DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE
Generic: DILTIAZEM HYDROCHLORIDE
Basic Information
Manufacturer
WG Critical Care, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8bae87a5-2137-467e-a1ad-79b2bc075e07
Indications & Usage
1 INDICATIONS AND USAGE Diltiazem Hydrochloride in Sodium Chloride Injection is a non-dihydropyridine calcium-channel blocker indicated for the following: • Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
( 1.1) • Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
( 1.2 ) 1.1 Atrial Fibrillation or Atrial Flutter Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for the temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
1.2 Paroxysmal Supraventricular Tachycardia Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
( 1.1) • Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
( 1.2 ) 1.1 Atrial Fibrillation or Atrial Flutter Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for the temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
1.2 Paroxysmal Supraventricular Tachycardia Diltiazem Hydrochloride in Sodium Chloride Injection is indicated in adults for rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
Adverse Reactions
6 ADVERSE REACTIONS 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%, vasodilation (flushing) - 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) - 1%.
In addition, the following events were reported infrequently (less than 1%): Gastrointestinal - Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Nervous System - Dizziness Other - dyspnea, edema, headache, Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Dermatologic - Erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, petechiae, photosensitivity, purpura, pruritus, rash, urticaria, acute generalized exanthematous pustulosis, Gastrointestinal - Anorexia, dysgeusia, dyspepsia Other - Allergic reactions, angioedema (including facial or periorbital edema), gingival hyperplasia, hyperglycemia, impotence.
Most common adverse reactions are hypotension, itching and burning at injection site, vasodilation, and arrhythmia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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%, vasodilation (flushing) - 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) - 1%.
In addition, the following events were reported infrequently (less than 1%): Gastrointestinal - Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Nervous System - Dizziness Other - dyspnea, edema, headache, Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Dermatologic - Erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, petechiae, photosensitivity, purpura, pruritus, rash, urticaria, acute generalized exanthematous pustulosis, Gastrointestinal - Anorexia, dysgeusia, dyspepsia Other - Allergic reactions, angioedema (including facial or periorbital edema), gingival hyperplasia, hyperglycemia, impotence.
Most common adverse reactions are hypotension, itching and burning at injection site, vasodilation, and arrhythmia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.