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CITALOPRAM HYDROBROMIDE 20 mg Tablet, 90-count — NDC 76282-0629-90 package photo

CITALOPRAM HYDROBROMIDE 20 mg Tablet, 90-count

by Exelan Pharmaceuticals Inc. · 90 TABLET in 1 BOTTLE (76282-629-90)
NDC 76282-0629-90
🏷️ FDA NDC (as labeled) 76282-629-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.0290 NADAC Per package$2.61 / 90 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.2723/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 76282-629-90
Product NDC 76282-629
11-digit billing NDC 76282062990
NCPDP billing unit EA — each (per item)
RxCUI 200371, 283672, 309314
UNII I1E9D14F36
UPC 0376282208909, 0376282629902, 0376282628905
Application # ANDA077534
SPL Set ID a8e8fde2-8392-4d5b-902b-e2b9dd55a02d
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-11-10
Route ORAL
Dosage form TABLET
Substance CITALOPRAM HYDROBROMIDE
GPI-14 58160020100320
GPI class Citalopram Hydrobromide
GCN Seq No 046203
GCN 16342
HICL code 010321
Ingredient (HICL) Citalopram Hydrobromide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2S
Therapeutic class — specific (HIC3) Selective Serotonin Reuptake Inhibitor (Ssris)
AHFS code 28:16.04.20
AHFS class Selective-Serotonin Reuptake Inhibitors
FDB label name CITALOPRAM HBR 20 MG TABLET
FDB brand name Citalopram Hbr
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 76282-629-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76282-0629-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor
Drug family (ATC) Selective serotonin reuptake inhibitors
How it works Serotonin Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerExelan Pharmaceuticals Inc.
Application holderINVAGEN PHARMACEUTICALS INC
FDA applicationANDA077534 (ANDA)
Labeler code76282
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio88 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CITALOPRAM HBR 20 MG TABLET Ingredient Citalopram Hydrobromide
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Citalopram guide →
1
Nutrient depletion considerations

Citalopram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown / Pink / White
ShapeRound
ImprintIG;208
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.
  • 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.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.029 $2.61 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.2723 $24.51 / 90 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Feb 2022 Sep 2022 Jan 2026 Aug 2026 $0.033 $0.028
▼ Down 4% over the last 22 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Citalopram 20 mg 00378-6232-01 Mylan 100 tablets $0.029 AB Availability likely
Citalopram 20 mg 00904-6085-61 Major 100 tablets $0.029 AB Availability likely
Citalopram 20 mg 13668-0010-01 Torrent 100 tablets $0.029 AB Availability likely
Citalopram 20 mg 42806-0020-01 Epic 100 tablets $0.029 AB Availability likely
Citalopram Hydrobromide 20 mg 65862-0006-01 Aurobindo 100 tablets $0.029 Availability likely
Citalopram Hydrobromide 20 mgthis 76282-0629-90 Exelan 90 tablets $0.029 AB Availability likely
Citalopram 20 mg 82009-0107-05 QUALLENT 500 tablets $0.029 AB Availability likely
Celexa 20 mg 00456-4020-01 Allergan, 100 tablets $9.017 AB Availability likely +30994%
Citalopram 20 mg 00615-8023-05 NCS 15 tablets AB FDA listed
Citalopram 20 mg 42708-0019-30 QPharma, 30 tablets AB FDA listed
Citalopram 20 mg 42708-0091-30 QPharma, 30 tablets AB FDA listed
Citalopram 20 mg 43063-0063-14 PD-Rx 14 tablets FDA listed
Citalopram 20 mg 43063-0683-30 PD-Rx 30 tablets AB FDA listed
Citalopram 20 mg 50090-5172-00 A-S 30 tablets AB FDA listed
Citalopram 20 mg 50090-6433-00 A-S 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 50090-6846-00 A-S 90 tablets AB FDA listed
Citalopram 20 mg 51655-0137-26 Northwind 90 tablets AB FDA listed
Citalopram 20 mg 51655-0664-25 Northwind 60 tablets AB FDA listed
Citalopram 20 mg 51655-0680-26 Northwind 90 tablets AB FDA listed
Citalopram 20 mg 55154-3329-00 Cardinal 10 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 55700-0851-30 Quality 30 tablets AB Discontinued
Citalopram 20 mg 60760-0495-30 St. 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 63187-0203-00 Proficient 100 tablets AB FDA listed
Citalopram 20 mg 63187-0679-00 Proficient 100 tablets AB FDA listed
Citalopram 20 mg 65162-0053-03 Amneal 30 tablets FDA listed
Citalopram 20 mg 67046-0795-03 Coupler 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 68071-1830-01 NuCare 100 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 68071-1906-03 NuCare 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 68071-2198-03 NuCare 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 68071-5132-03 NuCare 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 68788-0802-01 Preferred 100 tablets AB FDA listed
Citalopram 20 mg 69097-0823-02 Cipla 30 tablets AB FDA listed
Citalopram 20 mg 70518-2617-01 REMEDYREPACK 30 tablets AB Discontinued
Citalopram 20 mg 70518-4114-01 REMEDYREPACK 90 tablets AB FDA listed
Citalopram 20 mg 70518-4335-00 REMEDYREPACK 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 71335-0238-01 Bryant 30 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 71610-0092-15 Aphena 15 tablets AB FDA listed
Citalopram 20 mg 72162-2517-01 Bryant 100 tablets AB FDA listed
Citalopram 20 mg 72162-2567-01 Bryant 100 tablets AB FDA listed
Citalopram Hydrobromide 20 mg 72657-0110-01 Glenmark 100 tablets FDA listed
Citalopram 20 mg 80425-0093-01 Advanced 30 tablets AB FDA listed
Citalopram 20 mg 87063-0220-01 ASCLEMED 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 76282-0629-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
44
Units reimbursed last 4 qtrs
2.1K
Gross reimbursed last 4 qtrs
$563.76
Avg / prescription
$12.81
Avg / unit
$0.2723
Latest quarter Q4 2025
16Rx
Medicaid pays / ea
$0.2723
gross reimbursed
vs
NADAC / ea
$0.0290
acquisition cost
=
Spread
+$0.2433
+839% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 44 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,070 units · 35.0 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
35.035.0
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 35.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets76282-0629-10 639 Rx · $86,592
500 tablets76282-0629-05 No Medicaid data
30 tablets76282-0629-30 No Medicaid data
Drug total (last 4 qtrs): 683 Rx · 25,606 units · $87,156 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CITALOPRAM HYDROBROMIDE (this brand).

Top reported reactions

Fatigue6,992
Nausea6,019
Headache5,146
Toxicity To Various Agents5,100
Diarrhoea4,832
Fall4,463
Pain4,429

Age at onset

Neonate337
Infant60
Child54
Adolescent175
Adult8,734
Elderly4,583

Reporter sex

0 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization37,401
Death17,007
Life-threatening6,315
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,606 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
76282-0629-05 500 TABLET in 1 BOTTLE (76282-629-05) 2017-11-10 Active
76282-0629-10 1000 TABLET in 1 BOTTLE (76282-629-10) $0.0290 / ea $29.00 2017-11-10 Active
76282-0629-30 30 TABLET in 1 BOTTLE (76282-629-30) 2017-11-10 Active
76282-0629-90 You're viewing this 90 TABLET in 1 BOTTLE (76282-629-90) $0.0290 / ea $2.61 2017-11-10 Active

You're viewing one of 4 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0290 NADAC).

This pack accounts for about 6.4% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 76282-0629-90?
NDC 76282-0629-90 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 76282-0629-90 and NDC 76282-0629-30?
Both are CITALOPRAM HYDROBROMIDE 20 mg Tablet — the drug itself is identical. NDC 76282-0629-90 is the 90-count package, while NDC 76282-0629-30 is the 30 tablets package.
What NDC number is used to bill for this package of CITALOPRAM HYDROBROMIDE 20 mg Tablet?
Bill NDC 76282-0629-90 — the 11-digit billing format is 76282062990. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 122 words

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 46 words

1 INDICATIONS AND USAGE Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).

⏱️ Dosage and Administration ~2 min read

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, reduce dosage gradually (2.4, 5.6 ).

2.1Recommended Dosage Administer Citalopram 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 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 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 maxium recommended dosage of Citalopram 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. Conversely, at least 14 days must elapse after stopping Citalopram 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 [see Warnings and Precautions ( 5.6 )]. Gradually reduce the dosage rather than stopping Citalopram abruptly whenever possible.

💊 Dosage Forms and Strengths 109 words

3 DOSAGE FORMS AND STRENGTHS Citalopram tablets, USP are available as: 10 mg: Beige film coated, round, biconvex tablets de-bossed with "IG" on one side and "206" on the other. 20 mg: Pink film coated, round, biconvex tablets de-bossed with "I" on the left side of bisect and "G" on the right side of bisect on one side and "207" on the other. 40 mg: White film coated, round, bi-convex tablets de-bossed with "I" on the left side of bisect and "G" on the right side of bisect on one side and "208" on the other.

Tablets: 10 mg; 20 mg, scored; and 40 mg, scored ( 3 )

Contraindications 127 words

4 CONTRAINDICATIONS Citalopram 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. 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 a MAOI. ( 4 ). Concomitant use of pimozide.

( 4 ). Known hypersensitivity to citalopram or any of the inactive ingredients of Citalopram ( 4 ).

⚠️ Warnings and Cautions ~3 min read

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 (e.g., SSRI, SNRI, triptans), but also when taken alone. If occurs, discontinue Citalopram 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 Citalopram is not approved for use in pediatric patients.

Drug-Placebo Difference in Number of Patients with Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥65 years old 6 fewer 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…

🤒 Adverse Reactions ~3 min read

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 Exelan Pharmaceuticals Inc. at 1-866-604-3268 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 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 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 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 Citalopram Treatment in Short-Term, Placebo-Controlled MDD 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 Placebo (N=1,063) % (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 the incidence of 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 duration.

The most common adverse reaction that occurred in Citalopram -treated patients with an incidence of 5% or greater and atleast 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 -Treated Patients* *Adverse reactions reported by at least 2% of patients treated with Citalopram are reported, except for the following adverse reactions which had an incidence on placebo ≥ Citalopram: headache, asthenia, dizziness, constipation, palpitation,vision abnorma…

🔄 Drug Interactions ~2 min read

7 DRUG INTERACTIONS Table 5 presents clinically important drug interactions with Citalopram. CYP2C19 Inhibitors : Citalopram 20 mg daily is the maximum recommended dosage for patients taking concomitant CYP2C19 inhibitors ( 5.2 , 7.1 ). Table 5: Clinically Important Drug Interactions with Citalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs, including Citalopram, and MAOIs increases the risk of serotonin syndrome.

Intervention Citalopram is 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 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 ( 12.2 )].

Intervention: Citalopram 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 ( 12.2 )]. Intervention: Avoid concomitant use of Citalopram with drugs that prolong the QT interval (Citalopram 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 ( 12.2 )]. Intervention: The maximum recommended dosage of Citalopram 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 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 initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of Citalopram 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 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 and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions ( 5.4 )].

👥 Use in Specific Populations ~2 min read

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. Healhcare providers are encouraged to advise patients 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, 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. Anim…

🤰 Pregnancy ~3 min read

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healhcare providers are encouraged to advise patients 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, 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…

🧒 Pediatric Use 83 words

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 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 133 words

8.5Geriatric Use Of 4422 patients in clinical studies of Citalopram, 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, i ncluding 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 119 words

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 ~3 min read

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 D1 and D2, α1-, α2-, and β-adrenergic, histamine H1, 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 mg (1.5 times the maxium 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 three phar…

🧬 Mechanism of Action 40 words

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 203 words

16 HOW SUPPLIED/STORAGE AND HANDLING Citalopram Tablets, USP 10 mg: They are supplied in Bottle of 30 NDC # 76282-628-30, Bottle of 90 NDC # 76282-628-90, Bottle of 500 NDC # 76282-628-05 and Bottle of 1,000 NDC # 76282-628-10 Beige, film coated round, bi-convex tablets debossed with IG on one side and “206” on the other. 20 mg: They are supplied in Bottle of 30 NDC # 76282-629-30, Bottle of 90 NDC # 76282-629-90, Bottle of 500 NDC # 76282-629-05 and Bottle of 1,000 NDC # 76282-629-10 Pink, film coated, round, bi-convex tablets debossed with I on the left side of bisect and G on right side of bisect on one side and “207” on the other.

40 mg: They are supplied in Bottle of 30 NDC # 76282-208-30, Bottle of 90 NDC # 76282-208-90, Bottle of 500 NDC # 76282-208-05 and Bottle of 1,000 NDC # 76282-208-10 White, film coated, round, bi-convex tablets debossed with I on the left side of bisect and G on right side of bisect on one side and “208” on the other. Storage and Handling Citalopram tablets should be stored at 20-25°C (68 to 77°F); excursions permitted between 15 and 30°C (59-86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read

11 DESCRIPTION Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative 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 is available only in tablet dosage form.

Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content.

The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients : copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.

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💬 Information for Patients ~2 min read

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 before taking any new medications [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7 )]. Serotonin Syndrome Caution patients about the the risk of serotonin syndrome, particularly with the concomitant use of Citalopram 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 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 and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Citalopram is discontinued [See Warnings and Precautions( 5.6 )].

Sexual Dysfunction Advise patients that use of Citalopram 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 [see Use in Specific Populations ( 8.1 )].

Advise patients that Citalopram 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 )] .

Revised: 08/2024

💬 Medication Guide ~3 min read

MEDICATION GUIDE Citalopram Tablets,USP (sih-TAL-oh-pram) What is the most important information I should know about Citalopram? Citalopram may cause serious side effects, including: Increased risk of suicidal thoughts and actions. Citalopram 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 is 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: thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity or talking (mania) attempts to commit suicide new or worse anxiety acting on dangerous impulses panic attacks new or worse irritability other unusual changes in behavior or mood What is Citalopram?

Citalopram 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 is safe and effective for use in children. Who should not take Citalopram?

Do not take Citalopram 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. See the end of this Medication Guide for a complete list of ingredients in Citalopram. 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. Before taking Citalopram, 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 may harm your unborn baby. Taking Citalopram 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. There is a pregnancy registry for females who are exposed to Citalopram during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Citalopram and their baby.

If you become pregnant during treatment with Citalopram, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressan…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.