Sertranex capsules

Sertranex

  • Active Ingredient: Sertraline
  • 100 mg, 50 mg, 25 mg
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What is Sertranex?

The active ingredient of Sertranex brand is sertraline. Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline tablets, USP for oral administration are supplied as scored tablets containing Sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of Sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.

Used for

Sertranex is used to treat diseases such as: Anxiety and Stress, Bipolar Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Depression, Dissociative Identity Disorder, Dysautonomia, Generalized Anxiety Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Persistent Depressive Disorder, Post Traumatic Stress Disorder, Postpartum Depression, Premenstrual Dysphoric Disorder, Social Anxiety Disorder, Somatoform Pain Disorder, Transverse Myelitis, Trichotillomania, Vulvodynia.

Side Effect

Possible side effects of Sertranex include: dry skin and hair; flushing or redness of the skin, with feeling of warmth or heat; loss of appetite; blurred vision; fever; hostility; unexplained weight loss; Aggressive reaction.

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Q: I am withdrawing from Zoloft 150 mg after years of taking it. What can happen? I have been without it for four days and I feel dizzy.

A: Zoloft (Sertranex) is classified as a selective serotonin reuptake inhibitor (SSRI). Zoloft is approved for the treatment of depression, obsessive compulsive disorder (OCD), panic disorder, post traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD) and social anxiety disorder. According to medical references, Zoloft has warnings associated with withdrawal syndrome. It is recommended that Zoloft should be gradually tapered down when discontinuing the medication. If intolerable symptoms occur after stopping the medication, the recommendation is made for the physician to consider resuming the previous dosage and then begin a more gradual taper. All dosing and tapering of dosages should only be done as directed by your physician. Signs and symptoms of withdrawal syndrome include: dysphoric (unpleasant) mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability (excessive emotional reactions), insomnia, hypomania, tinnitus (ringing of the ears) and seizures. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jen Marsico, RPh

8. Cautions with other medicines

Some medicines and Sertranex can interfere with each other and increase the chances of you having side effects.

  • any medicines that affect your heartbeat - Sertranex can speed up or change your heartbeat
  • any other medicines for depression - some antidepressants can interfere with Sertranex to cause very high blood pressure even when they have been stopped

  • Serotonin syndrome: This drug may cause a possibly life-threatening condition called serotonin syndrome. The symptoms of serotonin syndrome include hallucinations and delusions, agitation, coma, fast heart rate, and changes in blood pressure. They also include dizziness, loss of consciousness, seizures, shakiness, muscle tremor or stiff muscles, sweating, nausea, and vomiting.
  • Severe allergic reaction: This drug can sometimes cause a severe allergic reaction. Call 911 or go to the emergency room right away if you have swelling of your face, tongue, or throat, or you have trouble breathing. A severe allergic reaction may cause death. You should not take this medication again if you have ever had an allergic reaction to it.

Sertranex oral tablet is a prescription drug that’s available as the brand-name drug Zoloft. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version. This drug is also available as an oral solution.

Q: Does Zoloft cause bloating and weight gain?

A: Zoloft (Sertranex) is classified as a selective serotonin reuptake inhibitor antidepressant medication. Zoloft is approved for the treatment of depression, obsessive compulsive disorder (OCD), panic disorder, post traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD) and social anxiety disorder. According to medical references, the most common gastrointestinal side effects associated with Zoloft include: anorexia, diarrhea, nausea and dry mouth. These have been reported in greater than 10% of studied patients taking the medication. Other reported gastrointestinal side effects include decreased appetite, constipation, upset stomach, flatulence, vomiting and weight gain. These were reported in 1% to 10% of studied patients. The feeling of bloatedness can be associated with some of these possible side effects. These are not all of the possible side effects associated with Zoloft. If you think that you are experiencing a side effect from your medication, talk with your physician. Do not stop taking or change the dose of your medication without first talking to your physician. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Regards, Jen Marsico, RPh

Hepatic

Although Sertranex is prescribed extensively for depression and anxiety disorders, drug-induced hepatitis secondary is rare. A case of Sertranex-induced acute hepatic injury was reported .

A 20-week pregnant 26-year-old woman presented with nausea, vomiting, malaise and dark urine 6 months after commencing Sertranex 50 mg per day for depression, increased to 100 mg per day in the 3 weeks before presentation. She also described mild epigastric discomfort, vomiting and mild pruritus. On examination, there was no hepatosplenomegaly or stigmata of chronic liver disease. Investigations revealed increased transaminases (ALT 700 U/L (ref 7–56 U/L), AST 410 U/L (10–50 U/L), ALP 113 U/L (30–120 U/L)): γ-glutamyl transpeptidase 26 U/L (7–64 U/L) and bilirubin 25 mmol/L (0–20 mmol/L). Liver biopsy showed lobular hepatitis, with a mild prominence of eosinophils, suggestive of a drug or toxic aetiology. Extensive investigation revealed no other factor which could account for hepatitis. Sertranex was suspected as the cause of a drug-induced liver injury, and was ceased. Liver function tests normalised after cessation of Sertranex. Application of the Naranjo Adverse Drug Reaction Probability Scale indicated that Sertranex was the ‘probable cause’ of the hepatocellular injury.

Contraindications

Do not use disulfiram concomitantly with oral solution due to alcohol in preparation

Concomitant pimozide: Risk of long QT syndrome

Coadministration with serotonergic drugs

  • Do not use MAOIs concomitantly or within 14 days before initiating Sertranex or within 14 days after discontinuing Sertranex
  • Reactions to concomitant administration with MAO inhibitors include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neurolepticmalignantsyndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma
  • Starting Sertranex in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
  • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNStoxicity; may resume 24 hours after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first

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Q: How should I take Zoloft and Chantix together?

A: Although no documented drug interaction or contraindication exists between Zoloft (Sertranex) and Chantix (varenicline), both medications have similar black box warnings regarding the possible risk for suicidality and serious neuropsychiatric adverse events, respectively. Therefore, taking Zoloft and Chantix together may increase the risk for worsening depression, suicidal thoughts and behaviors and precipitate a dangerous, life-threatening situation. According to the black box warning, there is a potential risk for serious neuropsychiatric events associated with treatment with Chantix. Possible neuropsychiatric events may include depression, suicidal ideation, suicide attempt and completed suicide have all been reported in patients being treated with Chantix. While depressed mood may be an indication of a neuropsychiatric event, it may also be a symptom of nicotine withdrawal as patients have experienced depression, rarely associated with suicidal ideation, upon smoking cessation without treatment. Patients with a diagnosis of schizophrenia, bipolar disorder and major depressive disorder did not participate in the premarketing clinical studies of Chantix, therefore, the safety and efficacy in this population has not been established. Neuropsychiatric events were observed in patients with and without pre-existing psychiatric illness. There were reports of patients experiencing a worsening of psychiatric illness with Chantix. The prescribing information advises that all patients being treated with Chantix be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric disease. Neuropsychiatric symptoms include behavioral changes, hostility, agitation, depressed mood, suicidal ideation or behaviors or attempted suicide. During postmarketing studies of Chantix for smoking cessation, neuropsychiatric symptoms, worsening of psychiatric illness and suicide were all been reported. The black box warning further recommends that the risks of Chantix should be weighed against the benefits. According to the black box warning for Zoloft, treatment with antidepressants may worsen depression and precipitate suicidal ideation and related behavior or unusual behavioral changes during initiation of therapy. Whether or not this risk exists with prolonged treatment is still inclear. All patients treated with Zoloft should be appropriately monitored and closely observed for clinical worsening of depression, suicidality or unusual changes in behavior. Symptoms may include anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggression, impulsivity, restlessness, hypomania or mania, unusual changes in behavior or suicidal ideation or behaviors. It is essential to consult with a physician regarding the risk of taking Zoloft and Chantix together, prior to beginning treatment.

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking Sertranex.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Sertranex.

Q: My son is 16 and on Zoloft. Today he had an anxiety attack. He has been on the medication for about 12 weeks and was fine until today, although he did not began to show signs of improvement until about a week ago. He also has a lot of issues with acne and has been on almost all antibiotics recommended for it. I heard that there is an effective medication, but that there are many side effects for it including depression.

A: Zoloft (Sertranex) is used to treat both depression and anxiety attacks. As with all antidepressant medications, it can take several weeks to show effectiveness. Side effects are patient-specific and often dose-related. The most common antibiotic used to treat acne is tetracycline. All antibiotics also have side effects which are patient-specific. Please talk to your son's doctors about your concerns.

Musculoskeletal

Rhabdomyolysis has again been attributed to Sertranex .

A 71-year-old woman took Sertranex 50 mg/day for depression and 2 months later was found to have markedly increased creatine kinase, lactate dehydrogenase, and aspartate aminotransferase activities and serum myoglobin concentration. These abnormalities resolved within 1 week of Sertranex withdrawal, but recurred dramatically 2 weeks after re-introduction of Sertranex. Once again, everything resolved after withdrawal of Sertranex. She was successfully treated with escitalopram without recurrence of the biochemical disturbances.

Q: What are the most common side effects of the drug Zoloft?

A: According to the prescribing information for Zoloft (Sertranex), the most common side effects of the medication include nausea, insomnia, diarrhea, dizziness, dry mouth, fatigue or drowsiness, indigestion, loss of appetite, increased sweating, headaches, hot flashes, tremor or shakiness. Zoloft is a medication that is used to treat depression, panic disorder, and anxiety. It is categorized in the class of medications called SSRIs that work by bringing a balance to the chemical serotonin in the brain that is causing your symptoms. Lori Poulin, PharmD

How should this medicine be used?

Sertranex comes as a tablet and a concentrate (liquid) to take by mouth. It is usually taken once daily in the morning or evening. To treat premenstrual dysphoric disorder, Sertranex is taken once a day, either every day of the month or on certain days of the month. Take Sertranex at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Sertranex exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sertranex concentrate must be diluted before use. Immediately before taking it, use the provided dropper to remove the amount of concentrate your doctor has told you to take. Mix the concentrate with 4 ounces (1/2 cup ) of water, ginger ale, lemon or lime soda, lemonade, or orange juice. After mixing, the diluted solution may be hazy; this is normal. Do not mix the concentrate with any liquids other than the ones listed. Drink the diluted solution immediately.

Your doctor may start you on a low dose of Sertranex and gradually increase your dose, not more than once a week.

It may take a few weeks or longer before you feel the full benefit of Sertranex. Continue to take Sertranex even if you feel well. Do not stop taking Sertranex without talking to your doctor. If you suddenly stop taking Sertranex, you may experience withdrawal symptoms such as nausea, sweating, depression, mood changes, frenzied or abnormally excited mood, irritability, anxiety, confusion, dizziness, headache, tiredness, seizures, ringing in the ears, numbness or tingling in the arms, legs, hands, or feet, difficulty falling asleep or staying asleep.

Important information

You should not use Sertranex if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use Sertranex if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some children and young adults have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Summary

Zoloft (Sertranex) is a medication prescribed for the treatment of depression, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder and premenstrual dysphoric disorder (PMDD). Side effects include skin rash, constipation, upset stomach, loss of appetite, headache, diarrhea, abnormal ejaculation, decreased interest in sexual activity, and dry mouth. Drug interactions, dosage, and a pregnancy and breastfeeding safety information should be reviewed prior to taking this medication.


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