NORTRIPTYLINE HYDROCHLORIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

STAT RX USA LLC

INN (nume internaţional):

NORTRIPTYLINE HYDROCHLORIDE

Compoziție:

NORTRIPTYLINE HYDROCHLORIDE 25 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. The use of nortriptyline hydrochloride or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline hydrochloride is started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug. Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

Rezumat produs:

Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 10 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 25 mg supplied in bottles of 100, 500 and 1000. Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted NORTRIPTYLINE and DAN 50 mg supplied in bottles of 100 and 500. Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted NORTRIPTYLINE and DAN 75 mg supplied in bottles of 100. Dispense in a tight container, as defined in the USP, with a child-resistant closure. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: September 2008 0908B                             173679 Medication Guide 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? 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? 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 worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants. Manufactured By: Watson Pharma Private Limited                               Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc.                          Corona, CA 92880 USA Revised: September 2008 0908B                             173679

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

NORTRIPTYLINE HYDROCHLORIDE - NORTRIPTYLINE HYDROCHLORIDE CAPSULE
STAT RX USA LLC
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NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP
REVISED: SEPTEMBER 2008
RX ONLY 173679
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
Nortriptyline hydrochloride is 1-Propanamine,
3-(10,11-dihydro-5_H-_dibenzo[_a,d_]cyclohepten-5-
ylidene)-_N_-methyl-, hydrochloride. The structural formula is
represented below:
C
H N•HCl M.W. 299.84
Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg,
50 mg and 75 mg
Nortriptyline), for oral administration, contain the following
inactive ingredients: colloidal silicon
dioxide, magnesium stearate, pregelatinized starch and sodium lauryl
sulfate. The 10 mg, 25 mg, 50 mg
and 75 mg capsule shells contain: gelatin, methylparaben,
propy