Sertraline Hydrochloride 25 mg Tablet, Film Coated, 1,000-count
Other active recalls for Sertraline Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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?
Patient education
Supplement & herbal interactions
Sertraline may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.028 | $28.20 / 1000 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2277 | $227.70 / 1000 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1097 | $109.70 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sertraline Hydrochloride 25 mg 00904-6924-61 | Major | 1 tablet | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 16714-0611-01 | NorthStar | 30 tablets | $0.028 | AB | Availability likely | — |
| Sertraline 25 mg 23155-0757-03 | Heritage | 30 tablets | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 31722-0145-05 | Camber | 500 tablets | $0.028 | — | Availability likely | — |
| Sertraline 25 mg 50268-0768-15 | AvPAK | 1 tablet | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 50268-0823-15 | AvPAK | 1 tablet | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 60687-0231-01 | American | 100 tablets | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 65862-0011-01 | Aurobindo | 100 tablets | $0.028 | — | Availability likely | — |
| Sertraline Hydrochloride 25 mgthis 68180-0978-03 | Lupin | 1000 tablets | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 68645-0521-54 | Legacy | 30 tablets | $0.028 | AB | Availability likely | — |
| Sertraline Hydrochloride 25 mg 69097-0833-02 | Cipla | 30 tablets | $0.028 | AB | Availability likely | — |
| Sertraline hydrochloride 25 mg 70010-0203-03 | Granules | 30 tablets | $0.028 | AB | Availability likely | — |
| Sertraline 25 mg 76282-0212-01 | Exelan | 100 tablets | $0.028 | AB | Discontinued | — |
| Sertraline Hydrochloride 25 mg 16729-0215-10 | Accord | 30 tablets | $0.039 | AB | FDA listed | +40% |
| Zoloft 25 mg 58151-0574-93 | Viatris | 30 tablets | $14.879 | AB | Availability likely | +52701% |
| Sertraline Hydrochloride 25 mg 00615-8596-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 43602-0979-15 | Ascent | 30 tablets | — | — | FDA listed | — |
| Sertraline 25 mg 50090-5848-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 50090-6613-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 50090-6614-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 50090-7230-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Sertraline hydrochloride 25 mg 50090-7395-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Sertraline hydrochloride 25 mg 50090-7396-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 50090-7614-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 50090-7615-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 50090-7698-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 50090-7699-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 50228-0467-05 | ScieGen | 500 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 51655-0345-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 63187-0478-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 63187-0859-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 67046-1665-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 68071-3951-03 | NuCare | 30 tablets | — | — | FDA listed | — |
| Sertraline Hydrochloride 25 mg 68071-4462-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 68180-0351-01 | Lupin | 100 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 68788-4045-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 68788-6437-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Sertraline hydrochloride 25 mg 68788-8689-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 70518-0938-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 70518-1748-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Sertraline hydrochloride 25 mg 70518-4171-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 70518-4307-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 70518-4425-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 70518-4606-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 71205-0343-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 71335-0328-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 71335-0808-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Sertraline Hydrochloride 25 mg 71335-1078-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Sertraline hydrochloride 25 mg 71335-2587-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Sertraline 25 mg 71335-2659-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 72789-0346-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 72865-0205-05 | XLCare | 500 tablets | — | — | FDA listed | — |
| Sertraline Hydrochloride 25 mg 76420-0779-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 84386-0097-29 | Aurobindo | 20000 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 87441-0075-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Sertraline Hydrochloride 25 mg 67046-1181-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68180-0978-01 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-978-01) | $0.0282 / ea | $0.85 | 2025-07-20 | Active |
| 68180-0978-02 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-978-02) | $0.0282 / ea | $2.54 | 2025-07-20 | Active |
| 68180-0978-03 You're viewing this | 1000 TABLET, FILM COATED in 1 BOTTLE (68180-978-03) | $0.0282 / ea | $28.18 | 2025-07-20 | Active |
You're viewing the largest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0282 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 79% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68180-0978-03?
What is the difference between NDC 68180-0978-03 and NDC 68180-0978-01?
What NDC number is used to bill for this package of Sertraline Hydrochloride 25 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions ( 5.1 )]. 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 ▾
1 INDICATIONS AND USAGE Sertraline hydrochloride tablets are 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 tablet 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 ▾
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 to 12) 200 mg per day 50 mg per day (ages ≥ 13) 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 to 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 tablets, reduce dose gradually ( 2.6 , 5.4 )
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 to 200 mg OCD 50 mg PD, PTSD, SAD 25 mg Pediatric Patients OCD (ages 6 to 12 years old) 25 mg 50 to 200 mg OCD (ages 13 to 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 tablets 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 Tablets Prior to initiating treatment with sertraline hydrochloride tablets 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 tablets in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 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 tablets. In addition, at least 14 days must elapse after stopping sertraline hydrochloride tablets before starting an MAOI antidepressant [See Contraindicat…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 25 mg Tablets Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side. 50 mg Tablets Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side. 100 mg Tablets Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side.
Tablets: 25 mg, 50 mg and 100 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sertraline hydrochloride tablets 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 (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 , 5.4 )
⚠️ Warnings and Cautions ▾
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 tablets and serotonergic agents 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 tablets, in patients with untreated anatomically narrow angles.
( 5.7 ) QTc Prolongation: sertraline hydrochloride tablets should be used with caution in patients with risk factors for QTc prolongation. ( 5.10 ) Sexual Dysfunction: sertraline hydrochloride tablets may cause symptoms of sexual dysfunction. ( 5.11 )
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 to 24 5 additional patients Decreases Compared to Placebo 25 to 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 tablets, 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 selective serotonin reuptake inhibitors (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, meperidine, methadone, 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, diaphor…
🤒 Adverse Reactions ▾
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 )] 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 )] Sexual Dysfunction [See Warnings and Precautions ( 5.11 )] 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 Placebo-Controlled Clinical Trials In al…
🔄 Drug Interactions ▾
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, opioids, lithium, tryptophan, buspirone, amphetamines, and 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 C linical Imp…
👥 Use in Specific Populations ▾
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 Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 ) and Clinical Considerations] .
Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data]. There are clinical considerations regarding neonates exposed to SSRIs 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 to 4% and 15 to 20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride tablets.
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 tablets 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 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 tri…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.3 ) and Clinical Considerations] .
Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data]. There are clinical considerations regarding neonates exposed to SSRIs 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 to 4% and 15 to 20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing sertraline hydrochloride tablets.
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 tablets 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 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, seizu…
🧒 Pediatric Use ▾
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 to 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 to 11) and adolescents (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 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. 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 to 17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).
🧓 Geriatric Use ▾
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 ▾
10 OVERDOSAGE The following have been reported with sertraline 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 ▾
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 to 45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40 to 45% of the administered radioactivity was accounted for in feces, including 12 to 14% unchanged sertraline.
Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0 to 24-hour), C max and C min , with about a 5- to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14. Prote…
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sertraline Hydrochloride Tablets USP, 25 mg Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side. NDC 68180-978-01 Bottles of 30 NDC 68180-978-02 Bottles of 90 NDC 68180-978-03 Bottles of 1000 Sertraline Hydrochloride Tablets USP, 50 mg Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side.
NDC 68180-986-01 Bottles of 30 NDC 68180-986-02 Bottles of 90 NDC 68180-986-03 Bottles of 500 NDC 68180-986-04 Bottles of 5000 Sertraline Hydrochloride Tablets USP, 100 mg Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. NDC 68180-992-01 Bottles of 30 NDC 68180-992-02 Bottles of 90 NDC 68180-992-03 Bottles of 500 NDC 68180-992-04 Bottles of 5000 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature].
Preserve in tight containers.
📋 Description ▾
11 DESCRIPTION Sertraline hydrochloride tablet USP contains sertraline hydrochloride, 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 white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide.
Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 112.0 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: Ascorbic acid (in 25 mg, 50 mg and 100 mg tablets), D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin.
Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance. image-1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially 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 tablets with other serotonergic drugs including triptans, tricyclic antidepressants, 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). 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 tablets 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 tablets and to discuss any tapering regimen with their healthcare provider.
Adverse reactions can occur when sertraline hydrochloride tablets are discontinued [See Warnings and Precautions ( 5.5 )]. Sexual Dysfunction Advise patients that use of sertraline hydrochloride tablets 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 ( 5.11 )].
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 tablets may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations ( 8.1 )]. Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to sertraline hydrochloride tablets during pregnancy LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.
Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States MADE IN INDIA Revised: September 2024 ID#: 276276 Image
💬 Medication Guide ▾
Medication Guide Sertraline Hydrochloride (ser' tra leen hye'' droe klor' ide) Tablets What is the most important information I should know about sertraline hydrochloride tablets? Sertraline hydrochloride tablets 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.
1. Suicidal thoughts or actions: Sertraline hydrochloride tablets 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 tablets are 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 2. 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 3. Increased chance of bleeding : Sertraline hydrochloride tablets 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.
4. 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 5.
Seizures or convulsions. 6. Glaucoma (angle-closure glaucoma).
Many antidepressant medicines including sertraline hydrochloride tablets 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. 7. Changes in appetite or weight .
Children and adolescents should have height and weight monitored during treatment. 8. 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, memory problems 9. Sexual problems (dysfunction).
Taking serotonin and norepinephrine reuptake inhibitors (SSRIs), including sertraline hydrochloride tablets, may cause sexual problems. Symptoms in males may include: Delayed ejaculation or inability to have an ejaculation Decreased sex drive Problems getting or keeping an erection Symptoms in females may include: Decreased sex drive Delayed orgasm or inability to have an orgasm Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with sertraline hydroch…