Rexepi Combi Dosage

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Dosage of Rexepi Combi in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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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))

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What other drugs will affect Rexepi Combi?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Rexepi Combi with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with Rexepi Combi. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Rexepi Combi, especially:

This list is not complete and many other drugs can interact with Rexepi Combi. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Rexepi Combi interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Rexepi Combi, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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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)

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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

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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.


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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. FDA/SPL Indexing Data. "N7U69T4SZR: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Antidepressive Agents, Second-Generation". https://www.ncbi.nlm.nih.gov/mesh/68... (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

2 consumers reported frequency of use

How frequently do I need to take Rexepi Combi?
It was reported by ndrugs.com website users that Rexepi Combi should ideally be taken Once in a day as the most common frequency of the Rexepi Combi. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Rexepi Combi should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
Users%
Once in a day2
100.0%


2 consumers reported doses

What doses of Rexepi Combi drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Rexepi Combi drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users%
6-10mg1
50.0%
1-5mg1
50.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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