CITALOPRAM tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Pharmaceuticals Inc.

INN (nemzetközi neve):

CITALOPRAM HYDROBROMIDE

Összetétel:

CITALOPRAM 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] . Citalopram tablets are contraindicated in patients: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . 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] . Available data from published epidemiologic studies and postmarketing reports with citalopram use in pregnancy have not established an increased risk of major birth defects or miscarriage. Published studies demonstrated that citalopram levels in both cord blood and amniotic fluid are similar to those observed in maternal serum. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including citalopram tablets, during pregnancy. There also are risks associated with untreated depression in pregnancy (see Clinical Considerations) . In animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Use of citalopram in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.4)] . Neonates exposed to citalopram and other SSRIs late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of SSRIs or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.3)] . Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Citalopram was administered orally to pregnant rats during the period of organogenesis at doses of 32, 56, and 112 mg/kg/day, which are approximately 8, 14, and 27 times the Maximum Recommended Human Dose (MRHD) of 40 mg, based on mg/m2 body surface area. Citalopram caused maternal toxicity of CNS clinical signs and decreased weight gain at 112 mg/kg/day, which is 27 times the MRHD. At this maternally toxic dose, citalopram decreased embryo/fetal growth and survival and increased fetal abnormalities (including cardiovascular and skeletal defects). The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity is 56 mg/kg/day, which is approximately 14 times the MRHD. Citalopram was administered orally to pregnant rabbits during the period of organogenesis at doses up to 16 mg/kg/day, which is approximately 8 times the MRHD of 40 mg, based on mg/m2 body surface area. No maternal or embryofetal toxicity was observed. The NOAEL for maternal and embryofetal toxicity is 16 mg/kg/day, which is approximately 8 times the MRHD. Citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 40 mg, based on mg/m2 body surface area. Citalopram increased offspring mortality during the first 4 days of birth and decreased offspring growth at 32 mg/kg/day, which is approximately 8 times the MRHD. The NOAEL for developmental toxicity is 12.8 mg/kg/day, which is approximately 3 times the MRHD. In a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the MRHD. A NOAEL was not determined in that study. Data from the published literature report the presence of citalopram in human milk at relative infant doses ranging between 0.7 to 9.4% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.78 to 4.3. There are reports of breastfed infants exposed to citalopram experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss (see Clinical Considerations) . There is no information about effects of citalopram on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for citalopram tablets and any potential adverse effects on the breastfed child from citalopram or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The safety and effectiveness of citalopram have not been established in pediatric patients. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with citalopram, 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. Of 4422 patients in clinical studies of citalopram tablets, 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 ≥ 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 citalopram tablets, 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)] . Increased citalopram exposure occurs in patients with hepatic impairment. The maximum recommended dosage of citalopram tablets is lower in patients with hepatic impairment [see Dosage and Administration (2.3), Clinical Pharmacology (12.3)] . Citalopram tablets (citalopram HBr) are not a controlled substance. Animal studies suggest that the abuse liability of citalopram tablets is low. Citalopram tablets have not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with citalopram tablets did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, health care providers should carefully evaluate citalopram tablets patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

Termék összefoglaló:

Citalopram Tablets, USP are available containing citalopram hydrobromide, USP equivalent to 10 mg, 20 mg or 40 mg citalopram. The 10 mg tablets are orange, film-coated, round, unscored tablets debossed with MX31 on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-6231-01 bottles of 100 tablets NDC 0378-6231-05 bottles of 500 tablets The 20 mg tablets are pink, film-coated, round, scored tablets debossed with MX32 on one side of the tablet and a score line on the other side. They are available as follows: NDC 0378-6232-01 bottles of 100 tablets NDC 0378-6232-05 bottles of 500 tablets The 40 mg tablets are white, film-coated, round, scored tablets debossed with MX33 on one side of the tablet and a score line on the other side. They are available as follows: NDC 0378-6233-01 bottles of 100 tablets NDC 0378-6233-05 bottles of 500 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Citalopram Tablets
(sye talʹ oh pram)
What is the most important information I should know about citalopram
tablets?
Citalopram tablets may cause serious side effects, including:
•
Increased risk of suicidal thoughts and actions. Citalopram tablets
and other antidepressant
medicines may increase suicidal thoughts and actions in some children,
adolescents, and young
adults especially within the first few months of treatment or when the
dose is changed. Citalopram
tablets are not for use in children.
o
Depression and other mental illnesses are the most important causes of
suicidal thoughts and
actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
o
Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts,
or feelings, or if you develop suicidal thoughts or actions. This is
very important when an
antidepressant medicine is started or when the dose is changed.
o
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
o
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you or your family
member have any of the following symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
new or worse depression
•
feeling very agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, being angry, or violent
•
an extreme increase in activity or talking
(mania)
•
attempts to commit suicide
•
new or worse anxiety
•
acting on dangerous impulses
•
panic attacks
•
new or worse irritability
•
other unusual changes in behavior or mood
What are citalopram tablets?
Citalopram tablets are a prescription medicine used to treat a certain
type of depression called Major
Depre

Termékjellemzők

CITALOPRAM- CITALOPRAM TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CITALOPRAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CITALOPRAM TABLETS.
CITALOPRAM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.3, 5.4) 8/2023
INDICATIONS AND USAGE
Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of major
depressive disorder (MDD) in adults _(1)_.
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg; 20 mg, scored; and 40 mg, scored _(3)_
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT
PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL
ANTIDEPRESSANT-TREATED
PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS
_(5.1)_.
CITALOPRAM TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS
_(8.4)_.
Administer once daily with or without food _(2)_.
Initial dosage is 20 mg once daily; after one week may increase to
maximum dosage of 40 mg once
daily _(2.1)_.
Patients greater than 60 years of age, patients with hepatic
impairment, and CYP2C19 poor
metabolizers: maximum recommended dosage is 20 mg once daily _(2.2)_.
When discontinuing citalopram tablets, reduce dosage gradually _(2.4,
5.6)_.
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
14 days of discontinuing a
MAOI _(4)_.
Concomitant use of pimozide _(4)_.
Known hypersensitivity to citalopram or any of the inactive
ingredients of citalopram tablets _(4)_.
_QT-Prolongation and Torsade de Pointes:_ Dose-dependent QTc
prolongation, Torsade de pointes,
ventricular tachycardia, and sudden death have occurred. Avoid use of
citalopram tablets in p