citalopram 30 mg Capsule, 30-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
- 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?
Patient education
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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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII PN2ZH5LOQY
A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.910 | $147.29 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $5.42 | $162.63 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $5.42 | $162.46 / 30 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| citalopram 30 mgthis 52427-0691-30 | Almatica | 30 capsules | $4.910 | AB | Availability likely | — |
| Citalopram 30 mg 59651-0964-30 | Aurobindo | 30 capsules | $4.910 | AB | Availability likely | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 52427-0691-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (52427-691-30) | 2022-03-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior 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 Capsules 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 behaviors 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 Capsules is not approved for use in pediatric patients ( 8.4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Citalopram Capsules are indicated for the treatment of Major Depressive Disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for treatment of Major Depressive Disorder (MDD) in adults. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Do not initiate treatment with Citalopram Capsules. Use another citalopram product for initial dosage titration or dosages other than 30 mg once daily. ( 2.1 ) Administer once daily with or without food.
( 2.1 ) Recommended dosage of Citalopram Capsules is 30 mg once daily. ( 2.1 ) Citalopram dosages above 40 mg once daily are not recommended due to the risk of QT prolongation. ( 2.1 ) When discontinuing Citalopram Capsules, reduce dose gradually.
Gradual dosage reduction will require use of another citalopram product. ( 2.4 , 5.6 )
2.1Recommended Dosage Do not initiate treatment with Citalopram Capsules because the only available dose strength is 30 mg. Use another citalopram product for initial dosage, titration, and dosages other than 30 mg once daily. Refer to Prescribing Information of the other citalopram products for the recommended dosage for those products.
Administer Citalopram Capsules orally, once daily, with or without food. Citalopram should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg once daily at an interval of no less than one week. Citalopram 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 Capsules Prior to initiating treatment with Citalopram Capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5 )] .
2.3Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepresssant At least 14 days must elapse between discontinuation of an monoamine oxidase inhibitor (MAOI) and initiation of therapy with Citalopram Capsules. Conversely, at least 14 days must elapse after stopping Citalopram Capsules before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] .
2.4Discontinuing Treatment with Citalopram Capsules Adverse reactions may occur upon discontinuation of Citalopram Capsules [see Warnings and Precautions ( 5.6 )] . Gradually reduce the dosage rather than stopping Citalopram Capsules abruptly whenever possible. Given that 30 mg is only available dosage strength of Citalopram Capsules, gradual dosage reduction will require the use of another citalopram product.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 30 mg: Hard shell gelatin capsules, with “ALM” printed axially on the blue opaque cap in black ink and “691” printed axially on the white opaque body in black ink. Citalopram Capsules dosage strength is based on the active moiety, citalopram. Capsules: 30 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Citalopram Capsules 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 Citalopram Capsules. Reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] .
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing an MAOI. ( 4 ) Concomitant use of pimozide. ( 4 ) Known hypersensitivity to citalopram or any of the inactive ingredients of Citalopram Capsules.
( 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 Capsules 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 Capsules 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 it occurs, discontinue Citalopram Capsules and serotonergic agents and initiate supportive treatment ( 4 , 5.3 , 7 ) 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 or Hypomania: Screen patients for bipolar disorder. ( 5.5 ) Discontinuation Syndrome: When discontinuing Citalopram Capsules, reduce dosage gradually and monitor for discontinuation symptoms. Gradual reduction will require use of another citalopram product.
( 5.6 ) Seizures: Use with caution in patients with seizure disorder. ( 5.7 ) Angle Closure Glaucoma: Avoid use of Citalopram Capsules in patients with untreated anatomically narrow angles treated. ( 5.8 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion.
( 5.9 ) Sexual Dysfunction: Citalopram Capsules may cause symptoms of sexual dysfunction. ( 5.10 )
5.1Suicidal Thoughts and Behaviors in Adolescent 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 over 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. These drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients with Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients *Citalopram Capsules is not approved for use in pediatric patients.
Age Range Drug-Placebo Difference in Number of Patients* with Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional cases 18 to 24 years old 5 additional cases Decreases Compared to Placebo 25 to 64 years old 1 fewer case ≥65 years old 6 fewer cases 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 any indication 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 Citalo…
🤒 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 Adolescent 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 commonly observed adverse reactions (incidence at least twice the incidence of placebo) are: fever, arthalgia, myalgia, anorexia, agitation, yawning, sinusitis, ejaculation disorder (primarily ejaculatory delay), decreased libido, and impotence ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma LLC at 1-877-447-7979, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of Citalopram Capsules for the treatment for major depressive disorder (MDD) in adults is based upon adequate and well-controlled studies of another citalopram product. The results of these adequate and well-controlled studies of citalopram are presented below.
The safety for citalopram included 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 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 at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks in 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-treated patients at a rate at least twice that of placebo) are shown in Table 2.
Table 2: Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled, Depression Trials * A patient can report more than one reason for discontinuation and be counted more than once in this table. Body System/Adverse Reaction Citalopram* (N=1,063) % Placebo (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 Table 3 enumerates adverse reactions that occurred among 1,063 patients with MDD who received citalopram at doses ranging from 10 mg to 80 mg once daily in placebo-controlled trials of up to 6 weeks in duration.
The most common adverse reaction that occurred in citalopram-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 patient…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with Citalopram Capsules. CYP2C19 inhibitors and CYP2C19 poor metabolizers: Avoid concomitant use. There is an increased risk of QT prolongation with concomitant use.
( 7 ) Table 5: Clinically Important Drug Interactions with Citalopram Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including Citalopram Capsules, and MAOIs increases the risk of serotonin syndrome. Intervention: Citalopram Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Pimozide Clinical Impact: Concomitant use of citalopram 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 alone [see Clinical Pharmacology ( 12.3 )].
Intervention: Citalopram Capsules is 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 with drugs that prolong QT can cause additional QT prolongation compared to the use of citalopram alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of Citalopram Capsules with drugs that prolong the QT interval (Citalopram Capsules is contraindicated in patients taking pimozide) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] .
CYP2C19 Inhibitors Clinical Impact: Concomitant use of citalopram with CYP2C19 inhibitors increases the risk of QT prolongation and/or ventricular arrhythmias compared to the use of citalopram alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of Citalopram Capsules with CYP2C19 inhibitors [see Warnings and Precautions ( 5.2 )]. Other Serotonergic Drugs Clinical Impact: Concomitant use of Citalopram Capsules with 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 Capsules initiation and changes in citalopram dosage. If serotonin syndrome occurs, consider discontinuation of Citalopram Capsules and/or concomitant serotonergic drugs [see Dosage and Administration ( 2.1 , 2.4 ), Warnings and Precautions ( 5.3 )] .
Drugs That Interfere With Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: Concomitant use of citalopram 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 Capsules and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions ( 5.4 )].
👥 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 ) Elderly patients: Not recommended. ( 8.5 ) Hepatic Impairment: Not recommended. ( 8.6 )
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 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. 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 Capsules, 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 Capsules 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 gener…
🤰 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 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. 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 Capsules, 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 Capsules 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…
🧒 Pediatric Use ▾
8.4Pediatric Use 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 other another formulation of 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.
🧓 Geriatric Use ▾
8.5Geriatric Use Citalopram Capsules is not recommended for use in the elderly because dosage adjustments are not possible with the available strengths of Citalopram Capsules. 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. Of 4,422 patients in clinical studies of citalopram, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over.
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 Capsules overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a Citalopram Capsules 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 as an antidepressant 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-HT 1A , 5-HT 2A , 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 (QTcNi) 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 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 Biotransformation of citalopram is mainly hepatic, with a mean terminal half-life of about 52.7 hours (30 mg capsule). 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 (30 mg capsule) of citalopram, peak blood levels occur at about 3.5 hours. The absolute bioavailability of citalopram was about 80% relative to an intravenous dose. Effect of Food Administration of citalopram capsules with a high-fat and high calorie breakfast did not have a significant effect on exposure of citalopram.
However, median T max of citalopram is delayed by approximately 1 hour (6 vs 5 hours). 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 Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of citalopram as an antidepressant 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 Capsules are supplied as: 30 mg capsules: Hard shell gelatin capsules, with “ALM” printed axially on the blue opaque cap in black ink and “691” printed axially on the white opaque body in black ink: NDC 52427-691-30 Bottle of 30 capsules Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Citalopram Capsules contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5carbonitrile, 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 is a white to almost white crystalline powder.
Citalopram hydrobromide is freely soluble in chloroform and sparingly soluble in ethanol and water. Citalopram Capsules is for oral administration and contains 30 mg of citalopram, equivalent to 37.5 mg of citalopram hydrobromide. The strengths reflect citalopram base equivalent content.
Citalopram Capsules also contain the inactive ingredients copovidone, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The capsule shells contain the colorants FD&C Blue #1 and FD&C Red #3.
💬 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 during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . QTc Prolongation and Torsade de Pointes Advise patients to consult their healthcare provider immediately if they feel faint, lose consciousness, or have heart palpitations.
Instruct patients to inform their healthcare provider that they are taking Citalopram Capsules before taking any new medications [see Warnings and Precautions ( 5.2 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Citalopram Capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, amphetamines, tryptophan, buspirone, 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 Capsules 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 provider if they are taking or are 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 Capsules and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Citalopram Capsules is discontinued [see Warnings and Precautions ( 5.6 )] .
Sexual Dysfunction Advise patients that use of Citalopram Capsules 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 pregnant women to notify their healthcare providers if they become pregnant or intend to become pregnant during treatment with Citalopram Capsules.
Advise patients that Citalopram Capsules 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 )] .
💬 Medication Guide ▾
MEDICATION GUIDE Citalopram (sye tal' oh pram) Capsules for oral use What is the most important information I should know about Citalopram Capsules? Citalopram Capsules may cause serious side effects, including: Increased risk of suicidal thoughts and actions. Citalopram Capsules 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 Capsules is not for use in children. Depression or 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 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 and (mania) attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood What is Citalopram Capsules?
Citalopram Capsules is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. It is not known if Citalopram Capsules is safe and effective for use in children. Who should not take Citalopram Capsules?
Do not take Citalopram Capsules 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 Capsules. See the end of this Medication Guide for a complete list of ingredients in Citalopram Capsules. 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 Capsules. Before taking Citalopram Capsules, tell your healthcare provider about all your medical conditions, including if you: have or had 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 Capsules may harm your unborn baby. Taking Citalopram Capsules 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 Capsules. There is a pregnancy registry for females who are exposed to Citalopram Capsules during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Citalopram Capsules and their baby.
If yo…