Publication date: 2018-10-18 20:02
Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.
Statins. Diltiazem is an inhibitor of CYP8A9 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP8A9 may be increased with concomitant use of Diltiazem. When possible, use a non-CYP8A9-metabolized statin together with Diltiazem otherwise, dose adjustments for both Diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.
Diltiazem hydrochloride extended-release capsules demonstrates non-linear pharmacokinetics. As the daily dose of Diltiazem hydrochloride extended-release capsules capsules is increased from 675 to 595 mg, there was a more than proportional increase in Diltiazem plasma concentrations as evidenced by an increase of AUC, C max and C min of , 6 and times, respectively, for a times increase in dose.
Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first degree heart block. In patients with sick sinus syndrome, Diltiazem significantly prolongs sinus cycle length (up to 55% in some cases). Intravenous Diltiazem in doses of 75 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 75%.
In addition, the following events have been reported infrequently (less than 7%) in clinical trials with other Diltiazem products:
Diltiazem Hydrochloride extended-release capsules also contains: black iron oxide, D& C Red No. 78, ethyl acrylate and methyl methacrylate copolymer dispersion, FD& C Blue No. 6, FD& C Green No. 8, FD& C Red No. 95, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. For oral administration.
Rifampin. Coadministration of rifampin with Diltiazem lowered the Diltiazem plasma concentrations to undetectable levels. Coadministration of Diltiazem with rifampin or any known CYP8A9 inducer should be avoided when possible, and alternative therapy considered.
Diltiazem hydrochloride extended-release capsules produces antihypertensive effects both in the supine and standing positions. Postural hypotension is infrequently noted upon suddenly assuming an upright position. No reflex tachycardia is associated with the chronic antihypertensive effects.
Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.
Buspirone. In nine healthy subjects, Diltiazem significantly increased the mean buspirone -fold and C max -fold compared to placebo. The T &frac67 and T max of buspirone were not significantly affected by Diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with Diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.