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sertraline HCl sertraline hydrochloride 200 mg Capsule, 30-count

by Almatica Pharma LLC · 30 CAPSULE in 1 BOTTLE (52427-672-30)
NDC 52427-0672-30
🏷️ FDA NDC (as labeled) 52427-672-30 billing pads the product segment with a zero
Rx only Brand 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Sertraline Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 5, 2025 — Defective container - seal not adhering to bottles (Lupin Pharmaceuticals Inc.) · FDA recall D-0227-2026
Class II · Dec 11, 2023 — CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. (Legacy Pharmaceutical Packaging LLC) · FDA recall D-0205-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 52427-672-30
Product NDC 52427-672
11-digit billing NDC 52427067230
NCPDP billing unit EA — each (per item)
RxCUI 251201, 410584
UNII UTI8907Y6X
UPC 0352427664304, 0352427672309
Application # NDA215133
SPL Set ID 8c8bcba9-eaeb-aa44-f9ea-b580de55a439
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Cytochrome P450 2D6 Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-04
Route ORAL
Dosage form CAPSULE
Substance SERTRALINE HYDROCHLORIDE
GPI-14 58160070100140
GPI class Sertraline HCl
GCN Seq No 046235
GCN 16383
HICL code 006324
Ingredient (HICL) Sertraline Hcl
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 SERTRALINE 200 MG CAPSULE
FDB brand name Sertraline Hcl
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 52427-672-30 — 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 → 52427-0672-30. 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, Cytochrome P450 2D6 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

LabelerAlmatica Pharma LLC
Application holderALMATICA PHARMA LLC
FDA applicationNDA215133 (NDA)
Labeler code52427
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio26 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 SERTRALINE 200 MG CAPSULE Ingredient Sertraline Hcl
📗 Our plain-language guide HelloPharmacist
  • Most people don't feel the full benefit right away — sertraline typically takes several weeks to build up to steady levels in your body. Some people notice small improvements in sl...
  • How long does it take for sertraline to start working?
  • You should be cautious. Sertraline affects the blood's ability to clot, and combining it with aspirin, ibuprofen, naproxen, or other anti-inflammatory pain relievers raises your ri...
  • Is it okay to take sertraline with ibuprofen or aspirin?
📖 Read our full Sertraline guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Sertraline nutrient depletion report →
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 Yellow / White / Green
ShapeCapsule
ImprintALM;672
Size19 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 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 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.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 DailyMed — 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

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 $1.988 $59.65 / 30 capsules
Medicaid paysCMS SDUD · 12 mo $5.43 $162.79 / 30 capsules
Medicare drug plans payPart D · Q2 2026 $5.08 $152.34 / 30 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jul 2022 Jan 2024 Mar 2026 Aug 2026 $4.938 $1.988
▼ Down 58% over the last 16 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
sertraline hydrochloride 200 mg 47781-0962-30 Alvogen, 30 capsules $1.988 AB Availability likely —
sertraline HCl 200 mgthis 52427-0672-30 Almatica 30 capsules $1.988 AB Availability likely —
Sertraline Hydrochloride 200 mg 69097-0451-02 Cipla 30 capsules $1.988 AB Availability likely —
Sertraline HCl 200 mg 70377-0129-11 Biocon 30 capsules $1.988 AB Availability likely —
Sertraline Hydrochloride 200 mg 70710-1949-03 Zydus 30 capsules $1.988 AB Availability likely —
Sertraline Hydrochloride 200 mg 70954-0900-10 ANI 30 capsules $1.988 AB Availability likely —
Sertraline Hydrochloride 200 mg 75907-0311-30 Dr. 30 capsules $1.988 AB Availability likely —
Sertraline HCl 200 mg 69238-2791-01 Amneal 30 capsules — AB FDA listed —
Sertraline Hydrochloride 200 mg 70771-1914-03 Zydus 30 capsules — AB FDA listed —
Sertraline HCl 200 mg 60290-0071-01 Umedica 30 capsules — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 52427-0672-30, 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
23.9K
Units reimbursed last 4 qtrs
826.3K
Gross reimbursed last 4 qtrs
$4.48M
Avg / prescription
$187.38
Avg / unit
$5.4262
Latest quarter Q4 2025
2.3KRx
Medicaid pays / ea
$5.4262
gross reimbursed
vs
NADAC / ea
$1.9883
acquisition cost
=
Spread
+$3.4379
+173% 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 ⓘ
74% FFS 26% MCO
Fee-for-service · 17,713 Rx Managed care · 6,214 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 384 units · 4.9 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 540 units · 9.4 per 100k residents MN Wisconsin: 360 units · 6.1 per 100k residents WI Michigan: 43,767 units · 436 per 100k residents MI New York: 154,423 units · 789 per 100k residents NY Vermont: no data reported VT New Hampshire: 9,266 units · 661 per 100k residents NH Oregon: 45,978 units · 1,086 per 100k residents OR Nevada: 7,929 units · 248 per 100k residents NV Wyoming: no data reported WY South Dakota: 420 units · 45.7 per 100k residents SD Iowa: 1,585 units · 49.4 per 100k residents IA Illinois: 5,873 units · 46.8 per 100k residents IL Indiana: 51,462 units · 750 per 100k residents IN Ohio: 32,411 units · 275 per 100k residents OH Pennsylvania: 5,476 units · 42.2 per 100k residents PA New Jersey: 1,650 units · 17.8 per 100k residents NJ Massachusetts: 944 units · 13.5 per 100k residents MA California: 289,221 units · 742 per 100k residents CA Utah: 390 units · 11.4 per 100k residents UT Colorado: 12,004 units · 204 per 100k residents CO Nebraska: 2,232 units · 113 per 100k residents NE Missouri: no data reported MO Kentucky: 24,400 units · 539 per 100k residents KY West Virginia: no data reported WV Virginia: 6,360 units · 73.0 per 100k residents VA Maryland: 40,575 units · 657 per 100k residents MD Connecticut: 7,755 units · 214 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,517 units · 33.9 per 100k residents AZ New Mexico: 1,230 units · 58.2 per 100k residents NM Kansas: 1,620 units · 55.1 per 100k residents KS Arkansas: no data reported AR Tennessee: 2,610 units · 36.6 per 100k residents TN North Carolina: 13,478 units · 124 per 100k residents NC South Carolina: 930 units · 17.3 per 100k residents SC Delaware: 393 units · 38.1 per 100k residents DE Oklahoma: 900 units · 22.2 per 100k residents OK Louisiana: 14,248 units · 311 per 100k residents LA Mississippi: no data reported MS Alabama: 3,960 units · 77.5 per 100k residents AL Georgia: 450 units · 4.1 per 100k residents GA D.C.: no data reported DC Hawaii: 3,787 units · 264 per 100k residents HI Texas: 28,324 units · 92.9 per 100k residents TX Florida: 6,417 units · 28.4 per 100k residents FL
Units reimbursed · per 100k residents
4.11,086
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 Oregon 1,086 /100k
2 New York 789 /100k
3 Indiana 750 /100k
4 California 742 /100k
5 New Hampshire 661 /100k
6 Maryland 657 /100k
7 Kentucky 539 /100k
8 Michigan 436 /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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sertraline HCl — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sertraline HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$42.3M
Claims incl. refills
4.2M
Beneficiaries
2.5M
Spend / beneficiary
$17.09
Spend / claim
$10.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Sertraline hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea8,166
Fatigue7,659
Headache6,792
Anxiety6,427
Depression6,330
Diarrhoea5,690
Dizziness5,510

Age at onset

Neonate102
Infant24
Child167
Adolescent461
Adult7,543
Elderly4,000

Reporter sex

117,838 reports

Serious outcomes

Hospitalization32,957
Death8,819
Life-threatening4,095
Disabling3,885
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,875 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 Marketing startStatus
52427-0672-30 You're viewing this 30 CAPSULE in 1 BOTTLE (52427-672-30) 2021-11-01 Active

📄 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 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 93 words ▾

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 )] . 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 )

🎯 Indications and Usage 78 words ▾

1 INDICATIONS AND USAGE Sertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline Hydrochloride (HCl) Capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Do not initiate treatment with Sertraline HCl Capsules. Use another sertraline HCl product for initial dosage, titration, and dosages below 150 mg once daily ( 2.1 ) Recommended dosage is 150 mg or 200 mg once daily ( 2.1 ) Maximum recommended dosage is 200 mg once daily ( 2.1 ) Swallow capsules whole. Do not open, crush, or chew ( 2.2 ) When discontinuing Sertraline HCl Capsules, reduce dose gradually whenever possible.

Gradual dosage reduction will require use of another sertraline HCl product ( 2.5 , 5.5 )

2.1Dosage in Patients with MDD and OCD Do not initiate treatment with Sertraline HCl Capsules because the only available dose strengths are 150 mg and 200 mg. Use another sertraline HCl product for initial dosage, titration, and dosages below 150 mg once daily. Refer to Prescribing Information of the other sertraline HCl products for the recommended dosage for those products.

Sertraline HCl Capsules can be initiated in patients receiving 100 mg or 125 mg of sertraline HCl for at least one week. The recommended dosage of Sertraline HCl Capsules is 150 mg or 200 mg once daily. The maximum recommended dosage is 200 mg once daily.

2.2Administration Instructions Administer Sertraline HCl Capsules orally. Swallow capsules whole; do not open, crush, or chew.

2.3Screen for Bipolar Disorder Prior to Starting Sertraline HCl Capsules Prior to initiating treatment with Sertraline HCl Capsules or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.4 )] .

2.4Switching 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 Sertraline HCl Capsules. In addition, at least 14 days must elapse after stopping Sertraline HCl Capsules before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] .

2.5Discontinuation of Treatment with Sertraline HCl Capsules Adverse reactions may occur upon discontinuation of Sertraline HCl Capsules [see Warnings and Precautions ( 5.5 )] . Gradually reduce the dosage rather than stopping Sertraline HCl Capsules abruptly whenever possible. Given that dosage strengths lower than 150 mg of Sertraline HCl Capsules are not available, gradual dosage reduction will require the use of another sertraline HCl product.

💊 Dosage Forms and Strengths 92 words ▾

3 DOSAGE FORMS AND STRENGTHS 150 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body. 200 mg capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body. Dosage strengths are based on the active moiety, sertraline.

The 150 mg capsules contain 168 mg of sertraline HCl. The 200 mg capsules contain 224 mg of sertraline HCl. Capsules: 150 mg and 200 mg ( 3 )

⛔ Contraindications 117 words ▾

4 CONTRAINDICATIONS Sertraline HCl Capsules are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Taking pimozide [see Drug Interactions ( 7.1 )] . With known hypersensitivity to sertraline or the excipients in Sertraline HCl Capsules (e.g., anaphylaxis, angioedema) [see Adverse Reactions ( 6.1 , 6.2 )] .

Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 , 7.1 ) Concomitant use of pimozide ( 4 , 7.1 ) Known hypersensitivity to sertraline or excipients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue Sertraline HCl Capsules and serotonergic agents and initiate supportive treatment ( 4 , 5.2 , 7.1 ) Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder ( 5.4 ) Discontinuation Syndrome: When discontinuing Sertraline HCl Capsules, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms.

Gradual reduction will require use of another sertraline HCl product ( 5.5 ) Seizures: Use with caution in patients with seizure disorders ( 5.6 ) Angle Closure Glaucoma: Avoid use of antidepressants, including Sertraline HCl Capsules, in patients with untreated anatomically narrow angles ( 5.7 ) QTc Prolongation: Sertraline HCl Capsules should be used with caution in patients with risk factors for QTc prolongation ( 5.10 ) Allergic Reactions to FD&C Yellow No. 5 (Tartrazine): Contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons ( 5.11 ) Sexual Dysfunction: Sertraline HCl Capsules may cause symptoms of sexual dysfunction ( 5.12 )

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. The 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 of Suicidal Thoughts or Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 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 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 Sertraline HCl Capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome SSRIs, including Sertraline HCl Capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (includin…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline or excipients of Sertraline HCl Capsules [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescent and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )] Seizures [see Warnings and Precautions ( 5.6 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )] Hyponatremia [see Warnings and Precautions ( 5.8 )] QTc Prolongation [see Warnings and Precautions ( 5.10 )] Allergic reactions to FD&C Yellow No.

5 (Tartrazine) [see Warnings and Precautions ( 5.11 )] Sexual Dysfunction [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled clinical trials with sertraline HCl were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido ( 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 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 trials of another drug and may not reflect the rates observed in practice. The safety of Sertraline HCl Capsules for the treatment of MDD and OCD is based on adequate and well-controlled studies of another sertraline HCl product. Below is a display of adverse reactions of sertraline HCl (referred to as “sertraline” in this section) from those adequate and well-controlled studies in MDD, OCD, and other conditions.

The data described below reflect exposure in randomized, double-blind, placebo-controlled trials of sertraline in 3066 adults. These 3066 patients exposed to sertraline for 8 to 12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males.

The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline-treated patients (MDD, OCD, and other conditions) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 2). The following are the most common adverse reactions in trials of sertraline (≥5% and twice placebo) by indication that were not mentioned previously. MDD: somnolence OCD: insomnia, agitation Table 2: Common Adverse Reactions (Greater than 2% of Adults with MDD, OCD, and Other Conditions Treated with Sertraline Hydrochloride and Greater than or Equal to Twice the Incidence of Placebo) in Pooled Placebo-Controlled Trials* (1) Denominator used was for male patients only (n=1316 sertraline; n=973 placebo). * Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients.

Sertraline Hydrochloride (N=3066) % Placebo (N=2293) % Cardiac disorders Palpitations 4 2 Eye disorders Visual impairment 4 2 Gastrointestinal Disorders Nausea 26 12 Diarrhea/Loose Stools 20 10 Dry mouth 14 9 Dyspepsia 8 4 Constipation 6 4 Vomiting 4 1 General disorders and administration site conditions Fatigue 12 8 Metabolism and nutrition disorders Decreased appetite 7 2 Nervous system disorders Dizziness 12 8 Somnolence 11 6 Tremor 9 2 Psychiatric Disorders Insomnia 20 13 Agitation 8 5 Libido Decreased 6 2 Reproductive system and breast disorders Ejaculation failure (1) 8 1 Erectile dysfunction (1) 4 1 Ejaculation…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Protein-bound drugs: Monitor for adverse reactions and reduce dosage of Sertraline HCl Capsules or other protein-bound drugs (e.g., warfarin) as warranted ( 7.1 , 12.3 ) CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 ( 7.1 , 12.3 )

7.1Clinically Significant Drug Interactions Table 4 includes clinically significant drug interactions with Sertraline HCl Capsules [see Clinical Pharmacology ( 12.3 )] . Table 4. Clinically-Significant Drug Interactions with Sertraline HCl Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs, including Sertraline HCl Capsules, and MAOIs increases the risk of serotonin syndrome.

Intervention: Sertraline HCl Capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.4 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and Sertraline HCl Capsules is contraindicated [see Contraindications ( 4 )] .

Other Serotonergic Drugs Clinical Impact: Concomitant use of Sertraline HCl 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 treatment initiation and dosage increases.

If serotonin syndrome occurs, consider discontinuation of Sertraline HCl Capsules and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )] . Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with Sertraline HCl Capsules may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of Sertraline HCl Capsules and antiplatelet agents and anticoagulants.

For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions ( 5.3 )] . Drugs Highly Bound to Plasma Protein Clinical Impact: Sertraline is highly bound to plasma protein. The concomitant use of Sertraline HCl Capsules with another drug that is highly bound to plasma protein may increase free concentrations of sertraline or other tightly-bound drugs in plasma [see Clinical Pharmacology ( 12.3 )] .

Intervention: Monitor for adverse reactions and reduce dosage of Sertraline HCl Capsules or other protein-bound drugs as warranted. Drugs Metabolized by CYP2D6 Clinical Impact: Sertraline HCl Capsules are a CYP2D6 inhibitor [see Clinical Pharmacology ( 12.3 )] . The concomitant use of Sertraline HCl Capsules with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate.

Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant Sertraline HCl Capsules use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if Sertraline HCl Capsules are discontinued. Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug.

Sertraline HCl Capsules may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating Sertraline HCl Capsules. Reduce phenytoin dosage if needed.

Drugs that Prolong the QTc Interval Clinical Impact: The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of Sertraline HCl Capsules with other drugs which prolong the QTc interval [see Warnings and Precautions ( 5.10 ), Clinical Pharmacology ( 12.2 )] . Intervention: Pimozide is contraindicated for use with Sertraline HCl Capsules. Avoid the concomitant use of drugs known to pro…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate ( 8.1 ) Pediatric use: Safety and effectiveness in pediatric patients other than those with OCD (6 to 17 years) have not been established ( 8.4 ) 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 should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 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 ( 5.3 ) and Clinical Considerations] .

Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive (see Data) . There are clinical considerations regarding neonates exposed to SSRIs, including Sertraline HCl Capsules, during the third trimester of pregnancy (see Clinical Considerations) .

Although no malformations were observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses approximately 4 times the MRHD in rabbits on a mg/m 2 basis in adults. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD (see Data) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing Sertraline HCl Capsules.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions Use of Sertraline HCl Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] . Fetal/Neonatal Adverse Reactions Exposure to SSRIs, including Sertraline HCl Capsules, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with Sertraline HCl Capsules during the third trimester, carefully consider both the potential risks and benefits of treatment.

Monitor neonates who were exposed to sertraline in the third trimester of pregnancy for PPHN and drug discontinuation syndrome (see Data) . Data Human Data Third Trimester Expo…

🤰 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. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 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 ( 5.3 ) and Clinical Considerations] .

Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive (see Data) . There are clinical considerations regarding neonates exposed to SSRIs, including Sertraline HCl Capsules, during the third trimester of pregnancy (see Clinical Considerations) .

Although no malformations were observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses approximately 4 times the MRHD in rabbits on a mg/m 2 basis in adults. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD (see Data) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing Sertraline HCl Capsules.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions Use of Sertraline HCl Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 )] . Fetal/Neonatal Adverse Reactions Exposure to SSRIs, including Sertraline HCl Capsules, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with Sertraline HCl Capsules during the third trimester, carefully consider both the potential risks and benefits of treatment.

Monitor neonates who were exposed to sertraline in the third trimester of pregnancy for PPHN and drug discontinuation syndrome (see Data) . Data Human Data Third Trimester Exposure Neonates exposed to sertraline and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports.

Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglyce…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of Sertraline HCl Capsules have been established in the treatment of OCD in pediatric patients aged 6 to 17 [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )] . Safety and effectiveness in pediatric patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD.

Two placebo-controlled trials were conducted with another sertraline HCl product in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients. Monitoring Pediatric Patients Treated with Sertraline HCl Capsules Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [see Boxed Warning , Warnings and Precautions ( 5.1 )] .

Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with SSRIs including Sertraline HCl Capsules. Weight Loss in Studies in Pediatric Patients with MDD In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50 to 200 mg) outpatient trials for MDD (n=373) with another sertraline HCl product, there was a difference in weight change between sertraline HCl and placebo of roughly 1 kg, for both pediatric patients ages 6 to 11 and pediatric patients ages 12 to 17, in both age groups representing a slight weight loss for the sertraline HCl group compared to a slight gain for the placebo group.

For pediatric patients (ages 6 to 11), about 7% of the sertraline HCl-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for pediatric patients (ages 12 to 17), about 2% of sertraline HCl-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients. A subset of patients who completed the randomized controlled trials in patients with MDD (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study.

Those subjects who completed 34 weeks of sertraline HCl treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. However, there are no studies that directly evaluate the long-term effects of sertraline HCl on the growth, development, and maturation in pediatric patients. Juvenile Animal Toxicity Data A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females.

In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period.

The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

🧓 Geriatric Use 200 words ▾

8.5Geriatric Use Of the total number of patients with MDD, OCD, and other conditions in clinical studies with another sertraline product, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In 354 geriatric subjects treated with another sertraline HCl product in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 2 [see Adverse Reactions ( 6.1 )] , except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients. SSRIs, including sertraline HCl, 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 ( 5.8 )] .

🆘 Overdosage 99 words ▾

10 OVERDOSAGE The following have been reported with sertraline HCl 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. 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). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline 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 Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

12.2Pharmacodynamics Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors.

The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors. Sertraline does not inhibit monoamine oxidase. Alcohol In healthy subjects, the acute cognitive and psychomotor effects of alcohol were not potentiated by sertraline.

Cardiac Electrophysiology The effect of sertraline on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects. At 2-fold the maximum recommended daily dose (~3-fold the steady-state exposure for sertraline and N-desmethylsertraline), the largest mean ΔΔQTc was 10 ms with upper bound of two-sided 90% confidence interval of 12 ms. The length of the QTc interval was also positively correlated with serum concentrations of sertraline and N-desmethylsertraline concentrations.

These concentration-based analyses, however, indicated a lesser effect on QTc at maximally observed concentration than in the primary analysis [see Warnings and Precautions ( 5.10 ), Adverse Reactions ( 6 ), Drug Interactions ( 7.1 ), Overdosage ( 10 )] .

12.3Pharmacokinetics Absorption Following a single dose of Sertraline HCl Capsule at 150 mg, the mean peak plasma concentrations (C max ) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing.

Linear dose-proportional pharmacokinetics are likely over a range of 150 to 200 mg. Effect of Food Administration of Sertraline HCl Capsules with food causes a small increase in C max and AUC. Distribution In vitro protein binding studies performed with radiolabeled 3H-sertraline showed that sertraline is highly bound to serum proteins (98%) in the range of 20 to 500 ng/mL.

However, at up to 300 and 200 ng/mL concentrations, respectively, sertraline and N-desmethylsertraline did not alter the plasma protein binding of two other highly protein bound drugs, warfarin and propranolol. Elimination Metabolism Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation.

N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline. Excretion Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation.

In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40 to 45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine.

For the same period, about 40 to 45% of the administered radioactivity was accounted for in feces, including 12 to 14% unchanged sertraline. Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0 to 24-hour), C max and…

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

📦 How Supplied / Storage and Handling 92 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sertraline HCl Capsules are supplied as: 150 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellow cap and "664" printed axially on the opaque white body. NDC 52427-664-30 Bottles of 30 200 mg Capsules: Hard shell capsules, with "ALM" printed axially on the opaque yellowish green cap and "672" printed axially on the opaque white body. NDC 52427-672-30 Bottles of 30 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 144 words ▾

11 DESCRIPTION Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)-N-methyl-tetralin-1-amine hydrochloride. The empirical formula C 17 H 17 Cl 2 N • HCl is represented by the following structural formula: Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol.

Sertraline HCl Capsules is for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, silicon dioxide and titanium dioxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive.

The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.

Chemical Structure

💬 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 and Warnings and Precautions ( 5.1 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Sertraline HCl Capsules 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 ( 5.2 ), Drug Interactions ( 7.1 )] . Increased Risk of Bleeding Inform patients about the concomitant use of Sertraline HCl 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 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 ( 5.3 )] . 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 ( 5.4 )] . Discontinuation Syndrome Advise patients not to abruptly discontinue Sertraline HCl Capsules and to discuss any tapering regimen with their healthcare provider.

Inform patients that adverse reactions can occur when Sertraline HCl Capsules is discontinued [see Warnings and Precautions ( 5.5 )] . Sexual Dysfunction Advise patients that use of Sertraline HCl 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 ( 5.12 )] .

Allergic Reactions and Reactions to FD&C Yellow No. 5 (Tartrazine) Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions ( 6.2 )] . Advise patients that Sertraline HCl Capsules contain FD&C Yellow No.

5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons or in patients who also have an aspirin hypersensitivity [see Warnings and Precautions ( 5.11 )] . Pregnancy Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with Sertraline HCl Capsules. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to Sertraline HCl Capsules during pregnancy.

Inform women that Sertraline HCl Capsules may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. MEDICATION GUIDE Sertraline (ser' tra leen) HCl capsules What is the most important information I should know about Sertraline Hydrochloride (HCl) Capsules?

Sertraline HCl Capsules may cause serious side effects, including: Increased risk of suicidal thoughts or actions. Sertraline HCl Capsules and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. How can I watch for and try to prevent suicidal thoughts and actions?

Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you or your child 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 or if you or your child develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider or get emergency help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive or violent new or worse depression feeling agitated, restless, angry, or irritable an increase in activity and talking more than what is normal for you acting on dangerous impulses thoughts about suicide or dying new or worse anxiety or panic attacks trouble sleeping other unusual changes in behavior or mood What are Sertraline HCl Capsules?

Sertraline HCl Capsules are a prescription medicine used to treat: A certain type of depression called Major Depressive Disorder (MDD) in adults. Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older. It is not known if Sertraline HCl Capsules are safe and effective for use in children under 6 years of age with OCD or children with other behavioral health conditions.

Do not take Sertraline HCl Capsules if you or your child: are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI). are being treated with the antibiotic linezolid or intravenous methylene blue. are taking the antipsychotic medicine pimozide because this can cause serious problems. are allergic to sertraline or any of the ingredients in Sertraline HCl Capsules. See the end of this Medication Guide for a complete list of ingredients in Sertraline HCl Capsules. Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Sertraline HCl Capsules. Before taking Sertraline HCl Capsules, tell your healthcare provider about all medical conditions, including if you or your child: have or have had bleeding problems have, or have a family history of, bipolar disorder, mania, or hypomania have or have had seizures or convulsions have high pressure in the eye (glaucoma) have low sodium levels in your blood have heart problems have kidney or liver problems have an allergy or sensitivity to FD&C Yellow No.

5 (Tartrazine) are pregnant or plan to become pregnant. Sertraline HCl Capsules may harm the unborn baby. Taking Sertraline HCl Capsules during the third trimester of pregnancy may cause the baby to have withdrawal symptoms after birth or may cause the baby to be at an increased risk for a serious lung problem at birth.

Talk to your healthcare provider about the risk to the mother and the unborn baby if Sertraline HCl Capsules are taken during pregnancy. Tell your hea…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.