Citalopram Tablets, USP
Suicidality and Antidepressant Drugs
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics
Pharmacokinetics
Absorption and Distribution
Metabolism and Elimination
Population Subgroups
Drug-Drug Interactions
Clinical Efficacy Trials
Comparison of Clinical Trial Results
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Clinical Worsening and Suicide Risk
| Increases Compared to Placebo | |
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
Screening Patients for Bipolar Disorder
Potential for Interaction with Monoamine Oxidase Inhibitors
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
PRECAUTIONS
General
Discontinuation of Treatment with Citalopram Tablets
Abnormal Bleeding
Hyponatremia
Activation of Mania/Hypomania
Seizures
Interference with Cognitive and Motor Performance
Use in Patients with Concomitant Illness
Information for Patients
Laboratory Tests
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
Impairment of Fertility
Pregnancy
Nonteratogenic Effects
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials
Adverse Events Associated with Discontinuation of Treatment
| General | ||
| Asthenia | 1% | <1% |
| Gastrointestinal Disorders | ||
| Nausea | 4% | 0% |
| Dry Mouth | 1% | <1% |
| Vomiting | 1% | 0% |
| Central and Peripheral Nervous System Disorders | ||
| Dizziness | 2% | <1% |
| Psychiatric Disorders | ||
| Insomnia | 3% | 1% |
| Somnolence | 2% | 1% |
| Agitation | 1% | <1% |
Adverse Events Occurring at an Incidence of 2% or More Among Citalopram-Treated Patients
| Autonomic Nervous System Disorders | ||
| Dry Mouth | 20% | 14% |
| Sweating Increased | 11% | 9% |
| Central & Peripheral Nervous System Disorders | ||
| Tremor | 8% | 6% |
| Gastrointestinal Disorders | ||
| Nausea | 21% | 14% |
| Diarrhea | 8% | 5% |
| Dyspepsia | 5% | 4% |
| Vomiting | 4% | 3% |
| Abdominal Pain | 3% | 2% |
| General | ||
| Fatigue | 5% | 3% |
| Fever | 2% | <1% |
| Musculoskeletal System Disorders | ||
| Arthralgia | 2% | 1% |
| Myalgia | 2% | 1% |
| Psychiatric Disorder | ||
| Somnolence | 18% | 10% |
| Insomnia | 15% | 14% |
| Anxiety | 4% | 3% |
| Anorexia | 4% | 2% |
| Agitation | 3% | 1% |
| Dysmenorrhea1 | 3% | 2% |
| Libido Decreased | 2% | <1% |
| Yawning | 2% | <1% |
| Respiratory System Disorders | ||
| Upper Respiratory Tract Infection | 5% | 4% |
| Rhinitis | 5% | 3% |
| Sinusitis | 3% | <1% |
| Urogenital | ||
| Ejaculation Disorder2,3 | 6% | 1% |
| Impotence3 | 3% | <1% |
Dose Dependency of Adverse Events
Male and Female Sexual Dysfunction with SSRIs
| Abnormal Ejaculation (mostly ejaculatory delay) | 6.1%(males only) | 1%(males only) |
| Libido Decreased | 3.8%(males only) | <1%(males only) |
| Impotence | 2.8%(males only) | <1%(males only) |
Vital Sign Changes
Weight Changes
Laboratory Changes
ECG Changes
Other Events Observed During the Premarketing Evaluation of Citalopram Tablets
Other Events Observed During the Postmarketing Evaluation of Citalopram Tablets
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Physical and Psychological Dependence
OVERDOSAGE
Human Experience
Management of Overdose
DOSAGE AND ADMINISTRATION
Initial Treatment
Special Populations
Treatment of Pregnant Women During the Third Trimester
Maintenance Treatment
Discontinuation of Treatment with Citalopram Tablets
Switching Patients To or From a Monoamine Oxidase Inhibitor
HOW SUPPLIED
They are supplied by State of Florida DOH Central Pharmacy as follows:
| 53808-0227-1 | 40 mg | 30 Tablets in a Blister Pack | WHITE | 65862-007 |
ANIMAL TOXICOLOGY
Retinal Changes in Rats
Cardiovascular Changes in Dogs
This Product was Repackaged By:
State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
Medication Guide
This Product was Repackaged By:
State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental illness