Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)
Hospira, Inc.
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HOSPIRA, INC. ---------- 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 Perskaitykite visą dokumentą