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Sertraline Hydrochloride 200 mg Capsule, 30-count — NDC 70771-1914-03 package photo

Sertraline Hydrochloride 200 mg Capsule, 30-count

by Zydus Lifesciences Limited · 30 CAPSULE in 1 BOTTLE (70771-1914-3)
NDC 70771-1914-03
🏷️ FDA NDC (as labeled) 70771-1914-3 billing pads the package segment with a zero
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 →

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) 70771-1914-3
Product NDC 70771-1914
11-digit billing NDC 70771191403
RxCUI 251201, 410584
UNII UTI8907Y6X
Application # ANDA220275
SPL Set ID 96dedceb-81ad-447c-800e-800cf473d4e4
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Cytochrome P450 2D6 Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-29
Route ORAL
Dosage form CAPSULE
Substance SERTRALINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70771-1914-3 — a 5-4-1 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 package segment → 70771-1914-03. 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

LabelerZydus Lifesciences Limited
Application holderZYDUS LIFESCIENCES GLOBAL FZE
FDA applicationANDA220275 (ANDA)
Labeler code70771
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio717 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

📖 What it is MedlinePlus · NLM

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, (mood swings, irrita...

Read the full MedlinePlus article ↗
📗 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 White / Green
ShapeCapsule
Imprint1949
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 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 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 8VAB711C5E
    Hydroxypropyl cellulose is a plant-based thickener made from cellulose. In medicines, it acts as a binder to hold ingredients together, a coating to protect the tablet or capsule, and a thickener to create the right texture in liquids or gels.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

13 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $5.08 $152.34 / 30 capsules
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 mg 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 mgthis 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 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization32,957
Life-threatening4,095
Disabling3,885
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 5,432 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
70771-1914-03 You're viewing this 30 CAPSULE in 1 BOTTLE (70771-1914-3) 2026-01-29 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70771-1914-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1914-03, written without dashes as 70771191403. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1914-03, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1914) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 💬 Patient Medication Information
🚨 Boxed Warning 90 words ▾

BOXED WARNING 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 76 words ▾

1 INDICATIONS AND USAGE Sertraline hydrochloride capsules are 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 capsules are 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 hydrochloride capsules. Use another sertraline hydrochloride 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 hydrochloride capsules, reduce dose gradually whenever possible.

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

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

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

2.2Administration Instructions Administer sertraline hydrochloride capsules orally. Swallow capsules whole; do not open, crush, or chew.

2.3Screen for Bipolar Disorder Prior to Starting Sertraline Hydrochloride Capsules Prior to initiating treatment with sertraline hydrochloride 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 hydrochloride capsules. In addition, at least 14 days must elapse after stopping sertraline hydrochloride capsules before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] .

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

💊 Dosage Forms and Strengths 115 words ▾

3 DOSAGE FORMS AND STRENGTHS 150 mg capsules: White to off white granular powder filled in size "2" empty hard gelatin capsules having a cream colored opaque cap imprinted with "1948" in blank ink and a cream colored opaque body. 200 mg capsules: White to off white granular powder filled in size "1" empty hard gelatin capsules having a light green colored opaque cap imprinted with "1949" in blank ink and a light green colored opaque body. Dosage strengths are based on the active moiety, sertraline.

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

⛔ Contraindications 117 words ▾

4 CONTRAINDICATIONS Sertraline hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride capsules, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms.

Gradual reduction will require use of another sertraline hydrochloride product ( 5.5 ) Seizures: Use with caution in patients with seizure disorders ( 5.6 ) Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride capsules, in patients with untreated anatomically narrow angles ( 5.7 ) QTc Prolongation: Sertraline hydrochloride capsules should be used with caution in patients with risk factors for QTc prolongation ( 5.10 ) Sexual Dysfunction: Sertraline hydrochloride 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 hydrochloride capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome SSRIs, including sertraline hydrochloride capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetami…

🤒 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 hydrochloride 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 )] Sexual Dysfunction [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled clinical trials with sertraline hydrochloride capsules were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 hydrochloride capsules for the treatment of MDD and OCD is based on adequate and well-controlled studies of another sertraline hydrochloride product. Below is a display of adverse reactions of sertraline hydrochloride (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 3,066 adults. These 3,066 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* Sertraline Hydrochloride (N=3,066) % Placebo (N=2,293) % 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 disorder (1) 3 0 Male sexual dysfunction (1) 2 0 Skin and subcutaneous tissue disorders Hyperhidrosis 7 3 (1) Denominator used was for male patients only (n=1,316 sertraline; n=973 placebo). * Adverse reactions that occurred greater than 2% in sertraline hydrochloride-treated patients and at lea…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride 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 hydrochloride capsules [see Clinical Pharmacology ( 12.3 )] . Table 4. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Capsules Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs, including sertraline hydrochloride capsules, and MAOIs increases the risk of serotonin syndrome.

Intervention: Sertraline hydrochloride capsules are 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 hydrochloride capsules are contraindicated [see Contraindications ( 4 )] .

Other Serotonergic Drugs Clinical Impact: Concomitant use of sertraline hydrochloride 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 hydrochloride 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 hydrochloride capsules may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride 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 hydrochloride 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 hydrochloride capsules or other protein-bound drugs as warranted. Drugs Metabolized by CYP2D6 Clinical Impact: Sertraline hydrochloride capsules are a CYP2D6 inhibitor [see Clinical Pharmacology ( 12.3 )] . The concomitant use of sertraline hydrochloride 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 hydrochloride capsules use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride capsules are discontinued. Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug.

Sertraline hydrochloride capsules may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating sertraline hydrochloride 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 hydrochloride capsules with other drugs which prolong the QTc interval [see Warn…

👥 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 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respirat…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 postmarketing reports. 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 features are consistent with either a direct toxic effect of SSRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [see Warnings and Precautions ( 5.2 )] . Exposu…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of sertraline hydrochloride 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 hydrochloride 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 Hydrochloride 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 hydrochloride 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 mg to 200 mg) outpatient trials for MDD (n=373) with another sertraline hydrochloride product, there was a difference in weight change between sertraline hydrochloride 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 hydrochloride group compared to a slight gain for the placebo group.

For pediatric patients (ages 6 to 11), about 7% of the sertraline hydrochloride-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 hydrochloride-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 hydrochloride 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 hydrochloride 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 mg/kg/day 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 198 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 hydrochloride 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 hydrochloride, 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 hydrochloride 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 hydrochloride capsules 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 mg to 200 mg. Effect of Food Administration of sertraline hydrochloride 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 ng/mL to 500 ng/mL.

However, at up to 300 ng/mL 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 inc…

🧬 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 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sertraline hydrochloride capsules are supplied as: 150 mg Capsules: White to off white granular powder filled in size "2" empty hard gelatin capsules having a cream colored opaque cap imprinted with "1948" in blank ink and a cream colored opaque body. NDC 70771-1913-3 Bottles of 30 with child-resistant closure. 200 mg Capsules: White to off white granular powder filled in size "1" empty hard gelatin capsules having a light green colored opaque cap imprinted with "1949" in blank ink and a light green colored opaque body.

NDC 70771-1914-3 Bottles of 30 with child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 168 words ▾

11 DESCRIPTION Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride, USP has a molecular weight of 342.690 g/mol and has the following chemical name: (1S,4S)-4-(3,4-Dichlorophenyl)-N-methyl-1,2,3,4-tetrahydro-1-naphthalen amine hydrochloride. The molecular formula C 17 H 17 Cl 2 N • HCl is represented by the following structural formula: Sertraline hydrochloride, USP is a white or off white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol.

Sertraline hydrochloride capsules are for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, USP equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 150 mg capsules contain D&C Yellow 10 and FD&C red 40 as color additives. The 200 mg capsules contain D&C Yellow 10 and FD&C blue 1 as a color additive.

Each capsule is imprinted with black ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Image

💬 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 hydrochloride 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 hydrochloride 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 hydrochloride capsules and to discuss any tapering regimen with their healthcare provider.

Inform patients that adverse reactions can occur when sertraline hydrochloride capsules are discontinued [see Warnings and Precautions ( 5.5 )] . Sexual Dysfunction Advise patients that use of sertraline hydrochloride 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 )] .

Pregnancy Advise women to notify their healthcare provider if they are pregnant or are planning to become pregnant during treatment with sertraline hydrochloride capsules. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride capsules during pregnancy. Inform women that sertraline hydrochloride capsules may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations ( 8.1 )] .

Manufactured by: Zydus Pharmaceuticals Ltd., Ahmedabad-382213, India Rev.: 03/25

💬 Patient Medication Information ~3 min read ▾

PATIENT MEDICATION INFORMATION SECTION MEDICATION GUIDE Sertraline (ser' tra leen) hydrochloride Capsules What is the most important information I should know about sertraline hydrochloride capsules? Sertraline hydrochloride capsules may cause serious side effects, including: Increased risk of suicidal thoughts or actions. Sertraline hydrochloride 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 on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry, or irritable trouble sleeping an increase in activity and talking more than what is normal for you other unusual changes in behavior or mood What are sertraline hydrochloride capsules?

Sertraline hydrochloride 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 hydrochloride capsules are safe and effective for use in children under 6years of age with OCD or children with other behavioral health conditions.

Do not take sertraline hydrochloride 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 hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride 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 hydrochloride capsules. Before taking sertraline hydrochloride 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 are pregnant or plan to become pregnant.

Sertraline hydrochloride capsules may harm the unborn baby. Taking sertraline hydrochloride 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 hydrochloride capsules are taken during…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70771-1913-03 · Zydus 70771-1916-01 · Zydus →
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.