Archive for January, 2008
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Description
ZOLOFTÒ (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: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.
ZOLOFT belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by blocking the uptake of a chemical called serotonin into nerve cells in the brain. Serotonin and other chemicals called amines are involved in controlling mood. Your doctor, however, may prescribe ZOLOFT for another purpose. Ask your doctor if you have any questions about why ZOLOFT has been prescribed for you. This medicine is only available with a doctor’s prescription. There is no evidence that ZOLOFT is addictive. Before you take ZOLOFT When you must not take it Do not take ZOLOFT if: 1. you have ever had an allergic reaction to ZOLOFT or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction to ZOLOFT may include a skin rash, itchiness, difficulty breathing and swelling of the face. 2. you have epilepsy not properly controlled by medication. 3. you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days. Taking ZOLOFT with a MAOI (eg Aurorix, Eldepryl, Nardil, Parnate) may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and convulsions (fits). 4. you are taking phentermine (used to help weight loss), tryptophan, tramadol or medicines used to treat migraine, eg sumatriptan (Imigran). These medicines can cause an exaggerated response to ZOLOFT. 5. you are taking pimozide (used to treat disturbances in thinking, feeling and behaviour). Ask your doctor or pharmacist if you are not sure if you have been taking one of these medicines. Do not give ZOLOFT to children unless the doctor has prescribed it for the treatment of OCD. If you are not sure whether you should be taking ZOLOFT, talk to your doctor. Do not take ZOLOFT if: * the expiry date marked on the packaging has passed, even though the tablets may look alright. * the packaging is torn or shows signs of tampering. If this is the case, take the tablets to your pharmacist.
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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 PRECAUTIONS, Information for Patients and DOSAGE AND ADMINISTRATION).
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Pharmacology
The mechanism of action of sertraline is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha 1 , alpha 2 , beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT 1A , 5HT 1B , 5HT 2 ), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of sertraline was found in animals to downregulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. Sertraline does not inhibit monoamine oxidase.
Pharmacokinetics
Systemic Bioavailability -In man, following oral once-daily dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours. Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately one week of once-daily dosing. Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the Cmax and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation, compared to a single dose, of sertraline with repeated dosing over a 50 to 200 mg dose range. The single dose bioavailability of sertraline tablets is approximately equal to an equivalent dose of solution.
In a relative bioavailability study comparing the pharmacokinetics of 100 mg sertraline as the oral solution to a 100 mg sertraline tablet in 16 healthy adults, the solution to tablet ratio of geometric mean AUC and Cmax values were 114.8% and 120.6%, respectively. 90% confidence intervals (CI) were within the range of 80-125% with the exception of the upper 90% CI limit for Cmax which was 126.5%.
The effects of food on the bioavailability of the sertraline tablet and oral concentrate were studied in subjects administered a single dose with and without food. For the tablet, AUC was slightly increased when drug was administered with food but the Cmax was 25% greater, while the time to reach peak plasma concentration (Tmax) decreased from 8 hours post-dosing to 5.5 hours. For the oral concentrate, Tmax was slightly prolonged from 5.9 hours to 7.0 hours with food.
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Metabolism -Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N-demethylation. N-desmethylsertraline has a plasma terminal elimination half-life of 62 to 104 hours. Both in vitro biochemical and in vivo pharmacological testing have shown N-desmethylsertraline to be substantially less active than sertraline. Both sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity. About 40-45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40-45% of the administered radioactivity was accounted for in feces, including 12-14% unchanged sertraline.
Desmethylsertraline exhibits time-related, dose dependent increases in AUC (0-24 hour), Cmax and Cmin, with about a 5-9 fold increase in these pharmacokinetic parameters between day 1 and day 14.
There are many drugs available in the market with which you can treat panic attacks and among them is Zoloft for panic attack which is essentially a Selective Serotonin Reuptake Inhibitor (SSRI) which is a new type of anti-depressant drug that was recently introduced in the United States sometimes during the eighties after another drug known as Prozac was introduced a bit earlier. However, Zoloft panic attack does not work quite the same as Prozac or other anti-depressants because it in fact, assists the brain in keeping the level of neurotransmitter serotonin at proper levels even despite the fact that panic attacks cause their levels to become low.
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Side Effects
However, as useful as Zoloft for panic attack is, there are still certain side effects to contend with such as nausea, headaches, insomnia and also sexual difficulties and also a certain amount of agitation initially. Nevertheless, Zoloft for panic attack is useful because it will help a person suffering from panic attack to keep some semblance of control over them and it can even help prevent changes to the personality.
A person suffering from a panic attack will be sure to have repeated as well as unexpected bouts of panic that can cause acute distress and even anxiety that can peak ten minutes after the onset of the attack. Zoloft for panic attack can only prove helpful to you if you take proper care and are aware of the benefits and dangers of using it. Thus, if you are taking Zoloft for panic attack, you should then not take any monoamine oxidase inhibitors that are often also taken to treat depression.
It means that you need to quit taking the monoamine oxidase inhibitors at least two weeks prior to trying Zoloft for panic attack, if you don’t want to suffer serious side effects by mixing up your medications. In fact, taking Zoloft for panic attack along with monoamine oxidase inhibitors can even result in death if both medications are taken at the same time, and so you must check with your doctor that any medications that you are taking are not in fact a monoamine oxidase inhibitor.
Furthermore, if you are taking Zoloft for panic attack in liquid form, be sure to not take it along with Antabuse, and in any case, it should only be taken if the doctor considers it right for you. In addition, there are a number of medications that can affect the effectiveness of Zoloft for panic attack and so you need to check again with your doctor to see whether you need to continue taking the other medications or stop them before taking Zoloft.