Clexiclor capsules

Clexiclor

  • Active Ingredient: Fluoxetine
  • 20 mg, 10 mg
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What is Clexiclor?

The active ingredient of Clexiclor brand is fluoxetine. Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. Fluoxetine affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms. C17H18F3NO•HCl M.W. 345.79 Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each tablet contains Fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 μmol) of Fluoxetine. In addition, each tablet also contains the following inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, talc, and titanium dioxide.

Used for

Clexiclor is used to treat diseases such as: Anxiety and Stress, Binge Eating Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Bulimia, Depression, Dissociative Identity Disorder, Dysautonomia, Fibromyalgia, Hot Flashes, Intermittent Explosive Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, PANDAS Syndrome, Panic Disorder, Persistent Depressive Disorder, Postpartum Depression, Premature Ejaculation, Premenstrual Dysphoric Disorder, Schizoaffective Disorder, Somatoform Pain Disorder, Trichotillomania, Vulvodynia.

Side Effect

Possible side effects of Clexiclor include: eye pain; vomiting of blood; loss of appetite; noisy breathing; increased sensitivity of the skin to sunlight; pain in the ankles or knees.

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Generic Name: Clexiclor (floo OX e teen)Brand Names: PROzac, PROzac Weekly, PROzac Pulvules, Sarafem

Medically reviewed by Kaci Durbin, MD Last updated on Dec 20, 2018.

Before taking this medicine

Do not use Clexiclor if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before you can take Clexiclor. You must wait 5 weeks after stopping Clexiclor before you can take thioridazine or an MAOI.

You should not use Clexiclor if you are allergic to it, if you also take pimozide or thioridazine, or if you are being treated with methylene blue injection.

Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Paxil, Pexeva, Symbyax, Viibryd, or Zoloft.

Some medicines can interact with Clexiclor and cause a serious condition called serotonin syndrome. Be sure your doctor knows about all other medicines you use. Ask your doctor before making any changes in how or when you take your medications.

To make sure Clexiclor is safe for you, tell your doctor if you have:

cirrhosis of the liver;

seizures or epilepsy;

bipolar disorder (manic depression);

a history of drug abuse or suicidal thoughts; or

if you are being treated with electroconvulsive therapy (ECT).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking Clexiclor during pregnancy without your doctor's advice.

Clexiclor can pass into breast milk. Tell your doctor if you are breast-feeding a baby.

Clexiclor is not approved for use by anyone younger than 18 years old.

Q: I'm currently taking Prozac. My depression seems to be getting worse. Could I double my daily dose?

A: Prozac (Clexiclor) is an antidepressant classified as a selective serotonin reuptake inhibitor (SSRI). Prozac is used to treat depression and anxiety. It can take approximately one month to see the full effects of this class of medications. However, there should be some improvement within the first few days of taking it. If you have been taking Prozac for a couple of weeks, and there is no improvement, you may want to ask your doctor to consider treatment with a different antidepressant. If there has been some improvement, your doctor may decide to increase the dose to 40 mg. The maximum dose of Prozac is 80 mg, but most people respond to the medication at lower doses. There are many affordable alternative SSRIs, including Zoloft (sertraline), Paxil (paroxetine), and Celexa (citalopram). They are all available in a generic form. Everyone responds differently to medications. With treatment with SSRIs, one medication may work well for one person, but not be optimal for someone else. It takes some time, but it is a matter of finding the right fit for your specific situation. Once you have been on an SSRI for an extended period of time, you should not stop taking it all of a sudden, as it can bring on extreme depression and anxiety. The medications should be tapered down when stopping, especially at high doses. If your doctor changes you to a different medication, there may be a cross-taper (coming down on one medication, while going up in dose on the new medication. There are also other types of antidepressants that can be used if treatment with an SSRI is not right for you. It is important to work with your doctor to find the right medication at the right dose for you. It is extremely important not to increase your current dose dose without the approval from your doctor. 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. Patti Brown, PharmD

Dosing Modifications

Upon therapy discontinuation, taper gradually over 4-6 months to minimize incidence of withdrawal symptoms and allow for detection of re-emerging symptoms; if withdrawal symptoms intolerable, following a dose reduction, resume previously prescribed dose and/or decrease dose at more gradual rate

Renal impairment: Use caution; drug accumulation may occur with severe renal impairment

Hepatic impairment (cirrhosis): Decreased clearance of parent drug and active metabolite (norClexiclor); lower or less frequent dose recommended

Q: How do I take Prozac for depression?

A: To take Prozac (Clexiclor) for depression, patients should be advised that treatment may require four weeks or longer before the full therapeutic effect of Prozac is observed. It is essential for patients to take Prozac for depression exactly as prescribed by a health care provider and not to adjust the dosing regimen or discontinue treatment with Prozac without the supervision of their doctor. Prozac is indicated for the treatment of depression in adult and pediatric patients, aged 8 to 18 years. To take Prozac for depression, the initial adult dose is 20 mg per day administered in the morning. The usual dosage of Prozac for depression ranges from 20 to 80 mg daily. During clinical trials for depression, 20 mg daily was an adequate dosage, in most patients, to achieve a desired therapeutic outcome. Research suggests that dosages higher than 20 mg per day may be administered once daily in the morning or may be administered twice daily when necessary, in the morning and at noon. To take Prozac for depression, the maximum daily dose is 80 mg. Prozac for weekly administration is also effective for treating depression in adults. To take Prozac for depression in children and adolescents, age 8 and older, the usual dose of Prozac is 10 to 20 mg daily. For both adult and pediatric patients, an increase in dosage of Prozac may be considered after several weeks of treatment if a less than satisfactory clinical improvement is observed. It is essential that patients are periodically monitored and reassessed to determine if further treatment is required. When taking Prozac for depression, doses are typically administered in the morning unless otherwise instructed. Patients taking Prozac for depression should be informed regarding the most commonly observed adverse reactions. During clinical trials, adverse reactions reported in 5% of patients or greater included abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, decreased libido, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation and yawn. Prior to beginning treatment with Prozac for depression, it is essential to inform your physician of any other medications you are currently taking, including prescription medications, over the counter products and dietary or herbal supplements to avoid potentially dangerous interactions.

Discontinuation Of Treatment

Symptoms associated with discontinuation of Clexiclor, SNRIs, and SSRIs, have been reported .

On this page

  1. About Clexiclor
  2. Key facts
  3. Who can and can't take Clexiclor
  4. How and when to take it
  5. Side effects
  6. How to cope with side effects
  7. Pregnancy and breastfeeding
  8. Cautions with other medicines
  9. Common questions

When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.

Administer Clexiclor in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of Clexiclor. Make dosage adjustments, if indicated, according to efficacy and tolerability within dose ranges of Clexiclor 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and Clexiclor in combination with a dose range of olanzapine 6 to 12 mg and Clexiclor 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg Clexiclor has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.

Children and adolescents (10 -17 years of age)

Administer olanzapine and Clexiclor combination once daily in the evening, generally beginning with 2.5 mg of olanzapine and 20 mg of Clexiclor. Make dosage adjustments, if indicated, according to efficacy and tolerability. Safety of co-administration of doses above 12 mg of olanzapine with 50 mg of Clexiclor has not been evaluated in pediatric clinical studies. Periodically re-examine the need for continued pharmacotherapy.

Safety and efficacy of Clexiclor in combination with olanzapine was determined in clinical trials supporting approval of Symbyax (fixed-dose combination of olanzapine and Clexiclor). Symbyax is dosed between 3 mg/25 mg (olanzapine/Clexiclor) per day and 12 mg/50 mg (olanzapine/Clexiclor) per day. The following table demonstrates the appropriate individual component doses of PROZAC and olanzapine versus Symbyax. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.

Table 1: Approximate Dose Correspondence Between Symbyax 1 and the Combination of PROZAC and Olanzapine

PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

Q: What are the possible Prozac withdrawal symptoms?

A: There are possible Prozac (Clexiclor) withdrawal symptoms which may be associated with abrupt discontinuation of the medication. According to the prescribing information for Prozac, during marketing of Prozac, serotonin norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), there were spontaneous reports of withdrawal symptoms which occurred upon discontinuation of these medications, particularly when discontinuation was abrupt. Possible Prozac withdrawal symptoms may include dysphoric mood, irritability, agitation, dizziness, sensory disturbances, such electric shock sensations, anxiety, confusion, headache, lethargy, excessive emotional reactions and frequent mood changes, insomnia and hypomania. Marketing research indicated that most of these reactions were typically self-limiting and did not require treatment. However, there were reports of serious symptoms associated with discontinuation. Patients are advised against abrupt discontinuation of Prozac. Patients are also advised to take Prozac exactly as prescribed and should not alter the dosing regimen or discontinue treatment with Prozac without consulting their health care provider. Patients should be appropriately monitored, by their health care provider, for these symptoms during the discontinuation period. To avoid the possible Prozac withdrawal symptoms, it is recommended for patients to gradually reduce the dosage of Prozac rather than abruptly discontinue treatment. An appropriate tapering period which implements a gradual dosage reduction should be under the supervision of a health care provider. As a result of the long elimination half-lives of Prozac and its active metabolite, norClexiclor, concentrations in the blood gradually decrease upon appropriate discontinuation of treatment which minimizes the risk for developing the possible Prozac withdrawal symptoms. Typically, even when treatment has been discontinued, active drug substances remain in the body for weeks, depending on patient specific characteristics, as well as previous dosing regimen and length of treatment.


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