MAPROTILINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MAPROTILINE HYDROCHLORIDE (UNII: 7C8J54PVFI) (MAPROTILINE - UNII:2U1W68TROF)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

MAPROTILINE HYDROCHLORIDE

Composition:

MAPROTILINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Maprotiline hydrochloride tablets are indicated for the treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic depressive illness, depressed type (major depressive disorder). Maprotiline is also effective for the relief of anxiety associated with depression. Maprotiline hydrochloride tablets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.

Product summary:

Maprotiline Hydrochloride, USP is available as tablets containing 25 mg, 50 mg, or 75 mg of maprotiline hydrochloride. The 25 mg tablets are white film-coated, round, scored tablets debossed with 6 to the left of the score and 0 to the right of the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0060-01 bottles of 100 tablets The 50 mg tablets are light blue film-coated, round, scored, tablets debossed with 8 to the left of the score and 7 to the right of the score on one side and M on the other side. They are available as follows: NDC 0378-0087-01 bottles of 100 tablets The 75 mg tablets are white film-coated, round, scored tablets debossed with 9 to the left of the score and 2 to the right of the score on one side and M on the other side. They are available as follows: NDC 0378-0092-01 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MAPROTILINE HYDROCHLORIDE- MAPROTILINE 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?
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers, and
young adults within the first few months of treatment.
•
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?
1.
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.
2.
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
3.
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

Summary of Product characteristics

MAPROTILINE HYDROCHLORIDE- MAPROTILINE HYDROCHLORIDE TABLET, FILM
COATED
MYLAN PHARMACEUTICALS INC.
----------
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
MAPROTILINE 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.
MAPROTILINE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS AND PRECAUTIONS: PEDIATRIC
USE.)
DESCRIPTION
Maprotiline hydrochloride, USP is a tetracyclic antidepressant,
available as 25 mg, 50 mg and 75 mg
tablets for oral administration. Its chemical name is
N-methyl-9,10-ethanoanthracene-9(10H)-
propylamine hydrochloride, and its structural formula is:
C
H N•HCL
Maprotiline hydrochloride is a fine, white to off-white, practically
odorless crystalline powder. It is
freely soluble in methanol and in chloroform, slightly soluble in
water, and practically insoluble in
isooctane. Its molecular weight is 313.87.
The tablets contain the following inactive ingredients: colloidal
silicon dioxide, croscarmellose
sodium, hypromellose, magnesium stearate, microcry