Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Pregnancy
Exposure Registry
There
is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to antidepressants during pregnancy. Healthcare providers are
encouraged to advise patients to register by calling the National
Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
What are the
possible side effects of CELEXA?
…
Talk
to your healthcare provider if you develop any changes in your sexual function or
if you have any questions or concerns about sexual problems during treatment with
CELEXA. There may be treatments your healthcare provider can suggest.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Serotonin
Syndrome
Additions
and/or revisions underlined:
SSRIs,
including CELEXA, can precipitate serotonin syndrome, a potentially
life-threatening condition. The risk is increased with concomitant use of other
serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, meperidine, methadone, tryptophan, buspirone,
amphetamines, and St. John’s Wort) and with drugs that impair metabolism of
serotonin, i.e., MAOIs [see
Contraindications (4), Drug Interactions (7)]. Serotonin syndrome
can also occur when these drugs are used alone. Symptoms of serotonin syndrome
were noted in 0.1% of MDD patients treated with CELEXA in premarketing clinical
trials.
5.4 Increased Risk of Bleeding
Additions
and/or revisions underlined:
Drugs
that interfere with serotonin reuptake inhibition, including CELEXA, increase
the risk of bleeding events. Concomitant use of aspirin, nonsteroidal
anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other
anticoagulants may add to this risk. Case reports and epidemiological studies
(case-control and cohort design) have demonstrated an association between use
of drugs that interfere with serotonin reuptake and the occurrence of
gastrointestinal bleeding. Based on data from the published observational
studies, exposure to SSRIs, particularly in the month before delivery, has been
associated with a less than 2-fold increase in the risk of postpartum
hemorrhage [see Use in Specific
Populations (8.1)]. Bleeding
events related to drugs that interfere with serotonin reuptake have ranged from
ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.
…
6
Adverse Reactions
6.2 Postmarketing
Experience
Additions and/or revisions underlined:
Respiratory, Thoracic and Mediastinal Disorders: anosmia, hyposmia
7
Drug Interactions
Addition
of other serotonergic drugs listed in table 5; please refer to label for
complete information
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or revisions underlined:
Risk
Summary
Based
on data from published observational studies, exposure to SSRIs, particularly
in the month before delivery, has been associated with a less than 2-fold
increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.4) and Clinical Considerations].
…
Maternal Adverse
Reactions
Use
of CELEXA in the month before delivery may be associated with an increased risk
of postpartum hemorrhage [see Warnings
and Precautions (5.4)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or revisions underlined:
Serotonin
Syndrome
Caution
patients about the the risk of serotonin syndrome, particularly with the
concomitant use of CELEXA with other serotonergic drugs including triptans,
tricyclic antidepressants, opioids, lithium, tryptophan, buspirone,
amphetamines, St. John’s Wort, and with drugs that impair metabolism of
serotonin (in particular, MAOIs, both those intended to treat psychiatric
disorders and also others, such as linezolid). Instruct patients to contact
their health care provider or report to the emergency room if they experience
signs or symptoms of serotonin syndrome [see
Warnings and Precautions (5.3), Drug
Interactions (7)].
…
MEDICATION GUIDE
Additions and/or revisions underlined:
Especially
tell your healthcare provider if you take:
…
- tramadol, fentanyl, meperidine, methadone, or
other opioids
…
Approved Drug Label (PDF)
Boxed Warning
PLR conversion as below:
WARNING: Suicidal Thoughts and Behaviors
Antidepressants
increased the risk of suicidal thoughts and behaviors in pediatric and young
adult patients in short- term studies. Closely monitor all
antidepressant-treated patients for clinical worsening, and for emergence of
suicidal thoughts and behaviors [see
Warnings and Precautions (5.1)]. CELEXA is not approved for use in
pediatric patients [see Use in Specific
Populations (8.4)].
4
Contraindications
PLR conversion with additions and/or revisions underlined:
CELEXA is contraindicated in patients:
taking, or within 14 days of stopping, MAOIs
(including MAOIs such as linezolid or intravenous methylene blue) because
of an increased risk of serotonin syndrome [see
Warnings and Precautions (5.3), Drug Interactions (7)]. taking pimozide
because of risk of QT prolongation [see Drug Interactions (7)].
with known hypersensitivity to citalopram or any of the inactive ingredients in
CELEXA. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2)].
5
Warnings and Precautions
PLR conversion
with extensive changes; please refer to label for complete information. Subsection titles as below:
5.1 Behavior in
Adolescents and Young Adults
5.2
QT-Prolongation and Torsade de Pointes
5.3 Serotonin
Syndrome
5.4 Increased Risk
of Bleeding
5.5 Activation of
Mania or Hypomania
5.6
Discontinuation Syndrome
5.7 Seizures
5.8 Angle Closure
Glaucoma
5.9 Hyponatremia
5.10 Sexual
Dysfunction
6
Adverse Reactions
PLR conversion; addition
of bulleted line listing:
The following adverse
reactions are discussed in greater detail in other sections of the labeling:
Hypersensitivity reactions [see Contraindications (4)]
Suicidal thoughts and behaviors in adolescents and
young adults [see Warnings and
Precautions (5.1)]
QT-prolongation and torsade de pointes [see Warnings and Precautions (5.2)] Serotonin
syndrome [see Warnings and Precautions (5.3)]
Increased risk of bleeding [see Warnings and Precautions (5.4)]
Activation of mania or hypomania [see Warnings and Precautions (5.5)]
Discontinuation syndrome [see Warnings and Precautions (5.6)]
Seizures [see
Warnings and Precautions (5.7)]
Angle-closure glaucoma [see Warnings and Precautions (5.8)]
Hyponatremia [see
Warnings and Precautions (5.9)]
Sexual Dysfunction [see Warnings and Precautions (5.10)]
6.1 Clinical
Trials Experience
PLR conversion
with extensive changes throughout.
Please refer to label for complete information.
6.2 Postmarketing
Experience
PLR conversion
with newly created subsection. Please
refer to label for complete information.
7
Drug Interactions
PLR conversion
with extensive changes throughout including newly created table. Please refer to label for complete
information.
8
Use in Specific Populations
PLR conversion
with PLLR conversion. Please refer to label for complete information on the
extensive changes in the following two subsections:
8.1 Pregnancy
8.2 Lactation
Additions and/or
revisions underlined in the following newly created subsection titles:
8.4 Pediatric Use
The safety and effectiveness
of CELEXA have not been established in pediatric patients. Two
placebo-controlled trials in 407 pediatric patients with MDD have been
conducted with CELEXA, and the data were not sufficient to support use in
pediatric patients.
Antidepressants
increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1)]. Decreased
appetite and weight loss have been observed in association with the use of
SSRIs in pediatric patients.
8.5 Geriatric Use
Of 4422 patients
in clinical studies of CELEXA, 1357 were 60 and over, 1034 were 65 and over,
and 457 were 75 and over. In two pharmacokinetic studies,
citalopram AUC was increased by 23% and 30%, respectively, in subjects greate
than or equal to 60 years of age as compared to younger subjects, and its
half-life was increased by 30% and 50%, respectively [see Clinical Pharmacology (12.3)]. Therefore, the maximum recommended dosage in patients 60 years of age
and older is lower than younger patients [see
Dosage and Administration (2.3),Warnings and Precautions
(5.2)].
SSRIs, including
CELEXA, have been associated with cases of clinically significant hyponatremia
in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.9)].
Newly created:
8.6 Hepatic
Impairment
Increased citalopram
exposure occurs in patients with hepatic impairment. The maximum recommended
dosage of CELEXA is lower in patients with hepatic impairment [see Dosage and Administration (2.3),
Clinical Pharmacology (12.3)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
PLR conversion
with new formatting. Please refer to label for complete information.
PATIENT COUNSELING INFORMATION
PLR conversion
with newly created section. Please refer
to label for complete information.
Other
Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
(Additions and/or
revisions underlined)
…
Sexual
Dysfunction: Advise patients that
use of Celexa may cause symptoms of sexual dysfunction in both male and female
patients. Inform patients that they should discuss any changes in sexual
function and potential management strategies with their healthcare provider
(see WARNINGS).
…
WARNINGS
(Additions and/or
revisions underlined)
…
Sexual
Dysfunction
Use of SSRIs, including Celexa, may cause symptoms
of sexual dysfunction (see ADVERSE REACTIONS). In male patients, SSRI
use may result in ejaculatory delay or failure, decreased libido, and erectile
dysfunction. In female patients, SSRI use may result in decreased libido and
delayed or absent orgasm.
It is important for prescribers to inquire about
sexual function prior to initiation of Celexa and to inquire specifically about
changes in sexual function during treatment, because sexual function may not be
spontaneously reported. When evaluating changes in sexual function, obtaining a
detailed history (including timing of symptom onset) is important because
sexual symptoms may have other causes, including the underlying psychiatric
disorder. Discuss potential management strategies to support patients in making
informed decisions about treatment.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
…
Keep
all follow?up visits with your healthcare provider and call between visits
if you are worried about symptoms.
…
Sexual problems
(dysfunction). Taking selective serotonin reuptake inhibitors
(SSRIs), including Celexa, may cause sexual problems.
Approved Drug Label (PDF)
5
Warnings and Precautions
Serotonin Syndrome
Additions and/or revisions below:
The development of a potentially
life-threatening serotonin syndrome has been reported with SNRIs and SSRIs,
including Celexa, alone but particularly with concomitant use of other
serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, trytophan, buspirone, amphetamines, and St. John’s
Wort) …
If concomitant use of Celexa with other
serotonergic drugs including, triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, buspirone, amphetamines, trytophan and St. John’s
Wort …
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