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Dificid
Overview
What is Dificid?
DIFICID (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4--(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2--methyl-β-D- mannopyranosyl]oxy]methyl]-12-[[6-deoxy-5--methyl-4--(2-methyl-1-oxopropyl)-β-D--hexopyranosyl]oxy]-11-ethyl-8 -hydroxy-18-[(1)-1-hydroxyethyl]-9,13,15-trimethyl-, (3,5,8,9,11,12,13,15,18)-. The structural formula of fidaxomicin is shown in Figure 1.
DIFICID tablets (200 mg) are film-coated and contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, and lecithin (soy).
What does Dificid look like?
What are the available doses of Dificid?
Film-coated tablets: 200 mg ()
What should I talk to my health care provider before I take Dificid?
Pediatrics: The safety and effectiveness of DIFICID has not been studied in patients <18 years of age. ()
How should I use Dificid?
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by .
The recommended dose is one 200 mg DIFICID tablet orally twice daily for 10 days with or without food.
What interacts with Dificid?
Sorry No Records found
What are the warnings of Dificid?
Sorry No Records found
What are the precautions of Dificid?
Sorry No Records found
What are the side effects of Dificid?
Sorry No records found
What should I look out for while using Dificid?
Hypersensitivity to fidaxomicin.
What might happen if I take too much Dificid?
No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.
How should I store and handle Dificid?
Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015Mexiletine hydrochloride capsules USP, 200 mg are white granular powder in a hard gelatin capsule with an opaque orange cap and an opaque orange body, imprinted with "N" on one side and "740" and "200" on the other in black ink. They are supplied as follows: 0093-8740-01 bottles of 100.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Manufactured In Canada By:TEVA CANADA LIMITEDToronto, Canada M1B 2K9Manufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. D 3/2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fidaxomicin is an antibacterial drug .
Non-Clinical Toxicology
Hypersensitivity to fidaxomicin.Since mexiletine hydrochloride is a substrate for the metabolic pathways involving CYP2D6 and CYP1A2 enzymes, inhibition or induction of either of these enzymes would be expected to alter mexiletine plasma concentrations. In a formal, single-dose interaction study (n = 6 males) the clearance of mexiletine was decreased by 38% following the coadministration of fluvoxamine, an inhibitor of CYP1A2. In another formal study (n = 8 extensive and n = 7 poor metabolizers of CYP2D6), coadministration of propafenone did not alter the kinetics of mexiletine in the poor CYP2D6 metabolizer group. However, the metabolic clearance of mexiletine in the extensive metabolizer phenotype decreased by about 70% making the poor and extensive metabolizer groups indistinguishable. In this crossover steady state study, the pharmacokinetics of propafenone were unaffected in either phenotype by the coadministration of mexiletine. Addition of mexiletine to propafenone did not lead to further electrocardiographic parameters changes of QRS, QT, RR, and PR intervals than propafenone alone. When concomitant administration of either of these two drugs is initiated, the dose of mexiletine should be slowly titrated to desired effect.
In a large compassionate use program mexiletine has been used concurrently with commonly employed antianginal, antihypertensive, and anticoagulant drugs without observed interactions. A variety of antiarrhythmics such as quinidine or propranolol were also added, sometimes with improved control of ventricular ectopy. When phenytoin or other hepatic enzyme inducers such as rifampin and phenobarbital have been taken concurrently with mexiletine, lowered mexiletine plasma levels have been reported. Monitoring of mexiletine plasma levels is recommended during such concurrent use to avoid ineffective therapy.
In a formal study, benzodiazepines were shown not to affect mexiletine plasma concentrations. ECG intervals (PR, QRS, and QT) were not affected by concurrent mexiletine and digoxin, diuretics, or propranolol.
Concurrent administration of cimetidine and mexiletine has been reported to increase, decrease, or leave unchanged mexiletine plasma levels; therefore patients should be followed carefully during concurrent therapy.
Mexiletine does not alter serum digoxin levels but magnesium-aluminum hydroxide, when used to treat gastrointestinal symptoms due to mexiletine, has been reported to lower serum digoxin levels.
Concurrent use of mexiletine and theophylline may lead to increased plasma theophylline levels. One controlled study in eight normal subjects showed a 72% mean increase (range 35 to 136%) in plasma theophylline levels. This increase was observed at the first test point which was the second day after starting mexiletine. Theophylline plasma levels returned to pre-mexiletine values within 48 hours after discontinuing mexiletine. If mexiletine and theophylline are to be used concurrently, theophylline blood levels should be monitored, particularly when the mexiletine dose is changed. An appropriate adjustment in theophylline dose should be considered.
Additionally, in one controlled study in five normal subjects and seven patients, the clearance of caffeine was decreased 50% following the administration of mexiletine.
Since there is minimal systemic absorption of fidaxomicin, DIFICID is not effective for treatment of systemic infections.
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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