Adult Dosing
Schizophrenia
- Acute therapy: 5 mg SL bid. Max: 10 mg SL bid
- Maintenance therapy: Start with 5 mg SL bid with an increase up to 10 mg bid after 1 wk based on tolerability
- Max: 10 mg SL bid
Manic/mixed bipolar disorder
- Monotherapy: 10 mg SL bid
- Adjunctive Therapy: Start with 5 mg SL bid as adjunctive therapy with lithium/valproate. Max: 10 mg SL bid
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Geriatric patients with dementia-related psychosis treated with antipsychotics are at greater risk of death, not approved for the treatment of patients with dementia-related psychosis (US Black box warning)
- Cerebrovascular adverse events, including stroke have occurred in geriatrics with dementia-related psychosis
- Neuroleptic Malignant Syndrome has been reported in association with administration of antipsychotic drugs. Manage with immediate discontinuation and close monitoring in such conditions
- It may develop a syndrome of potentially irreversible, involuntary, dyskinetic movements. Discontinue therapy in such cases
- Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness in hyperglycemic and diabetes mellitus patients. Monitor glucose regularly in patients with, and at risk for, diabetes
- Patient may gain weight during the therapy. Patients should receive regular monitoring of weight
- During initial stage of therapy dizziness, tachycardia or bradycardia, and syncope may occur including orthostatic hypotension. Cautiously use in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naive patients
- It may cause leukopenia, neutropenia, agranulocytosis. Monitor CBC frequently during the first few months of therapy in patients with a pre-existing low WBC count or a history of leukopenia/neutropenia. Discontinue therapy at the first sign of a decline in WBC in the absence of other causative factors
- QT Prolongation is observed with administration of drug. Avoid use in patients with risk factors for prolonged QT interval and with drugs that also increase the QT interval
- Episodes of seizures have occurred on administration, avoid concomitant use with drugs lowering seizure threshold
- Prescribe for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose
- May impair body temperature regulation
- Closely supervise high-risk patients as the possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder
Cautions: Use cautiously in
- Hepatic impairment
- Dementia
- Neuroleptic malignant syndrome
- Cardiovascular disease
- Cerebrovascular disease
- Dehydration
- Hypovolemia
- History or risk of seizure
- Aspiration pneumonia risk
- Diabetes mellitus
- Risk of diabetes mellitus
- History of drug-induced leukopenia or neutropenia
- Leukopenia
- Geriatrics
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness, including operating vehicles and hazardous machinery
- Sublingual administration may cause application-site reactions, including oral ulcers, blisters, peeling/sloughing, and inflammation
Pregnancy Category:C
Breastfeeding: Safety unknown; data unavailable, prefer an alternative drug while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 December 2010). Manufacturer advises caution while administering drug to nursing woman. It is recommended that women receiving asenapine should not breast feed
Pricing data from www.DrugStore.com in U.S.A.
- Saphris 10 MG SUBL [Box] (ORGANON)
10 mg = $114
60 mg = $665.99 - Saphris 5 MG SUBL [Box] (ORGANON)
60 mg = $676.02
180 mg = $1885.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Saphris 10 MG Sublingual Tablet
Ingredient(s): Asenapine
Imprint: 10
Color(s): White
Shape: Round
Size (mm): 12.00
Score: 1
Inactive Ingredient(s): gelatin / mannitol / sucralose
Drug Label Author:
Organon Pharmaceuticals USA
DEA Schedule:
Non-Scheduled
Drug Name: Saphris 5 MG Sublingual Tablet
Ingredient(s): Asenapine
Imprint: 5
Color(s): White
Shape: Round
Size (mm): 12.00
Score: 1
Inactive Ingredient(s): gelatin / mannitol / sucralose
Drug Label Author:
Organon Pharmaceuticals USA
DEA Schedule:
Non-Scheduled
