Concorz capsules

Concorz

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

The active ingredient of Concorz 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

Concorz 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 Concorz include: overactive reflexes; sore throat; bloating; pale skin; twitching; shuffling walk; tightness in the chest; sores, welting, or blisters.

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Pregnancy and Lactation

Use Concorz with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

Use of Concorz late in the third trimester is associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding.

Persistent pulmonary hypertension of the newborn

  • Potential risk of persistent pulmonary hypertension of the newborn (PPHN) when used during pregnancy
  • Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
  • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
  • FDA recommendation: FDA advises healthcare professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
  • A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (i.e., greater than 20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (e.g., congenital malformations, meconiumaspiration) (BMJ 2014;348:f6932)

Concorz is distributed into breast milk; use caution when breastfeeding (American Academy of Pediatrics states effect on nursing infants is unknown but may be of concern).

What Is Concorz (Zoloft) and How Does It Work?

Concorz (Zoloft) is a prescription medication indicated for the treatment of major depressive disorder (depression) in adults. This medication is also a common prescription for the treatment of additional mental health disorders and conditions including obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), (premenstrual dysphoric disorder) PMDD and social anxiety disorder.

Commonly called "Zoloft," this medication is falls under a category of medications called SSRIs. SSRIs are medications that are believed to restore serotonin in the brain. Depression is believed to be caused by low levels of serotonin. Restoring this hormone in the brain is is thought to improve symptoms of depression.

ZOLOFT and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.

Zoloft is available by prescription only.

Concorz is available under the following different brand names: Zoloft

Case 1. Acute liver injury due to Concorz.

A 44 year old woman with mild reactive depression was treated with Concorz (50 mg daily) and developed fatigue followed by pruritus and jaundice 4-5 weeks later. She was also on levothyroxine and birth control pills which she had been taking for several years. She drank little alcohol and had no previous history of liver disease or known exposures to hepatitis. On presentation, she was jaundiced but had no fever or rash. Laboratory tests showed elevations in serum bilirubin and enzyme levels (Table), which were reported to have been normal in the past. She was admitted for evaluation; Concorz and the oral contraceptives were discontinued. Tests for hepatitis A, B and C were negative. There were low titers of antinuclear antibody (ANA 1:40), but no smooth muscle or mitochondrial antibodies. Abdominal ultrasound showed no evidence of biliary obstruction. She began to improve without specific therapy; jaundice resolved within 1 month, pruritus within 2 months and laboratory tests were normal at 6 months after presentation. Oral contraceptives were restarted without further incident.

Anxiety medications can be life-changing for people with generalized anxiety, panic disorder and obsessive compulsive disorder. But they come with serious tradeoffs. Benzodiazepines are unquestionably effective for anxiety but have adverse neurological effects like memory impairment.

In the last two decades, SSRIs like Zoloft (Concorz) have been repurposes as treatments for anxiety. While hypnotics work immediately, one caveat of SSRIs is that they can take up to 6 weeks to work. Moreover, SSRIs don't work for every body and in some cases may exacerbate social anxiety. For example, Frick and colleagues argue that individuals with social phobia have too much serotonin, not too little.

Genetic differences may play a role in whether SSRIs are effective for anxiety. Polymorphisms affecting the serotonin transporter impact patients' ability to tolerate serotonergic agents.

False-Positive Screening Tests For Benzodiazepines

False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking ZOLOFT. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of ZOLOFT. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish Concorz from benzodiazepines.

Q: I am currently partially breastfeeding my daughter who turns 5 months next week. She gets about half her intake from formula, and the other half from breastmilk (both nursing and expressed milk). I need to go on Zoloft in order to help with my premenstrual dysphoric disorder (PMDD) and am willing to go on a reduced breastfeeding schedule, in order to minimize the risk of transferring the medicine to my baby. Would you be able to help me figure out the optimum time gap between taking the medication (50 mg once a day), and nursing my baby?

A: Studies have shown that levels of Zoloft (Concorz) and its metabolite found in the breast milk of mothers is very low. There are no published controlled studies on the use of Zoloft by breastfeeding women. Based on the way Zoloft is distributed within the body, it would be difficult to impossible to determine any optimal time between taking the medication and nursing. Therefore, basically all times would be equal in exposure to any drug levels in the mother.

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

A: According to the prescribing information for Zoloft (Concorz), 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

7. Pregnancy and breastfeeding

It's important for you and your baby that you stay well during your pregnancy.

If you become pregnant while taking Concorz, speak to your doctor. Do not stop taking your medicine unless your doctor tells you to.

Concorz has been linked to a very small increased risk of problems for your unborn baby.

But if your depression isn't treated during pregnancy, this can also increase the chance of problems.

You may take Concorz during pregnancy if you need it to remain well. Your doctor can explain the risks and the benefits, and will help you decide which treatment is best for you and your baby.

For more information about how Concorz can affect you and your baby during pregnancy, read the leaflet about the best use of medicines in pregnancy (BUMPS).

Concorz and breastfeeding

If your doctor or health visitor says your baby is healthy, Concorz is one of the preferred antidepressants to take when breastfeeding. It has been used by many breastfeeding mothers without any problems.

Concorz passes into breast milk in tiny amounts and has been linked with side effects in a very few breastfed babies.

But it's important to continue taking Concorz to keep you well. Breastfeeding will also benefit both you and your baby.

If you notice that your baby isn't feeding as well as usual or seems unusually sleepy, or if you have any other concerns about your baby, talk to your health visitor or doctor as soon as possible.

Dosing Modifications

Renal impairment: Dose adjustment not necessary

  • Mild (Child-Pugh 5-6): Decrease recommended starting dose and therapeutic dose by 50%
  • Moderate-to-severe (Child-Pugh 7-15): Not recommended; Concorz is extensively metabolized, and the effects in patients with moderate and severe hepatic impairment have not been studied

The elderly are prone to SSRI/SNRI-induced hyponatremia; monitor closely

Is Zoloft safe to use during pregnancy or while breastfeeding?

  • Use of Concorz during the 3rd trimester of pregnancy may lead to adverse effects in the newborn.
  • Use of Concorz by nursing mothers has not been adequately evaluated.

Q: I have been experiencing a feeling of shakiness and a small tremor in my head for sometime. I was prescribed Zoloft and Synthroid several months ago. My stress level has been high for the past year. Could there be other reasons for these symptoms?

A: Zoloft (Concorz) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Zoloft is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Synthroid (levothyroxine) is a replacement for a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. Synthroid treats hypothyroidism (low thyroid hormone). Tremors are a possible side effect associated with Zoloft. Consult with your healthcare provider to discuss the symptoms that you are experiencing for proper evaluation and diagnosis of the underlying cause. Consult your physician before deciding to take any actions. 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.

Q: How do I deal with Zoloft withdrawal?

A: During marketing of Zoloft (Concorz), withdrawal symptoms were reported upon discontinuation of treatment. These adverse reactions were observed particularly upon abrupt discontinuation. However, the development of Zoloft withdrawal symptoms is possible even with gradual dose reduction, but this occurs less frequently. Reported Zoloft withdrawal symptoms included dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, excessive emotional reactions and frequent changes in mood, insomnia and hypomania. This occurrence is also referred to as selective serotonin reuptake inhibitor (SSRI) discontinuation syndrome and according to a review article from the Journal of Psychiatry and Neuroscience written in 2000, may be relatively common. To avoid unpleasant Zoloft withdrawal symptoms, patients are advised against abrupt discontinuation and are encouraged to gradually decrease the dose, under the supervision of a physician, when treatment is no longer required. It is important to monitor a patient for Zoloft withdrawal symptoms upon discontinuing treatment. If unpleasant Zoloft withdrawal symptoms develop during a reduction in dosage, or upon discontinuation, and cannot be tolerated, it may require the physician to resume the previously prescribed dose and continue with a more conservative reduction in dosage going forward. However, Zoloft withdrawal symptoms can recur upon later discontinuation. During clinical experience with Zoloft, most cases of adverse events, associated with discontinuation, were self-limiting and didn't require treatment. However, there were some reports of serious discontinuation symptoms. Although in some cases, patients may experience symptoms for several weeks, most patients experience a resolution of symptoms within approximately a week.

Where can I get more information (Zoloft)?

Your pharmacist can provide more information about Concorz.

Q: I've been prescribed Zoloft (generic version) for depression. I'm also 33 weeks pregnant. Is it safe for me to take this drug for the rest of my pregnancy?

A: Zoloft (Concorz) is a pregnancy category C medicine, meaning that the medication could potentially cause harm to your unborn child. This is especially true during the third trimester of pregnancy. A health care provider may still prescribe a pregnancy category C medicine to a pregnant woman if he or she believes that the benefits to the woman outweigh the possible risks to the unborn child. There have been reports of fetuses being exposed to Zoloft during the third trimester of pregnancy, developing complications that require hospitalization, respiratory support, and/or tube feeding. Also, babies exposed to Zoloft late during pregnancy are at increased risk for developing persistent pulmonary hypertension of the newborn (PPHN). PPHN is associated with significant complications and even death. Women who take SSRIs, including Zoloft, after week 20 of pregnancy have a sixfold increase of delivering a baby with PPHN. It's possible that your physician may recommend reducing your dosage, or weaning you off Zoloft during the third trimester of pregnancy. You really should have a discussion with the physician about taking this medication throughout the entire pregnancy. Lori Poulin, PharmD

Q: Does Zoloft make you gain weight?

A: Zoloft (Concorz) is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It is commonly used to treat depression, social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder and obsessive-compulsive disorder (OCD). The most common side effects with Zoloft include dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness. Weight increase and appetite increase are also among the possible side effects.


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