Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

SERTRALINE LIQUID CONCENTRATE - ORAL

(SER-truh-leen)

COMMON BRAND NAME(S): Zoloft

Uses

Sertraline is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic attacks, obsessive compulsive disorders (OCD), post-traumatic stress disorder (PTSD), social anxiety disorder (social phobia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder or PMDD). This medication works by helping to restore the balance of certain natural chemicals in the brain.

OTHER

Uses

This medication has also been used to treat a type of decreased sexual ability (premature ejaculation) in men.

How To Use

At the time your dose is to be taken, use the dropper provided and remove the prescribed amount of liquid from the medication bottle. Mix this liquid with one-half cup (4 oz. or 120 ml) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Do not use any other types of liquids for mixing this drug. The mixture may appear cloudy; this is normal. Mix each dose just before taking it. Do not pre-mix doses for use at a later time. Take this medication/liquid mixture by mouth usually once daily with or without food; or as directed by your doctor. It is recommended that you take your dosage at the same time each day, either in the morning or in the evening. Use this medication regularly in order to get the most benefit from it. The dosage is based on your medical condition and response to therapy. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. It may take up to 4 weeks before the full benefit of this drug takes effect.

Side Effects

Nausea, dry mouth, increased sweating, drowsiness, diarrhea, upset stomach, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: uncontrollable shaking (tremor), loss of appetite, unusual weight loss. Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased interest in sex, decrease in sexual ability (ejaculation delay). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual or rapid weight gain, unusual or severe mental/mood changes, seizures. Males - in the unlikely event you experience a painful or prolonged erection, seek immediate medical attention as this is considered a medical emergency. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, seizures, heart disease, thyroid disease (e.g., hypothyroidism), any allergies (especially to latex). Sertraline oral concentrate contains alcohol. This drug may make you drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug. The elderly are more susceptible to developing a type of electrolyte imbalance (hyponatremia), especially if they are also taking "water pills" or diuretics with this medication. Caution is advised when using this drug in children because they may be more sensitive to the side effects of the drug, especially loss of appetite and weight loss. It is important to monitor weight and growth in children who are taking this drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Certain medications taken with this product could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication. Consult your doctor or pharmacist for additional information. This drug should also not be used with the following medications because very serious interactions may occur: astemizole, disulfiram, dihydroergotamine, metronidazole, pimozide, terfenadine, tryptophan, weight loss drugs (e.g., sibutramine, phentermine). If you are currently using any of these medications, tell your doctor or pharmacist before starting sertraline. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: ayahuasca, buspirone, carbamazepine, clozapine, dextromethorphan, flecainide, lithium, melatonin, meperidine, propafenone, nefazodone, other SSRI anti-depressants (e.g., citalopram, fluvoxamine), St. John's wort, thioridazine, tramadol, trazodone, tricyclic anti-depressants (e.g., amitriptyline), "triptan" migraine drugs (e.g., sumatriptan), venlafaxine, warfarin. Other drugs besides sertraline which may affect the heart rhythm (QTc prolongation in the EKG) include dofetilide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. Tell your doctor if you take any drugs that cause drowsiness such as: anti-anxiety drugs (e.g., diazepam), antihistamines that cause drowsiness (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: increased heartbeat, dizziness, agitation.

Notes

Do not share this medication with others. Laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).