Rexepi Combi Uses

sponsored
How do you administer this medicine?

What is Rexepi Combi?

Fluoxetine (Rexepi Combi) is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Olanzapine (Rexepi Combi) is an antipsychotic medication. These drugs affect chemicals in the brain.

Rexepi Combi is a combination medicine used to treat depression caused by bipolar disorder (manic depression). Rexepi Combi is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Rexepi Combi may also be used for other purposes not listed in this medication guide.

Rexepi Combi indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
sponsored

Depressive Episodes Associated with Bipolar I Disorder

Rexepi Combi® is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder.

Treatment Resistant Depression

Rexepi Combi is indicated for the acute treatment of treatment resistant depression (Major Depressive Disorder in adults who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).

How should I use Rexepi Combi?

Use Rexepi Combi as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rexepi Combi comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rexepi Combi refilled.
  • Take Rexepi Combi by mouth on an empty stomach or with food.
  • Take Rexepi Combi in the evening, unless your doctor tells you otherwise.
  • Continue to take Rexepi Combi even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Rexepi Combi without checking with your doctor. Side effects may occur. They may include mental or mood changes, agitation, anxiety, irritability, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Rexepi Combi and whenever a change in dose is made.
  • If you miss a dose of Rexepi Combi, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rexepi Combi.

Uses of Rexepi Combi in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
sponsored

Use: Labeled Indications

Depression, acute (associated with bipolar I disorder): Treatment of acute depressive episodes associated with bipolar I disorder

Depression, treatment-resistant: Treatment of treatment-resistant depression (eg, unresponsive to 2 trials of different antidepressants in the current episode)

Rexepi Combi dosage

Rexepi Combi Dosage

Generic name: Olanzapine (Rexepi Combi) 6mg, Fluoxetine (Rexepi Combi) hydrochloride 25mg

Dosage form: capsule

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Depressive Episodes Associated with Bipolar I Disorder

Adults — Administer Rexepi Combi once daily in the evening, generally beginning with the 6 mg/25 mg (mg Olanzapine (Rexepi Combi)/mg equivalent Fluoxetine (Rexepi Combi)) capsule. While food has no appreciable effect on the absorption of Olanzapine (Rexepi Combi) and Fluoxetine (Rexepi Combi) given individually, the effect of food on the absorption of Rexepi Combi has not been studied. Make dosage adjustments, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with Rexepi Combi in a dose range of Olanzapine (Rexepi Combi) 6 mg to 12 mg and Fluoxetine (Rexepi Combi) 25 mg to 50 mg. The safety of doses above 18 mg of Olanzapine (Rexepi Combi) and 75 mg of Fluoxetine (Rexepi Combi) has not been evaluated in adult clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Children and Adolescents (10 to 17 years of age) — Administer Rexepi Combi once daily in the evening, generally beginning with the 3 mg/25 mg capsule, without regard to meals, with a recommended target dose within the approved dosing range (6/25; 6/50; 12/25; 12/50 mg). The safety of doses above 12 mg of Olanzapine (Rexepi Combi) and 50 mg of Fluoxetine (Rexepi Combi) has not been evaluated in pediatric clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Treatment Resistant Depression

Administer Rexepi Combi once daily in the evening, generally beginning with the 6 mg/25 mg capsule. While food has no appreciable effect on the absorption of Olanzapine (Rexepi Combi) and Fluoxetine (Rexepi Combi) given individually, the effect of food on the absorption of Rexepi Combi has not been studied. Adjust dosage, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with Rexepi Combi in a dose range of Olanzapine (Rexepi Combi) 6 mg to 18 mg and Fluoxetine (Rexepi Combi) 25 mg to 50 mg. The safety of doses above 18 mg/75 mg has not been evaluated in clinical studies. Periodically reexamine the need for continued pharmacotherapy.

Specific Populations

Start Rexepi Combi at 3 mg/25 mg or 6 mg/25 mg in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of Rexepi Combi (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to Olanzapine (Rexepi Combi). Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. Rexepi Combi has not been systematically studied in patients >65 years of age or in patients <10 years of age.

Treatment of Pregnant Women — When treating pregnant women with Fluoxetine (Rexepi Combi), a component of Rexepi Combi, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding..

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Rexepi Combi. Conversely, at least 5 weeks should be allowed after stopping Rexepi Combi before starting an MAOI intended to treat psychiatric disorders.

Use of Rexepi Combi with Other MAOIs such as Linezolid or Methylene Blue

Do not start Rexepi Combi in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.

In some cases, a patient already receiving Rexepi Combi therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, Rexepi Combi should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Rexepi Combi may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Rexepi Combi is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.

Discontinuation of Treatment with Rexepi Combi

Symptoms associated with discontinuation of Fluoxetine (Rexepi Combi), a component of Rexepi Combi, SNRIs, and SSRIs, have been reported.

More about Rexepi Combi (Fluoxetine (Rexepi Combi) / Olanzapine (Rexepi Combi))

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Espanol
  • 46 Reviews - Add your own review/rating
  • Generic Availability

Consumer resources

  • Rexepi Combi
  • Rexepi Combi (Advanced Reading)

Professional resources

  • Rexepi Combi (FDA)

Related treatment guides

  • Depression
  • Major Depressive Disorder
  • Bipolar Disorder

Rexepi Combi interactions

See also:
What other drugs will affect Rexepi Combi?

sponsored

The risks of using Rexepi Combi in combination with other drugs have not been extensively evaluated in systematic studies. The drug-drug interactions sections of Rexepi Combi are applicable to Rexepi Combi. As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status.

Monoamine Oxidase Inhibitors (MAOIs)

.

CNS Acting Drugs

Caution is advised if the concomitant administration of Rexepi Combi and other CNS-active drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status.

Serotonergic Drugs

.

Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, Warfarin)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are coadministered with warfarin. Warfarin (20 mg single dose) did not affect Olanzapine (Rexepi Combi) pharmacokinetics. Single doses of Olanzapine (Rexepi Combi) did not affect the pharmacokinetics of warfarin. Patients receiving warfarin therapy should be carefully monitored when Rexepi Combi is initiated or discontinued.

Electroconvulsive Therapy (ECT)

There are no clinical studies establishing the benefit of the combined use of ECT and Fluoxetine (Rexepi Combi). There have been rare reports of prolonged seizures in patients on Fluoxetine (Rexepi Combi) receiving ECT treatment.

Potential for Other Drugs to Affect Rexepi Combi

Benzodiazepines Co-administration of diazepam with Olanzapine (Rexepi Combi) potentiated the orthostatic hypotension observed with Olanzapine (Rexepi Combi).

Inducers of 1A2 Carbamazepine therapy (200 mg BID) causes an approximate 50% increase in the clearance of Olanzapine (Rexepi Combi). This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in Olanzapine (Rexepi Combi) clearance.

Alcohol Ethanol (45 mg/70 kg single dose) did not have an effect on Olanzapine (Rexepi Combi) pharmacokinetics.

Inhibitors of CYP1A2 Fluvoxamine decreases the clearance of Olanzapine (Rexepi Combi). This results in a mean increase in Olanzapine (Rexepi Combi) Cmax following fluvoxamine administration of 54% in female nonsmokers and 77% in male smokers. The mean increase in Olanzapine (Rexepi Combi) AUC is 52% and 108%, respectively. Lower doses of the Olanzapine (Rexepi Combi) component of Rexepi Combi should be considered in patients receiving concomitant treatment with fluvoxamine.

The Effect of Other Drugs on Olanzapine (Rexepi Combi) Fluoxetine (Rexepi Combi), an inhibitor of CYP2D6, decreases Olanzapine (Rexepi Combi) clearance a small amount. Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may cause an increase in Olanzapine (Rexepi Combi) clearance. The effect of CYP1A2 inhibitors, such as fluvoxamine and some fluoroquinolone antibiotics, on Rexepi Combi has not been evaluated. Although Olanzapine (Rexepi Combi) is metabolized by multiple enzyme systems, induction or inhibition of a single enzyme may appreciably alter Olanzapine (Rexepi Combi) clearance. Therefore, a dosage increase (for induction) or a dosage decrease (for inhibition) may need to be considered with specific drugs.

Potential for Rexepi Combi to Affect Other Drugs

Pimozide Concomitant use of Rexepi Combi and pimozide is contraindicated. Pimozide can prolong the QT interval. Rexepi Combi can increase the level of pimozide through inhibition of CYP2D6. Rexepi Combi can also prolong the QT interval. Clinical studies of pimozide with other antidepressants demonstrate an increase in drug interaction or QTc prolongation. While a specific study with pimozide and Rexepi Combi has not been conducted, the potential for drug interactions or QTc prolongation warrants restricting the concurrent use of pimozide and Rexepi Combi.

Carbamazepine Patients on stable doses of carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant Fluoxetine (Rexepi Combi) treatment.

Alcohol The coadministration of ethanol with Rexepi Combi may potentiate sedation and orthostatic hypotension.

Thioridazine Thioridazine should not be administered with Rexepi Combi or administered within a minimum of 5 weeks after discontinuation of Rexepi Combi, because of the risk of QT prolongation.

In a study of 19 healthy male subjects, which included 6 slow and 13 rapid hydroxylators of debrisoquin, a single 25 mg oral dose of thioridazine produced a 2.4-fold higher Cmax and a 4.5-fold higher AUC for thioridazine in the slow hydroxylators compared with the rapid hydroxylators. The rate of debrisoquin hydroxylation is felt to depend on the level of CYP2D6 isozyme activity. Thus, this study suggests that drugs that inhibit CYP2D6, such as certain SSRIs, including Fluoxetine (Rexepi Combi), will produce elevated plasma levels of thioridazine.

Thioridazine administration produces a dose-related prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsades de pointes-type arrhythmias and sudden death. This risk is expected to increase with Fluoxetine (Rexepi Combi)-induced inhibition of thioridazine metabolism.

Due to the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated thioridazine plasma levels, thioridazine should not be administered with Fluoxetine (Rexepi Combi) or within a minimum of 5 weeks after Fluoxetine (Rexepi Combi) has been discontinued.

Tricyclic Antidepressants (TCAs) — Single doses of Olanzapine (Rexepi Combi) did not affect the pharmacokinetics of imipramine or its active metabolite desipramine.

In 2 Fluoxetine (Rexepi Combi) studies, previously stable plasma levels of imipramine and desipramine have increased > 2- to 10fold when Fluoxetine (Rexepi Combi) has been administered in combination. This influence may persist for 3 weeks or longer after Fluoxetine (Rexepi Combi) is discontinued. Thus, the dose of TCA may need to be reduced and plasma TCA concentrations may need to be monitored temporarily when Rexepi Combi is coadministered or has been recently discontinued.

Antihypertensive Agents Because of the potential for Olanzapine (Rexepi Combi) to induce hypotension, Rexepi Combi may enhance the effects of certain antihypertensive agents.

Levodopa and Dopamine Agonists The Olanzapine (Rexepi Combi) component of Rexepi Combi may antagonize the effects of levodopa and dopamine agonists.

Benzodiazepines Multiple doses of Olanzapine (Rexepi Combi) did not influence the pharmacokinetics of diazepam and its active metabolite N-desmethyldiazepam.

When concurrently administered with Fluoxetine (Rexepi Combi), the half-life of diazepam may be prolonged in some patients. Coadministration of alprazolam and Fluoxetine (Rexepi Combi) has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels.

Clozapine Elevation of blood levels of clozapine has been observed in patients receiving concomitant Fluoxetine (Rexepi Combi).

Haloperidol Elevation of blood levels of haloperidol has been observed in patients receiving concomitant Fluoxetine (Rexepi Combi).

Phenytoin Patients on stable doses of phenytoin have developed elevated plasma levels of phenytoin with clinical phenytoin toxicity following initiation of concomitant Fluoxetine (Rexepi Combi).

Drugs Metabolized by CYP2D6 In vitro studies utilizing human liver microsomes suggest that Olanzapine (Rexepi Combi) has little potential to inhibit CYP2D6. Thus, Olanzapine (Rexepi Combi) is unlikely to cause clinically important drug interactions mediated by this enzyme.

Fluoxetine (Rexepi Combi) inhibits the activity of CYP2D6 and may make individuals with normal CYP2D6 metabolic activity resemble a poor metabolizer. Coadministration of Fluoxetine (Rexepi Combi) with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution. Therapy with medications that are predominantly metabolized by the CYP2D6 system and that have a relatively narrow therapeutic index should be initiated at the low end of the dose range if a patient is receiving Fluoxetine (Rexepi Combi) concurrently or has taken it in the previous 5 weeks. If Fluoxetine (Rexepi Combi) is added to the treatment regimen of a patient already receiving a drug metabolized by CYP2D6, the need for a decreased dose of the original medication should be considered. Drugs with a narrow therapeutic index represent the greatest concern (including but not limited to, flecainide, propafenone, vinblastine, and TCAs).

Drugs Metabolized by CYP3A In vitro studies utilizing human liver microsomes suggest that Olanzapine (Rexepi Combi) has little potential to inhibit CYP3A. Thus, Olanzapine (Rexepi Combi) is unlikely to cause clinically important drug interactions mediated by these enzymes.

In an in vivo interaction study involving the coadministration of Fluoxetine (Rexepi Combi) with single doses of terfenadine (a CYP3A substrate), no increase in plasma terfenadine concentrations occurred with concomitant Fluoxetine (Rexepi Combi). In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A activity, to be at least 100 times more potent than Fluoxetine (Rexepi Combi) or norfluoxetine as an inhibitor of the metabolism of several substrates for this enzyme, including astemizole, cisapride, and midazolam. These data indicate that Fluoxetine (Rexepi Combi)'s extent of inhibition of CYP3A activity is not likely to be of clinical significance.

Effect of Olanzapine (Rexepi Combi) on Drugs Metabolized by Other CYP Enzymes In vitro studies utilizing human liver microsomes suggest that Olanzapine (Rexepi Combi) has little potential to inhibit CYP1A2, CYP2C9, and CYP2C19. Thus, Olanzapine (Rexepi Combi) is unlikely to cause clinically important drug interactions mediated by these enzymes.

Lithium Multiple doses of Olanzapine (Rexepi Combi) did not influence the pharmacokinetics of lithium.

There have been reports of both increased and decreased lithium levels when lithium was used concomitantly with Fluoxetine (Rexepi Combi). Cases of lithium toxicity and increased serotonergic effects have been reported. Lithium levels should be monitored in patients taking Rexepi Combi concomitantly with lithium.

Drugs Tightly Bound to Plasma Proteins The in vitro binding of Rexepi Combi to human plasma proteins is similar to the individual components. The interaction between Rexepi Combi and other highly protein-bound drugs has not been fully evaluated. Because Fluoxetine (Rexepi Combi) is tightly bound to plasma protein, the administration of Fluoxetine (Rexepi Combi) to a patient taking another drug that is tightly bound to protein (e.g., Coumadin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from displacement of protein-bound Fluoxetine (Rexepi Combi) by other tightly bound drugs.

Valproate In vitro studies using human liver microsomes determined that Olanzapine (Rexepi Combi) has little potential to inhibit the major metabolic pathway, glucuronidation, of valproate. Further, valproate has little effect on the metabolism of Olanzapine (Rexepi Combi) in vitro. Thus, a clinically significant pharmacokinetic interaction between Olanzapine (Rexepi Combi) and valproate is unlikely.

Biperiden Multiple doses of Olanzapine (Rexepi Combi) did not influence the pharmacokinetics of biperiden.

Theophylline Multiple doses of Olanzapine (Rexepi Combi) did not affect the pharmacokinetics of theophylline or its metabolites.

Drugs that Prolong the QT Interval

Do not use Rexepi Combi in combination with thioridazine or pimozide. Use Rexepi Combi with caution in combination with other drugs that cause QT prolongation. These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus). Fluoxetine (Rexepi Combi) is primarily metabolized by CYP2D6. Concomitant treatment with CYP2D6 inhibitors can increase the concentration of Fluoxetine (Rexepi Combi). Concomitant use of other highly protein-bound drugs can increase the concentration of Fluoxetine (Rexepi Combi).

Drug Abuse And Dependence

Dependence

Rexepi Combi, as with Rexepi Combi, has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical studies did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Rexepi Combi (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

In studies in rats and rhesus monkeys designed to assess abuse and dependence potential, Olanzapine (Rexepi Combi) alone was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence at oral doses up to 15 (rat) and 8 (monkey) times the MRHD (20 mg) on a mg/m² basis.

Rexepi Combi side effects

See also:
What are the possible side effects of Rexepi Combi?

sponsored

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.

Clinical Trials Experience

Adverse reactions were recorded by clinical investigators using descriptive terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a limited (i.e., reduced) number of standardized reaction categories.

In the tables and tabulations that follow, MedDRA or COSTART Dictionary terminology has been used to classify reported adverse reactions. The data in the tables represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is possible that reactions reported during therapy were not necessarily related to drug exposure.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing clinician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Adults

The information below is derived from a clinical study database for Rexepi Combi consisting of 2547 patients with treatment resistant depression, depressive episodes associated with Bipolar I Disorder, Major Depressive Disorder with psychosis, or sexual dysfunction with approximately 1085 patient-years of exposure. The conditions and duration of treatment with Rexepi Combi varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or long-term exposure.

Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression

Overall, 11.3% of the 771 patients in the Rexepi Combi group discontinued due to adverse reactions compared with 4.4% of the 477 patients for placebo. Adverse reactions leading to discontinuation associated with the use of Rexepi Combi (incidence of at least 1% for Rexepi Combi and greater than that for placebo) using MedDRA Dictionary coding were weight increased (2%) and sedation (1%) versus placebo patients which had 0% incidence of weight increased and sedation.

Commonly Observed Adverse Reactions in Short-Term, Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression

The most commonly observed adverse reactions associated with the use of Rexepi Combi (incidence ≥ 5% and at least twice that for placebo in the Rexepi Combi-controlled database) using MedDRA Dictionary coding were: disturbance in attention, dry mouth, fatigue, hypersomnia, increased appetite, peripheral edema, sedation, somnolence, tremor, vision blurred, and weight increased. Adverse reactions reported in clinical trials of Olanzapine (Rexepi Combi) and Fluoxetine (Rexepi Combi) in combination are generally consistent with treatment-emergent adverse reactions during Olanzapine (Rexepi Combi) or Fluoxetine (Rexepi Combi) monotherapy.

Adverse Reactions Occurring at an Incidence of 2% or More in Short-Term Controlled Studies Including Depressive Episodes Associated with Bipolar I Disorder and Treatment Resistant Depression

Table 13 enumerates the treatment-emergent adverse reactions associated with the use of Rexepi Combi (incidence of at least 2% for Rexepi Combi and twice or more than for placebo). The Rexepi Combi-controlled column includes patients with various diagnoses while the placebo column includes only patients with bipolar depression and major depression with psychotic features.

Table 13: Treatment-Emergent Adverse Reactions: Incidence in the Adult Controlled Clinical Studies

System Organ Class Adverse Reaction Percentage of Patients Reporting Event
Rexepi Combi-Controlled

(N=771)

Placebo

(N=477)

Eye disorders Vision blurred 5 2
Gastrointestinal disorders Dry mouth 15 6
Flatulence 3 1
Abdominal distension 2 0
General disorders and administration site conditions Fatigue 12 2
EdemaThese terms represent serious adverse events but do not meet the definition for adverse drug reactions. They are included here because of their seriousness.

Rexepi Combi contraindications

See also:
What is the most important information I should know about Rexepi Combi?

Monoamine Oxidase Inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with Rexepi Combi or within 5 weeks of stopping treatment with Rexepi Combi is contraindicated because of an increased risk of serotonin syndrome. The use of Rexepi Combi within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Starting Rexepi Combi in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome..

Other Contraindications

  • Pimozide
  • Thioridazine

Pimozide and thioridazine prolong the QT interval. Rexepi Combi can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Rexepi Combi can also prolong the QT interval.

Active ingredient matches for Rexepi Combi:

Fluoxetine/Olanzapine in Georgia.


List of Rexepi Combi substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Olapin Plus 20 mg/5 mg Tablet (Crescent Formulations Pvt Ltd (Crescent Therapeutics Ltd. ))$ 0.10
OLAWEB FL 5MG/20MG TABLET 1 strip / 10 tablets each (RKG Pharma)$ 0.62
Olaweb FL 20 mg/5 mg Tablet (RKG Pharma)$ 0.06
OLEE FORTE tab 10's (Tweet India)$ 1.37
OLEE PLUS tab 10's (Tweet India)$ 0.95
OLET PLUS 5MG/20MG TABLET 1 strip / 10 tablets each (Altius Life Sciences)$ 1.12
Olet Plus 20 mg/5 mg Tablet (Altius Life Sciences)$ 0.11
OLINE FORTE 10MG/20MG TABLET 1 strip / 10 tablets each (D D Pharmaceuticals)$ 1.03
Oline Forte 20 mg/10 mg Tablet (D D Pharmaceuticals)$ 0.10
OLINE PLUS 5MG/20MG TABLET 1 strip / 10 tablets each (D D Pharmaceuticals)$ 0.76
Oline Plus 20 mg/5 mg Tablet (D D Pharmaceuticals)$ 0.08
OLIPAR PLUS 20 MG/5 MG TABLET 1 strip / 10 tablets each (OSR Pharmaceuticals Pvt Ltd)$ 1.19
100's (Solitaire (Psychotop))$ 10.95
Olorest-F Olanzapine 10 mg, Fluoxetine20 mg. TAB / 100 (Solitaire (Psychotop))$ 10.95
OLOREST-F tab 10's (Solitaire (Psychotop))$ 1.10
Olorest-F Olanzapine 10 mg, Fluoxetine20 mg. TAB / 100 (Solitaire (Psychotop))$ 10.95
OLSUCA-F tab 10's (Curis)
OLTHA PLUS TABLET 1 strip / 10 tablets each (Shine Pharmaceuticals Ltd)$ 1.07
10's (Gentech HC)$ 1.21
Schizol Forte Olanzapine 10 mg, fluoxetine20 mg. TAB / 10 (Gentech HC)$ 1.21
SCHIZOL FORTE tab 10's (Gentech HC)$ 1.21
Schizol Forte Olanzapine 10 mg, Fluoxetine20 mg. TAB / 10 (Gentech HC)$ 1.21
10's (Gentech HC)$ 0.87
Schizol Plus Olanzapine 5 mg, fluoxetine 20mg. TAB / 10 (Gentech HC)$ 0.87
SCHIZOL PLUS tab 10's (Gentech HC)$ 0.87
Schizol Plus Olanzapine 5 mg, fluoxetine 20mg. TAB / 10 (Gentech HC)$ 0.87
Capsule; Oral; Fluoxetine Hydrochloride 25 mg; Olanzapine 3 mg (Lilly)
Capsule; Oral; Fluoxetine Hydrochloride 25 mg; Olanzapine 6 mg (Lilly)
Capsule; Oral; Fluoxetine Hydrochloride 25 mg; Olanzapine 12 mg (Lilly)
Capsule; Oral; Fluoxetine Hydrochloride 50 mg; Olanzapine 6 mg (Lilly)
Capsule; Oral; Fluoxetine Hydrochloride 50 mg; Olanzapine 12 mg (Lilly)
10's (Zodak)$ 0.86
Zolo-F Olanzapine 5 mg, Fluoxetine 20mg. TAB / 10 (Zodak)$ 0.86
ZOLO-F tab 10's (Zodak)$ 0.86
Zolo-F Olanzapine 5 mg, Fluoxetine 20mg. TAB / 10 (Zodak)$ 0.86
10's (Zodley)$ 0.94
Zool-F Olanzapine 5 mg, fluoxetine 20mg. TAB / 10 (Zodley)$ 0.94
ZOOL-F tab 10's (Zodley)$ 0.94
Zool-F Olanzapine 5 mg, Fluoxetine 20mg. TAB / 10 (Zodley)$ 0.94

References

  1. DailyMed. "FLUOXETINE HYDROCHLORIDE; OLANZAPINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "olanzapine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "fluoxetine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Rexepi Combi are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Rexepi Combi. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

No survey data has been collected yet


Consumer reported price estimates

No survey data has been collected yet


1 consumer reported time for results

To what extent do I have to use Rexepi Combi before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Rexepi Combi. To get the time effectiveness of using Rexepi Combi drug by other patients, please click here.
Users%
1 month1
100.0%


1 consumer reported age

Users%
46-601
100.0%


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 23 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2022 ndrugs.com All Rights Reserved