Metoprolol Tartrate (Page 4 of 4)

14 CLINICAL STUDIES

In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Metoprolol Tartrate Injection was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction.

Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock, and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of Metoprolol Tartrate Injection or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Metoprolol Tartrate Injection or placebo was then continued for 3 months. After this double-blind period, all patients were given Metoprolol Tartrate Injection and followed up to 1 year.

The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Metoprolol Tartrate Injection-and placebo-treatment groups. Among patients treated with Metoprolol Tartrate Injection, there were comparable reductions in 3-month mortality for those treated early (≤8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Metoprolol Tartrate Injection and were independent of the interval between onset of symptoms and initiation of therapy.

In this study, patients treated with metoprolol received the drug both very early (intravenously) and during a subsequent 3-month period, while placebo patients received no beta-blocker treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta-blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta blockers.

16 HOW SUPPLIED/STORAGE AND HANDLING

5 mL Single Dose Vials – each containing 5 mg of Metoprolol Tartrate, USP

Carton of 10 vials………………………………………………………………………………………………………..NDC 0143-9873-10
Carton of 25 vials………………………………………………………………………………………………………..NDC 0143-9873-25

Also available in oversized vials (10 mL) with large mouth (20 mm)

Carton of 10 vials………………………………………………………………………………………………………..NDC 0143-9660-10

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and heat. Do not freeze.

Retain in carton until time of use.

17 PATIENT COUNSELING INFORMATION

Advise patients

(1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with Metoprolol Tartrate Injection has been determined;

(2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking Metoprolol Tartrate Injection.

Manufactured by:
HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

Revised: 12/2020
PIN155-WES/13

PRINCIPAL DISPLAY PANEL

NDC 0143-9873 -01 Rx only
Metoprolol
Tartrate Injection, USP
5 mg per 5 mL
(1 mg/mL)
For Intravenous use ONLY 5 mL Single Dose Vial

5 mL vial resized
(click image for full-size original)

NDC 0143-9873 -10 Rx only
Metoprolol
Tartrate Injection, USP
5 mg per 5 mL
(1 mg/mL)
Discard unused portion.
For Intravenous use ONLY 10 x 5 mL Single Dose Vials

5 mL vial x 10
(click image for full-size original)

NDC 0143-9873 -25 Rx only
Metoprolol
Tartrate Injection, USP
5 mg per 5 mL
(1 mg/mL)
Discard unused portion.
For Intravenous use ONLY 25 x 5 mL Single Dose Vials

5 mL vial x 25
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9660 -01 Rx only
Metoprolol
Tartrate Injection, USP
5 mg per 5 mL
(1 mg/mL)
For Intravenous use ONLY 5 mL Single Dose Vial

5 mL in 10 mL oversized
(click image for full-size original)

NDC 0143-9660 -10 Rx only
Metoprolol
Tartrate Injection, USP
5 mg per 5 mL
(1 mg/mL)
Discard unused portion.
For Intravenous use ONLY 10 x 5 mL Single Dose Vials

5 mL in oversized 10 mL x 10
(click image for full-size original)

REPRESENTATIVE SERIALIZATION IMAGE

Layout1

METOPROLOL TARTRATE metoprolol tartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9873
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 45 mg in 5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9873-10 5 mL in 1 VIAL None
2 NDC:0143-9873-25 25 VIAL in 1 CARTON contains a VIAL (0143-9873-10)
2 NDC:0143-9873-10 5 mL in 1 VIAL This package is contained within the CARTON (0143-9873-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077761 05/30/2007
METOPROLOL TARTRATE metoroprolol tartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9660
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 45 mg in 5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9660-10 10 VIAL in 1 CARTON contains a VIAL (0143-9660-01)
1 NDC:0143-9660-01 5 mL in 1 VIAL This package is contained within the CARTON (0143-9660-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077761 05/30/2007
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)
Establishment
Name Address ID/FEI Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 ANALYSIS (0143-9873), ANALYSIS (0143-9660), LABEL (0143-9873), LABEL (0143-9660), MANUFACTURE (0143-9873), MANUFACTURE (0143-9660), PACK (0143-9873), PACK (0143-9660)

Revised: 12/2020 Hikma Pharmaceuticals USA Inc.

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