Note: These highlights do not include all the information needed to use Sertraline safely and effectively.
DOSAGE FORMS AND STRENGTHS:
Sertraline is made in 25 mg, 50 mg, 100 mg.
DOSES AND ADMINISTRATION:
When Taken As Needed:
The starting dose of sertraline for PE is usually 25 mg. It can be taken daily at a convenient time (e.g. after brushing your teeth in the morning) or it can be taken 4-8 hours before sex.
Based on effectiveness and tolerability, your physician may recommend an increase to 50 mg or higher.
Sertraline should not to be taken more than once per day.
Sertraline is administered orally. In young adults, steady-state concentrations are achieved after about 1 week when sertraline is taken daily.
After oral administration of sertraline for 14 days in adults, the mean peak plasma concentration (Cmax) occurs between 4.5 to 8.4 hours. Administration with food causes a small increase in peak plasma concentration.
For more information, please read the FDA Prescribing Information here.
CONTRAINDICATIONS: (Who Should Never Take Sertraline for PE)
- History of suicidal thoughts or attempts
- History of self-injurious behavior
- History of bipolar disorder
- History of manic or depressive episodes
- History of serotonin syndrome
- Patients taking an SSRI for another indication like depression or anxiety. (e.g., Lexapro, Celaxo, Paxil, Prozac, Viibryd, Zoloft, paroxetine, fluoxetine, citalopram, escitalopram)
- People taking MAOIs or who have taken MAOIs in the previous 2 weeks
- People with a history of long QT syndrome or who are taking drugs that lengthen the QT interval
- People with moderate-severe liver disease. People with mild liver disease may require reduced doses of sertraline.
- People who are pregnant or nursing
- Children under the age of 18
- People with bleeding disorders, or who are taking medications that increase their risks of bleeding, should discuss this with their doctor before taking sertraline. In most cases, an alternative treatment strategy will be used.
For a complete list of contraindications and precautions to sertraline, please see the PDR.
Most Common (≥2%):
Somnolence, tremor, dizziness, fatigue, abdominal pain, anorexia, constipation, diarrhea, dyspepsia, nausea, agitation, insomnia, decreased libido, ejaculation failure, dry mouth, and increased sweating.
As mentioned above, doses that are effective in the treatment of PE are often lower than doses used to treat depression and anxiety, which may result in a lower risk of side effects.
For a complete list of less common side effects, please read the FDA information here.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS AND PRECAUTIONS
Sertraline is contraindicated in patients with a hypersensitivity to sertraline or any of the formulation components.
Some reports suggest that a false positive urine drug screen may occur for benzodiazepines in patients who have received sertraline.
Avoid abrupt discontinuation of any SSRI, if possible. Gradual tapering is recommended during discontinuation of sertraline to decrease or prevent the occurrence of potential discontinuation symptoms. The most frequent SSRI discontinuation symptoms include dizziness, vertigo, nausea, vomiting, flu-like symptoms, sensory disturbances (e.g., paresthesias, electric shock sensation), sleep disturbances, irritability, anxiety, and/or agitation.
Children, growth inhibition, suicidal ideation
There is a causal relationship between the use of antidepressants, such as sertraline, and the risk of suicidal ideation and behavior in children, adolescents, and young adults (ages 18 to 24 years). People with depression and other conditions that are associated with suicidal thoughts and behaviors should not use sertraline for PE.
Bipolar disorder, mania
The use of antidepressants has been associated with the precipitation of mania or hypomania in susceptible individuals. Patients should be adequately screened for bipolar disorder prior to initiating an antidepressant.
Concomitant use of MAOI therapy with sertraline or within 14 days of stopping treatment with sertraline is contraindicated because of an increased risk of serotonin syndrome. The use of sertraline within 14 days of stopping MAOI therapy is also contraindicated. Starting sertraline in a patient who is being treated with linezolid or intravenous methylene blue, both of which inhibit monoamine oxidase, is also contraindicated because of an increased risk of serotonin syndrome. The development of a potentially life-threatening serotonin syndrome has been reported with the use of SSRIs such as sertraline alone, but particularly with concomitant use of other serotonergic drugs. If concomitant use of sertraline with certain other serotonergic drugs (i.e., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John’s Wort) is clinically warranted, be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Electroconvulsive therapy (ECT), seizure disorder
Sertraline should be used with caution in patients with a history of seizure disorder. Patients with a history of seizures were excluded from clinical studies with sertraline. Seizures have been reported rarely in patients taking SSRIs. The risks or benefits of using sertraline during electroconvulsive therapy (ECT) have not been established in clinical studies. Some clinicians have reported that in rare instances the ECT-induced seizure was prolonged in the presence of an antidepressant.
Dehydration, hyponatremia, hypovolemia
Selective serotonin reuptake inhibitors (SSRIs) such as sertraline may cause hyponatremia, which is frequently the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). In some cases, serum sodium levels less than 110 mmol/L have been reported; however, the adverse effect appeared reversible upon discontinuation of the causative SSRI. Elderly patients, those receiving diuretics or prone to dehydration, and those who are otherwise volume depleted (e.g., hypovolemia) appear to be at greatest risk. Hyponatremia may manifest as headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness which may result in falls. Severe manifestations include hallucinations, syncope, seizure, coma, respiratory arrest, and death. Symptomatic hyponatremia may require discontinuation of the SSRI, as well as implementation of the appropriate medical interventions.
Alcoholism, bradycardia, cardiac arrhythmias, cardiac disease, coronary artery disease, females, heart failure, hypertension, hypocalcemia, hypokalemia, hypomagnesemia, long QT syndrome, malnutrition, myocardial infarction, QT prolongation, thyroid disease
Cases of QT prolongation and torsade de pointes (TdP) have been reported during postmarketing use of sertraline. This is a potentially life threatening abnormal heart rhythm. Therefore, sertraline should be used with caution in patients with cardiac disease or other conditions that may increase the risk of QT prolongation including cardiac arrhythmias, congenital long QT syndrome, heart failure, bradycardia, myocardial infarction, hypertension, coronary artery disease, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to cause electrolyte imbalances. The manufacturer recommends against coadministration of sertraline and other medications known to prolong the QTc interval. Females, elderly patients, patients with diabetes, thyroid disease, malnutrition, alcoholism, or hepatic impairment may also be at increased risk for QT prolongation.
Dosage adjustments of sertraline are recommended in patients with hepatic disease. In studies of patients with chronic mild hepatic disease, sertraline clearance was reduced. For patients with mild hepatic impairment, the recommended initial dose and therapeutic range dosing is 50% of the normal daily dosage. The use of sertraline in patients with moderate or severe hepatic impairment is not recommended.
Anticoagulant therapy, bleeding, thrombolytic therapy
Monitor patients taking an SSRI for signs and symptoms of bleeding. Platelet aggregation may be impaired by selective serotonin reuptake inhibitors (SSRIs) due to platelet serotonin depletion, possibly increasing the risk of a bleeding complication (e.g., gastrointestinal bleeding, ecchymoses, epistaxis [nose bleeds], hematomas, petechiae, hemorrhage). Concurrent use of aspirin, NSAIDs, anticoagulant therapy (blood thinners), thrombolytic therapy, or other medications that enhance bleeding potential may increase this risk. Patients taking sertraline should be instructed to report promptly any bleeding events to the practitioner.
Bone fractures, osteoporosis
Use selective serotonin reuptake inhibitors (SSRIs), including sertraline, with caution in patients with osteoporosis. Patients at risk for osteoporosis, such as postmenopausal females, may benefit from more frequent monitoring of bone density during long-term use of an SSRI.
Closed-angle glaucoma, increased intraocular pressure
Caution is recommended when prescribing sertraline to patients with closed-angle glaucoma. The pupillary dilation that can occur with antidepressants may precipitate a closed-angle glaucoma attack in patients with anatomically narrow angles who do not have a patent iridectomy. An acute attack of closed-angle glaucoma is considered a medical emergency because the increased intraocular pressure is rapid and severe, and may quickly result in blindness if left untreated.
The use of sertraline or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment. Discontinue treatment with the SSRI if akathisia occurs.
Decreased appetite and weight loss have been observed during administration of SSRIs. Therefore, caution is advisable when administering sertraline to patients with anorexia nervosa or other conditions where weight loss is undesirable.
Driving or operating machinery, ethanol ingestion
Because any psychoactive drug may impair judgment, thinking, or motor skills, patients should use caution when driving or operating machinery, until they are reasonably certain that sertraline does not affect them adversely. Although sertraline has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid ethanol ingestion while taking sertraline.
Sertraline oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy. Use other sertraline formulations during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Sertraline use is not recommended during pregnancy unless the benefits to the mother are deemed to outweigh the risks to the fetus.
Sertraline use is not recommended during breastfeeding unless the benefits to the mother are deemed to outweigh the risks to the fetus.
The decision to use sertraline and other SSRIs should be made cautiously as patients over the age of 65 are more susceptible to some of the adverse effects, including gait problems, dizziness, falls, and hyponatremia.
- Sertraline is absolutely contraindicated in patients taking MAOIs (e.g., phenelzine, Nardil, tranylcypromine, Parnate, isocarboxazid, Marplan, selegiline, Emsam) within the past 14 days. Linezolid (Zyvox) also acts as a MAOI and should not be used within 14 days of using sertraline
- Sertraline interacts with all medications that prolong the QT interval. Use of sertraline with these medications may increase the risk of torsades de pointes, a potentially life threatening abnormal heart rhythm.
- Use of sertraline together with intravenous methylene blue (used to treat methemoglobinemia) is absolutely contraindicated
- The risk of bleeding complications is increased in patients taking sertraline together with medications that increase the risk of bleeding (e.g. aspirin, NSAIDs like motrin and naproxen, and blood thinners)
- Using sertraline together with other serotonergic medications increases the risk of serotonin syndrome. Serotonin syndrome is characterized by the rapid development of hyperthermia, hypertension, myoclonus, rigidity, autonomic instability, mental status changes (e.g., delirium or coma), and in rare cases, death. There are many drugs that fall under this category.
For a full list of drug interactions with sertraline, please see the PDR.
USE IN SPECIFIC POPULATIONS
- Geriatric use: Consider the risks vs. benefits in this population
- Renal impairment: No dosage adjustments are necessary
- Hepatic impairment: Patients with mild hepatic impairment may require reduced doses of sertraline. Sertraline is not recommended in patients with moderate-severe hepatic impairment.