Insertec capsules

Insertec

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

The active ingredient of Insertec 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

Insertec 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 Insertec include: high or low blood pressure; unexplained bleeding or bruising; stuffy or runny nose; Aggressive reaction; loss of balance control; hostility; lack of energy; sweating.

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Short-term Effects

In short-term studies, antidepressant medicines increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (younger than 24 years) taking antidepressants for major depressive disorders and other psychiatric diseases.

See “What Are Side Effects Associated with Using Insertec?”

Q: Is there a Zoloft liquid?

A: There is currently a Zoloft (Insertec) liquid formulation available. Zoloft liquid, or Zoloft Oral Concentrate, contains the active ingredient Insertec 20 mg/ml and 12% alcohol. The Zoloft liquid formulation is a clear, colorless solution with a menthol scent. It is available in two ounce bottles with an accompanying dropper to ensure accurate dose measurement. Bottles of Zoloft Oral Concentrate should be stored at controlled room temperature away from moisture and heat. Zoloft liquid must be diluted prior to administration. Prior to the administration of a dose, patients are instructed to use the calibrated dropper provided with the medication to remove the prescribed dose and mix with four ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice. Do not mix the Zoloft Oral Concentrate with any other liquids than those recommended. Patients should be instructed to administer the dose immediately after mixing and caution not to mix in advance. Often times a slight haze appears after mixing and is normal. According to the prescribing information, patients with a latex sensitivity should exercise caution as the dropper dispenser contains dry natural rubber. Zoloft Oral Concentrate is contraindicated with Antabuse (disulfiram) because of the alcohol content of the concentrate. Zoloft liquid is an antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class of medications which has been approved, by the U.S. Food and Drug Administration (FDA), for the treatment of major depressive disorder, panic disorders, anxiety disorders, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD). Similar to Zoloft tablets, Zoloft liquid may take four weeks or longer to achieve full therapeutic activity and before patients begin to feel better. Patients are advised not to discontinue treatment with Zoloft liquid without first consulting with a physician to avoid unpleasant withdrawal effects including agitation, irritability, dizziness, sensory disturbances, headache, confusion, insomnia, dysphoric mood, lethargy and anxiety.

Psychopharmacology

Paroxetine, Insertec , fluoxetine, and citralopram are the most commonly used daytime anxiolytic drugs and selective serotonin reuptake inhibitor (SSRI) antidepressants. Depending upon individual drug profiles, side effects such as increased irritability, drowsiness, or vertigo must be considered and explained to the patient. Drugs might not be equally effective against all PTSD symptoms. Recent treatment strategies for PTSD integrate (1) newer antipsychotics, such as olanzapine and risperidone, both of which are sedating, but the latter might reduce flashbacks and mood swings, or (2) antiepileptic/mood stabilizers such as valproic acid that might reduce irritability and flashbacks. As in all contacts with patients from other ethnic groups, ethnopharmacological considerations must be considered, especially cytochrome P450 subtypes and interactions with ethnic medication provided by local healers. 30

For PTSD, the SSRIs have been considered the gold standard by the guidelines for treatment. They are, in fact, helpful for many but not all symptoms of PTSD. SSRIs also have potential side effects of sexual dysfunction and discontinuation syndromes. Fluoxetine is a good choice, especially since it is long acting and a patient can miss a dose or two without much subjective distress. 31 The tricyclic antidepressants (TCAs) have been underutilized. They have many advantages, including effectiveness for depression, and the more sedating ones are useful for insomnia, anxiety, and panic disorder. Another major advantage is that blood levels are readily available, primarily to ensure medication compliance, which has been a large problem with many groups. 32, 33 The adrenergic blocking agents clonidine and prazosin are very helpful in reducing nightmares, 34 which SSRIs do not help. Adrenergic blocking agents also can reduce irritability and daytime flashbacks and help decrease blood pressure; however, the hypotensive effect is counteracted by tricyclics in hypertensive patients. Therefore, TCAs and clonidine probably should not be used together in such patients.

How should I take Insertec?

Take Insertec exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Insertec may be taken with or without food. Try to take the medicine at the same time each day.

The liquid (oral concentrate) form of Insertec must be diluted before you take it. To be sure you get the correct dose, measure the liquid with the medicine dropper provided. Mix the dose with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not use any other liquids to dilute the medicine. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Insertec can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Insertec.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Insertec suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Insertec.

Store at room temperature away from moisture and heat.

How should I take Insertec (Zoloft)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Insertec may be taken with or without food. Try to take the medicine at the same time each day.

The liquid (oral concentrate) form of Insertec must be diluted before you take it. To be sure you get the correct dose, measure the liquid with the medicine dropper provided. Mix the dose with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not use any other liquids to dilute the medicine. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Insertec.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Insertec suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Insertec.

Store at room temperature away from moisture and heat.

References

Allgulander, C, AA Dahl, C Austin, PL Morris, JA Sogaard, R Fayyad, SP Kutcher, and CM Clary. 2004. "Efficacy of Insertec in a 12-week trial for generalized anxiety disorder." Am J Psychiatry 1642-9.

Ball, SG, A Kuhn, D Wall, A Shekhar, and AW Goddard. 2005. "Selective serotonin reuptake inhibitor treatment for generalized anxiety disorder: a double-blind, prospective comparison between paroxetine and Insertec." J Clin Psychiatry 94-9.

Boyer, P, JP Tassin, B Falissart, and S Troy. 2000. "Sequential improvement of anxiety, depression and anhedonia with Insertec treatment in patients with major depression." J Clin Pharm Ther 363-71.

Brady, K, and CM Clary. 2003. "Affective and anxiety comorbidity in post-traumatic stress disorder treatment trials of Insertec." Compr Psychiatry 360-9.

Carrasco, JL, M Díaz-Marsá, and J Sáiz-Ruiz. 2000. "Insertec in the treatment of mixed anxiety and depression disorder." J Affect Disord 67-9.

Compton, SN, PJ Grant, AK Chrisman, PJ Gammon, VL Brown, and JS March. 2001. "Insertec in children and adolescents with social anxiety disorder: an open trial." J Am Acad Child Adolesc Psychiatry 564-71.

Davidson, JR, BO Rothbaum, BA van der Kolk, CR Sikes, and GM Farfel. 2001. "Multicenter, double-blind comparison of Insertec and placebo in the treatment of posttraumatic stress disorder." Arch Gen Psychiatry 485-92.

Günther, T, K Holtkamp, J Jolles, B Herpertz-Dahlmann, and K Konrad. 2005. "The influence of Insertec on attention and verbal memory in children and adolescents with anxiety disorders." J Child Adolesc Psychopharmacol 608-18.

Hirschfeld, RM. 2000. "Insertec in the treatment of anxiety disorders." Depress Anxiety 139-57.

Klerman GL, Hirschfeld RNA, Weissman MM, Pelicier Y, Ballenger JC, Costa e Silva JA, Judd LL Keller MB. 1993. Panic anxiety and its treatment. Report of the World Psychiatric Association Presidential Education Program Task Force. Washington, D.C: American Psychiatric Press, Inc.

Kronig, MH, J Apter, G Asnis, A Bystritsky, G Curtis, J Ferguson, R Landbloom, et al. 1999. "Placebo-controlled, multicenter study of Insertec treatment for obsessive-compulsive disorder." J Clin Psychopharmacol 172-6.

Liebowitz, MR, NA DeMartinis, K Weihs, PD Londborg, WT Smith, H Chung, R Fayyad, and CM Clary. 2003. "Efficacy of Insertec in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study." J Clin Psychiatry 785-92.

Moon, CA, W Jago, K Wood, and DP Doogan. 1994. "A double-blind comparison of Insertec and clomipramine in the treatment of major depressive disorder and associated anxiety in general practice." J Psychopharmacol 171-6.

Rynn, MA, L Siqueland, and K Rickels. 2001. "Placebo-controlled trial of Insertec in the treatment of children with generalized anxiety disorder." Am J Psychiatry 2008-14.

Steingard, RJ, B Zimnitzky, DR DeMaso, ML Bauman, and JP Bucci. 1997. "Insertec treatment of transition-associated anxiety and agitation in children with autistic disorder." J Child Adolesc Psychopharmacol 9-15.

Van Ameringen, MA, RM Lane, JR Walker, RC Bowen, PR Chokka, EM Goldner, DG Johnston, et al. 2001. "Insertec treatment of generalized social phobia: a 20-week, double-blind, placebo-controlled study." Van Ameringen MA1, Lane RM, Walker JR, Bowen RC, Chokka PR, Goldner EM, Johnston DG, Lavallee YJ, Nandy S, Pecknold JC, Hadrava V, Swinson RP Am J Psychiatry.

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 (Insertec) 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.

Introduction

Insertec is a selective serotonin reuptake inhibitor (SSRI) used in the therapy of depression, anxiety disorders and obsessive-compulsive disorder. Insertec therapy can be associated with transient asymptomatic elevations in serum aminotransferase levels and has been linked to rare instances of clinically apparent acute liver injury.

Q: Can Zoloft cause headaches and joint issues?

A: Zoloft (Insertec) belongs to the group of drugs known as selective serotonin reuptake inhibitors (SSRIs). Zoloft is used for the treatment of depression, obsessive-compulsive disorder, and anxiety disorders. According to the package insert, the most common side effects of Zoloft are nausea, diarrhea, insomnia, dry mouth, tiredness, dizziness, and tremor. Headache, muscle pain, muscle weakness, and joint pain have all been reported in patients taking Zoloft. This is not a complete list of the side effects associated with Zoloft. 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. When your doctor prescribes a new medication, be sure to discuss all your prescription and over-the-counter drugs, including dietary supplements, vitamins, botanicals, minerals, and herbals, as well as the foods you eat. Always keep a current list of the drugs and supplements you take and review it with your health care providers and your pharmacist. If possible, use one pharmacy for all your prescription medications and over-the-counter products. This allows your pharmacist to keep a complete record of all your prescription drugs and to advise you about drug interactions and side effects. Tell your health care provider about any negative side effects from prescription drugs. You can also report them to the U.S. Food and Drug Administration by visiting http://www.fda.gov/medwatch or by calling 1-800-FDA-1088. Michelle McDermott, RPh, PharmD

Q: Does Zoloft cause weight gain?

A: According to the literature available, Zoloft (Insertec) can cause changes in weight. If you have been experiencing unexplained changes in weight, with no changes in diet or activity level, you may want to contact your health care provider. For more information on Zoloft (Insertec) or weight management you may want to visit our Web site at: //www.everydayhealth.com/drugs/zoloft or //www.everydayhealth.com/weight/facts-about-calories.aspx.

Interactions that increase the risk of side effects

Taking certain medications with Insertec may result in increased side effects. These drugs include:

  • Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, aspirin and warfarin. Taking these drugs with Insertec increases your risk of bleeding or bruising.
  • Triptans such as sumatriptan. Your risk of serotonin syndrome is increased when you take these drugs with Insertec. Your doctor should watch you closely if you take these drugs together.
  • Lithium. Taking this drug with lithium increases your risk of serotonin syndrome.
  • Serotonergic medications such as fentanyl, tramadol, and St John’s wort. Taking these drugs with Insertec increases your risk of serotonin syndrome.
  • Cimetidine. Taking cimetidine with Insertec may cause a build-up of Insertec in your body. Your dose of Insertec might need to be lowered if you take it with cimetidine.
  • Tricyclic antidepressants such as amitriptyline, desipramine, and imipramine. Taking Insertec with these drugs may cause these drugs to build up in your body. Your doctor may need to adjust your dosage of tricyclic antidepressants while you take Insertec.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Insertec oral tablet comes with several warnings.

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

  • seizures
  • abnormal bleeding or bruising
  • agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  • rash
  • hives
  • swelling
  • difficulty breathing

Insertec may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving Insertec to your child.

Insertec may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Q: I take a generic version of Zoloft. Do you think that 25 mg could be causing me to gain weight?

A: Although people frequently gain weight while on antidepressants such as Zoloft (Insertec), it's not clear why. There are a couple of reasons why it's difficult to say that antidepressants cause weight gain. First, the studies of these medications usually last less than 12 weeks — not long enough to see significant weight changes. Second, since loss of appetite and weight loss are common symptoms of depression, it's possible that many cases of antidepressant-related weight gain are caused by the depression getting better, not by the medication itself. In general, it is thought that SSRIs, like Zoloft, Paxil, or Prozac, are more likely candidates to cause weight gain than the SNRIs, such as Effexor or Wellbutrin. The SNRIs tend to be a little more stimulating and cause appetite suppression, which may lead to people losing weight while on these medications. If the weight gain is substantial, you may want to have a discussion with your physician to see what other options are available to you. Lori Poulin, PharmD

3. Who can and can't take Insertec

Insertec can be taken by adults for depression or obsessive compulsive disorder.

Insertec can be taken by children aged 6 to 17, but only for obsessive compulsive disorder.

Check with your doctor before starting to take Insertec if you:

  • have had an allergic reaction to Insertec or any other medicines in the past
  • have a heart problem - Insertec can speed up or change your heartbeat
  • have ever taken any other medicines for depression - some rarely used antidepressants can interfere with Insertec to cause very high blood pressure, even when they have been stopped for a few weeks
  • are trying to become pregnant, already pregnant or breastfeeding
  • have an eye problem called glaucoma - Insertec can increase the pressure in your eye
  • have epilepsy or are having electroconvulsive treatment - Insertec may increase your risk of having a seizure

If you have diabetes, Insertec can make it more difficult to keep your blood sugar stable.

Monitor your blood sugar more often for the first few weeks of treatment with Insertec and adjust your diabetes treatment if necessary.

Q: Does Zoloft cause weight gain?

A: Zoloft (Insertec) is an antidepressant that is used in the treatment of depression, panic disorder, anxiety disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and pre-menstrual dysphoric disorder (PMDD). Weight gain or changes in appetite are a side effect that occurs with the use of Insertec. If you think a drug you are taking is causing weight gain, tell your health care provider. Do not stop any medication or change the dose without first talking to your provider. Megan Uehara, PharmD


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