IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
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 (eg, 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.
Warnings and Precautions
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients:
- Monitor all antidepressant-treated patients closely 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 the emergence of agitation, irritability, unusual changes in behavior, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers
- 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
Serotonin Syndrome: Patients on ZOLOFT should be monitored for the emergence of a potentially life-threatening serotonin syndrome, particularly with concomitant use of 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 (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). If concomitant use of ZOLOFT with other serotonergic drugs is clinically warranted, inform patients of the increased risk of serotonin syndrome and monitor for symptoms.
Increased Risk of Bleeding: SNRIs and SSRIs, including ZOLOFT, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of ZOLOFT and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation.
Activation of Mania or Hypomania: Prior to initiating treatment with ZOLOFT, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. It should be noted that ZOLOFT is not approved for use in treating bipolar disorder.
Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances, 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.
Seizures: ZOLOFT should be introduced with care in patients with a seizure disorder. ZOLOFT should be prescribed with caution in patients with a seizure disorder.
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.
Hyponatremia: Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including ZOLOFT. Discontinuation of ZOLOFT should be considered in patients with symptomatic hyponatremia, and appropriate medical intervention should be instituted.
QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation.
Prescriptions for ZOLOFT should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Patients should be told that until they learn how they respond to ZOLOFT, they should be careful doing activities during which they need to be alert, such as driving a car or operating machinery.
The use of ZOLOFT in patients with liver disease must be approached with caution.
Adverse Reactions
- The most commonly observed adverse reactions in patients treated with ZOLOFT (incidence of 5% or greater and at least twice the incidence in placebo patients) were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido
- In pediatric patients treated with ZOLOFT, the overall profile of adverse events was generally similar to that seen in adult studies. The following additional adverse events were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate: fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety. Safety and effectiveness of ZOLOFT in pediatric patients other than those with OCD have not been established
Drug Interactions
- Protein-bound drugs: Monitor for drug reactions and reduce dosage of ZOLOFT or other protein-bound drugs (eg, warfarin) as warranted
- CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6
Caution is advised if the concomitant administration of ZOLOFT and CNS-active drugs is required.
Patients should be advised that the use of any OTC product should be initiated cautiously according to the directions of use given for the OTC product.
Use in Specific Populations
Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate. Neonates exposed to ZOLOFT and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy, or if they are breastfeeding an infant while on ZOLOFT.
ZOLOFT is approved by the FDA to treat, in adults, Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD). It is also approved to treat Obsessive Compulsive Disorder (OCD) in children and adolescents aged 6-17 years.
Please see Full Prescribing Information, including BOXED WARNING and Medication Guide.
By participating in the ZOLOFT® (sertraline hydrochloride) Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
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This Savings Offer is not valid for prescriptions that are reimbursed, in whole or in part, by Medicaid, Medicare, TRICARE, Veterans Affairs healthcare, or any other federal or state healthcare program (including any state prescription drug assistance program), or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
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The value of this Savings Offer is limited to $150 per use or the amount of your co-pay, whichever is less
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This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs
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You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
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Eligible patients may pay a minimum of $4 per monthly prescription fill. By using this Savings Offer, eligible patients may receive a savings of up to $150 per fill off their co-pay or out-of-pocket costs. This Savings Offer is available for a maximum savings of $1,800 per year ($150 per month x 12 months). This Savings Offer may limit your prescription cost to $4, subject to a maximum $150 monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $150, you will save $150 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $175, you will pay $25 ($175 – $150 = $25).] If your co-pay or out-of-pocket costs are no more than $150, you pay $4. For a mail-order 3-month prescription, your total maximum savings will be $450 ($150 x 3)
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Patients who are enrolled in Medicare, Medicaid, or another state or federal healthcare program may use this Savings Offer if paying for the prescription covered by this Savings Offer outside of their government insurance benefit, and no claim is submitted to Medicare, Medicaid, or any federal or state healthcare program. Such patients must not apply any out-of-pocket expenses incurred using this Savings Offer toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D true out-of-pocket (TrOOP) costs
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You are responsible for reporting use of this Savings Offer to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using this Savings Offer, as may be required. You should not use this Savings Offer if your insurer or health plan prohibits use of manufacturer Savings Offers
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This Savings Offer is not valid (i) for Massachusetts residents or (ii) for California residents whose prescriptions are covered, in whole or in part, by third-party insurance
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This Savings Offer is not valid where prohibited by law
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This Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
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This Savings Offer will be accepted only at participating pharmacies
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This Savings Offer is not health insurance
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This Savings Offer is good only in the U.S. and Puerto Rico
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This Savings Offer is limited to 1 per person during this offering period and is not transferable
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No other purchase is necessary
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This Savings Offer may not be redeemed more than once per 30 days per patient
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Data related to your redemption of this Savings Offer may be collected, analyzed, and shared with Pfizer for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Savings Offer redemptions and will not identify you
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Pfizer reserves the right to rescind, revoke, or amend the program without notice
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No membership fees. This Savings Offer and Program expire on 12/31/2021
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For help with the ZOLOFT Savings Offer, call 1-855-220-9547, visit ZOLOFT.com, or write: Pfizer Inc., 235 E 42nd Street, New York, NY 10017
If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this Savings Offer. Pay for your ZOLOFT prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: ZOLOFT Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your ZOLOFT Savings Card, your name, and mailing address.
