Sertraline

Brand Name: Zoloft

Description

Sertraline is used to treat mental depression, obsessive-compulsive disorder, and panic disorder.

Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a certain chemical, called serotonin, in the brain.

Pharmacology

The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

You may have to take sertraline for up to 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time.

In humans, following oral once-daily dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations of sertraline occurred between 4.5 to 8.4 hours post-dosing.

Indications and Usage

ZOLOFT® (sertraline hydrochloride) is indicated for the treatment of depression.

Obsessive-Compulsive Disorder: ZOLOFT is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD).

Zoloft is indicated for the treatment of panic disorder, with or without agoraphobia.

Contraindications

Patients with known hypersensitivity to Sertraline.

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated.

Warnings

Cases of serious sometimes fatal reactions have been reported in patients receiving ZOLOFT® (sertraline hydrochloride), a selective serotonin reuptake inhibitor (SSRI), 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. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, Zoloft should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping Zoloft before starting an MAOI.

Precautions

Activation of Mania/Hypomania: During premarketing testing, hypomania or mania occurred in approximately 0.4% of Zoloft (sertraline hydrochloride) treated patients.

Weight Loss: Significant weight loss may be an undesirable result of treatment with sertraline for some patients, but on average, patients in controlled trials had minimal, 1 to 2 pound weight loss, versus smaller changes on placebo. Only rarely have sertraline patients been discontinued for weight loss.

Seizure: Zoloft has not been evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product’s premarket testing. No seizures were observed among approximately 3000 patients treated with Zoloft in the development program for depression. However, 4 patients out of approximately 1800 (220 <18 years of age) exposed during the development program for obsessive-compulsive disorder experienced seizures, representing a crude incidence of 0.2%. Accordingly, Zoloft should be introduced with care in patients with a seizure disorder.

Suicide: The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. 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.

Because of the well-established comorbidity between both OCD and depression and panic disorder and depression, the same precautions observed when treating patients with depression should be observed when treating patients with OCD or panic disorder.

Hepatic Dysfunction: Sertraline is extensively metabolized by the liver. The pharmacokinetics and therapeutic efficacy of sertraline have not been studied in patients with significant hepatic dysfunction. Accordingly, it should be used with caution in such patients.

Renal Dysfunction: Sertraline is extensively metabolized and excretion of unchanged drug in the urine is a minor route of elimination. The pharmacokinetics of sertraline have not been studied in patients with renal impairment and, until adequate numbers of patients with mild, moderate or severe renal impairment have been evaluated during chronic treatment with sertraline, it should be used with caution in such patients.

Usage in Children: The safety and effectiveness of sertraline in children below the age of 18 have not been established.

Pregnancy & Nursing: The safety of sertraline during pregnancy and nursing has not been established and therefore, it should not be used in women of childbearing potential or nursing mothers, unless, in the opinion of the physician, the potential benefits to the patient outweigh the possible hazards to the fetus.

Interference with Cognitive or Motor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills, and patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that the drug treatment does not affect them adversely.

Drug Interactions

Zoloft will add to the effects of alcohol and other depressants.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes cyproheptadine, clozapine, dexfenfluramine, fenfluramine, astemizole, terfenadine, lithium, selegiline, tramadol, and medicines used to treat depression. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

Adverse Reactions

Side Effects That Should Be Reported To Your Doctor: (Less common or rare) Fast talking and excited feelings or actions that are out of control; fever; skin rash, hives, or itching.

Side effects, that may go away during treatment, include nervousness, trouble sleeping, headache, drowsiness, fatigue, nausea, vomiting, diarrhea, loss of appetite, dry mouth, sweating, dizziness, lightheadedness, muscle spasms, or changes in sexual function. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose

Signs and Symptoms

Symptoms of overdose may include sleepiness, nausea, vomiting, fast heartbeat, dilated pupils, and anxiety.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Establish and maintain an airway, insure adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdose.

Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures.

There are no specific antidotes for sertraline.

Dosage

Several weeks may pass before this medicine reaches its full effect. Do not stop taking this medicine without checking with your doctor.

Do not exceed the recommended dosage or take this medicine for longer than prescribed. Continue to take this medicine even if you feel better. Do not miss any doses.

Follow the directions for using this medicine provided by your doctor.
Store this medicine at room temperature, away from heat and light.
If you miss a dose of this medicine, contact your doctor or pharmacist for instructions. Do not take 2 doses at once.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The dose of sertraline will be different for different patients. Also, the number of capsules or tablets that you take depends on the strength of the medicine and the medical problem for which you are taking sertraline.

For oral dosage forms (capsules or tablets): For mental depression or obsessive-compulsive disorder:

Adults: To start, usually 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.

Elderly and Debilitated Patients: To start, usually 12.5 to 25 mg once a day, taken either in the morning or evening. Your doctor may gradually increase your dose if needed.

Children: Not recommended for use in children.

For oral dosage forms (capsules or tablets): For panic disorder:

Adults: To start, usually 25 mg once a day, taken either in the morning or evening. Your doctor may gradually increase your dose if needed. However, the dose is usually not more than 200 mg a day.

Elderly and Debilitated Patients: To start, usually 12.5 to 25 mg once a day, taken either in the morning or evening. Your doctor may gradually increase your dose if needed.

Sertraline should be administered with food once daily preferably with the evening meal, or, if administration in the morining is desired, with breakfast.

How Supplied

50 mg: Each white and yellow capsule contains: Sertraline HCl 50 mg. Tartrazine-free. White high density polyethylene botles of 100 and 250.

100 mg: Each orange capsule contains: Sertraline HCl 100 mg. Tartrazine-free. White high density polyethylene bottles of 100.

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.