Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DESIPRAMINE HYDROCHLORIDE (UNII: 1Y58DO4MY1) (DESIPRAMINE - UNII:TG537D343B)
Amneal Pharmaceuticals NY LLC
DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Desipramine hydrochloride tablets are indicated for the treatment of depression. 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, 10 mg are supplied as light blue to blue colored, round, biconvex, film-coated tablets, debossed “AA” and “11” on one side and plain on the other side. Bottles of 30: NDC 69238-1053-3 Bottles of 100: NDC 69238-1053-1 Desipramine Hydrochloride Tablets USP, 25 mg are supplied as light yellow to yellow colored, round, biconvex, film-coated tablets, debossed “AA” and “12” on one side and plain on the other side. Bottles of 30: NDC 69238-1055-3 Bottles of 100: NDC 69238-1055-1 Desipramine Hydrochloride Tablets USP, 50 mg are supplied as light green to green colored, round, biconvex, film-coated tablets, debossed “AA” and “13” on one side and plain on the other side. Bottles of 30: NDC 69238-1057-3 Bottles of 100: NDC 69238-1057-1 Desipramine Hydrochloride Tablets USP, 75 mg are supplied as light red to red colored, round, biconvex, film-coated tablets, debossed “AA” and “14” on one side and plain on the other side. Bottles of 30: NDC 69238-1059-3 Bottles of 100: NDC 69238-1059-1 Desipramine Hydrochloride Tablets USP, 100 mg are supplied as peach colored, round, biconvex, film-coated tablets, debossed “AA” and “15” on one side and plain on the other side. Bottles of 30: NDC 69238-1061-3 Bottles of 100: NDC 69238-1061-1 Desipramine Hydrochloride Tablets USP, 150 mg are supplied as white to off-white, round, biconvex, film-coated tablets, debossed “AA” and “16” on one side and plain on the other side. Bottles of 50: NDC 69238-1063-2 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from excessive heat. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2023-05
Abbreviated New Drug Application
DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE TABLET, FILM COATED Amneal Pharmaceuticals NY LLC ---------- MEDICATION GUIDE Desipramine (des-IP-ra-meen) Hydrochloride Tablets, USP 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? • You should not take Lees het volledige document
DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE TABLET, FILM COATED AMNEAL PHARMACEUTICALS NY LLC ---------- DESIPRAMINE HYDROCHLORIDE TABLETS, USP (10 MG, 25 MG, 50 MG, 75 MG, 100 MG & 150 MG) RX ONLY 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 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 is an antidepressant drug of the tricyclic type, and is chemically: 5_H_-Dibenz[_b_ƒ]azepine-5-propanamine,10,11-dihydro-_N_-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. INACTIVE INGREDIENTS Desipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blu Lees het volledige document