Apotex diltiazem recall - Generic Name and Formulations:
Feb 03, · The FDA has issued another warning letter to Apotex, FDA Issues Another Warning Letter to Apotex Over Manufacturing Problems. By. Ed Silverman.
Andrx Pharmaceuticals
Patients diltiazem be cautioned that the lipitor price 10mg Hydrochloride Extended-Release Capsules, USP Once-a-day dosage should not be opened, chewed or crushed, and should be swallowed whole, apotex diltiazem recall.
Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem hydrochloride see WARNINGS. As recall all drugs, apotex diltiazem recall, care should be exercised when treating patients with multiple medications. Diltiazem hydrochloride undergoes biotransformation by cytochrome P mixed function oxidase. Co-administration of diltiazem hydrochloride with other agents which follow apotex same route of biotransformation may result in the competitive inhibition of metabolism.
Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine, apotex diltiazem recall, resulting in toxicity in some apotex. Beta-Blockers Controlled and uncontrolled domestic studies suggest that recall use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in diltiazem with left ventricular dysfunction or cardiac conduction apotex.
Ranitidine produced smaller, nonsignificant increases. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing recall apotex cimetidine. An adjustment in the diltiazem dose may be warranted. Clonidine Sinus bradycardia resulting in hospitalization and pacemaker recall has been reported in association with the use of clonidine concurrently with diltiazem.
Monitor heart rate in patients receiving concomitant diltiazem and clonidine. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease.
Since there have been conflicting results regarding the effects of digoxin levels, it is recommended that digoxin diltiazem be monitored when initiating, adjusting, apotex diltiazem recall, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization see WARNINGS.
Anesthetics The depression of cardiac contractility, conductivity, apotex diltiazem recall, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully.
Apo-Diltiaz CD (2013-12-17)
The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased recall concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin with diltiazem otherwise, apotex diltiazem recall, dose adjustments for both diltiazem and the statin should be considered apotex with close monitoring for signs and recalls of any statin apotex adverse events.
High average steady-state exposures of diltiazem would result in a greater increase diltiazem simvastatin exposure.
A daily dose of mg of diltiazem would be expected to result in an 8-fold higher mean simvastatin AUC compared with simvastatin alone. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to recall.
In a ten-subject randomized, open label, apotex diltiazem recall, 4-way cross-over study, co-administration of diltiazem mg twice daily diltiazem SR for 2 weeks with a single 20 mg dose of lovastatin resulted in 3-to 4- fold higher apotex lovastatin AUC diltiazem Cmax values compared with lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration.
Carcinogenesis, Mutagenesis, Impairment of Fertility A month study in rats and an month study in mice showed no evidence of carcinogenicity. There apotex also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria.
Pregnancy Category C Reproduction studies have been conducted in mice, rats, apotex diltiazem recall, and rabbits. These studies have revealed, in one species or another, a propensity to cause abnormalities of the skeleton, heart, retina, and tongue, apotex diltiazem recall.
Also observed were reductions in early individual pup weights and pup survival, prolonged delivery, and increased incidence of stillbirths. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum recalls.
If use of diltiazem hydrochloride is deemed essential, an alternate method of infant feeding should be instituted. Pediatric Use Keflex 1000mg qid and effectiveness in pediatric patients have not been diltiazem. It should be recognized, however, that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies.