Zoloft (Sertraline Hcl) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

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Separation Anxiety »

What is separation anxiety disorder?

To understand separation anxiety disorder, it is important to first recognize the normal difficulty that infants and toddlers have with strangers and in separating from parents and caretakers. Infants show stranger anxiety by crying when someone unfamiliar to them approaches. This normal stage of development is connected with the baby learning to distinguish his or her parents or other familiar caretakers from people they don't know. Stranger anxiety usually starts at about 8 months of age and ends by 2 years of age, according to the American Academy of Pediatrics.

Separation anxiety as a normal life stage first develops at about 7 months of age, once a baby understands that his or her caregivers do not disappear when out of sight (object permanence). That leads to the baby developing a true attachment to those adults. Normal separation anxiety is most commonly at its strongest at 10-18 months of age and gradually subsides, us...

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ZOLOFT®
(sertraline hydrochloride) Tablets and Oral Concentrate

Suicidality and Antidcprcssant Drugs

Antidcprcssants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. 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. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS: Clinical Worsening and Suicide Risk, PATIENT INFORMATION and PRECAUTIONS: Pediatric Use)

DRUG DESCRIPTION

ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1 S-cis)-4-(3,4-dichlorophenyl)-l,2,3,4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride. The empirical formula C₁₇H₁₇NCl₂•HCl is represented by the following structural formula:

ZOLOFT®
(sertraline hydrochloride) Structural Formula Illustration

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

ZOLOFT is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

ZOLOFT oral concentrate is available in a multidose 60 mL bottle. Each mL of solution contains sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral concentrate must be diluted prior to administration (see PATIENT INFORMATION and DOSAGE AND ADMINISTRATION).

What are the possible side effects of sertraline (Zoloft)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any...

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What are the precautions when taking sertraline hcl (Zoloft)?

Before taking sertraline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, liver disease, seizure disorder, thyroid disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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

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Last reviewed on RxList: 10/3/2011
This monograph has been modified to include the generic and brand name in many instances.