In a 3week, bipolar mania pediatric trial, the incidence of adverse events related to abnormal prolactin levels were 0% in the saphris 2. Saphris is not a cure for your condition, but it can help manage your symptoms and reduce the risk of relapse. This guideline has been developed to advise on supporting people with dementia and their carers in health and social care. The allergan patient assistance program pap provides allergan medicines at no cost to eligible. Do not take saphris after the expiry date printed on the pack. Saphris asenapine sublingual tablets are available in two strengths as round, white to offwhite fast dissolving sublingual tablets at 5 mg strength with 5 on one side or 10 mg strength with 10 on one side and packaged in blisters. Generic saphris at this point, no generic versions of saphris asenapine are available because a patent protects the drug and prevents this. Saphris 1 saphris 5mg and 10mg sublingual wafers asenapine consumer medicine information what is in this leaflet this leaflet answers some common questions about saphris. It belongs to a class of drugs called atypical antipsychotics medications which balance the production of neurotransmitters in the brain.
Sep 19, 2018 file allegati 37 comunicato stampa 11082018. Warnings and precautions serious warnings and precautions various medicines of the group to which saphris belongs. May 14, 2020 saphris is a drug marketed by allergan and is included in one nda. Saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. The efficacy of saphris was established in two 6week trials and one maintenance trial in adults see clinical studies 14. Highlights of prescribing information these highlights do.
The allergan patient assistance program provides certain products to patients in the united states who are unable to afford the cost of their medication and who meet other eligibility requirements. If it has expired or is damaged, return it to your pharmacist for disposal. Bioenteritidis vaccine against salmonella enteritidis culture of salmonella enteritidis samples pt4, pt4a, pt6a, pt7, pt7a and pt9 cultivated in semisynthetic, inactivated and micro emulsified in oil. Asenapine, sold under the trade names saphris and sycrest among others, is an atypical antipsychotic medication used to treat schizophrenia and acute mania associated with bipolar disorder. Saphris asenapine is an antipsychotic medication used for the treatment of bipolar disorder and schizophrenia. Sep 19, 2018 18 may 2015 at the same time, every gap analysis template must have a few essential components. Nms may cause hyperpyrexia, muscle rigidity, delirium, and autonomic instability. While you are taking asenapine, you may be more sensitive to temperature extremes such as very hot or cold conditions.
Ask your doctor if you have any questions about why saphris has been prescribed for you. Saphris is not recommended for use in children below 18 years of age. Additionally, fao wishes to alert users to the fact that improper storage, handling, preparation andor use of pesticides can result in either a lowering or. Saphris is indicated for the treatment of schizophrenia. Saphris is a drug prescribed for patients who are suffering from bipolar disorder manic depression and schizophrenia. Saphris sublingual tablets are available in 5 mg and 10 mg strengths. Saphris asenapine dosing, indications, interactions. Saphris sublingual tablets contain the following inactive ingredients. The generic ingredient in saphris is asenapine maleate. Treatment of schizophrenia including prevention of relapse and maintenance of clinical improvement during continuation therapy, treatment of acute mania or mixed episodes associated with bipolar disorder and. All medically accepted indications not otherwise excluded from part d.
Saphris is available as 5 mg and 10 mg wafers containing 5 mg asenapine 7. This drug has thirtyfive patent family members in twentyone countries. Seek emergency medical attention or call the poison help line at 18002221222. Saphris complete drug information, side effects and. The guideline recommendations have been developed by a multidisciplinary team of health and social care professionals, a person with dementia, carers and guideline methodologists after careful consideration of the best available evidence. Saphris is not approved for the treatment of patients with dementiarelated psychosis. Pronunciation of saphris with 1 audio pronunciation and more for saphris. It does not take the place of talking to your doctor or pharmacist.
The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. As informacoes disponiveis nessa bula aplicamse exclusivamente ao perjeta. Fda approved indications saphris is indicated for the treatment of. Do not use saphris if the packaging is torn or shows signs of tampering. There are three patents protecting this drug and two paragraph iv challenges. Each wafer of saphris also contains gelatin and mannitol. Saving huge on saphris asenapine from our cipacertified.
Antipsychotic medications affect the chemicals that allow communication between nerve cells neurotransmitters. Saphris contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Sapsis user manual wisconsin department of health services. Saphris, saphris black cherry asenapine uses, side effects. Asenapine saphris is a prescription drug used to treat schizophrenia and manic or mixed episodes of bipolar disorder in adults and children.
Step i decide the areabusiness unit youre going to 23 dec 20 the gap analysis was completed, and the report published on december 16. Schizophrenia in adults bipolar i disorder as acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age. Saphris may be used as acute monotherapy or cotherapy with lithium or. There are twelve drug master file entries for this compound. What should i avoid while taking asenapine saphris, saphris black cherry. Saphris belongs to a group of medicines called antipsychotics. Stop taking this medicine and call your doctor at once if you have. Saphris is a psychiatric medication prescribed to help manage mental disorders such as schizophrenia and bipolar disorder. Saphris asenapine sublingual tablets side effects, images. Agn, headquartered in dublin, ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Includes 124 patient ratings with average score of 3. Saphris asenapine uses, dosage, sideeffects healthyplace. Saphris sublingual tablets should not be split, crushed, chewed, or swallowed see clinical pharmacology. There is not enough information on its effects in children.
Acute and maintenance treatment of schizophrenia in adults. Instant savings on your prescription for saphris asenapine with free coupon and discounts saphris asenapine coupon and saphris cost skip to. Aug 12, 2019 what happens if i overdose saphris, saphris black cherry. When this patent expires in 2015, provided there are no lawsuits or patents for other uses, drug manufacturers can produce a generic version. Indicated as monotherapy for acute treatment of manic or mixed episodes associated with bipolar i disorder. Your doctor may have prescribed saphris for another reason. You should not use asenapine if you are allergic to it, or if you have severe liver disease asenapine can cause serious neurologic problems. It helps to correct chemical imbalances in the brain, which may cause these mental illnesses.
Nms, a potentially fatal symptom complex, has been reported with antipsychotics. The active ingredient is asenapine, which is an atypical antipsychotic. Feb 01, 2017 in a 3week, bipolar mania pediatric trial, the incidence of adverse events related to abnormal prolactin levels were 0% in the saphris 2. Asenapine saphris for schizophrenia or bipolar i disorder. Conditions like bipolar disorder and schizophrenia are often treated with the prescription drug saphris. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. Indications and usage dosage and administration dosage forms and strengths contraindications warnings and precautions adverse reactions drug interactions use in specific populations. It has been approved for the acute treatment of manic episodes associated with bipolar disorder.
749 133 611 721 361 1640 1482 1295 1040 38 325 1630 1217 602 1559 1383 858 597 1165 1039 1629 1214 368 618 726 422 597 1338 626 1441 1217 1237 355