CELEXA Film-coated tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Allergan, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

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 ...

1. Description

Celexa (citalopram) 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 ...

2. Clinical Pharmacology

Pharmacodynamics The mechanism of action of citalopram HBr as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its ...

3. Indications and Usage

Celexa (citalopram) is indicated for the treatment of depression. The efficacy of Celexa in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded ...

4. Contraindications

The use of MAOIs intended to treat psychiatric disorders with Celexa or within 14 days of stopping treatment with Celexa is contraindicated because of an increased risk of serotonin syndrome. The use of ...

5. Warnings

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior ...

6.1. General

Discontinuation of Treatment with Celexa During marketing of Celexa and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring ...

6.2. Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Celexa. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Celexa ...

6.3. Laboratory Tests

There are no specific laboratory tests recommended.

6.4. Drug Interactions

Serotonergic Drugs See CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION. Triptans There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of citalopram in mice ...

6.7. Pregnancy

Pregnancy Category C In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses ...

6.8. Labor and Delivery

The effect of Celexa on labor and delivery in humans is unknown.

6.9. Nursing Mothers

As has been found to occur with many other drugs, citalopram is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss ...

6.10. Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOXED WARNING and WARNINGS—Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 407 pediatric patients ...

6.11. 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. No overall differences in safety or effectiveness were observed between these subjects ...

7. Adverse Reactions

The premarketing development program for Celexa included citalopram exposures in patients and/or normal subjects from 3 different groups of studies: 429 normal subjects in clinical pharmacology/pharmacokinetic ...

8. Drug Abuse and Dependence

Controlled Substance Class Celexa (citalopram) is not a controlled substance. Physical and Psychological Dependence Animal studies suggest that the abuse liability of Celexa is low. Celexa has not been ...

9. Overdosage

Human Experience In clinical trials of citalopram, there were reports of citalopram overdose, including overdoses of up to 2000mg, with no associated fatalities. During the postmarketing evaluation of ...

10. Dosage and Administration

Celexa should be administered once daily, in the morning or evening, with or without food. Initial Treatment Celexa (citalopram) should be administered at an initial dose of 20 mg once daily, with an increase ...

11. How Supplied

Tablets: 10 mg Bottle of 100 NDC # 0456-4010-01 Beige, oval, film-coated. Imprint on one side with FP. Imprint on the other side with 10 mg. 20 mg Bottle of 100 NDC # 0456-4020-01 10 10 Unit ...

12. Animal Pharmacology and/or Animal Toxicology

Retinal Changes in Rats Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2year carcinogenicity study with citalopram. There was an increase in both incidence ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).