DESIPRAMINE HYDROCHLORIDE- 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:
Sandoz Inc
INN (국제 이름):
DESIPRAMINE HYDROCHLORIDE
구성:
DESIPRAMINE HYDROCHLORIDE 10 mg
관리 경로:
ORAL
처방전 유형:
PRESCRIPTION DRUG
치료 징후:
Desipramine hydrochloride tablets, USP 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.
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 0781-5218-01 bottles of 100 NDC 0781-5218-10 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 to 25ºC (68º to 77ºF) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.
승인 상태:
Abbreviated New Drug Application
환자 정보 전단
Sandoz Inc
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MEDICATION GUIDE
Desipramine Hydrochloride Tablets, USP
(des-IP-ra-meen)
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 desipramine hydrochloride tablets if you take a
monoamine oxidase inhibitor
(
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제품 특성 요약
DESIPRAMINE HYDROCHLORIDE- DESIPRAMINE HYDROCHLORIDE TABLET, FILM
COATED
SANDOZ INC
----------
DESIPRAMINE HYDROCHLORIDE TABLETS, USP
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 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 t
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