PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

PERPHENAZINE (UNII: FTA7XXY4EZ) (PERPHENAZINE - UNII:FTA7XXY4EZ), AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

PERPHENAZINE

Sammansättning:

PERPHENAZINE 2 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets. Perphenazine and amitriptyline hydrochloride tablets are contraindicated in depression of the central nervous system from drugs (barbiturates, alcohol, narcotics, analgesics, antihistamines); in the presence of evidence of bone marrow depression; and in patients known to be hypersensitive to phenothiazines or amitriptyline. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. When it is desired to replace a monoamine oxidase inhibitor with perphenazine and amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Perphenazine and amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride is not recommended for use during the acute recovery phase following myocardial infarction.

Produktsammanfattning:

Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations: ACTIVE INGREDIENT     2 mg/10 mg Perphenazine, USP 2 Amitriptyline hydrochloride, USP 10   2 mg/ 25 mg Perphenazine, USP 2 Amitriptyline hydrochloride, USP 25   4 mg/10 mg Perphenazine, USP 4 Amitriptyline hydrochloride, USP 10   4 mg/25 mg Perphenazine, USP 4 Amitriptyline hydrochloride, USP 25   4 mg/50 mg Perphenazine, USP 4 Amitriptyline hydrochloride, USP 50 The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 330 on the other side. They are available as follows: NDC 0378-0330-01 bottles of 100 tablets NDC 0378-0330-05 bottles of 500 tablets The 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 442 on the other side. They are available as follows: NDC 0378-0442-01 bottles of 100 tablets NDC 0378-0442-05 bottles of 500 tablets The 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 727 on the other side. They are available as follows: NDC 0378-0042-01 bottles of 100 tablets The 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 574 on the other side. They are available as follows: NDC 0378-0574-01 bottles of 100 tablets NDC 0378-0574-05 bottles of 500 tablets The 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 73 on the other side. They are available as follows: NDC 0378-0073-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. * Poisindex Toxicologic Management. Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE- perphenazine and
amitriptyline
hydrochloride tablet, film coated
Mylan Pharmaceuticals Inc.
----------
Medication Guide
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.
Call a healthcare provider right away if you or your family member has
any of the foll

Produktens egenskaper

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE- PERPHENAZINE AND
AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ANALYSES OF
SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL DURATION OF 10 WEEKS),
LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A
RISK OF
DEATH IN DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF
DEATH IN PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL
10-WEEK
CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG-TREATED PATIENTS WAS ABOUT
4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN THE PLACEBO GROUP. ALTHOUGH
THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE
EITHER CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR
INFECTIOUS
(E.G., PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT,
SIMILAR
TO ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL
ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO WHICH THE
FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE
ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME
CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR. PERPHENAZINE AND
AMITRIPTYLINE HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS).
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
PERPHENAZINE
AND AMITRIPTYLINE 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 WI