PROTRIPTYLINE HYDROCHLORIDE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Epic Pharma, LLC

Designació comuna internacional (DCI):

PROTRIPTYLINE HYDROCHLORIDE

Composición:

PROTRIPTYLINE HYDROCHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Its activating properties make it particularly suitable for withdrawn and anergic patients.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 including prolongation of the QT interval, cardiac arrhythmias and conduction system disturbances. This drug should not be used during the acute recovery phase following myocardial infarction.

Resumen del producto:

Protriptyline Hydrochloride Tablets USP, 5 mg are dark orange, round biconvex, film coated tablets, de-bossed “ Є96” on one side, and plain on the other side, available in bottles of 30 (NDC: 42806-096-30), in bottles of 100 (NDC: 42806-096-01) and in bottles of 1000 (NDC: 42806-096-10). Protriptyline Hydrochloride Tablets USP, 10 mg are light orange, round biconvex, film coated tablets, de-bossed “ Є97” on one side, and plain on the other side, available in bottles of 30 (NDC: 42806-097-30), in bottles of 100 (NDC: 42806-097-01) and in bottles of 1000 (NDC: 42806-097-10). Dispense in a tight container as defined in the USP. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

PROTRIPTYLINE HYDROCHLORIDE- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
Epic Pharma, LLC
----------
DISPENSE WITH MEDICATION GUIDE
AVAILABLE AT:WWW.EPIC-
PHARMA.COM/MEDGUIDE/PROTRIPTYLINE-
HYDROCHLORIDE-TABLET.PDF
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 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 con

Fitxa tècnica

PROTRIPTYLINE HYDROCHLORIDE- PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
EPIC PHARMA, LLC
----------
PROTRIPTYLINE HYDROCHLORIDE TABLETS, USP
RX ONLY
BOXED WARNING
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 and its structural formula is:
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 steara