Home › NDC Lookup › Ingredients › Sertraline Hydrochloride › 71610-0433-15
⚪image loading
(from DailyMed)

SERTRALINE HYDROCHLORIDE 100 mg Tablet, Film Coated, 15-count

by Aphena Pharma Solutions - Tennessee, LLC · 15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15)
NDC 71610-0433-15
🏷️ FDA NDC (as labeled) 71610-433-15 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 16, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2020. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71610-433-15
Product NDC 71610-433
11-digit billing NDC 71610043315
NCPDP billing unit EA — each (per item)
RxCUI 312938
UNII UTI8907Y6X
Application # NDA019839
SPL Set ID ccb264a4-5d50-4317-a67e-ba6daa2b8297
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2020)
Marketing start 2019-08-12
Route ORAL
Dosage form TABLET, FILM COATED
Substance SERTRALINE HYDROCHLORIDE
GPI-14 58160070100320
GPI class Sertraline HCl
GCN Seq No 046229
GCN 16375
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 HCL 100 MG TABLET
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 71610-433-15 — 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 → 71610-0433-15. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderVIATRIS SPECIALTY LLC
FDA applicationNDA019839 (NDA AUTHORIZED GENERIC)
Labeler code71610
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio795 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 HCL 100 MG TABLET 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.1097 $1.65 / 15 tablets
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 100 mg 16729-0217-15 Accord 90 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 00904-6926-61 Major 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 16714-0613-01 NorthStar 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 31722-0147-05 Camber 500 tablets $0.050 — Availability likely —
Sertraline 100 mg 50268-0770-15 AvPAK 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 50268-0825-15 AvPAK 1 tablet $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 60687-0253-01 American 100 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 65862-0013-01 Aurobindo 100 tablets $0.050 — Availability likely —
Sertraline Hydrochloride 100 mg 68180-0992-01 Lupin 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 68645-0523-54 Legacy 30 tablets $0.050 AB Availability likely —
Sertraline Hydrochloride 100 mg 69097-0835-02 Cipla 30 tablets $0.050 AB Availability likely —
Sertraline hydrochloride 100 mg 70010-0205-03 Granules 30 tablets $0.050 AB Availability likely —
Sertraline 100 mg 76282-0214-01 Exelan 100 tablets $0.050 AB Discontinued —
Sertraline Hydrochloride 100 mg 82009-0050-05 Quallent 500 tablets $0.050 AB Availability likely —
Zoloft 100 mg 00049-4910-30 ROERIG 30 tablets $14.947 AB Discontinued —
Zoloft 100 mg 58151-0576-88 Viatris 1 tablet $14.950 AB Availability likely —
Sertraline Hydrochloride 100 mg 00615-8604-05 NCS 15 tablets — AB FDA listed —
Sertraline 100 mg 23155-0759-03 Heritage 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43063-0754-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43353-0447-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 43602-0981-15 Ascent 30 tablets — — FDA listed —
Sertraline 100 mg 50090-0991-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-2080-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-3203-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-6917-00 A-S 90 tablets — AB FDA listed —
Sertraline 100 mg 50090-7295-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7693-00 A-S 30 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7694-00 A-S 90 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 50090-7700-00 A-S 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50090-7701-00 A-S 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 50228-0469-05 ScieGen 500 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 51655-0173-26 Northwind 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-3570-00 Cardinal 1 tablet — AB FDA listed —
Sertraline Hydrochloride 100 mg 55154-4692-00 Cardinal 10 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 55700-0362-30 Quality 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 60760-0091-90 St. 90 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 60760-0738-90 St. 90 tablets — AB FDA listed —
Sertraline 100 mg 63187-0212-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 63187-0795-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 67046-0554-03 Coupler 30 tablets — AB FDA listed —
Sertraline hydrochloride 100 mg 67046-1682-03 Coupler 30 tablets — AB FDA listed —
Sertraline 100 mg 68071-3534-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4658-03 NuCare 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68071-4973-06 NuCare 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68180-0353-01 Lupin 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-6835-01 Preferred 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 68788-8210-03 Preferred 30 tablets — AB FDA listed —
Sertraline 100 mg 70518-1040-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-2448-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 70518-4590-00 REMEDYREPACK 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0047-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71205-0455-30 Proficient 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0210-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71335-0510-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-0896-01 Bryant 30 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71335-3110-01 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 71335-3115-01 Bryant 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mgthis 71610-0433-15 Aphena 15 tablets — AB Discontinued —
Sertraline Hydrochloride 100 mg 71610-0435-45 Aphena 45 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0651-15 Aphena 15 tablets — AB FDA listed —
Sertraline 100 mg 71610-0769-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 71610-0886-15 Aphena 15 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72162-2407-03 Bryant 30 tablets — AB FDA listed —
Sertraline 100 mg 72162-2411-00 Bryant 1000 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72189-0122-30 DIRECT 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0088-60 PD-Rx 60 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0092-30 PD-Rx 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72789-0273-01 PD-Rx 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 72865-0207-05 XLCare 500 tablets — — FDA listed —
Sertraline Hydrochloride 100 mg 76420-0786-01 Asclemed 100 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 80425-0310-01 Advanced 30 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 84386-0099-59 Aurobindo 5000 tablets — AB FDA listed —
Sertraline Hydrochloride 100 mg 87441-0076-01 Unit 30 tablets — AB FDA listed —
Sertraline hydrochloride 100 mg 70518-4707-00 REMEDYREPACK 1 tablet — AB FDA listed —
Sertraline Hydrochloride 100 mg 82804-0311-90 Proficient 90 tablets — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

🔬 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
71610-0433-15 You're viewing this 15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15) 2020-06-16 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 71610-433-15, 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: 71610-0433-15, written without dashes as 71610043315. 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 71610-0433-15, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0433) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 91 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.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 )

🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE Sertraline hydrochloride is indicated for the treatment of the following [See Clinical Studies (14) ] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Starting Dosage Maximum Dosage MDD ( 2.1 ) 50 mg per day 200 mg per day OCD ( 2.1 ) 25 mg per day (ages 6–12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD ( 2.1 ) 25 mg per day 200 mg per day PMDD ( 2.2 ) continuous dosing 50 mg per day 150 mg per day PMDD ( 2.2 ) intermittent dosing 50 mg per day during luteal phase only 100 mg per day during luteal phase only If inadequate response to starting dosage, titrate in 25–50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD ( 2.1 ) See Full Prescribing Information for titration in PMDD ( 2.2 ) Hepatic impairment: Mild: Recommended starting and maximum dosage is half recommended dosage ( 2.4 ) Moderate or severe: Not recommended ( 2.4 ) When discontinuing sertraline hydrochloride, reduce dose gradually ( 2.6 , 5.4 ) Oral solution: Must be diluted before administration ( 2.7 )

2.1Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day.

Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week. Table 1: Recommended Daily Dosage of Sertraline Hydrochloride in Patients with MDD, OCD, PD, PTSD, and SAD Indication Starting Dose Therapeutic Range Adults MDD 50 mg 50–200 mg OCD 50 mg PD, PTSD, SAD 25 mg Pediatric Patients OCD (ages 6–12 years old) 25 mg 50–200 mg OCD (ages 13–17 years old) 50 mg

2.2Dosage in Patients with PMDD The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

When dosing continuously , patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day. When dosing intermittently , patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.

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

2.4Dosage Modifications in Patients with Hepatic Impairment Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1 , 2.2) ] . The use of sertraline hydrochloride in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10–15) is not recommended [See Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ].

2.5Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride. In addition, at least 14 days must elapse after stopping sertraline hydrochloride before starting an MAOI antidepressant [See Contraindications (4) ,…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS 25 mg tablets: light green film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg" 50 mg tablets: light blue film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" 100 mg tablets: light yellow film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg" 25 mg tablets : light green film-coated, engraved on one side with "G 4960" and on the other side scored and engraved with "25 mg" 50 mg tablets : light blue film-coated, engraved on one side with "G 4900" and on the other side scored and engraved with "50 mg" 100 mg tablets : light yellow film-coated, engraved on one side with "G 4910" and on the other side scored and engraved with "100 mg" Oral solution (new name, same product as oral concentrate): a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol.

It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. Tablets: 25 mg, 50 mg and 100 mg ( 3 ) Oral solution (new name, same product as oral concentrate): 20 mg/mL ( 3 )

⛔ Contraindications 160 words ▾

4 CONTRAINDICATIONS Sertraline hydrochloride is 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 (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1 , 6.2) ].

In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution is contraindicated in patients: Taking disulfiram. Sertraline hydrochloride oral solution contains alcohol, and concomitant use of sertraline hydrochloride and disulfiram may result in a disulfiram-alcohol reaction. 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 , 5.4 ) Sertraline hydrochloride oral solution only: Concomitant use of disulfiram ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue sertraline hydrochloride and initiate supportive treatment. ( 5.2 ) 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/Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Seizures: Use with caution in patients with seizure disorders. ( 5.6 ) Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride, in patients with untreated anatomically narrow angles.

( 5.7 ) QTc Prolongation: Sertraline hydrochloride should be used with caution in patients with risk factors for QTc prolongation. ( 5.10 )

5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18–24 5 additional patients Decreases Compared to Placebo 25–64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients 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. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing sertraline hydrochloride, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including sertraline hydrochloride, 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, tryptophan, buspirone, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [See Contraindications (4) , Drug Interactions (7.1) ] .

Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The con…

🤒 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 [See Contraindications (4) ] Disulfiram-alcohol reaction when sertraline hydrochloride oral solution is taken with disulfiram [See Contraindications (4) ] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4) , Clinical Pharmacology (12.2) ] Suicidal thoughts and behaviors [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/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) ] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 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 data described below are from randomized, double-blind, placebo-controlled trials of sertraline hydrochloride (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to sertraline hydrochloride for 8 to12 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 hydrochloride-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3 ). The following are the most common adverse reactions in trials of sertraline hydrochloride (≥5% and twice placebo) by indication that were not mentioned previously.

MDD: somnolence; OCD: insomnia, agitation; PD: constipation, agitation; PTSD: fatigue; PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain; SAD: insomnia, dizziness, fatigue, dry mouth, malaise. Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD 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 Denominator used was for male patients only (n=1316 sertraline hydrochloride; n=973 placebo).

8% 1% Erectile dysfunction 4% 1% Ejaculation disorder 3% 0% Male sexual dysfunction 2% 0% Skin and subcutaneous tissue disorders Hyperhidrosis 7% 3% Adverse Reactions Leading to Discontinuation in P…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride 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 5 includes clinically significant drug interactions with sertraline hydrochloride [See Clinical Pharmacology (12.3) ] . Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome.

Intervention: Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See Dosage and Administration (2.5) , Contraindications (4) , Warnings and Precautions (5.2) ]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue 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 is contraindicated [See Contraindications (4) ].

Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs with sertraline hydrochloride 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 and/or concomitant serotonergic drugs [See Warnings and Precautions (5.2) ].

Examples: other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with sertraline hydrochloride may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of sertraline hydrochloride and antiplatelet agents and anticoagulants.

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

Intervention: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs as warranted. Examples: warfarin Drugs Metabolized by CYP2D6 Clinical Impact: Sertraline hydrochloride is a CYP2D6 inhibitor [See Clinical Pharmacology (12.3) ] . The concomitant use of sertraline hydrochloride 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 use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if sertraline hydrochloride is discontinued. Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thoridazine, tolterodine, venlafaxine Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug.

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

Examples: phenytoin, fosphenytoin Drugs that Prolong the QTc Interval Clinical Impact: The risk of QT…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate ( 8.1 ) Pediatric use : Safety and effectiveness of sertraline hydrochloride in pediatric patients other than those with OCD have not been established ( 8.4 )

8.1Pregnancy Risk Summary 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 and SNRIs, including sertraline hydrochloride, during the third trimester of pregnancy [See Clinical Considerations ].

Although no teratogenicity was 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 3.1 times the MRHD in rabbits on a mg/m 2 basis in adolescents. 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 2–4% and 15–20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride.

Sertraline hydrochloride oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy. 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. Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including sertraline hydrochloride 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 during the third trimester, carefully consider both the potential risks and benefits of treatment.

Monitor neonates who were exposed to sertraline hydrochloride in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [See Data ]. Data Human Data Third Trimester Exposure Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs 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, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.

In some cases, the clinical picture was consistent with serotonin syndrome [See Warnings and Prec…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary 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 and SNRIs, including sertraline hydrochloride, during the third trimester of pregnancy [See Clinical Considerations ].

Although no teratogenicity was 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 3.1 times the MRHD in rabbits on a mg/m 2 basis in adolescents. 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 2–4% and 15–20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride.

Sertraline hydrochloride oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy. 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. Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including sertraline hydrochloride 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 during the third trimester, carefully consider both the potential risks and benefits of treatment.

Monitor neonates who were exposed to sertraline hydrochloride in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [See Data ]. Data Human Data Third Trimester Exposure Neonates exposed to sertraline hydrochloride and other SSRIs or SNRIs 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, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.

In some cases, the clinical picture was consistent with serotonin syndrome [See Warnings and Precautions (5.2) ] . Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1–2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality.

In a retrospective case-…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and efficacy of sertraline hydrochloride 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 in 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 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 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 an SSRI such as sertraline hydrochloride. Weight Loss in Studies in Pediatric Patients with MDD In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50–200 mg) outpatient trials for MDD (n=373), there was a difference in weight change between sertraline hydrochloride and placebo of roughly 1 kg, for both children (ages 6–11) and adolescents (ages 12–17), in both age groups representing a slight weight loss for the sertraline hydrochloride group compared to a slight gain for the placebo group.

For children, 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 adolescents, 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 hydrochloride 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. Alcohol Content in Sertraline Hydrochloride Oral Solution Sertraline hydrochloride oral solution contains 12% alcohol.

Juvenile Animal 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 – 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 in clinical studies of sertraline hydrochloride in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 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 sertraline hydrochloride in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 3 [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. SNRIs and 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 96 words ▾

10 OVERDOSAGE Human Experience The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported. Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QTc-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope [See Clinical Pharmacology (12.2) ] .

Overdose Management No specific antidotes for sertraline hydrochloride are known. Contact Poison Control (1-800-222-1222) for latest 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 hydrochloride.

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) , Adverse Reactions (6) , Drug Interactions (7) , Overdosage (10) ] .

12.3Pharmacokinetics Absorption Following oral once-daily sertraline hydrochloride dosing over the range of 50 to 200 mg for 14 days, 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 were demonstrated in a single dose study in which the C max and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. The single dose bioavailability of sertraline hydrochloride tablets is approximately equal to an equivalent dose of sertraline hydrochloride oral solution. Administration with food causes a small increase in C max and AUC.

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. 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 40–45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40–45% of the administered radioactivity was accounted for in feces, including 12–14% unchanged sertraline.

Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0–24-hour), C max and C min , with about a 5- to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14. Protein Binding In vi…

🧬 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 ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sertraline hydrochloride 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg" NDC 59762-6347-1 Bottles of 30 Sertraline hydrochloride 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" NDC 59762-6443-1 Bottles of 30 NDC 59762-6443-2 Bottles of 100 NDC 59762-6443-3 Bottles of 500 Sertraline hydrochloride 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg" NDC 59762-5160-1 Bottles of 30 NDC 59762-5160-2 Bottles of 100 NDC 59762-5160-3 Bottles of 500 Sertraline hydrochloride 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "G 4960" and on the other side scored and engraved with "25 mg" NDC 59762-4960-1 Bottles of 30 Sertraline hydrochloride 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "G 4900" and on the other side scored and engraved with "50 mg" NDC 59762-4900-4 Bottles of 100 NDC 59762-4900-5 Bottles of 500 NDC 59762-4900-2 Bottles of 5000 NDC 59762-4900-3 Unit Dose Packages of 100 Sertraline hydrochloride 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "G 4910" and on the other side scored and engraved with "100 mg" NDC 59762-4910-4 Bottles of 100 NDC 59762-4910-5 Bottles of 500 NDC 59762-4910-2 Bottles of 5000 NDC 59762-4910-3 Unit Dose Packages of 100 Sertraline hydrochloride oral solution (new name, same product as sertraline hydrochloride oral concentrate): clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol NDC 59762-4940-1 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

NDC 59762-0067-1 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. Store sertraline hydrochloride 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].

📦 Storage and Handling 24 words ▾

Store sertraline hydrochloride 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 ~1 min read ▾

11 DESCRIPTION Sertraline hydrochloride is an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17 H 17 NCl 2 ∙HCl is represented by the following structural formula: Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

Sertraline hydrochloride tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

Sertraline hydrochloride oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT).

The oral solution must be diluted prior to administration [See Dosage and Administration (2.7) ] . The dispenser contains dry natural rubber. 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) ] . Important Administration Instructions for Oral Solution For patients prescribed sertraline hydrochloride oral solution, inform them that: Sertraline hydrochloride oral solution must be diluted before use.

Do not mix in advance. Use the dropper provided to remove the required amount of sertraline hydrochloride oral solution and mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix sertraline hydrochloride oral solution with anything other than the liquids listed.

Take the dose immediately after mixing. At times, a slight haze may appear after mixing; this is normal. The dropper dispenser contains dry natural rubber, a consideration for patients with latex sensitivity.

Disulfiram Contraindication for sertraline hydrochloride Oral Solution Inform patients not to take disulfiram when taking sertraline hydrochloride oral solution. Concomitant use is contraindicated due the alcohol content of the oral solution [See Contraindication (4) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, 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). Patients should 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 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/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 and to discuss any tapering regimen with their healthcare provider.

Adverse reactions can occur when sertraline hydrochloride is discontinued [See Warnings and Precautions (5.5) ]. Allergic Reactions 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) ] . Pregnancy Inform pregnant women that sertraline hydrochloride 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 ▾

Medication Guide SERTRALINE HYDROCHLORIDE Tablets and Oral Solution This Medication Guide has been approved by the U.S. Food and Drug Administration What is the most important information I should know about sertraline hydrochloride? Sertraline hydrochloride and other antidepressant medicines may cause serious side effects.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency. Suicidal thoughts or actions: Sertraline hydrochloride 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. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline hydrochloride is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, 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 or 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 Serotonin Syndrome.

This condition can be life-threatening and symptoms may include: agitation, hallucinations, coma, or other changes in mental status racing heartbeat, high or low blood pressure coordination problems or muscle twitching (overactive reflexes) nausea, vomiting, or diarrhea sweating or fever muscle rigidity Increased chance of bleeding : sertraline hydrochloride and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

Manic episodes. Symptoms may include: greatly increased energy racing thoughts unusually grand ideas severe trouble sleeping reckless behavior excessive happiness or irritability talking more or faster than usual Seizures or convulsions. Glaucoma (angle-closure glaucoma).

Many antidepressant medicines including sertraline hydrochloride may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include: Headache weakness or feeling unsteady confusion, problems concentrating or thinking, or memory problems Do not stop sertraline hydrochloride without first talking to your healthcare provider.

Stopping sertraline hydrochloride too quickly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or changes in sleep habits headache, sweating, nausea, dizziness electric shock-like sensations, shaking, confusion What is sertraline hydrochloride? Sertraline hydrochloride is a prescription medicine used to treat: Major Depressive Disorder (MDD) Panic Disorder Social Anxiety Disorder Obsessive Compulsive Disorder (OCD) Posttraumatic Stress Disorder (PTSD) Premenstrual Dysphoric D…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71610-0431-45 · Aphena 71610-0434-18 · Aphena →
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.