PAMELOR- nortriptyline hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)

Available from:

SpecGx LLC

INN (International Name):

NORTRIPTYLINE HYDROCHLORIDE

Composition:

NORTRIPTYLINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased risk of serotonin syndrome.  The use of Pamelor within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see  WARNINGS  and DOSAGE AND ADMINISTRATION ). Starting Pamelor 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 ). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between Pamelor and other dibenzazepines is a possibility. Myocardial Infarction Pamelor is contraindicated during the acute recovery period after myoc

Product summary:

Pamelor™ (nortriptyline HCl) Capsules USP Pamelor™ (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows: 10 mg:      Light orange opaque cap printed “PAMELOR 10 mg” in black and white opaque body printed “” in black.      Bottles of 30..................NDC 0406-9910-03 25 mg:      Light orange opaque cap printed “PAMELOR 25 mg” in black and white opaque body printed ““ in black.      Bottles of 30..................NDC 0406-9911-03 50 mg:      White opaque cap printed “PAMELOR 50 mg” in black and white opaque body printed “” in black.      Bottles of 30..................NDC 0406-9912-03 75 mg:      Light orange opaque cap printed “PAMELOR 75 mg” in black and light orange opaque body printed “” in black.      Bottles of 30..................NDC 0406-9913-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo,  and other brands are trademarks of a Mallinckrodt company. © 2019 Mallinckrodt. Manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5 Manufactured for: SpecGx LLC Webster Groves, MO 63119 USA  Rev 04/2019                                               Mallinckrodt™ Pharmaceuticals

Authorization status:

New Drug Application

Patient Information leaflet

PAMELOR- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
SpecGx LLC
----------
MEDICATION GUIDE – PAMELOR™
(NORTRIPTYLINE HCL) CAPSULES 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. 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 following symptoms,
especially if they are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or wors

Summary of Product characteristics

PAMELOR- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
SPECGX LLC
----------
PAMELOR
_(NORTRIPTYLINE HCL) CAPSULES 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
NORTRIPTYLINE 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.
NORTRIPTYLINE 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
Pamelor
(nortriptyline HCl) is 1-propanamine,
3-(10,11-dihydro-_5H_-dibenzo[_a,d_] cyclohepten-5-
ylidene)-_N_-methyl-, hydrochloride.
The structural formula is as follows:
_10 MG, 25 MG, 50 MG, AND 75 MG CAPSULES_
_Active Ingredient:_ nortriptyline hydrochloride USP.
_10 MG, 25 MG, AND 75 MG CAPSULES_
™
™
_Inactive Ingredients:_ D&C Yellow #10, FD&C Yellow #6, gelatin,
silicone fluid, starch, and titanium
dioxide.
_50 MG CAPSULES_
_Inactive Ingredients:_ gelatin, silicone fluid, starch, and titanium
dioxide.
CLINICAL PHARMACOLOGY
The mechanism of mood elevation by tricyclic antidepressants is at
present