SERTRALINE HYDROCHLORIDE 20 mg/mL Solution
Other active recalls for Sertraline Hydrochloride (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, (mood swings, irrita...
Read the full MedlinePlus article ↗- 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.
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🧪 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.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 mL | Per 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 | $0.6619 | $39.71 / 60 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sertraline Hydrochloride 20 mg/mL 16714-0601-02 | NorthStar | 1 bottle | $0.397 | AA | Availability likely | — |
| Sertraline hydrochloride 20 mg/mL 59762-0067-01 | Mylan | 60 ml | $0.397 | AA | Availability likely | — |
| Sertraline Hydrochloride 20 mg/mL 64980-0409-06 | Rising | 1 bottle | $0.397 | AA | Availability likely | — |
| Zoloft 20 mg/mL 00049-0050-01 | ROERIG | 1 bottle | — | AA | Discontinued | — |
| Zoloft 20 mg/mL 58151-0601-35 | Viatris | 1 bottle | — | AA | FDA listed | — |
| Sertraline Hydrochloride 20 mg/mLthis 63629-8774-01 | Bryant | 1 bottle | — | AA | FDA listed | — |
| Sertraline Hydrochloride 20 mg/mL 65862-0224-20 | Aurobindo | 1 bottle | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-8774-01 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER | 2021-10-26 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 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 oral solution 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 oral solution 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 6-12) 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 oral Solution, 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 oral solution 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 oral solution, the recommended interval between dose changes is one week. Table 1: Recommended Daily Dosage of Sertraline Hydrochloride oral solution 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 oral solution dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride oral solution 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 Oral Solution Prior to initiating treatment with sertraline hydrochloride oral solution 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 oral solution 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 oral solution. In addition, at least…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sertraline Hydrochloride Oral solution USP is a clear, colorless solution liquid containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL. It is supplied as a 60 bottle with an accompanying calibrated dispensing dropper. • Oral solution: 20 mg/mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sertraline hydrochloride oral solution 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 )].
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 ▾
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 oral solution should be used with caution in patients with risk factors for QTc prolongation. ( 5.10 ) Sexual Dysfunction: Sertraline hydrochloride 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 18-24 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, incoordi…
🤒 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) ] 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) ] 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 ACI Healthcare USA, Inc. at 1-888-802-1213 or www.acihealthcareusa.com 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 to 12 weeks represent 568 patient-years of exposure.
The mean age was 40 years; 57% were females and 43% were males. The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all sertraline 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: 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 hydrochloridetreated patients and at least 2% greater in sertraline hydrochloride-treated patients than placebo-treated patients.
Sertraline Hydrochloride Oral Solution (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 oral solution; n=973 placebo).
8% 1% Erectile dysfunction 4% 1% Ejaculation disorder 3% 0% Male s…
🔄 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, 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 Q…
👥 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 ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
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.
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 Reaction 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, 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 hypertens…
🆘 Overdosage ▾
10 OVERDOSAGE The following have been reported with sertraline 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 oral solution.
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 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…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sertraline Hydrochloride Oral Solution USP is a clear, colorless solution containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL. It is supplied as a 60 mL bottle with an accompanying calibrated dropper. Bottles of 60 mL NDC 63629-8774-1 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Sertraline hydrochloride oral solution, USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.5 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, USP is a white to off-white, crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride oral solution USP is available in a multidose 60 mL bottle. Each mL of solution contains sertraline hydrochloride USP equivalent to 20 mg of sertraline per mL.
The solution contains the following inactive ingredients:propylene glycol. The oral solution must be diluted prior to administration [See Dosage and Administration (2.7) ].
💬 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) ]. 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 dispensing dropper 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) ]. Sexual Dysfunction Advise patients that use of sertraline hydrochloride 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 may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [see Use in Specific Populations (8.1) ] . This product’s label may have been updated.
For full prescribing information, please visit www.acihealthcareusa.com ® Trademarks are the property of their respective owners. Manufa…
💬 Medication Guide ▾
MEDICATION GUIDE Sertraline Hydrochloride Oral Solution, USP (ser′ tra leen hye″ droe klor′ ide) Rx Only What is the most important information I should know about sertraline hydrochloride Oral Solution? Sertraline hydrochloride Oral Solution 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 Oral Solution 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 Oral Solution 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 on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you 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 nausea, vomiting, or diarrhea racing heartbeat, high or low blood pressure sweating or fever coordination problems or muscle twitching (overactive reflexes) muscle rigidity 3. Increased chance of bleeding: Sertraline hydrochloride oral solution 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 severe trouble sleeping excessive happiness or irritability racing thoughts reckless behavior talking more or faster than usual unusually grand ideas 5.
Seizures or convulsions. 6. Glaucoma (angle-closure glaucoma).
Many antidepressant medicines including Sertraline hydrochloride oral solution 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 reuptake inhibitors (SSRIs), including sertraline hydrochloride oral solution, 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…