PROTRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PROTRIPTYLINE HYDROCHLORIDE (UNII: 44665V00O8) (PROTRIPTYLINE - UNII:4NDU154T12)

Доступно од:

Hi-Tech Pharmacal Co., Inc.

INN (Међународно име):

PROTRIPTYLINE HYDROCHLORIDE

Састав:

PROTRIPTYLINE HYDROCHLORIDE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients. Protriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with a monoamine oxidase inhibiting compound. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. Protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Protriptyline is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interactions includ

Резиме производа:

Protriptyline Hydrochloride Tablets USP, 5 mg are dark orange, round, biconvex, film coated tablets, de-bossed “Є 96” on one side, and plain on the other side, available in bottles of 100’s. Protriptyline Hydrochloride Tablets USP, 10 mg are light orange, round, biconvex, film coated tablets, de-bossed “Є 97” on one side, and plain on the other side, available in bottles of 100’s. Dispense in a tight container as defined in the USP. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

PROTRIPTYLINE HYDROCHLORIDE- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
Hi-Tech Pharmacal Co., Inc.
----------
MEDICATION GUIDE
Protriptyline Hydrochloride Tablets, USP
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 when the medicine is first started.
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.
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
first started or when the dose is
changed.
•
Call the healthcare provider right away to report new or sudden
changes in moods, 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

Карактеристике производа

PROTRIPTYLINE HYDROCHLORIDE- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
HI-TECH PHARMACAL CO., INC.
----------
PROTRIPTYLINE 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
PROTRIPTYLINE 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.
PROTRIPTYLINE 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
Protriptyline HCl is N-methyl-5H dibenzo
[a,d]-cycloheptene-5-propanamine hydrochloride. Its
molecular formula is C
H N●HCl
Protriptyline HCl, a dibenzocycloheptene derivative, has a molecular
weight of 299.84. It is a white to
yellowish powder that is freely soluble in water and soluble in dilute
HCl. Protriptyline HCl is
supplied as 5 mg or 10 mg film-coated tablets. Inactive ingredients
are microcrystalline cellulose,
pregelatinized starch, lactose monohydrate, dibasic calcium phosphate,
sodium starch glycolate,
magnesium stearate, hypromellose, triacetin, polysorbate,