Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DESIPRAMINE HYDROCHLORIDE (UNII: 1Y58DO4MY1) (DESIPRAMINE - UNII:TG537D343B)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
The use of MAOIs intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of desipramine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting desipramine hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.
Desipramine hydrochloride tablets, USP for oral administration are available as: 50 mg: white to off white, round biconvex, coated tablets with 'I82' debossed on one side and plain on other side. NDC 68788-7303-3: bottles of 30 NDC 68788-7303-6: bottles of 60 NDC 68788-7303-9: bottles of 90 NDC 68788-7303-1: bottles of 100 Rx only Rev. 10/17 Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Made in India Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE Desipramine Hydrochloride Tablets, USP (des-IP-ra-meen HYE-droe-KLOR-ide) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with your, or your family member's, antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment . 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.Some people may have a particularly high risk of having suicidal thoughts or actions . These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Who should not take desipramine hydrochloride tablets, USP? Przeczytaj cały dokument
DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET PREFERRED PHARMACEUTICALS INC. ---------- DESIPRAMINE HYDROCHLORIDE TABLETS, USP THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DESIPRAMINE HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE) TABLET FOR ORAL USE. INITIAL U.S. APPROVAL: SUICIDALITY AND ANTIDEPRESSANT DRUGS ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL THINKING AND BEHAVIOR (SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES OF MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF DESIPRAMINE HYDROCHLORIDE TABLETS OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. DESIPRAMINE HYDROCHLORIDE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK , PRECAUTIONS: INFORMATION FOR PATIENTS , AND PRECAUTIONS: PEDIATRIC USE .) DESCRIPTION Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5 H - Dibenz [bƒ] azepine - 5 - propanamine, 10, 11 - dihydro - N - methyl -, monohydrochloride. INACTIVE INGREDIENTS The following inactive ingredients are contained in all dosage strengths: Lactose monohydrate, Przeczytaj cały dokument