Labetalol Hydrochloride (Labetalol Hydrochloride)

Trade Name	Labetalol Hydrochloride
Active Ingredient
Power	100 mg/1
Type / form	Tablets
Status
Manufacturer	Alvogen Inc.

Storage and handling for Labetalol Hydrochloride

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

Disclaimer

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 Alvogen Inc.. It is available in strength of 100 mg/1 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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Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.
Labetalol hydrochloride (HCl) 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 HCl has the empirical formula CHNOu2219HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,Ru00b4 stereoisomer, makes up 25% of racemic labetalol.
Labetalol HCl is a white or off-white crystalline powder, soluble in water.
Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100-mg and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.

Labetalol HCl 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 are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Labetalol Hydrochloride Tablets are 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.

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Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of Labetalol Hydrochloride Tablets due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely betau2011blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alphau2011agonist 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 HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl 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 2,400 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 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:
Body as a Whole:
Cardiovascular:
Central and Peripheral Nervous Systems:
Collagen Disorders:
Eyes:
Immunological System:
Liver and Biliary System:
Musculoskeletal System:
Respiratory System:
Skin and Appendages:
Urinary System:
Hypersensitivity:
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.
Potential Adverse Effects:
Central Nervous System:
Cardiovascular:
Allergic:
Hematologic:
Gastrointestinal:
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.
Clinical Laboratory Tests:

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: u2014administer atropine or epinephrine. u2014administer a digitalis glycoside and a diuretic. Dopamine or dobutamine may also be useful. u2014administer vasopressors, e.g., norepinephrine. There is pharmacologic evidence that norepinephrine may be the drug of choice. u2014administer epinephrine and/or an aerosolized beta-agonist. u2014administer 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 HCl 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 >2 g/kg. The IV 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 every 2 or 3 days. The usual dosage of labetalol HCl is between 200 mg and 400 mg daily.
Since the full antihypertensive effect of labetalol HCl 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 1,200 mg to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.
When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl 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.
As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg 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 .

Labetalol Hydrochloride Tablets, 100 mg, light orange, round, scored, film-coated tablets debossed on one side with u201cCL 37u201d and u201c100u201d, bottles of 100 (NDC 47781-552-01) and bottles of 500 (NDC 47781-552-05).
Labetalol Hydrochloride Tablets, 200 mg, white, round, scored, film-coated tablets debossed on one side with u201cCL 38u201d and u201c200u201d, bottles of 100 (NDC 47781-553-01) and bottles of 500 (NDC 47781-553-05).
Labetalol Hydrochloride Tablets, 300 mg, mid-orange, round, scored, film-coated tablets debossed on one side with u201cCL 39u201d and u201c300u201d, bottles of 100 (NDC 47781-554-01).
Labetalol Hydrochloride Tablets should be stored between 2u00b0 and 30u00b0C (36u00b0 and 86u00b0F).

Product of Italy
Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA
For Inquiries Call: 1-866-770-3024
All trademarks are the property of their respective owners.
PI552-00 Rev. 10/2016

NDCn- 552
Labetalol Hydrochloride Tablets 100 mg
Equivalent to 90 mg Labetalol per tablet
Rx only 100 Tablets

NDCn- 553
Labetalol Hydrochloride Tablets 200 mg
Equivalent to 180 mg Labetalol per tablet
Rx only 100 Tablets
Array

NDCn- 554
Labetalol Hydrochloride Tablets 300 mg
Equivalent to 270 mg Labetalol per tablet
Rx only 100 Tablets
Array