DILTIAZEM HYDROCHLORIDE injection, solution DILTIAZEM HYDROCHLORIDE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

DILTIAZEM HYDROCHLORIDE

Composition:

DILTIAZEM HYDROCHLORIDE 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diltiazem Hydrochloride Injection or Diltiazem Hydrochloride for Injection are 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. In addition, Diltiazem Hydrochloride Injection is indicated for: 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 or diltiazem hydrochloride for injection should be undertaken with caution when the patient is compromised hemodynamically or is t

Product summary:

Diltiazem Hydrochloride Injection is supplied in single-dose Fliptop vials as follows: NDC 0409-1171-01 Carton containing 10 Single-Dose Fliptop Vials 25 mg/5 mL (5 mg/mL) NDC 0409-1171-11 5 mL Single-Dose Fliptop Vial NDC 0409-1171-02 Carton containing 10 Single-Dose Fliptop Vials 50 mg/10 mL (5 mg/mL) NDC 0409-1171-12 10 mL Single-Dose Fliptop Vial DILTIAZEM HYDROCHLORIDE INJECTION IS TO BE STORED UNDER REFRIGERATION 2 TO 8°C (36 TO 46°F). DO NOT FREEZE. MAY BE STORED AT ROOM TEMPERATURE FOR UP TO 1 MONTH. DESTROY AFTER 1 MONTH AT ROOM TEMPERATURE. SINGLE-DOSE VIALS. DISCARD UNUSED PORTION. Diltiazem Hydrochloride for Injection for continuous infusion is supplied in single-dose ADD-Vantage vials as follows: NDC 0409-4350-03 Tray containing 10 ADD-Vantage Vials 100 mg NDC 0409-4350-13 100 mg/ADD-Vantage Vial DILTIAZEM HYDROCHLORIDE FOR INJECTION IS TO BE STORED AT 20° TO 25°C (68° TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DO NOT FREEZE. RECONSTITUTED MATERIAL IS STABLE FOR 24 HOURS AT CONTROLLED ROOM TEMPERATURE OR REFRIGERATED 2° to 8°C (36° to 46°F). SINGLE-DOSE VIAL.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
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DILTIAZEM HYDROCHLORIDE
INJECTION
SINGLE-DOSE FLIPTOP VIAL
DILTIAZEM HYDROCHLORIDE FOR INJECTION
SINGLE-DOSE ADD-VANTAGE VIAL
FOR CONTINUOUS INTRAVENOUS INFUSION
NOT FOR BOLUS
R ONLY
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or
calcium channel antagonist). Chemically, diltiazem hydrochloride is
1,5-benzothiazepin-
4(5_H_)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,
3-dihydro-2-(4-methoxyphenyl)-,
monohydrochloride,(+)-cis-. The chemical structure is:
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.
It has a pH range of 3.7 to 4.1.
Diltiazem hydrochloride injection is for direct intravenous bolus
injection and continuous
intravenous infusion.
25-mg, 5-mL vial-each sterile vial contains 25 mg diltiazem
hydrochloride, 3.75 mg citric
acid USP, 3.25 mg sodium citrate dihydrate USP, 250 mg sorbitol NF and
water for
injection USP up to 5 mL. Sodium hydroxide or hydrochloric acid is
used for pH
adjustment.
®
X
50-mg, 10-mL vial-each sterile vial contains 50 mg diltiazem
hydrochloride, 7.5 mg citric
acid USP, 6.5 mg sodium citrate dihydrate USP, 500 mg sorbitol NF and
water for
injection USP up to 10 mL. Sodium hydroxide or hydrochloric acid is
used for pH
adjustment.
DILTIAZEM HYDROCHLORIDE FOR INJECTION is an off-white lyophilized
powder and, after
reconstitution in an infusion bag, produces a clear, colorless,
sterile, nonpyrogenic
solution.
Diltiazem hydrochloride for injection for continuous intravenous
infusion is available in
ADD-Vantage Vials. The vial contains lyophilized powder comprised of
diltiazem
hydrochloride 100 mg and mannitol USP 75 mg for recon