and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Saphris (application NDA022117). Other asenapine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Starting Dose Recommended Dose Maximum Dose Schizophrenia – acute treatment in adults ( 2.2 ) 5 mg sublingually twice daily 5 mg sublingually twice daily 10 mg sublingually twice daily Schizophrenia – maintenance treatment in adults ( 2.2 ) 5 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – adults: acute and maintenance monotherapy ( 2.3 ) 5-10 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania –pediatric patients (10 to 17 years): monotherapy ( 2.3 ) 2.5 mg sublingually twice daily 2.5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – adults: as an adjunct to lithium or valproate ( 2.3 ) 5 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily 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. ( 2.1 , 17 ) 2.1 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,…
The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 and 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.3 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.4 )] Metabolic Changes [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Contraindications, Warnings and Precautions ( 5.6 )] Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.9 )] QT Interval Prolongation [see Warnings and Precautions ( 5.10 )] Hyperprolactinemia [see Warnings and Precautions ( 5.11 )] Seizures [see Warnings and Precautions ( 5.12 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.13 )] Body Temperature Regulation [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $74 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 10 | 10 mg | white | round | — |
| B;1 | 5 mg | white | round | — |
| B;2 | 10 mg | white | round | — |
| B;3 | 5 mg | white | round | — |
| B;4 | 10 mg | white | round | — |
| B;5 | 2.5 mg | white |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
SAPHRIS is contraindicated in patients with: Severe hepatic impairment (Child-Pugh C) [see Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] . A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6 )] . Severe hepatic impairment (Child-Pugh C). ( 8.7 , 12.3 ) Known hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation. ( 4 , 5.6 , 17 )
Antihypertensive Drugs: SAPHRIS may cause hypotension. ( 5.7 , 7.1 , 12.3 ) Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with SAPHRIS. ( 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Drug Interactions with SAPHRIS Table 12: Clinically Important Drug Interactions with SAPHRIS Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Antihypertensive Drugs Because of its α 1 -adrenergic antagonism with potential for inducing hypotension, SAPHRIS may enhance the effects of certain antihypertensive agents [see Warnings and Precautions ( 5.7 )] . Monitor blood pressure and adjust dosage of antihypertensive drug accordingly. Strong CYP1A2 Inhibitors (e.g., Fluvoxamine) SAPHRIS is metabolized by CYP1A2. Marginal increase of asenapine exposure was observed when SAPHRIS is used with fluvoxamine at 25 mg administered twice daily [ see Clinical Pharmacology ( 12.3 )] . However, the tested fluvoxamine dose was suboptimal. Full therapeutic dose of fluvoxamine is expected to cause a greater increase in asenapine exposure. Dosage reduction for SAPHRIS based on clinical response may be necessary. CYP2D6 substrates and inhibitors (e.g., paroxetine) SAPHRIS may enhance the inhibitory effects of paroxetine on its own metabolism. Concomitant use of paroxetine with SAPHRIS increased the paroxetine exposure by 2-fold as…
| 68/100 |
| Prescription |
| Tablet |
| Generic |
| $74 |
| View → |
| 3 | Not yet rated | Prescription | Film | Generic | $74 | View → |
| round |
| — |
| B;4 | 10 mg | white | round | — |
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| 5 | 5 mg | white | round | — |
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| B;3 | 5 mg | white | round | — |
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| B;5 | 2.5 mg | white | round | — |
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| B;1 | 5 mg | white | round | — |
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| B;2 | 10 mg | white | round | — |
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