Zoloft (Sertraline Hydrochloride)


Indications

ZOLOFT is indicated for the treatment of the following:

  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Posttraumatic stress disorder (PTSD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD)

contraindications

ZOLOFT 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.
  • Taking pimozide.
  • With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema)

In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT oral solution is contraindicated in patients:

  • Taking disulfiram. ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction.

adverse reactions

The following adverse reactions are described in more detail in other sections of the prescribing information:

  • Hypersensitivity reactions to sertraline
  • Disulfiram-alcohol reaction when ZOLOFT oral solution is taken with disulfiram
  • QT prolongation and ventricular arrhythmias when taken with pimozide
  • Suicidal thoughts and behaviors
  • Serotonin syndrome
  • Increased risk of bleeding
  • Activation of mania/hypomania
  • Discontinuation syndrome
  • Seizures
  • Angle-closure glaucoma
  • Hyponatremia

6.1 Clinical 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 ZOLOFT (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 ZOLOFT 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 ZOLOFT-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 ZOLOFT (≥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*
ZOLOFT
(N=3066)
Placebo
(N=2293)
*
Adverse reactions that occurred greater than 2% in ZOLOFT-treated patients and at least 2% greater in ZOLOFT-treated patients than placebo-treated patients.
Denominator used was for male patients only (n=1316 ZOLOFT; n=973 placebo).
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 † 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 all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received ZOLOFT discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in ZOLOFT-treated patients:

  • MDD, OCD, PD, PTSD, SAD and PMDD: nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).
  • MDD (>2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting.
  • OCD: somnolence.
  • PD: nervousness and somnolence.

Male and Female Sexual Dysfunction

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of ZOLOFT-treated patients and twice placebo from pooled placebo-controlled trials. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.

Table 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from ZOLOFT Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD
ZOLOFT Placebo
Men only (N=1316) (N=973)
  Ejaculation failure 8% 1%
  Libido decreased 7% 2%
  Erectile dysfunction 4% 1%
  Ejaculation disorder 3% 0%
  Male sexual dysfunction 2% 0%
Women only (N=1750) (N=1320)
  Libido decreased 4% 2%

Adverse Reactions in Pediatric Patients

In 281 pediatric patients treated with ZOLOFT in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.

Other Adverse Reactions Observed During the Premarketing Evaluation of ZOLOFT

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with ZOLOFT were:

 
– tachycardia
 
– tinnitus
 
– hypothyroidism
 
– mydriasis, blurred vision
 
hematochezia, melena, rectal hemorrhage
 
– edema, gait disturbance, irritability, pyrexia
 
– elevated liver enzymes
 
– anaphylaxis
 
– diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite
 
– arthralgia, muscle spasms, tightness, or twitching
 
– ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope
 
– aggression, bruxism, confusional state, euphoric mood, hallucination
 
– hematuria
 
– galactorrhea, priapism, vaginal hemorrhage
 
– bronchospasm, epistaxis, yawning
 
– alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura; erythematous, follicular, or maculopapular rash; urticaria
 
– hemorrhage, hypertension, vasodilation

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ZOLOFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

 
– increased coagulation times (altered platelet function)
 
– AV block, bradycardia, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including Torsade de Pointes)
 
– gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH
 
– blindness, optic neuritis, cataract
 
– severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis
 
– agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness
 
– angioedema
 
– hyponatremia, hyperglycemia
 
– trismus
 
– serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis
 
– psychosis, enuresis, paroniria
 
– acute renal failure
 
– pulmonary hypertension
 
– photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
 
cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

warnings and precautions

5.1 Suicidal 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 ZOLOFT, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2 Serotonin Syndrome

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including ZOLOFT, 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. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of ZOLOFT with MAOIs is contraindicated. In addition, do not initiate ZOLOFT in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking ZOLOFT, discontinue ZOLOFT before initiating treatment with the MAOI.

Monitor all patients taking ZOLOFT for the emergence of serotonin syndrome. Discontinue treatment with ZOLOFT and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ZOLOFT with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

5.3 Increased Risk of Bleeding

Drugs that interfere with serotonin reuptake inhibition, including ZOLOFT, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

5.4 Activation of Mania or Hypomania

In patients with bipolar disorder, treating a depressive episode with ZOLOFT or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with ZOLOFT. Prior to initiating treatment with ZOLOFT, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

5.5 Discontinuation Syndrome

Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible

5.6 Seizures

ZOLOFT has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. ZOLOFT should be prescribed with caution in patients with a seizure disorder.

5.7 Angle-Closure Glaucoma

The pupillary dilation that occurs following use of many antidepressant drugs including ZOLOFT may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles.

5.8 Hyponatremia

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including ZOLOFT. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue ZOLOFT and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs.

5.9 False-Positive Effects on Screening Tests for Benzodiazepines

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking ZOLOFT. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of ZOLOFT. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish ZOLOFT from benzodiazepines.

general medication guide

  This Medication Guide has been approved by the U.S. Food and Drug Administration
Medication Guide
ZOLOFT (ZOH-loft)
(sertraline hydrochloride)
Tablets and Oral Solution
What is the most important information I should know about ZOLOFT?
ZOLOFT 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:
  • ZOLOFT 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 ZOLOFT is started or when the dose is changed.
    • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
 
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • attempts to commit suicide
  • acting aggressive or violent
  • new or worse depression
  • feeling agitated, restless, angry or irritable
  • an increase in activity or talking more than what is normal for you
  • acting on dangerous impulses
  • thoughts about suicide or dying
  • new or worse anxiety or panic attacks
  • trouble sleeping
  • other unusual changes in behavior or mood
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: ZOLOFT 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 ZOLOFT 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, or memory problems
Do not stop ZOLOFT without first talking to your healthcare provider. Stopping ZOLOFT too quickly may cause serious symptoms including:
  • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion
What is ZOLOFT?
ZOLOFT is a prescription medicine used to treat:
  • Major Depressive Disorder (MDD)
  • Panic Disorder
  • Social Anxiety Disorder
  • Obsessive Compulsive Disorder (OCD)
  • Posttraumatic Stress Disorder (PTSD)
  • Premenstrual Dysphoric Disorder (PMDD)
It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
ZOLOFT is safe and effective in treating children with OCD age 6 to 17 years.
It is not known if ZOLOFT is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.
Talk to your healthcare provider if you do not think that your condition is getting better with ZOLOFT treatment.
Who should not take ZOLOFT?
Do not take ZOLOFT if you:
  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • have taken an MAOI within 2 weeks of stopping ZOLOFT unless directed to do so by your healthcare provider.
  • have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
  • take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride).
  • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
  • are allergic to sertraline or any of the ingredients in ZOLOFT. See the end of this Medication Guide for a complete list of ingredients in ZOLOFT.
  • take Antabuse® (disulfiram) (if you are taking the liquid form of ZOLOFT) due to the alcohol content.
People who take ZOLOFT close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • high fever
  • rapid changes in heart rate or blood pressure
  • uncontrolled muscle spasms
  • confusion
  • stiff muscles
  • loss of consciousness (pass out)
What should I tell my healthcare provider before taking ZOLOFT?
Before starting ZOLOFT, tell your healthcare provider:
  • if you have:
  • liver problems
  • heart problems
  • bipolar disorder or mania
  • kidney problems.
  • or have had seizures or convulsions
  • low sodium levels in your blood
  • a history of a stroke
  • high blood pressure
  • or have had bleeding problems
  • are pregnant or plan to become pregnant. Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking ZOLOFT during pregnancy.
  • are breastfeeding or plan to breastfeed. A small amount of ZOLOFT may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking ZOLOFT.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZOLOFT and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take ZOLOFT with your other medicines. Do not start or stop any medicine while taking ZOLOFT without talking to your healthcare provider first.
How should I take ZOLOFT?
  • Take ZOLOFT exactly as prescribed. Your healthcare provider may need to change the dose of ZOLOFT until it is the right dose for you.
  • ZOLOFT Tablets may be taken with or without food.
  • ZOLOFT Oral Solution may look cloudy or hazy after mixing, this is normal.
  • ZOLOFT Oral Solution must be diluted before use:
    • Do not mix ZOLOFT until you are ready to take it.
    • When diluting ZOLOFT Oral Solution, use only water, ginger ale, lemon/lime soda, lemonade, or orange juice.
    • The oral dropper contains latex. If you are sensitive or allergic to latex, ask your healthcare provider or pharmacist about the best way to measure your medicine.
  • If you miss a dose of ZOLOFT, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ZOLOFT at the same time.
If you take too much ZOLOFT, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.
What should I avoid while taking ZOLOFT?
ZOLOFT can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZOLOFT affects you. Do not drink alcohol while you take ZOLOFT.
What are the possible side effects of ZOLOFT?
ZOLOFT may cause serious side effects, including:
  • See "What is the most important information I should know about ZOLOFT?"
The most common side effects in adults who take ZOLOFT include:
  • nausea, loss of appetite, diarrhea, or indigestion
  • increased sweating
  • tremor or shaking
  • agitation
  • change in sleep habits including increased sleepiness or insomnia
  • sexual problems including decreased libido and ejaculation failure
  • feeling tired or fatigued
  • anxiety
The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with ZOLOFT.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZOLOFT. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store ZOLOFT?
  • Store ZOLOFT at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep ZOLOFT bottle closed tightly.
Keep ZOLOFT and all medicines out of the reach of children.
General information about the safe and effective use of ZOLOFT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZOLOFT for a condition for which it was not prescribed. Do not give ZOLOFT to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about ZOLOFT. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about ZOLOFT that is written for healthcare professionals.
For more information about ZOLOFT call 1-800-438-1985 or go to www.pfizer.com
What are the ingredients in ZOLOFT?
Active ingredient: sertraline hydrochloride
Inactive ingredients:
Tablets: dibasic calcium phosphate dihydrate, D&C Yellow #10 aluminum lake (in 25 mg tablet), FD&C Blue #1 aluminum lake (in 25 mg tablet), FD&C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.
Oral solution: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)

LAB-0540-6.0
December 2016

overdosage

Human Experience

The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported.

Other important adverse events reported with ZOLOFT overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope.

Overdose Management

No specific antidotes for ZOLOFT are known. Contact Poison Control (1-800-222-1222) for latest recommendations.

description

ZOLOFT 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 C17H17NCl2∙HCl is represented by the following structural formula:

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

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

ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration. The dispenser contains dry natural rubber.

About the Author

Truman Lewis
Truman has been a bureau chief and correspondent in D.C., Los Angeles, Phoenix and elsewhere, reporting for radio, television, print and news services, for more than 30 years. Most recently, he has reported extensively on health and consumer issues for ConsumerAffairs.com and FairfaxNews.com.