Drug Catalog - Product Detail
METOPROLOL TARTRATE FOR INJECTION INJECT. 1MG/ML 25X6ML
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
00143-9873-25 | HIKMA | 5 | 5MG/5ML | NA |
PACKAGE FILES
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=meto1vial.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=meto1vial.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metolabel.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metolabel.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metoprolol-tartrate-injection-1.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metoprolol-tartrate-injection-1.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metoprolol-tartrate-injection-7.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b624095a-d1c1-1ce0-e053-2995a90a0698&name=metoprolol-tartrate-injection-7.jpg)
Generic Name
METOPROLOL TARTRATE
Substance Name
METOPROLOL TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
ANDA077761
Description
DESCRIPTION Metoprolol Tartrate Injection, USP, is a selective beta 1 -adrenoreceptor blocking agent, available in 5 mL single dose vials for intravenous administration. Each vial contains a sterile solution of Metoprolol Tartrate, USP, 5 mg, Sodium Chloride, USP, 45 mg, and Water for Injection, USP. Metoprolol Tartrate, USP is (±)-1-(Isopropylamino)-3-[ p -(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is: Molecular Formula: (C 15 H 25 NO 3 ) 2 •C 4 H 6 O 6 Metoprolol Tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. chemical structure
How Supplied
HOW SUPPLIED Metoprolol Tartrate Injection, USP is a clear and colorless solution available as: 5 mL Single Dose Vials - each containing 5 mg Metoprolol Tartrate, USP. Cartons of 10 vials NDC 0143-9873-10 Cartons 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 Carton of 25 vials NDC 0143-9660-25 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light and heat. Do not freeze. Retain in carton until time of use. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL CORP. Eatontown, NJ 07724 USA Revised: 10/2015 PIN155-WES/11
Indications & Usage
INDICATIONS AND USAGE Myocardial Infarction Metoprolol Tartrate Injection, USP is indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. Treatment with intravenous Metoprolol Tartrate Injection, USP can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Myocardial Infarction Early Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of metoprolol each; give the injections at approximately 2-minute intervals. During the intravenous administration of metoprolol, monitor blood pressure, heart rate, and electrocardiogram. In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg orally twice daily. Start patients who appear not to tolerate the full intravenous dose on metoprolol tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue metoprolol (see WARNINGS ). Special populations Pediatric patients: No pediatric studies have been performed. The safety and efficacy of metoprolol in pediatric patients have not been established. Renal impairment: No dose adjustment of metoprolol is required in patients with renal impairment. Hepatic impairment: Metoprolol blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol should be initiated at low doses with cautious gradual dose titration according to clinical response. Geriatric patients (> 65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Method of administration: Parenteral administration of metoprolol should be done in a setting with intensive monitoring. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.