Labetalol Hydrochloride (Labetalol Hydrochloride)

Trade Name : Labetalol Hydrochloride

West-Ward Pharmaceuticals Corp

INJECTION

Strength 5 mg/mL

LABETALOL HYDROCHLORIDE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Labetalol Hydrochloride (Labetalol Hydrochloride) which is also known as Labetalol Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 5 mg/mL per ml. Read more

Labetalol Hydrochloride (Labetalol Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Rx only

Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.
Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula:
Labetalol HCl has the molecular formula CHNOu2022HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol.
Labetalol HCl is a white or off-white crystalline powder, soluble in water.
Labetalol HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.

Labetalol combines both selective, competitive, alpha-adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and intravenous administration, respectively. Beta-agonist activity has been demonstrated in animals with minimal beta-agonist (ISA) activity detected. In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated.

Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.

Labetalol HCl injection is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see ).
Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

No data

No data

Labetalol HCl injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with labetalol HCl with the incidence per 100 patients as noted:
Arrayn- Cardiovascular System:
Arrayn- Central and Peripheral Nervous Systems:
Arrayn- Gastrointestinal System:
Arrayn- Metabolic Disorders:
Arrayn- Psychiatric Disorders:
Arrayn- Respiratory System:
Arrayn- Skin:
The incidence of adverse reactions depends upon the dose of labetalol HCl. The largest experience is with oral labetalol HCl (see Labetalol HCl Tablet Product Information for details). Certain of the side effects increased with increasing oral dose, as shown in the following table that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
In addition, a number of other less common adverse events have been reported:u00a0
Arrayn- Cardiovascular:
Arrayn- Liver and Biliary System:
Arrayn- Hypersensitivity:
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.
Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.

Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary:
Excessive bradycardian- Cardiac failuren- Hypotensionn- Bronchospasmn- Seizures
In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves).
Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol from the general circulation (<1%).
The oral LD value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat is greater than 2 g/kg. The intravenous LD in these species is 50 to 60 mg/kg.

Labetalol HCl injection is intended for intravenous use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing.
Patients should always be kept in a supine position during the period of intravenous drug administration. A substantial fall in blood pressure on standing should be expected in these patients. The patientu2019s ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities.
Either of two methods of administration of labetalol HCl injection may be used: a) repeated intravenous injection, or b) slow continuous infusion.

Labetalol HCl Injection, USP, 5 mg/mL, is supplied in 20 mL (100 mg) multidose vials, individually-boxed () and 40 mL (200 mg) multidose vials, individually-boxed ().
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. n
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
For Product Inquiry call 1-877-845-0689.
Manufactured by:
HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, PORTUGAL
Distributed by:
West-Ward Pharmaceuticals
Eatontown, NJ 07724 USA
Revised December 2015
PIN424-WES/1

NDC 0143-9622-01
Rx only
Labetalol HCL Injection, USP
100 mg/20mL
(5 mg/mL)
FOR INTRAVENOUS INJECTION ONLYu00a0

NDC 0143-9623-01
Rx only
Labetalol HCl Injection, USP
200 mg/40 mL
(5 mg/mL)
FOR INTRAVENOUS INJECTION ONLY

NDC 0143-9622-01
Rx only
Labetalol HCL Injection, USP
100 mg/20mL
(5 mg/mL)
FOR INTRAVENOUS INJECTION ONLYu00a0
Sterile

NDC 0143-9623-01
Rx only
Labetalol HCl Injection, USP
200 mg/40 mL
(5 mg/mL)
FOR INTRAVENOUS INJECTION ONLY
Sterile

No data

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Labetalol Hydrochloride (Labetalol Hydrochloride)

Trade Name : Labetalol Hydrochloride

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Labetalol Hydrochloride (Labetalol Hydrochloride)

Trade Name : Labetalol Hydrochloride

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

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