Zoloft

Grapefruit and grapefruit juice may interact with Zoloft and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before starting Zoloft, tell your healthcare provider if you:

• Are taking certain drugs such as:
  • Medicines used to treat migraine headaches such as triptans;
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
    • tricyclic antidepressants
    • lithium
    • diazepam
    • SSRIs
    • SNRIs
    • antipsychotic drugs
    • valproate
  • Medicines used to treat seizures such as phenytoin;
  • Medicines used to treat pain such as tramadol;
  • Medicines used to thin your blood such as warfarin;
  • Medicines used to control your heartbeat such as:
    • propafenone
    • flecainide
    • digitoxin
  • Medicines used to treat type II diabetes such as tolbutamide;
  • Cimetidine used to treat heartburn;
  • Over-the-counter medicines or supplements such as:
    • Aspirin or other NSAIDs
    • tryptophan
    • St. John's Wort
• have liver problems;
• have kidney problems;
• have heart problems;
• have or had seizures or convulsions;
• have bipolar disorder or mania;
• have low sodium levels in your blood;
• have a history of a stroke;
• have high blood pressure;
• have or had bleeding problems;
• are pregnant or breastfeeding.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription 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.

Major Depressive Disorder

Management of major depressive disorder.1 3 4 5 10 11 33 59 62 148 149 150 151 152 158 159 339 341

Efficacy in hospital settings not established.1

APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, TCAs, MAOIs, and other antidepressants (e.g., bupropion, mirtazapine, trazodone).a Choose antidepressant based mainly on patient preference; nature of prior response to medication; safety, tolerability, and anticipated adverse effects; concurrent psychiatric and medical conditions; and specific properties of the medication (e.g., half-life, actions on CYP450 enzymes, other drug interactions).a For most patients, an SSRI, SNRI, mirtazapine, or bupropion is considered optimal.a Consult APA’s Practice Guidelines for the Treatment of Patients with Major Depressive Disorder for additional information.a

Obsessive-Compulsive Disorder (OCD)

Management of OCD; reduces but does not completely eliminate obsessions and compulsions.1 29 156 235 236

Panic Disorder

Management of panic disorder with or without agoraphobia.1

Posttraumatic Stress Disorder (PTSD)

Management of PTSD;1 2 268 270 more effective in women than in men.1

Not effective for combat- or war-related PTSD.2 255

Premenstrual Dysphoric Disorder (PMDD)

Management of PMDD; improves symptoms (e.g., depressed mood, premenstrual anger/irritability) and functional impairment (e.g., difficulty in concentrating, lethargy) associated with this disorder.1 140 160

Efficacy when used in conjunction with oral contraceptives for the treatment of PMDD is unknown.1 140

Social Phobia

Management of social phobia (social anxiety disorder).1 281 282

Premature Ejaculation

Has been used in the management of premature ejaculation†.67 217 218 219

Vascular Headaches

Has been used in the management of vascular headaches† with equivocal efficacy.220 221

Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.358 Inhibits CYP2D6 and 3A4, but less potent as an inhibitor than many other drugs.1

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interactions (increased plasma concentrations of CYP2D6 substrates).1

Clinically important pharmacokinetic interactions with substrates of 3A4 unlikely.1 100

Drugs Affecting Hepatic Microsomal Enzymes

Clinically important pharmacokinetic interactions with inhibitors or inducers of CYP2D6 or 3A4 unlikely.1 100

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.1 83 289 311 312 Use with caution.1 (See Abnormal Bleeding under Cautions.)

Protein-bound Drugs

Potential for displacement of sertraline or other protein-bound drugs from binding sites.1 Monitor patients for potential adverse effects.1

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions) with serotonergic agents.173 174 175 176 177 189 207 323 601 Avoid such use, or use with caution.179 198 323 601 (See Contraindications and see Serotonin Syndrome or Neuroleptic Malignant Syndrome [NMS]-like Reactions under Cautions.) If serotonin syndrome or NMS occurs, immediately discontinue sertraline and any concurrently administered serotonergic or antidopaminergic agents and initiate supportive and symptomatic treatment.601

Specific Drugs

• Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).1 3 19 59 62 75 76 82 88 93

• Has very weak effects on the reuptake of norepinephrine or dopamine1 3 76 and does not exhibit clinically important anticholinergic, antihistaminic, or adrenergic (α1, α2, β) blocking activity at usual therapeutic dosages.1 3 82 88

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

The tablets may be taken with or without food.

If you are taking the oral liquid, use the dropper provided to measure your dose and mix it with 1/2 cup (4 ounces) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Do not mix this medicine with any other liquid. Drink it right away after mixing. Do not mix the medicine with the liquid until you are ready to take your dose. It is okay if the mixture looks hazy.

You may have to take this medicine for several months before you begin to feel better.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  • For depression:
    • Adults—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For obsessive-compulsive disorder:
    • Adults and teenagers—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children 6 to 12 years of age—At first, 25 mg once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For panic disorder, posttraumatic stress disorder, or social anxiety disorder:
    • Adults—At first, 25 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For premenstrual dysphoric disorder:
    • Adults—At first, 50 milligrams (mg) once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day throughout your menstrual cycle or 100 mg per day if you are only taking it during your premenstrual time.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 [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)].

In addition to the contraindications for all Zoloft formulations listed above, Zoloft oral concentrate and oral solution are contraindicated in patients:

• Taking disulfiram. Zoloft oral concentrate and oral solution contain alcohol, and concomitant use of Zoloft and disulfiram may result in a disulfiram-alcohol reaction.

Controlled Substance

Zoloft contains sertraline, which is not a controlled substance.

Abuse

In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of Zoloft, alprazolam, and d-amphetamine in humans, Zoloft did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs.

UNIT DOSE

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-4900-41

Pfizer

Zoloft®
(sertraline HCl) tablets

50 mg *

For in-institution use only

100 Tablets
Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-0050-01

Pfizer

Zoloft®
(sertraline hydrochloride)
oral solution

equivalent to
20 mg/mL*
of sertraline

Must Be Diluted
Before Use
(see side panel for instructions)

60 mL
Rx only

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0049-0050-01
New Label,
Same Product.

Pfizer

Zoloft®
(sertraline hydrochloride)
oral solution

equivalent to
20 mg/mL*
of sertraline

Must Be Diluted
Before Use
(see side panel for instructions)

CALIBRATED DROPPER ENCLOSED

60 mL
Rx only

Zoloft (sertraline) is an antidepressant belonging to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms.

Zoloft is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

You should not use Zoloft if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use Zoloft if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

• This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• This drug may increase suicidal thoughts or behavior in some children, teenagers, or young adults. The risk of this is greatest within the first few months of treatment or when the dosage is changed. Call your healthcare provider right away if you have new or sudden changes in your mood, behavior, actions, thoughts, or feelings, especially if they are severe. Pay extra close attention when you start taking this drug or when your dosage is changed.

• Serotonin syndrome: This drug may cause a possibly life-threatening condition called serotonin syndrome. The symptoms of serotonin syndrome include hallucinations and delusions, agitation, coma, fast heart rate, and changes in blood pressure. They also include dizziness, loss of consciousness, seizures, shakiness, muscle tremor or stiff muscles, sweating, nausea, and vomiting.
• Severe allergic reaction: This drug can sometimes cause a severe allergic reaction. Call 911 or go to the emergency room right away if you have swelling of your face, tongue, or throat, or you have trouble breathing. A severe allergic reaction may cause death. You should not take this medication again if you have ever had an allergic reaction to it.

Sertraline oral tablet comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your face, tongue, eyes, or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction

Drinking alcohol while you take sertraline can increase your risk of sleepiness. It can also affect your ability to make decisions, think clearly, or react quickly. If you drink alcohol, talk to your doctor.

Warnings for people with certain health conditions

For people with glaucoma: Taking this drug may trigger a glaucoma attack. If you have glaucoma, talk to your doctor before taking this drug.

For people with bipolar disorder: Taking this drug may trigger a manic episode. If you have a history of mania or bipolar disorder, talk to your doctor before using this drug.

For people with seizures: Taking this drug increases your risk of seizures. If you already have seizures, talk to your doctor before taking this drug. If you have a seizure while using this drug, you should stop taking it.

For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects. This drug may also decrease your kidney function, making your kidney disease worse.

For people with liver problems: If you have liver problems or a history of liver disease, your body may not be able to process this drug as well. This may increase the levels of this drug in your body and cause more side effects.

Warnings for other groups

For pregnant women: This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus. Call your doctor right away if you become pregnant while taking this drug.

For women who are breastfeeding: This drug may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. If you are over the age of 65 years, you may be at higher risk of developing muscle problems while taking this drug, including low salt levels in the blood (known as hyponatremia).

For children: This medication has not been studied in children as treatment for major depressive disorder, panic disorder, posttraumatic disorder, social anxiety disorder, and premenstrual dysphoric disorder. It should not be used for these disorders in people younger than 18 years.

This medication has only been studied in children with obsessive-compulsive disorder. For treatment of obsessive-compulsive disorder, it should not be used in people younger than 6 years.