SENTRALOPRAM AM-10- citalopram hydrobromide, choline kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V)

Available from:

Physician Therapeutics LLC

INN (International Name):

CITALOPRAM HYDROBROMIDE

Composition:

CITALOPRAM HYDROBROMIDE 10 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of depression.   The efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).   A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms:  depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.   The antidepressant action of citalopram tablets in hospitalized depressed patients has not been

Product summary:

HOW SUPPLIED Citalopram tablets are supplied as: 10 mg Tablets – Peach coloured, biconvex, round shaped film coated tablets debossed with ‘A’ on one side and ‘05’ on the other side.                        Bottles of 30                              NDC 65862-005-30                      Bottles of 60                              NDC 65862-005-60                      Bottles of 90                              NDC 65862-005-90                      Bottles of 100                            NDC 65862-005-01                      Bottles of 500                            NDC 65862-005-05                      10 x 10 Unit Dose                      NDC 65862-005-10                      30 Unit-of-use packaging           NDC 65862-005-32 20 mg Tablets – Light pink coloured, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘6’ on other side.                       Bottles of 30                              NDC 65862-006-30                     Bottles of 60                              NDC 65862-006-60                     Bottles of 90                              NDC 65862-006-90                     Bottles of 100                            NDC 65862-006-01                     Bottles of 500                            NDC 65862-006-05                     10 x 10 Unit Dose                      NDC 65862-006-10                     30 Unit-of-use packaging           NDC 65862-006-32 40 mg Tablets – White coloured, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘0’ and ‘7’ on other side.                       Bottles of 30                              NDC 65862-007-30                     Bottles of 60                              NDC 65862-007-60                     Bottles of 90                              NDC 65862-007-90                     Bottles of 100                            NDC 65862-007-01                     Bottles of 500                            NDC 65862-007-05                     10 x 10 Unit Dose                      NDC 65862-007-10                     30 Unit-of-use packaging           NDC 65862-007-32 Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810   Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India   Revised: 02/2009 How Supplied  Sentra AM is supplied in opaque orange and white, size 0 capsules in bottles of 60 capsules.  Physician Supervision Sentra AM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.  U.S. patent pending.  Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225  Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com   Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved  NDC # 68405-1002-02

Authorization status:

unapproved drug other

Patient Information leaflet

Physician Therapeutics LLC
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
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?
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

Summary of Product characteristics

SENTRALOPRAM AM-10 - CITALOPRAM HYDROBROMIDE, CHOLINE
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
SENTRALOPRAM AM-10
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 citalopram
tablets 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. Citalopram is not approved for use in pediatric patients.
(See WARNINGS: Clinical
Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and
PRECAUTIONS:
Pediatric Use.)
DESCRIPTION
Citalopram hydrobromide is an orally administered selective serotonin
reuptake inhibitor (SSRI) with a
chemical structure unrelated to that of other SSRIs or of tricyclic,
tetracyclic, or other available
antidepressant agents. Citalopram hydrobromide is a racemic bicyclic
phthalane derivative designated
(±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile,
hydrobromide with the following structural formula:
The molecular form