ZOLOFT is approved by the FDA to treat in adults Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, and Social Anxiety Disorder. This item is shipped from our pharmacy
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:
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 healthcare provider about all the medicines that you take including
prescription and non-prescription medicine, vitamins, and herbal supplements.
Call
a healthcare provider 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 doctor 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 or Neuroleptic Malignant 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 any antidepressant without consulting their doctor.
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.
Do
not stop ZOLOFT without first talking to your healthcare provider. 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.
