ZOLOFT® (sertraline HCl) tablets are available in 25, 50, and 100 mg.
Indications for 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), Premenstrual Dysphoric Disorder (PMDD), and Social Anxiety Disorder. It is also approved to treat Obsessive-Compulsive Disorder (OCD) in children and adolescents aged 6-17 years.
IMPORTANT SAFETY INFORMATION
Suicidality and Antidepressant Drugs
Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults especially within the first few months of treatment. Depression and certain other serious mental illnesses are important causes of suicidal thoughts and actions. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Anyone considering the use of ZOLOFT or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. ZOLOFT is not approved for use in pediatric patients except for patients with Obsessive-Compulsive Disorder (OCD).
Do not take ZOLOFT if you:
- Take a Monoamine Oxidase Inhibitor (MAOI), including linezolid or methylene blue, or if you stopped taking an MAOI in the last 2 weeks. Do not take an MAOI within 2 weeks of stopping ZOLOFT. Ask your Physician or pharmacist if you are not sure if your medicine is an MAOI
- Take Orap
- Are allergic to sertraline or any of the inactive ingredients in ZOLOFT
Do not take the ZOLOFT liquid formulation if you take Antabuse® (disulfiram) due to the alcohol content of the liquid form of ZOLOFT.
Tell your physician about all the medicines that you take including prescription and nonprescription medicine, vitamins, and herbal supplements.
Call a physician right away if you or a person you know who is taking ZOLOFT has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry or irritable; trouble sleeping; acting aggressive or violent; acting on dangerous impulses; an increase in activity or talking from what is normal for you (mania); or any other unusual changes in behavior or mood.
Tell your physician immediately if you:
- Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life-threatening condition called Serotonin Syndrome
- Have a rash, itchy welts (hives) or blisters, alone or with fever or joint pain; swelling of the face, tongue, eyes, or mouth; or trouble breathing, as these may be the symptoms of a severe allergic reaction
- Have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
- Have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this
ZOLOFT can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZOLOFT affects you.
Drinking alcohol while taking ZOLOFT is not recommended.
Women who are pregnant, plan to become pregnant, or who are breastfeeding should not take ZOLOFT without consulting their physician.
The most commonly observed adverse reactions in patients treated with ZOLOFT (seen in 5% or more of patients and at least twice as high as the control group) were nausea (25%), delayed ejaculation (14%), shakiness (8%), increased sweating (7%), lack of appetite (6%), and reduced sexual desire (6%).
In children and adolescents treated with ZOLOFT, adverse reactions were generally similar to adults. However, the following additional adverse reactions were reported in 2% or more of children/adolescents and at least twice as high as the control group: fever, hyperactivity, bedwetting, aggressive reaction, sinusitis, nosebleeds, and a bleeding sign resembling a bruise.
Consult your physician before you stop taking ZOLOFT. Stopping ZOLOFT may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or sleepy; headache, sweating, nausea, dizziness; electric shock-like sensations, tremor, and confusion.
Please click here to see full Prescribing Information, including Boxed Warning and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Terms and Conditions
By using the ZOLOFT $4 Co-pay Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma De Salud"])
- The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs
- Patients must be 18 or older
- By using the Card, patients will pay a minimum of $4 per refill and receive savings of up to $75 per refill. The Card is good for a maximum savings of $900 per program period. This card limits your prescription cost to $4, subject to a $75 maximum monthly benefit. Thus, if your co-pay is more than $79, you pay $4 plus the amount over $79. (Example: if your co-pay is $100, you will pay $25 [$100-$79 + $4 = $25].)
- You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- The Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law
- The Card cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription
- The Card will be accepted only at participating pharmacies
- The Card is not health insurance
- This offer is good only in the United States and Puerto Rico
- The Card is limited to one per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the Card without notice
The Card expires on March 31, 2014.
Valid from 3/8/13 to 3/31/14.
No membership fees apply.
For help with the ZOLOFT $4 Co-pay Card, call 1-800-293-5963, or write:
P.O. Box 2210
Morrisville, PA 19067-0510