Centrally acting drugs,

Fluvoxamine, paraoxetine,

Antihypertensives, levodopa, dopaminerergics, CYP2D6 substrates and inhibitors

Drugs that prolong QT intervals ( ziprasidone,  chloepromazine, thioridazine,
Moxifloxacin, alcohlol )

Anticholinergics

Moderate to severe maniac episode

Anxiety, headache, dizziness, weight gain, increased appetite, movement disorders,
seizures,  parkinsonism, sedation, risk of neuroleptic malignant syndrome, disconitunue
 if suspected

Dizziness, dysgeusia, hypoanesthesia,
Increased ALT,  muscle rigidity fatigue, akathesia, blood dyscrasias,

orthostatic hypotension, syncope, hyperprolactinemia, hyperglycemia,
and dysphagia, tardive dyskinesia

Severe hepatic renal impairment CrCl < 15ml/min
dimentia related psychosis
Lactation

Special precaution-

Moderate hepatic impairment,
History of risk of seizures,

Monitor high risk patients for suicidal behaviour,
Cardiovascular disease, CAD, MI , heart failure,

Family history of QT prolongation, cardiac arrhyhthmias, diabetics, risk factors for diabetes or hypotension,
Risk of tardive dyskinesia, consider discontinuation if occurs.

History of leucopenia, neutropenia ( monitor )
breast cancer dehydration,

Strenous excercise, extrem heat, Parkinsons disease dementia with Lewy bodies
Prolonged use  12 weeks.

 High dose, Dysphagia, elderly,
Pregnancy, ( risk of extrapyrimidal symptoms . post delivery in neonates)

Indication-

Moderate to severe maniac episode

Dosage-
5-10mg morning or evening
Do not swallow , suck, or chew,
Avoid eating and drinking for 10 minutes after administration

Not recommended for patients below 18 years

Full prescribing information for SAPHRIS. SAPHRIS® (asenapine) sublingual tablets

PATIENT COUNSELING INFORMATION

Dosage and Administration-                                                                                 Counsel patients on proper sublingual administration of SAPHRIS and advise them to read the FDA-approved patient labeling (Instructions for Use). When initiating treatment with SAPHRIS, provide dosage escalation instructions 

Hypersensitivity Reactions-                                                                                  Counsel patients on the signs and symptoms of a serious allergic reaction (e.g., difficulty breathing, itching, swelling of the face, tongue or throat, feeling lightheaded etc.) and to seek immediate emergency assistance if they develop any of these signs and symptoms 

Application Site Reactions -                                                                                     Inform patients that application site reactions, primarily in the sublingual area, including oral ulcers, blisters, peeling/sloughing and inflammation have been reported.

Instruct patients to monitor for these reactions 

Inform patients that numbness or tingling of the mouth or throat may occur directly after administration of SAPHRIS and usually resolves within 1 hour 

Neuroleptic Malignant Syndrome-                                                                        Counsel patients about a potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) that has been reported in association with administration of antipsychotic drugs.

Patients should contact their health care provider or report to the emergency room if they experience the following signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) 

Tardive Dyskinesia-                                                                                                Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their health care provider if these abnormal movements occur 

Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain)-                                                                                                          Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia (high blood sugar) and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight 

Orthostatic Hypotension-                                                                                      Educate patients about the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing) especially early in treatment, and also at times of re-initiating treatment or increases in dose 

Leukopenia/Neutropenia-                                                                                         Advise patients with a pre-existing low W BC or a history of drug induced leukopenia/neutropenia they should have their CBC monitored while taking SAPHRIS 

Interference with Cognitive and Motor Performance-                                          Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that SAPHRIS therapy does not affect them adversely 

Heat Exposure and Dehydration-                                                                           Counsel patients regarding appropriate care in avoiding overheating and dehydration 

. Concomitant Medications-                                                                                     Advise patients to inform their health care provider if they are taking, or plan to take, any prescription or over-thecounter medications since there is a potential for interactions 

Pregnancy-                                                                                                                Advise patients that SAPHRIS may cause fetal harm as well as extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with a known or suspected pregnancy 

Pregnancy Registry-                                                                                                 Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHRIS during pregnancy 

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 U.S. Patent Nos. 5,763,476 and 7,741,358. © 2013 Merck Sharp & Dohme B. V.; used by. Actavis, Inc. or its affiliates under license. © 2015 Actavis. All rights reserved.

The trademark SAPHRIS is used by Actavis, Inc. or its affiliates under license from Merck Sharp & Dohme B.V. Reference ID: 3715184

INSTRUCTIONS FOR USE SAPHRIS® (asenapine) sublingual tablets Read

Observe caution if required to be used