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Sertraline

Medical and Pharmacy Editor:

Brand Name: Zoloft

Generic Name: sertraline

Drug Class: Antidepressants, SSRIs

What Is Sertraline (Zoloft) and How Does It Work?

Sertraline (Zoloft) is a prescription medication indicated for the treatment of major depressive disorder (depression) in adults. This medication is also a common prescription for the treatment of additional mental health disorders and conditions including obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), (premenstrual dysphoric disorder) PMDD and social anxiety disorder.

Commonly called "Zoloft," this medication is falls under a category of medications called SSRIs. SSRIs are medications that are believed to restore serotonin in the brain. Depression is believed to be caused by low levels of serotonin. Restoring this hormone in the brain is is thought to improve symptoms of depression.

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.

Zoloft is available by prescription only.

Sertraline is available under the following different brand names: Zoloft

Dosages of Sertraline Should Be Given As Follows:

Dosage Forms & Strengths

Tablets

  • 25mg
  • 50mg
  • 100mg

Oral concentrate

  • 20mg/mL

Dosage Considerations – Should be Given as Follows:

Treatment for Major Depressive Disorder (Depression)

  • Initial: 50 mg orally once/day
  • May increase by 25 mg at 1-week intervals; not to exceed 200 mg once/day
  • Geriatric: 25 mg orally once/day initially; may increase by 25 mg every 2-3 days; not to exceed 200 mg once/day
  • Alzheimer dementia related depression: Start at 12.5 mg/day and titrate every 1-2 weeks to response; not to exceed 150-200 mg

Treatment for Obsessive-Compulsive Disorder (OCD)

  • Initial: 50 mg orally once/day
  • May increase by 25 mg at 1-week intervals; not to exceed 200 mg once/day
  • Less than 6 years: Safety and efficacy not established
  • 6-12 years: 25 mg orally once/day initially
  • 12-17 years: 50 mg orally once/day initially; May increase by 50 mg once/day at 1-week intervals to no more than 200 mg once/day give once at bedtime if somnolence experienced

Treatment for Panic Disorder, Posttraumatic Stress Disorder (PTSD)

  • Initial: 25 mg orally once/day

Treatment for Premenstrual Syndrome(Off-label)

  • 0.25 mg orally once every 6-12 hours; initiate treatment on day 16-18 of menses (not to exceed 3-4 mg/day); taper dose over 2-3 days once menses occurs
  • May increase by 25 mg at 1-week intervals; not to exceed 200 mg once/day

Treatment for Social Anxiety Disorder

  • Initial: 25 mg orally once/day
  • May increase by 25 mg at 1-week intervals not to exceed 200 mg once/day

Treatment for Premenstrual Dysphoric Disorder (PMDD)

  • Initial: 50 mg orally once/day given continuously throughout menstrual cycle or given during luteal phase only
  • May increase by 50 mg at the onset of each new menstrual cycle; no more than 150 mg once/day when administered continuously or 100 mg once/day when administered during luteal phase only

Treatment for Pruritus (Itching) (Off-label)

  • 25-100 mg daily for up to 5 years; 75-100 mg doses found to be most effective

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment

  • Mild (Child-Pugh 5-6): Decrease recommended starting dose and therapeutic dose by 50%
  • Moderate-to-severe (Child-Pugh 7-15): Not recommended; sertraline is extensively metabolized, and the effects in patients with moderate and severe hepatic impairment have not been studied

The elderly are prone to SSRI/SNRI-induced hyponatremia; monitor closely

What Are Side Effects Associated with Using Sertraline (Zoloft)?

Common side effects of sertraline include:

The information contained in this document does not contain all possible side effects and other side effects or problems may occur as result of using this medicine. Check with your doctor for additional medical information about side effects of this medicine or other health concerns.

What Other Drugs Interact with Sertraline (Zoloft)?

If your doctor has directed you to use this medicine, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first for more information.

Severe Interactions of sertraline include:

Sertraline serious interactions with at least 73 different drugs.

Sertraline moderate interactions with at least 150 different drugs.

Sertraline has mild interactions with at least 44 different drugs

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician for medical advice if you have health questions or concerns.

What Are Warnings and Precautions for Sertraline?

Warnings

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (younger than 24 years) taking antidepressants for major depressive disorders and other psychiatric diseases.

This increase was not seen in patients over age 24 years; a slight decrease in suicidal thinking was seen in adults over age 65 years.

In children and young adults, risks must be weighed against the benefits of taking antidepressant medicines.

Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments.

The patient's family should communicate any abrupt changes in behavior to the healthcare provider.

Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.

This drug is not approved for use in pediatric patients for major depressive disorder but it is approved for obsessive-compulsive disorder in children older than 6 years.

Not approved for the treatment of bipolar depression.

This medication contains sertraline. Do not take Zoloft if you are allergic to sertraline or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Hypersensitivity

Do not use disulfiram concomitantly with oral solution due to alcohol in preparation

Concomitant pimozide: Risk of long QT syndrome

Coadministration with serotonergic drugs

  • Do not use MAOIs concomitantly or within 14 days before initiating sertraline or within 14 days after discontinuing sertraline
  • Reactions to concomitant administration with MAO inhibitors include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma
  • Starting sertraline in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
  • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hours after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first

Effects of Drug Abuse

No information available

Short-term Effects

In short-term studies, antidepressant medicines increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (younger than 24 years) taking antidepressants for major depressive disorders and other psychiatric diseases.

See “What Are Side Effects Associated with Using Sertraline?”

Long-term Effects

See “What Are Side Effects Associated with Using Sertraline?”

Cautions

Clinical worsening and suicide ideation may occur despite medication.

Use caution in patients with seizure disorders.

May worsen mania symptoms or precipitate mania in patients with bipolar disorder.

Increases risk of hyponatremia and impairment of cognitive/motor functions in the elderly.

Increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly.

Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

Pregnancy: Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn.

In neonates exposed to SNRIs/SSRIs late in third trimester: Risk of complications such as feeding difficulties, irritability, and respiratory problems.

Avoid abrupt withdrawal.

Bone fractures reported with antidepressant therapy; consider the possibility if patient presents with bone pain, bruising, or point of tenderness.

Coadministration of this medicine with other drugs that enhance the effects of serotonergic neurotransmission (e.g., tryptophan, fenfluramine, fentanyl, 5-HT agonists, St. John's wort) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction.

May cause false-positive urine immunoassay screening tests for benzodiazepines.

SSRIs and SNRIs are associated with development of SIADH; hyponatremia reported.

Pregnancy and Lactation

Use sertraline with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

Use of sertraline late in the third trimester is associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding.

Persistent pulmonary hypertension of the newborn

  • Potential risk of persistent pulmonary hypertension of the newborn (PPHN) when used during pregnancy
  • Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
  • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
  • FDA recommendation: FDA advises healthcare professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
  • A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (i.e., greater than 20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (e.g., congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)

Sertraline is distributed into breast milk; use caution when breastfeeding (American Academy of Pediatrics states effect on nursing infants is unknown but may be of concern).

Reviewed on 3/28/2017


SOURCE:
Medscape. Sertraline.
https://reference.medscape.com/drug/zoloft-sertraline-342962#0
References:
DailyMed. Sertraline.
https://dailymed.nlm.nih.gov/dailymed/
drugInfo.cfm?setid=2238e083-08f2-0aa8-59b7-16b6d68dbd48

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