Detailed Drug Information:
DRUG CLASS AND MECHANISM: Sertraline belongs to a class of drugs calledselective serotonin reuptake inhibitors (SSRI). Other drugs in this class areProzac (fluoxetine), Paxil (paroxetine), Celexa (citalopram) and Luvox(fluvoxamine). Serotonin is a neurotransmitter (a chemical messenger) producedby nerve cells in the brain that is used by the nerves to communicate with oneanother. A nerve releases the serotonin it produces into the space surroundingit. The serotonin either travels across the space and attaches to receptors onthe surface of nearby nerves or it attaches to receptors on the surface of thenerve that produced it, to be taken up by the nerve and released again (aprocess referred to as re-uptake). A balance is reached for serotonin betweenattachment to the nearby nerves and reuptake. Selective serotonin inhibitorsblock the reuptake of serotonin and therefore change the level of serotonin inthe brain. It is believed that some illnesses such as depression are caused bydisturbances in the balance between serotonin and other neurotransmitters. Theleading theory is that drugs such as sertraline restore the chemical balanceamong neurotransmitters in the brain. Sertraline was approved by the Food andDrug Administration in December, 1991. PREPARATIONS: Tablets: 25, 50, and 100 mg; oral concentrate: 20 mg/ml STORAGE: Store at room temperature between 15-30°C (59-86°F). PRESCRIBED FOR: Sertraline is a drug that is used to treat depression,obsessive-compulsive disorder, panic disorder, and post-traumatic stress disorder. Like other SSRIs, sertraline also is used for treating social anxiety disorderand postmenstrual dysphoric disorder. DOSING: The recommended dose of sertralineis 25-200 mg once daily. Treatment usually is started at 25-50 once daily andthen increased at weekly intervals until the desired response is seen.Sertraline may be taken with or without food. DRUG INTERACTIONS: Serious reactions such as hyperthermia, fluctuations inblood pressure and rigidity of muscles may occur when SSRIs are used incombination with monoamine oxidase inhibitors (MAOI) such as phenelzine,tranylcypromine (Parnate) and isocarboxazid. Therefore, SSRIs should not be usedin combination with MAOIs. In addition, SSRIs and MAOIs should not be usedwithin 14 days of each other. Cimetidine may increase the levels in blood of sertraline by reducing theelimination of sertraline by the liver. Increased levels of sertraline may leadto more side effects. Sertraline increases the blood level of pimozide (Orap) by 40%. High levelsof pimozide can affect electrical conduction in the heart and lead to suddendeath. Therefore, patients should not receive treatment with both pimozide andsertraline. Through unknown mechanisms, sertraline may increase the blood thinning actionof warfarin. The effect of warfarin should be monitored when sertraline isstarted or stopped. PREGNANCY: Sertraline's safety in pregnancy has not been established. NURSING MOTHERS: Use of sertraline by nursing mothers has not been adequatelyevaluated. SIDE EFFECTS: The most common side effects of sertraline are sleepiness,nervousness, insomnia, dizziness, nausea, tremor, skin rash, upset stomach, lossof appetite, headache, diarrhea, abnormal ejaculation, dry mouth and weightloss. Important side effects are irregular heartbeats, allergic reactions andactivation of mania in patients with bipolar disorder. If sertraline is discontinued abruptly, some patients experience symptomssuch as abdominal cramps, flu like symptoms, fatigue and memory impairment.Although this reaction is not well established, it is reasonable to graduallyreduce the dose when therapy is discontinued. It has been suggested that SSRIs may cause depression to worsen and even lead to suicide in a small number of patients. These potential side effects are difficult to evaluate in depressed patients because depression can progress with or without treatment, and suicide is itself a consequence of depression. Moreover, the evidence supporting these potential side effects is weak. Therefore, no conclusions can yet be drawn about the relationship between SSRIs and worsening depression and suicide. Until better information is available, patients receiving SSRIs should be monitored for worsening depression and suicidal tendencies. |