DILTIAZEM HYDROCHLORIDE injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

DILTIAZEM HYDROCHLORIDE

Skład:

DILTIAZEM HYDROCHLORIDE 5 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Diltiazem Hydrochloride Injection is indicated for the following: 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. 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 impu

Podsumowanie produktu:

Diltiazem Hydrochloride Injection 5 mg/mL is available in the following:     5 mL Vial (25 mg/vial) packaged in 10s (NDC 0641-9217-10)     10 mL Vial (50 mg/vial) packaged in 10s (NDC 0641-9218-10)     25 mL Vial (125 mg/vial) packaged in 10s (NDC 0641-9219-10) SINGLE-DOSE VIALS. DISCARD UNUSED PORTION. This product, including the packaging components, is free of latex. Store diltiazem hydrochloride injection under refrigeration 2º-8ºC (36º-46ºF). DO NOT FREEZE. May be stored at room temperature for up to 1 month. Destroy after 1 month at room temperature.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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DILTIAZEM HYDROCHLORIDE INJECTION
RX ONLY NOVAPLUS®
DESCRIPTION
DILTIAZEM HYDROCHLORIDE is a calcium ion influx inhibitor (slow
channel blocker or
calcium channel antagonist). Chemically, diltiazem hydrochloride is
(+)-5-[2-
(Dimethylamino)ethyl]-_cis_-2,3-dihydro-3-hydroxy-2-(_p_-methoxyphenyl)-1,5-
benzothiazepin-4(5_H_)-one acetate(ester) monohydrochloride. The
structural formula is:
C
H
N O S• HCl MW: 450.98
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
soluble in water, methanol, and chloroform.
Diltiazem hydrochloride injection is a clear, colorless, sterile,
nonpyrogenic solution. It
has a pH range of 3.7 to 4.1.
Diltiazem hydrochloride injection is for direct intravenous bolus
injection and continuous
intravenous infusion.
Each mL contains: 5 mg Diltiazem Hydrochloride, USP, 0.75 mg Citric
Acid Anhydrous,
USP, 0.65 mg Sodium Citrate Dihydrate USP, 50 mg Sorbitol NF, and
Water for Injection,
USP q.s. Sodium Hydroxide or Hydrochloric Acid is used to adjust pH.
CLINICAL PHARMACOLOGY
MECHANISMS OF ACTION
Diltiazem inhibits the influx of calcium (Ca
+) ions during membrane depolarization of
cardiac and vascular smooth muscle. The therapeutic benefits of
diltiazem in
supraventricular tachycardias are related to its ability to slow AV
nodal conduction time
and prolong AV nodal refractoriness. Diltiazem exhibits frequency
(use) dependent
effects on AV nodal conduction such that it may selectively reduce the
heart rate during
tachycardias involving the AV node with little or no effect on normal
AV nodal conduction
22
26
2
4
2
at normal heart rates.
Diltiazem slows the ventricular rate in patients with a rapid
ventricular response during
atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal
supraventricular
tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry
circuit in AV nodal
reentrant tachycardias and reciprocating tachycardias, e