Information on Zoloft (sertraline)

Facts and Summary of Zoloft:

Generic Name: sertraline hydrochloride
Trade Name Zoloft
Category: Anxiety / Depression

Classification:

Sertraline hydrochloride belongs to the general class of antidepressant drugs.

Action:

Sertraline hydrochloride stops the uptake of serotonin by the nerves, thus making more serotonin available in the brain and central nervous system. This decreases the feeling of depression.

How drug is given:

Sertraline hydrochloride is given orally as a single dose in either the morning or evening. If you are changing from another antidepressant (monoamine oxidase inhibitor), you should wait at least 2 weeks before starting sertraline hydrochloride. If you change from nefazodone hydrochloride to a monoamine oxidase inhibitor-type antidepressant, you must wait 14 days after stopping sertraline hydrochloride before starting the new drug. Keep pills in a tightly closed container and out of reach of children.

Dosage Information:

This drug can be given at different strengths depending on the type of cancer being treated. Dosage will vary depending on your body weight and the type of cancer being treated.

Side Effects:

More Common Side Effects:
Headache
Difficulty sleeping
Nausea
Diarrhea

Less Common Side Effects:
Drowsiness
Dizziness
Agitation
Nervousness
Anxiety
Tremor
Dry mouth
Constipation
Heartburn
Changes in appetite
Vomiting
Urinary frequency

Rare Side Effects:
Decreased ability to concentrate
Acne
Twitching
Confusion
Lack of coordination
Hair loss
Palpitations
Swelling of feet
Change in blood pressure
Dizziness when getting up from lying or standing position
Changes in taste
Abdominal pain
Difficulty swallowing
Rash
Dry skin
Itching
Change in menses
Decreased sexual interest
Sweating

Side Effects/Symptoms of This Drug:
Take care in walking around or changing position if you are drowsy. Do not drive or operate heavy machinery if you are drowsy or dizzy. Call your doctor or nurse if the drowsiness does not go away, or if you have trouble walking or moving because of it.

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General Information Zoloft


Zoloft is in a class of drugs called selective serotonin reuptake inhibitors. Zoloft affects chemicals in the brain that may become unbalanced and cause depression, panic or anxiety, or obsessive or compulsive symptoms.

Zoloft is indicated for the treatment of major depressive disorder, Obsessive-Compulsive Disorder, Panic Disorder, Posttraumatic Stress Disorder, Premenstrual Dysphoric Disorder, Social Anxiety Disorder.

FDA Approval:

This drug is approved for cancer treatment.

Side Effects

Zoloft has numerous side effects on all the body systems

*Body as a Whole: Malaise(A vague feeling of bodily discomfort), fatigue, pain

*Dermatologic: Rash

*Cardiovascular: Palpitation, Vasodilation (increase in the internal diameter of a blood vessel causing increased blood flow)

*Gastrointestinal: Nausea, Dry Mouth, Decreased Appetite, Flatulence, vomiting, diarrhea, dyspepsia (impairment of digestive function),Abdominal Pain, Constipation

*Nervous System: Ejaculation Failure, Dry Mouth, Increased Sweating, Somnolence(sleepiness), tremor, dizziness

*Psychiatric Disorders: Agitation, Insomnia, decreased libido, Nervousness

*Special Senses: Abnormal vision

Precautions and drug interactions:

Zoloft has adverse interactions with many drugs. Zoloft should not be taken with the following medications:

*Gastrointestinal drugs: Cimetidine(Tagamet)

*Anticonvulsants: phenytoin, Tegretol

*Antipsychotics: haloperidol, clozapine

*Benzodiazepines: Valium, Xanax

*Lithium

*Tryptophan:(please note that tryptophan is present in high quantities in turkey and milk, so caution must be taken if ingesting these foods.)

*MAOI'S

*Other Antidepressants

*Warfarin and other blood thinners

*Sumatriptan(Imitrex)

*Alcohol

Other precautions

*Weight Loss: Significant weight loss may be an undesirable result of treatment with sertraline for some patients

* Abnormal Bleeding: Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake. Patients should be cautioned regarding the risk of bleeding associated with the concomitant use of ZOLOFT with non-selective NSAIDs such as aspirin, or other drugs that affect coagulation.

*Liver Impairment: The use of sertraline in patients with liver disease must be approached with caution. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used.

WARNING

*Cases of serious, sometimes fatal reactions have been reported in patients receiving ZOLOFT in combination with a monoamine oxidase inhibitor (MAOI). Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on an MAOI.

* Clinical Worsening and Suicide Risk: Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality). Patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

* Discontinuing Treatment: If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias(numbness and tingling in the limbs) such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

Pregnancy and Nursing Mothers

Zoloft is in pregnancy category C. Studies in rats have resulted in deaths and damage to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The effect of Zoloft on labor and delivery in humans is unknown. However, because Zoloft crosses the placenta and because of the possibility that Zoloft may have adverse effects on the newborn, Zoloft should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Like many other drugs, Zoloft is secreted in human milk, and caution should be exercised when ZOLOFT is administered to a nursing woman.

Pediatric Use

The risks, if any, that may be associated with ZOLOFT's use beyond 1 year in children and adolescents with OCD or major depressive disorder have not been systematically assessed. In particular, there are no studies that directly evaluate the effects of long-term sertraline use on the growth, development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that sertraline possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of sertraline to have adverse effects in chronic use.

Geriatric Use

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. As with other SSRIs, Zoloft has been associated with cases of clinically significant hyponatremia (low sodium levels) in elderly patients

Drug Abuse and Dependence
Zoloft is not a controlled substance.

Recommended Dosage

Recommended dosage differs depending upon the condition being treated.

* Major Depressive Disorder and Obsessive-Compulsive Disorder: ZOLOFT treatment should be administered at a dose of 50 mg once daily.

* Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder: ZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

* Premenstrual Dysphoric Disorder: ZOLOFT treatment should be initiated with a dose of 50 mg/day, daily throughout the menstrual cycle

Dosage for Children and Adolescents

*Obsessive-Compulsive Disorder: ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17).

Overdose

Of 1,027 cases of overdose involving sertraline hydrochloride worldwide, alone or with other drugs, there were 72 deaths (circa 1999). The most common signs and symptoms associated with non-fatal sertraline Zoloft overdosage were somnolence(sleepiness), vomiting, tachycardia(rapid heartbeat), nausea, dizziness, agitation and tremor.

Information for the informed athlete:

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