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Rexepi Combi Dosage |
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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.
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.
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.
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..
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.
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.
Symptoms associated with discontinuation of Fluoxetine (Rexepi Combi), a component of Rexepi Combi, SNRIs, and SSRIs, have been reported.
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:
any other antidepressant or medication to treat mental illness;
buspirone;
fentanyl, tramadol;
lithium;
St. John's Wort;
tryptophan (sometimes called L-tryptophan); or
migraine headache medicine--almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, zolmitriptan.
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.
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.
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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.
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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.
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.
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.
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.
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).
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.
Users | % | ||
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Once in a day | 2 | 100.0% |
Users | % | ||
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6-10mg | 1 | 50.0% | |
1-5mg | 1 | 50.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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