Labetalol Hcl (Labetalol Hcl)

Trade Name : Labetalol HCl

Eon Labs, Inc.

TABLET, FILM COATED

Strength 100 mg/1

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 Hcl (Labetalol Hcl) which is also known as Labetalol HCl and Manufactured by Eon Labs, Inc.. It is available in strength of 100 mg/1 per ml. Read more

Labetalol Hcl (Labetalol Hcl) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx Only
  • Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.
  • Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure:
  • Labetalol hydrochloride, USP 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,Ru2019 stereoisomer, makes up 25% of racemic labetalol.
  • Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water.
  • Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP.
  • In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, sodium starch glycolate (potato) and titanium dioxide.
  • Labetalol hydrochloride 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 (IV) 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 hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
  • Labetalol hydrochloride 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 .
  • 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
  • Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 monthsu2019 duration, discontinuation of labetalol hydrochloride due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients.
  • The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol hydrochloride and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged.
  • The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta-blocker therapy.
  • Clinical trials also included studies utilizing daily doses up to 2400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in the following table that depicts the entire U.S. 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:
  • Arrayn- Body as a Whole
  • Fever.
  • Arrayn- Cardiovascular
  • Hypotension, and rarely, syncope, bradycardia, heart block.
  • Arrayn- Central and Peripheral Nervous Systems
  • Paresthesia, most frequently described as scalp tingling.
  • In most cases, it was mild and transient and usually occurred at the beginning of treatment.
  • Arrayn- Collagen Disorders
  • Systemic lupus erythematosus, positive antinuclear factor.
  • Arrayn- Eyes
  • Dry eyes.
  • Arrayn- Immunological System
  • Antimitochondrial antibodies.
  • Arrayn- Liver and Biliary System
  • Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
  • Arrayn- Musculoskeletal System
  • Muscle cramps, toxic myopathy.
  • Arrayn- Respiratory System
  • Bronchospasm.
  • Arrayn- Skin and Appendages
  • Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronieu2019s disease, reversible alopecia.
  • Arrayn- Urinary System
  • Difficulty in micturition, including acute urinary bladder retention.
  • Arrayn- Hypersensitivity
  • Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
  • Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,800 patients was conducted for further safety and efficacy evaluation of this product. Results of this survey indicate that the type, severity, and incidence of adverse effects were comparable to those cited above.
  • Overdosage with labetalol hydrochloride 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 hydrochloride 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 bradycardia
  • Administer atropine or epinephrine.
  • Cardiac failure
  • Administer a digitalis glycoside and a diuretic. Dopamine or dobutamine may also be useful.
  • Hypotension
  • Administer vasopressors, e.g., norepinephrine. There is pharmacologic evidence that norepinephrine may be the drug of choice.
  • Bronchospasm
  • Administer epinephrine and/or an aerosolized beta-agonist.
  • Seizures
  • Administer diazepam.
  • In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 mg 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 hydrochloride from the general circulation (less than 1%).
  • The oral LD value of labetalol hydrochloride 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 mg/kg to 60 mg/kg.
  • DOSAGE MUST BE INDIVIDUALIZED. The recommended dosage is 100 mg daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. (twice daily) every 2 or 3 days. The usual dosage of labetalol hydrochloride tablets is between 200 mg and 400 mg daily.
  • Since the full antihypertensive effect of labetalol hydrochloride tablets is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.
  • Patients with severe hypertension may require from 1200 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d.(twice daily), the same total daily dose administered t.i.d. (three times daily) may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg b.i.d. (twice daily).
  • When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol hydrochloride tablet dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.
  • When transferring patients from other antihypertensive drugs, labetalol hydrochloride tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.
  • Elderly Patients
  • As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. (twice daily) as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 mg and 200 mg b.i.d. (twice daily).
  • Labetalol Hydrochloride Tablets, USP, for oral administration, are available as
  • Arrayn- 100 mg
  • Round, white, film-coated tablets, debossed u201c10u201d on one side and bisected on the other side and supplied as:
  • NDC 0185-0010-01 bottles of 100
  • NDC 0185-0010-05 bottles of 500
  • NDC 0185-0010-10 bottles of 1000
  • Arrayn- 200 mg
  • Round, white, film-coated tablets, debossed u201c117u201d on one side and bisected on the other side and supplied as:
  • NDC 0185-0117-01 bottles of 100
  • NDC 0185-0117-05 bottles of 500
  • NDC 0185-0117-10 bottles of 1000
  • Arrayn- 300 mg
  • Round, white, film-coated tablets, debossed u201c118u201d on one side and plain on the other side and supplied as:
  • NDC 0185-0118-01 bottles of 100
  • NDC 0185-0118-05 bottles of 500
  • NDC 0185-0118-10 bottles of 1000
  • Labetalol Hydrochloride Tablets, USP should be stored at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required.
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Manufactured by
  • Sandoz Inc.
  • Princeton, NJ 08540
  • Rev. October 2016
  • MF0010REV10/16
  • NDC 0185-0010-01
  • Labetalol Hydrochloride Tablets, USP
  • 100 mg
  • Rx only
  • 100 Tablets
  • Sandoz
  • NDC 0185-0117-01
  • Labetalol Hydrochloride Tablets, USP
  • 200 mg
  • Rx only
  • 100 Tablets
  • Sandoz
  • NDC 0185-0118-01
  • Labetalol Hydrochloride Tablets, USP
  • 300 mg
  • Rx only
  • 100 Tablets
  • Sandoz

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