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Viberzi
Overview
What is Viberzi?
The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist.
The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid.
Eluxadoline has a molecular weight of 569.65 and a molecular formula of CHNO. The chemical structure of eluxadoline is:
VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).
What does Viberzi look like?
What are the available doses of Viberzi?
75 mg and 100 mg tablets ()
What should I talk to my health care provider before I take Viberzi?
How should I use Viberzi?
VIBERZIis indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food.
The recommended dosage of VIBERZI is 75 mg taken orally twice daily with food in patients who:
Discontinue VIBERZI in patients who develop severe constipation
.
Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.
What interacts with Viberzi?
Sorry No Records found
What are the warnings of Viberzi?
Sorry No Records found
What are the precautions of Viberzi?
Sorry No Records found
What are the side effects of Viberzi?
Sorry No records found
What should I look out for while using Viberzi?
VIBERZI is contraindicated in patients:
What might happen if I take too much Viberzi?
No reports of overdosage with VIBERZI have been reported.
In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. The patient should be carefully observed and given standard supportive treatment as required. Given eluxadoline’s action at opioid receptors, administration of a narcotic mu-opioid antagonist, such as naloxone, should be considered. Considering the short half-life of naloxone, repeated administration may be necessary. In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.
How should I store and handle Viberzi?
Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. VIBERZI is available as: Bottle of 60: NDC 61874-075-60Bottle of 60: NDC 61874-100-60Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] VIBERZI is available as: Bottle of 60: NDC 61874-075-60Bottle of 60: NDC 61874-100-60Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] VIBERZI is available as: Bottle of 60: NDC 61874-075-60Bottle of 60: NDC 61874-100-60Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] VIBERZI is available as: Bottle of 60: NDC 61874-075-60Bottle of 60: NDC 61874-100-60Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM. In animals, eluxadoline interacts with opioid receptors in the gut.
Non-Clinical Toxicology
VIBERZI is contraindicated in patients:(See and ) Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and 2C19, and a moderate inhibitor of CYP3A4. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed. These are described in greater detail below:
Oral hypoglycemics Coumarin-type anticoagulants Phenytoin Cyclosporine Rifampin Theophylline Terfenadine Cisapride Astemizole Rifabutin Voriconazole Tacrolimus Short-acting benzodiazepines Tofacitinib Triazolam Oral Contraceptives Pimozide Quinidine Hydrochlorothiazide Alfentanil Amiodarone Amitriptyline, nortriptyline Amphotericin B Azithromycin Carbamazepine Calcium Channel Blockers Celecoxib Cyclophosphamide Fentanyl Halofantrine HMG-CoA reductase inhibitors Losartan Methadone Non-steroidal anti-inflammatory drugs Prednisone Saquinavir Sirolimus Vinca Alkaloids Vitamin A Zidovudine
Pancreatitis, with or without sphincter of Oddi spasm [ ], has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder [ ]. Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses.
In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting [ ].
The following adverse reactions described below and elsewhere in the labeling include:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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