CITALOPRAM 40 mg Tablet, Film Coated, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Citalopram is used to treat depression. Citalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Read the full MedlinePlus article ↗- Antidepressants like citalopram don't work overnight — most people start to notice some improvement in mood and sleep within a few weeks, but full benefit often takes 4 to 6 weeks...
- How long will it take before I start feeling better on citalopram?
- You should never stop citalopram suddenly. Stopping abruptly can cause discontinuation symptoms — things like dizziness, nausea, irritability, and strange electric shock–like sensa...
- Can I stop taking citalopram whenever I want, or do I have to taper off?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Citalopram — tap one for details:
Citalopram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1027 | $102.70 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Citalopram 40 mg 00378-6233-01 | Mylan | 100 tablets | $0.042 | AB | Availability likely | — |
| Citalopram 40 mg 13668-0011-01 | Torrent | 100 tablets | $0.042 | AB | Availability likely | — |
| Citalopram 40 mg 42806-0021-01 | Epic | 100 tablets | $0.042 | AB | Availability likely | — |
| Citalopram Hydrobromide 40 mg 65862-0007-01 | Aurobindo | 100 tablets | $0.042 | — | Availability likely | — |
| Citalopram 40 mg 82009-0108-05 | QUALLENT | 500 tablets | $0.042 | AB | Availability likely | — |
| Celexa 40 mg 00456-4040-01 | Allergan, | 100 tablets | $9.464 | AB | Availability likely | — |
| Citalopram 40 mg 00615-8141-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 43063-0670-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 43353-0112-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 50090-3136-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 50090-3208-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 50090-5175-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 50090-6947-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 50090-7039-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 51655-0209-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Citalopram 40 mgthis 60429-0175-10 | Golden | 1000 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 63187-0140-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 65162-0054-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Citalopram 40 mg 67046-0113-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 68071-3357-01 | NuCare | 15 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 68071-3384-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 68071-3558-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 68788-8962-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 69097-0824-02 | Cipla | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 70518-2228-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 70518-2601-00 | REMEDYREPACK | 90 tablets | — | AB | Discontinued | — |
| Citalopram 40 mg 70518-4334-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 71205-0764-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 71335-0480-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Citalopram 40 mg 71335-2232-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 71610-0412-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 71610-0413-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 71610-0422-45 | Aphena | 45 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 72657-0111-01 | Glenmark | 100 tablets | — | — | FDA listed | — |
| Citalopram 40 mg 72789-0071-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Citalopram Hydrobromide 40 mg 76282-0208-05 | Exelan | 500 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 87063-0221-01 | ASCLEMED | 100 tablets | — | AB | FDA listed | — |
| Citalopram 40 mg 51655-0667-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60429-0175-10 You're viewing this | 1000 TABLET, FILM COATED in 1 BOTTLE (60429-175-10) | 2011-05-20 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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) ]. Citalopram is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ].
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. 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 is not approved for use in pediatric patients ( 8.4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 ).
2.1Recommended Dosage Administer citalopram tablets once daily, with or without food, at an initial dosage of 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval of no less than one week. Dosages above 40 mg once daily are not recommended due to the risk of QT prolongation [see Warnings and Precautions (5.2) ].
2.2Screen for Bipolar Disorder Prior to Starting Citalopram Prior to initiating treatment with citalopram tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.5) ].
2.3Recommended Dosage for Specific Populations The maximum recommended dosage of citalopram tablets for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily [see Warnings and Precautions (5.2) , Clinical Pharmacology (12.3) ].
2.4Dosage Modifications with Concomitant Use of CYP2C19 Inhibitors The maximum recommended dosage of citalopram tablets when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily [see Warnings and Precautions (5.2) , Drug Interactions (7) ].
2.5Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of therapy with citalopram tablets. Conversely, at least 14 days must elapse after stopping citalopram tablets before starting an MAOI antidepressant [see Contraindications (4) and Warnings and Precautions (5.3) ].
2.6Discontinuing Treatment with Citalopram Adverse reactions may occur upon discontinuation of citalopram tablets [see Warnings and Precautions (5.6) ]. Gradually reduce the dosage rather than stopping citalopram tablets abruptly whenever possible.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Citalopram tablets are available as: 10 mg: modified oval shaped, white, film-coated tablets, debossed “ Є 19 ” on one side and plain on the other side. 20 mg: modified oval shaped, white, film-coated tablets, debossed “ Є ” to the left of bisect and “ 20 ” to the right of bisect on one side and plain on the other side. 40 mg: capsule-shaped, white, film-coated tablets, debossed “ Є ” to the left of bisect and “ 21 ” to the right of bisect on one side and plain on the other side.
Tablets: 10 mg; 20 mg; and 40 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Citalopram tablets are 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 citalopram tablets. Reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.2) ].
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within14 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 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS QT-Prolongation and Torsade de Pointes : Dose-dependent QTc prolongation, Torsade de pointes, ventricular tachycardia, and sudden death have occurred. Avoid use of citalopram in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval. Monitor electrolytes in patients at high risk for hypokalemia or hypomagnesemia.
Discontinue citalopram in patients with persistent QTc measurements > 500 ms ( 5.2 , 7 ). Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue citalopram and serotonergic agents and initiate supportive measures ( 5.3 ).
Increased Risk of Bleeding : Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin and other anticoagulants may increase this risk ( 5.4 ). Activation of Mania/Hypomania : Screen patients for bipolar disorder ( 5.5 ). Seizures : Use with caution in patients with seizure disorder ( 5.7 ).
Angle-Closure Glaucoma : Avoid use of citalopram in patients with untreated anatomically narrow angles ( 5.8 ). Hyponatremia : Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.9 ). Sexual Dysfunction : Citalopram may cause symptoms of sexual dysfunction.
( 5.10 ).
5.1Suicidal Thoughts and Behavior in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1 . Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range * Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated 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 * Citalopram is not approved for use in pediatric patients.
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.
Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing citalopram, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
5.2QT-Prolongation and Torsade de Pointes Citalopram causes dose-dependent QTc prolongation an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of whi…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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) ] Most common adverse reaction (incidence ≥ 5% and twice placebo) is ejaculation disorder (primarily ejaculation delay) ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact [Epic Pharma LLC at 1-888-374-2791] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The safety for citalopram tablets included citalopram exposures in patients and/or healthy subjects from 3 different groups of studies: 429 healthy subjects in clinical pharmacology/pharmacokinetic studies; 4,422 exposures from patients in controlled and uncontrolled clinical trials, corresponding to approximately 1,370 patient-exposure years.
There were, in addition, over 19,000 exposures from mostly open-label, European postmarketing studies. The conditions and duration of treatment with citalopram tablets varied greatly and included (in overlapping categories) open-label and double-blind studies, inpatient and outpatient studies, fixed-dose and dose-titration studies, and short-term and long-term exposure. Adverse Reactions Associated with Discontinuation of Treatment Among 1,063 patients with MDD who received citalopram tablets at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks duration, 16% discontinued treatment due to an adverse reaction, as compared to 8% of 446 patients receiving placebo.
The adverse reactions associated with discontinuation (i.e., associated with discontinuation in at least 1% of citalopram tablets-treated patients at a rate at least twice that of placebo) are shown in Table 2 . Table 2: Adverse Reactions Associated with Discontinuation of Citalopram Tablets Treatment in Short-Term, Placebo-Controlled MDD Trials * Body System/Adverse Event Citalopram Placebo (N=1063) % (N=446) % 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 *A patient can report more than one reason for discontinuation and be counted more than once in this table.
Table 3 enumerates the incidence of adverse reactions that occurred among 1,063 patients with MDD who received citalopram tablets at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks duration. The most common adverse reaction that occurred in citalopram tablets-treated patients with an incidence of 5% or greater and at least twice the incidence in placebo patients was ejaculation disorder (primarily ejaculatory delay) in male patients (see Table 3 ). Table 3: Adverse Reactions (≥2% and Greater than Placebo) Among Citalopram Tablets-Treated Patients * Body System/Adverse Event Citalopram Tablets Placebo (N=1063) % (N=446) % Gastrointestinal Disorders Nausea 21 14 Diarrhea 8 5 Dyspepsia 5 4 Vomiting 4 3 Abdominal Pain 3 2 Autonomic Nervous System Disorders Dry Mo…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with citalopram tablets. Table 5: Clinically Important Drug Interactions with Citalopram Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including citalopram tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Citalopram tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.5) , Contraindications (4) , Warnings and Precautions (5.3) ].
Pimozide Clinical Impact Concomitant use of citalopram tablets with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of citalopram tablets alone [see Clinical Pharmacology (12.2) ]. Intervention Citalopram tablets are contraindicated in patients taking pimozide [see Contraindications (4) , Warnings and Precautions (5.2) ]. Drugs that Prolong the QTc Interval Clinical Impact Concomitant use of citalopram tablets with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram tablets alone [see Clinical Pharmacology (12.2) ].
Intervention Avoid concomitant use of citalopram tablets with drugs that prolong the QT interval (citalopram tablets are contraindicated in patients taking pimozide) [see Contraindications (4) , Warnings and Precautions (5.2) ]. CYP2C19 Inhibitors Clinical Impact Concomitant use of citalopram tablets A with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram tablets alone [see Clinical Pharmacology (12.2) ]. Intervention The maximum recommended dosage of citalopram tablets is 20 mg daily when used concomitantly with a CYP2C19 inhibitor [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ].
Other Serotonergic Drugs Clinical Impact Concomitant use of citalopram tablets and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during citalopram tablets initiation and dosage increases.
If serotonin syndrome occurs, consider discontinuation of citalopram tablets and/or concomitant serotonergic drugs [see Warning and Precautions (5.3) ]. Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact Concomitant use of citalopram tablets and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of citalopram tablets and antiplatelet agents and anticoagulants.
For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions (5.4) ]. CYP2C19 Inhibitors : Citalopram tablets 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors ( 5.2 , 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: SSRI use, particularly late in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate ( 8.1 ).
8.1Pregnancy 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. 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].
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, 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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk 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. Maternal Adverse Reactions Use of citalopram in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.4)].
Fetal/Neonatal Adverse Reactions 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) ]. Data Human Data 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. Animal Data Citalopra…
🤰 Pregnancy ▾
8.1Pregnancy 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. 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].
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, 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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk 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. Maternal Adverse Reactions Use of citalopram in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.4)].
Fetal/Neonatal Adverse Reactions 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) ]. Data Human Data 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. Animal Data 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/m 2 body surface area. Citalopram caused maternal toxicity of CNS clinical si…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of citalopram tablets have not been established in pediatric patients. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with citalopram tablets, 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.
🧓 Geriatric Use ▾
8.5Geriatric Use 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, 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) ].
🆘 Overdosage ▾
10 OVERDOSAGE The following have been reported with citalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co‐ingestants including alcohol.
Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in citalopram overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a citalopram overdose.
Consider contacting a Poison Center (1‐800‐221‐2222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of citalopram is unclear, but is presumed to be related to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
12.2Pharmacodynamics In vitro and in vivo studies in animals suggest that citalopram is a selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake. Citalopram has no or very low affinity for 5-HT1A, 5-HT2A, dopamine D 1 and D 2 , α 1 -, α 2- , and β-adrenergic, histamine H 1 , gamma aminobutyric acid (GABA), muscarinic cholinergic, and benzodiazepine receptors. Cardiac Electrophysiology Individually corrected QTc (QTcN i ) interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, escalating multiple-dose study in 119 healthy subjects.
The maximum mean (upper bound of the 95% one-sided confidence interval) difference from placebo were 8.5 (10.8) and 18.5 (21.0) msec for 20 mg and 60 mg (1.5 times the maximum recommended dosage) citalopram, respectively. Based on the established exposure-response relationship, the predicted QTcNi change from placebo (upper bound of the 95% one-sided confidence interval) under the C max for the dose of 40 mg is 12.6 (14.3) msec [see Warnings and Precautions (5.2) ].
12.3Pharmacokinetics The single-and multiple-dose pharmacokinetics of citalopram are linear and dose-proportional in a dose range of 10 to 40 mg/day. Biotransformation of citalopram is mainly hepatic, with a mean terminal half-life of about 35 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week.
At steady state, the extent of accumulation of citalopram in plasma, based on the half-life, is expected to be 2.5 times the plasma concentrations observed after a single dose. Absorption Following a single oral dose (40 mg tablet) of citalopram, peak blood levels occur at about 4 hours. The absolute bioavailability of citalopram was about 80% relative to an intravenous dose, and absorption is not affected by food.
Distribution The volume of distribution of citalopram is about 12 L/kg and the binding of citalopram (CT), demethylcitalopram (DCT) and didemethylcitalopram (DDCT) to human plasma proteins is about 80%. Elimination Metabolism Citalopram is metabolized to demethylcitalopram (DCT), didemethylcitalopram (DDCT), citalopram-N-oxide, and a deaminated propionic acid derivative. In humans, unchanged citalopram is the predominant compound in plasma.
At steady state, the concentrations of citalopram's metabolites, DCT and DDCT, in plasma are approximately one-half and one-tenth, respectively, that of the parent drug. In vitro studies show that citalopram is at least 8 times more potent than its metabolites in the inhibition of serotonin reuptake, suggesting that the metabolites evaluated do not likely contribute significantly to the antidepressant actions of citalopram. In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes involved in the N-demethylation of citalopram.
Excretion Following intravenous administrations of citalopram, the fraction of drug recovered in the urine as citalopram and DCT was about 10% and 5%, respectively. The systemic clearance of citalopram was 330 mL/min, with approximately 20% of that due to renal clearance. Specific Populations Geriatric Patients Citalopram pharmacokinetics in subjects ≥ 60 years of age were compared to younger subjects in two normal volunteer studies.
In a single-dose study, citalopram AUC and half-life were increased in the subjects ≥ 60 years old by 30% and 50%, respectively, whereas in a multiple-dose study they were increased by 23% and 30%, respectively [see Dosage and Administration (2.3) , Warnings and Precautions (5.2) , Use in Specific Populations (8.5) ]. Male and Female Patients In thre…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of citalopram is unclear, but is presumed to be related to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Citalopram tablets are supplied as follows: Strength Color/Shape Engraved Descriptors Package Configuration NDC Number 10 mg modified oval shaped, white, film-coated tablets debossed “ Є 19 ” on one side and plain on the other side Bottle of 30 NDC 60429-173-30 Bottle of 1000 NDC 60429-173-10 20 mg modified oval shaped, white, film-coated tablets debossed “ Є ” to the left of bisect and “ 20 ” to the right of bisect on one side and plain on the other side Bottle of 30 NDC 60429-174-30 Bottle of 100 NDC 60429-174-01 Bottle of 1000 NDC 60429-174-10 40 mg capsule-shaped, white, film-coated tablets debossed “ Є ” to the left of bisect and “ 21 ” to the right of bisect on one side and plain on the other side Bottle of 30 NDC 60429-175-30 Bottle of 100 NDC 60429-175-01 Bottle of 1000 NDC 60429-175-10 Storage and Handling Citalopram tablets should be stored at 20 to 25°C (68 to 77°F); [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child-resistant closure as required.
📋 Description ▾
11 DESCRIPTION Citalopram tablets contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder.
Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram Tablets USP, 10 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 10 mg citalopram base.
Citalopram Tablets USP, 20 mg are modified oval-shaped, white, film-coated tablets, in strengths equivalent to 20 mg of citalopram base. Citalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets in strengths equivalent to 40 mg of citalopram base. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 and titanium dioxide. image-01.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning , Warnings and Precautions (5.1) ]. QT Prolongation and Torsade de Pointes Advise patients to consult their health care provider immediately if they feel faint, lose consciousness, or have heart palpitations.
Instruct patients to inform their health care provider that they are taking citalopram tablets before taking any new medications [see Warnings and Precautions (5.2) , Drug Interactions (7) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of citalopram tablets 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) ]. Increased Risk of Bleeding Inform patients about the concomitant use of citalopram tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the counter medications that increase the risk of bleeding [see Warnings and Precautions (5.4) ].
Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.5) ]. Discontinuation Syndrome Advise patients not to abruptly discontinue citalopram tablets and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when citalopram tablets are discontinued [See Warnings and Precautions (5.6) ].
Sexual Dysfunction Advise patients that use of citalopram tablets 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 and Precautions (5.10) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with citalopram tablets [see Use in Specific Populations (8.1) ].
Advise patients that citalopram tablets use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1) ]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to citalopram during pregnancy [see Use in Specific Populations (8.1) ]. Lactation Advise breastfeeding women to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2) ].
Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Citalopram-Tablet.pdf Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Manufactured in USA Rev. 09-2024-00 MF019REV09/24 OE1133 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA
💬 Medication Guide ▾
Medication Guide Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Citalopram-Tablet.pdf MEDICATION GUIDE Citalopram (suh-ta-luh-pram) Tablets, for oral use 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. 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?
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. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
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: What are citalopram tablets?
Citalopram tablets are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if citalopram tablets are safe and effective for use in children. Who should not take citalopram tablets?
Do not take citalopram tablets if you: take a Monoamine Oxidase Inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue take pimozide are allergic to citalopram or any of the ingredients in citalopram tablets. See the end of this Medication Guide for a complete list of ingredients in citalopram tablets. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you stop treatment with citalopram tablets. Before taking citalopram tablets, tell your healthcare provider about all your medical conditions, including if you: have or have a family history of suicide, depression, bipolar disorder, mania or hypomania have an abnormal heart rhythm called QT prolongation have or had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have low potassium, magnesium, or sodium levels in your blood have or had bleeding problems have or had seizures (convulsions) have high pressure in the eye (glaucoma) have or had kidney or liver problems are pregnant or plan to become pregnant.
Citalopram tablets may harm your unborn baby. Taking citalopram tablets late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks and benefits of treating depression during pregnancy.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with citalopram tablets. There is a pregnancy registry for females who are exposed to citalopram tablets during pregnancy. The purpose of the registry is to collect information about the health of females exposed to citalopram tablets and their baby.
If you become pregnant during treatment with citalopram tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or visiting online at https://womensmentalhea…