SERTRALINE

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs. Serotonin syndrome 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/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The pupillary dilation that occurs following use of many antidepressant drugs including sertraline may trigger an angle closure attack in a patient.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Common side effects:

• nausea,
• dizziness,
• drowsiness,
• dry mouth,
• loss of appetite,
• increased sweating,
• diarrhea,
• upset stomach, or
• trouble sleeping

Tell your doctor right away if any of these unlikely but serious side effects occur:

• easy bruising/bleeding,
• decreased interest in sex,
• decrease in sexual ability (ejaculation delay),
• muscle cramps/weakness,
• shaking (tremor),
• unusual weight loss
• black/bloody stools,
• vomit that looks like coffee grounds,
• eye pain/swelling/redness,
• vision changes (such as seeing rainbows around lights at night, blurred vision)
• males may have a painful or prolonged erection lasting 4 or more hours

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions:

General:

This drug may make you dizzy or drowsy.

Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially bleeding, or loss of coordination.

Children may be more sensitive to the side effects of the drug, especially loss of appetite and weight loss.

• Allergy: Before taking sertraline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Medical History: Before using this medication, tell your doctor or pharmacist if you had: bleeding problems, liver disease, seizure disorder, thyroid disease, personal or family history of glaucoma (angle-closure type).
• Sertraline may cause mania/ hypomania
• There have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.
• May increase the risk of bleeding events ranging from ecchymoses, hematomas, epistaxis, petechiae, and gastrointestinal hemorrhage to life-threatening hemorrhage

Pregnancy Risk: Category C- medication should be used only when clearly needed. It may harm an unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

Breastfeeding: This drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions:

• Some products that may interact with this drug include: pimozide, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, “blood thinners” such as warfarin).
• MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication
• The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including other SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others.
• Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
• Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson’s disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: severe dizziness, fainting.

Notes

Do not share this medication with others.

Keep all regular medical and psychiatric appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Also marketed as

• Setrof [ Hovid ] Zolotral [ Tianjin Huajin ]
• Zolpro [ InnoGen Pharmaceuticals ]
• Zotral [ Brown & Burk Phils ]