DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE (diltiazem hydrochloride) · HQ SPCLT PHARMA

Based on the results of pharmacokinetic studies in healthy volunteers administered different oral diltiazem hydrochloride formulations, constant rate intravenous infusions of diltiazem hydrochloride at 3, 5, 7, and 11 mg/h are predicted to produce steady-state plasma diltiazem concentrations equivalent to 120-, 180-, 240-, and 360-mg total daily oral doses of diltiazem hydrochloride tablets and diltiazem hydrochloride extended-release capsules.

DistributionThe volume of distribution of diltiaze...

In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it...

The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. Hypotension was the most commonly reported adverse event during clinical trials, with symptomatic hypotension occurring in 3.2% of patients. Other events reported in a least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) - 3.9%, ...

Diltiazem Hydrochloride in Sodium Chloride Injection is contraindicated in the following situations:

• Patients with sick sinus syndrome or second- or third-degree AV block except in the presence of a functioning ventricular pacemaker.
• Patients with severe hypotension or cardiogenic shock.
• Patients who have demonstrated hypersensitivity to the drug.
• Concomitant administration with IV beta-bl...

• Hemodynamic deterioration and ventricular fibrillation if administered to patients with wide complex tachycardia of ventricular origin. ( 5.2 )
• Second-or third-degree AV block. ( 5.3 )
• Heart failure. ( 5.4 )
• Hypotension. ( 5.5 ) 5.1 Tachycardia and Hypotension in patients with AF/AFL and accessory bypass tract Diltiazem may cause ventricular fibrillation if given to patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome. Distin...

7 DRUG INTERACTIONS Table 1. Clinically Relevant Interactions with Diltiazem Drug/Substance Class or Name Clinical implication Prevention/Management Agents Known to decrease peripheral resistance, cardiac contractility or conduction Increased risk of bradycardia, AV block, and heart failure. Monitor. Beta-blockers Increased risk of bradycardia, AV block, and depression of contractility. Beta-block...