Product Description.:
MYLAN 6060, MYLAN 6060
capsule , peach white , oblong oblong
Black ink
Diltiazem Hydrochloride Injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist).
Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98.
Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. pH is 3.9 (3.7 to 4.1).
Diltiazem Hydrochloride Injection is for direct intravenous bolus injection and continuous intravenous infusion.
Each mL contains 5 mg of diltiazem hydrochloride, 0.75 mg citric acid USP, 0.65 mg sodium citrate (dihydrate) USP, 71.4 mg sorbitol solution USP, and water for injection USP. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.9 (3.7 to 4.1).
INDICATIONS AND USAGE
Diltiazem hydrochloride injection is indicated for the following:
1.
Atrial Fibrillation or Atrial Flutter.Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome.
2.
Paroxysmal Supraventricular Tachycardia.Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection.
The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.
For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.
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 is generally short-lived, but may last from 1 to 3 hours.
A 24-hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.
In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.
In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.
Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.
CONTRAINDICATIONS
Diltiazem hydrochloride injection is contraindicated in:
1. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker.
2. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker.
3. Patients with severe hypotension or cardiogenic shock.
4. Patients who have demonstrated hypersensitivity to the drug.
5. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours).
6. Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome.
As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atria
