DESIPRAMINE HYDROCHLORIDE tablet, film coated
국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
환자 정보 전단 유효 성분:
DESIPRAMINE HYDROCHLORIDE (UNII: 1Y58DO4MY1) (DESIPRAMINE - UNII:TG537D343B)
제공처:
STAT RX USA LLC
INN (국제 이름):
DESIPRAMINE HYDROCHLORIDE
구성:
DESIPRAMINE HYDROCHLORIDE 10 mg
관리 경로:
ORAL
처방전 유형:
PRESCRIPTION DRUG
치료 징후:
Desipramine hydrochloride is indicated for the treatment of depression. Desipramine hydrochloride should not be given in conjunction with, or within 2 weeks of, treatment with an MAO inhibitor drug; hyperpyretic crises, severe convulsions, and death have occurred in patients taking MAO inhibitors and tricyclic antidepressants. When desipramine hydrochloride is substituted for an MAO inhibitor, at least 2 weeks should elapse between treatments. Desipramine hydrochloride should then be started cautiously and should be increased gradually. 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.
제품 요약:
Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as: 10 mg: debossed GG 63 on one side and plain on the reverse side, and supplied as: NDC 0781-1971-01 bottles of 100 NDC 0781-1971-10 bottles of 1000 25 mg: debossed GG 64 on one side and plain on the reverse side, and supplied as: NDC 0781-1972-01 bottles of 100 NDC 0781-1972-10 bottles of 1000 NDC 0781-1972-13 unit dose packages of 100 50 mg: debossed GG 65 on one side and plain on the reverse side, and supplied as: NDC 0781-1973-01 bottles of 100 NDC 0781-1973-10 bottles of 1000 NDC 0781-1973-13 unit dose packages of 100 75 mg: debossed GG 166 on one side and plain on the reverse side, and supplied as: NDC 0781-1974-01 bottles of 100 NDC 0781-1974-10 bottles of 1000 100 mg: debossed GG 167 on one side and plain on the reverse side, and supplied as: NDC 0781-1975-01 bottles of 100 NDC 0781-1975-10 bottles of 1000 150 mg: debossed GG 168 on one side and plain on the reverse side, and supplied as: NDC 0781-1976-50 bottles of 50 NDC 0781-1976-10 bottles of 1000 Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.
승인 상태:
Abbreviated New Drug Application
환자 정보 전단
DESIPRAMINE HYDROCHLORIDE - DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
STAT RX USA LLC
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with you 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.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, wors
전체 문서 읽기
제품 특성 요약
DESIPRAMINE HYDROCHLORIDE - DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
STAT RX USA LLC
----------
DESIPRAMINE HYDROCHLORIDE TABLETS, USP
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 available as tablets of 10
mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its
chemical name is 5_H_-
Dibenz[_bf_]azepine-5-propanamine, 10, 11-dihydro-_N_-methyl-,
monohydrochloride.
Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, starch (corn), and
titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Available evidence suggests that many depressions have a biochemical
basis in the
전체 문서 읽기
