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| Product NDC Code | 71930-037 | ||||||
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| Drug Name | Labetalol hydrochloride |
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| Type | Generic | ||||||
| Pharm Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, FILM COATED | ||||||
| RxCUI drug identifier | 896758, 896762, 896766 |
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| Application Number | ANDA207863 | ||||||
| Labeler Name | Eywa Pharma Inc | ||||||
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Labetalol Hydrochloride
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE 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. Treat symptoms of overdose with standard supportive care. 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. Treat symptoms of overdose with standard supportive care. Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%). The oral LD 50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is >2 g/kg. The IV LD 50 in these species is 50 mg/kg to 60 mg/kg.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension [see Warnings and Precautions ( 5.1 ) Bradycardia [see Warnings and Precautions ( 5.2 ) Cardiac failure [see Warnings and Precautions ( 5.3 ) Ischemic heart disease [see Warnings and Precautions ( 5.4 )] Nonallergic bronchospasm [see Warnings and Precautions ( 5.5 )] Use in patients with pheochromocytoma [see Warnings and Precautions ( 5.7 )] Hepatic injury [see Warnings and Precautions ( 5.8 )] Risk of severe acute hypersensitivity reaction [see Warnings and Precautions ( 5.9 )] Most commonly observed adverse reactions: fatigue, nausea, dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hibrow Healthcare Pvt. Ltd. at 1-888-400-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. The incidence rates of adverse reactions listed in Table 1 were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride and placebo over treatment periods of 3 and 4 months. Table 1: Adverse Reactions Occurring in at Least 2% of Patients and More Frequent on Labetalol Labetalol HCl (n=227) Placebo (n=98) Body as a whole Fatigue 5% 0% Headache 2% 1% Gastrointestinal Nausea 6% 1% Dyspepsia 3% 1% Central and peripheral nervous system Dizziness 11% 3% Autonomic nervous system Nasal stuffiness 3% 0% Respiratory Dyspnea 2% 0% Special senses Vertigo 2% 1% 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 Table 2 that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
| Fatigue | 5% | 0% |
| Headache | 2% | 1% |
| Nausea | 6% | 1% |
| Dyspepsia | 3% | 1% |
| Dizziness | 11% | 3% |
| | ||
| Nasal stuffiness | 3% | 0% |
| Dyspnea | 2% | 0% |
| Vertigo | 2% | 1% |
Labetalol Hydrochloride Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS Concomitant use with negative chronotropes can increase risk of bradycardia ( 7.1 ) Beta blockers antagonize the bronchodilator effect of beta-receptor agonists. ( 7.2 ) Increase hypotension may occur with halothane anesthesia. ( 7.3 ) Nitroglycerin may result in additional hypotensive effects. ( 7.4 ) 7.1 Negative Chronotropes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension [see Warnings and Precautions ( 5.2 )] . Coadministration of labetalol HCl with non-dihydropyridine calcium-channel antagonists (e.g., verapamil) is contraindicated [see Contraindications ( 4 )]. 7.2 Bronchodilators Labetalol HCl antagonizes the bronchodilatory effect of beta-receptor agonist drugs; therefore, labetalol HCl is contraindicated in patients with bronchial asthma [see Contraindications ( 4 )]. 7.3 Anesthesia Synergism has been shown between halothane anesthesia and intravenously administered labetalol. During controlled hypotensive anesthesia using labetalol in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. 7.4 Nitroglycerin Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. If labetalol HCl is used in patients with angina pectoris on nitroglycerin, monitor patients’ blood pressure and adjust labetalol dose as needed. In these patients, avoid initiating Labetalol Hydrochloride Tablets. 7.5 Drug/Laboratory Test Interactions The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic acid (VMA) when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with labetalol, a specific method, such as a high-performance liquid chromatographic assay with solid phase extraction should be employed in determining levels of catecholamines. Labetalol has also been reported to produce a false positive test for amphetamine when screening urine for the presence of drugs using the commercially available assay methods. When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirm using more specific methods, such as a gas chromatographic mass spectrometer technique.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Labetalol hydrochloride combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity. 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. 12.2 Pharmacodynamics The capacity of labetalol hydrochloride to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the pressor response caused by immersing the hand in ice cold water ("cold pressor test"). Labetalol hydrochloride's beta 1 receptor blockade in man was demonstrated by a small decrease in the resting heart rate, attenuation of tachycardia produced by isoproterenol or exercise, and by attenuation of the reflex tachycardia to the hypotension produced by amyl nitrite. Beta 2 receptor blockade was demonstrated by inhibition of the isoproterenol induced fall in diastolic blood pressure. Both the alpha- and beta blocking actions of orally administered labetalol hydrochloride contribute to a decrease in blood pressure in hypertensive patients. Labetalol hydrochloride consistently, in dose related fashion, blunted increases in exercise induced blood pressure and heart rate, and in their double product. The pulmonary circulation during exercise was not affected by labetalol hydrochloride dosing. The effects on A-V nodal refractoriness were inconsistent. Single oral doses of labetalol hydrochloride administered to patients with coronary artery disease had no significant effect on sinus rate, intraventricular conduction, or QRS duration. The atrioventricular (A-V) conduction time was modestly prolonged in two of seven patients. In another study, IV labetalol hydrochloride slightly prolonged A V nodal conduction time and atrial effective refractory period with only small changes in heart rate. Labetalol hydrochloride produces dose-related falls in blood pressure without reflex tachycardia and without significant reduction in heart rate, presumably through a mixture of its alpha- and beta-blocking effects. Hemodynamic effects are variable, with small, nonsignificant changes in cardiac output seen in some studies but not others, and small decreases in total peripheral resistance. Elevated plasma renins are reduced. Due to the alpha 1 - receptor blocking activity of labetalol hydrochloride, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (2%), including rare instances of syncope, can occur. Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when the recommended starting dose and titration increments are closely followed [see Dosage and Administration ( 2.1 )] . Symptomatic postural hypotension is most likely to occur 2 to 4 hours after a dose, especially following the use of large initial doses or upon large changes in dose. The peak effects of single oral doses of labetalol hydrochloride occur within 2 to 4 hours. The duration of effect depends upon dose, lasting at least 8 hours following single oral doses of 100 mg and more than 12 hours following single oral doses of 300 mg. The maximum, steady state blood pressure response upon oral, twice-a-day dosing occurs within 24 to 72 hours. The antihypertensive effect of labetalol has a linear correlation with the logarithm of labetalol plasma concentration, and there is also a linear correlation between the reduction in exercise induced tachycardia occurring at 2 hours after oral administration of labetalol hydrochloride and the logarithm of the plasma concentration. About 70% of the maximum beta-blocking effect is present for 5 hours after the administration of a single oral dose of 400 mg with suggestion that about 40% remains at 8 hours. 12.3 Pharmacokinetics Absorption Labetalol hydrochloride is absorbed with peak plasma levels occurring 1 to 2 hours after oral administration. The relative bioavailability of Labetalol Hydrochloride Tablets compared to an oral solution is 100%. The absolute bioavailability (fraction of drug reaching systemic circulation) of labetalol when compared to an IV infusion is 25%; this is due to extensive "first-pass" metabolism. There is a linear relationship between oral doses of 100 mg to 3,000 mg and peak plasma levels. Effect of Food The absolute bioavailability of labetalol is increased when administered with food. Distribution Labetalol has been shown to cross the placental barrier in humans. Labetalol is approximately 50% protein bound. Elimination The plasma half-life of labetalol following oral administration is about 6 to 8 hours. Steady-state plasma levels of labetalol are reached by about the third day of dosing. Metabolism Metabolism of labetalol is mainly through conjugation to glucuronide metabolites. Excretion Approximately 55% to 60% of a dose appears in the urine as conjugates or unchanged labetalol within the first 24 hours of dosing. These metabolites are present in plasma and are excreted in the urine and, via the bile, into the feces. Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%). Specific Populations Patients with Renal or Hepatic Impairment In patients with decreased hepatic or renal function, the elimination half-life of labetalol is not altered; however, the relative bioavailability in hepatically impaired patients is increased due to decreased "first pass" metabolism. Drug Interaction Studies Tricyclic Antidepressants In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol hydrochloride alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded. Cimetidine Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Labetalol hydrochloride combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity. 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.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics The capacity of labetalol hydrochloride to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the pressor response caused by immersing the hand in ice cold water ("cold pressor test"). Labetalol hydrochloride's beta 1 receptor blockade in man was demonstrated by a small decrease in the resting heart rate, attenuation of tachycardia produced by isoproterenol or exercise, and by attenuation of the reflex tachycardia to the hypotension produced by amyl nitrite. Beta 2 receptor blockade was demonstrated by inhibition of the isoproterenol induced fall in diastolic blood pressure. Both the alpha- and beta blocking actions of orally administered labetalol hydrochloride contribute to a decrease in blood pressure in hypertensive patients. Labetalol hydrochloride consistently, in dose related fashion, blunted increases in exercise induced blood pressure and heart rate, and in their double product. The pulmonary circulation during exercise was not affected by labetalol hydrochloride dosing. The effects on A-V nodal refractoriness were inconsistent. Single oral doses of labetalol hydrochloride administered to patients with coronary artery disease had no significant effect on sinus rate, intraventricular conduction, or QRS duration. The atrioventricular (A-V) conduction time was modestly prolonged in two of seven patients. In another study, IV labetalol hydrochloride slightly prolonged A V nodal conduction time and atrial effective refractory period with only small changes in heart rate. Labetalol hydrochloride produces dose-related falls in blood pressure without reflex tachycardia and without significant reduction in heart rate, presumably through a mixture of its alpha- and beta-blocking effects. Hemodynamic effects are variable, with small, nonsignificant changes in cardiac output seen in some studies but not others, and small decreases in total peripheral resistance. Elevated plasma renins are reduced. Due to the alpha 1 - receptor blocking activity of labetalol hydrochloride, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (2%), including rare instances of syncope, can occur. Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when the recommended starting dose and titration increments are closely followed [see Dosage and Administration ( 2.1 )] . Symptomatic postural hypotension is most likely to occur 2 to 4 hours after a dose, especially following the use of large initial doses or upon large changes in dose. The peak effects of single oral doses of labetalol hydrochloride occur within 2 to 4 hours. The duration of effect depends upon dose, lasting at least 8 hours following single oral doses of 100 mg and more than 12 hours following single oral doses of 300 mg. The maximum, steady state blood pressure response upon oral, twice-a-day dosing occurs within 24 to 72 hours. The antihypertensive effect of labetalol has a linear correlation with the logarithm of labetalol plasma concentration, and there is also a linear correlation between the reduction in exercise induced tachycardia occurring at 2 hours after oral administration of labetalol hydrochloride and the logarithm of the plasma concentration. About 70% of the maximum beta-blocking effect is present for 5 hours after the administration of a single oral dose of 400 mg with suggestion that about 40% remains at 8 hours.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption Labetalol hydrochloride is absorbed with peak plasma levels occurring 1 to 2 hours after oral administration. The relative bioavailability of Labetalol Hydrochloride Tablets compared to an oral solution is 100%. The absolute bioavailability (fraction of drug reaching systemic circulation) of labetalol when compared to an IV infusion is 25%; this is due to extensive "first-pass" metabolism. There is a linear relationship between oral doses of 100 mg to 3,000 mg and peak plasma levels. Effect of Food The absolute bioavailability of labetalol is increased when administered with food. Distribution Labetalol has been shown to cross the placental barrier in humans. Labetalol is approximately 50% protein bound. Elimination The plasma half-life of labetalol following oral administration is about 6 to 8 hours. Steady-state plasma levels of labetalol are reached by about the third day of dosing. Metabolism Metabolism of labetalol is mainly through conjugation to glucuronide metabolites. Excretion Approximately 55% to 60% of a dose appears in the urine as conjugates or unchanged labetalol within the first 24 hours of dosing. These metabolites are present in plasma and are excreted in the urine and, via the bile, into the feces. Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%). Specific Populations Patients with Renal or Hepatic Impairment In patients with decreased hepatic or renal function, the elimination half-life of labetalol is not altered; however, the relative bioavailability in hepatically impaired patients is increased due to decreased "first pass" metabolism. Drug Interaction Studies Tricyclic Antidepressants In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol hydrochloride alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded. Cimetidine Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS Labetalol Hydrochloride Tablets are contraindicated in patients with: bronchial asthma or obstructive airway disease decompensated heart failure greater than first degree heart block cardiogenic shock severe bradycardia Hypersensitivity reactions, including anaphylaxis, to labetalol non-dihydropyridine calcium-channel antagonists Bronchial asthma or obstructive airway disease ( 4 ) Overt cardiac failure ( 4 ) Greater‑than‑first‑degree heart block ( 4 ) Cardiogenic shock ( 4 ) Severe bradycardia ( 4 ) Non-dihydropyridine calcium-channel antagonists ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Labetalol Hydrochloride Tablets, USP contain labetalol hydrochloride, an adrenergic receptor blocking agent that has both selective alpha 1 adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride 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 structural formula: Labetalol hydrochloride has the empirical formula C 19 H 24 N 2 O 3 •HCl 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,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP contain 100 mg, 200 mg, or 300 mg of labetalol hydrochloride and are for oral administration. The tablets also contain the inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized corn starch, sodium starch glycolate. FDA approved dissolution test specifications differ from USP. struct
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION The recommended initial dosage is 100 mg twice daily, alone or added to a diuretic regimen. Titrate in increments of 100 mg twice daily every 2 or 3 days. Maintenance dosage is between 200 and 400 mg twice daily. ( 2.1 ) Severe Hypertension: May require from 1,200 to 2,400mg per day, with or without thiazide diuretics. Titrate in increments not to exceed 200 mg twice daily. (2.2) Elderly patients: Initiate at 100 mg twice daily. Titrate in increments of 100 mg twice daily as required for blood pressure control. Many elderly patients will require between 100 and 200 mg twice daily. (2.3) 2.1 Recommended Dosage Labetalol Hydrochloride dosage must be individualized. The recommended initial dosage of labetalol hydrochloride is 100 mg twice daily. Adjust dosage in increments of 100 mg twice daily at 2-to 3-day intervals based on response. The recommended maintenance dosage of labetalol hydrochloride is between 200 and 400 mg twice daily.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Labetalol Hydrochloride Tablets, USP are available in the following strengths: • 100 mg - White to off-white, biconvex, film coated tablets with “ET20” debossed on one side and non-functional scoring on the other side • 200 mg - White to off-white, biconvex, film coated tablets with “ET21” debossed on one side and non-functional scoring on the other side • 300 mg - White to off-white, biconvex, film coated tablets with “ET22” debossed on one side and non-functional scoring on the other side Tablets: 100 mg, 200 mg, and 300 mg tablets. ( 3 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol Hydrochloride Tablets, USP are a beta adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN ET20 Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN ET21 Labetalol Hydrochloride Labetalol Hydrochloride LABETALOL HYDROCHLORIDE LABETALOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN ET22
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term oral dosing studies with labetalol hydrochloride for 18 months in mice and for 2 years in rats showed no evidence of carcinogenesis. Studies with labetalol hydrochloride using dominant lethal assays in rats and mice and exposing microorganisms according to modified Ames tests showed no evidence of mutagenesis.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term oral dosing studies with labetalol hydrochloride for 18 months in mice and for 2 years in rats showed no evidence of carcinogenesis. Studies with labetalol hydrochloride using dominant lethal assays in rats and mice and exposing microorganisms according to modified Ames tests showed no evidence of mutagenesis.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 71930-035-12 Labetalol Hydrochloride Tablets, USP 100 mg Rx only 100 tablets Eywa-Hibrow Pharma NDC 71930-036-12 Labetalol Hydrochloride Tablets, USP 200 mg Rx only 100 tablets Eywa-Hibrow Pharma NDC 71930-037-12 Labetalol Hydrochloride Tablets, USP 300 mg Rx only 100 tablets Eywa-Hibrow Pharma 100mg 200mg 300mg
Labetalol Hydrochloride: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise patients to not interrupt or discontinue using Labetalol Hydrochloride Tablets without advice from their healthcare provider Advise patients to contact their healthcare provider about any signs or symptoms of impending cardiac failure or hepatic dysfunction [see Warnings and Precautions ( 5.3 , 5.8 )] Inform patients or caregivers that there is a risk of hypoglycemia when Labetalol Hydrochloride Tablets is given to patients who are fasting or who are vomiting. Monitor for symptoms of hypoglycemia [see Warnings and Precautions ( 5.6 )]. Manufactured for: Eywa-Hibrow Pharma 908 Oak Tree Road, Suite O South Plainfield, NJ 07080 Made in India Revised: 04/2025
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Although elderly patients may initiate therapy at the currently recommended dosage of 100 mg twice daily, elderly patients will generally require lower maintenance dosages than nonelderly patients.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation Risk Summary Available published data report the presence of labetalol in human milk at low levels. There are no data on the effects on the breastfed infant and on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for labetalol and any potential adverse effects on the breastfed infant from labetalol or from the underlying maternal condition.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary The extensive experience with use of labetalol in pregnant women, based on published interventional and observational studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproductive studies, oral administration of labetalol to pregnant rats and rabbits during organogenesis at doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively, resulted in no fetal malformations; however, increased fetal resorptions were seen in both species at doses approximating the MRHD (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Consideration Disease-Associated Materanl and/or Embryo/Fetal Ris k Hypertension in pregnancy increase the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Labetalol crosses the placenta. Newonates born to mothers who are receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratly depression and mange accordingly. Data Human Data Data from published interventional and observational studies did not demonstrate an association between major congenital malformations and the use of labetalol in pregnancy, however, most studies reported the maternal use of intravenous labetalol occurring after 20 weeks gestation. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of labetalol during pregnancy; however, these studies have methodological limitations hindering interpretation. These studies cannot definitively establish the absence of risk during pregnancy. Animal Data Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Increased fetal resorptions were seen in both species at doses approximating the MRHD. A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the MRHD revealed no evidence of drug-related harm to the fetus. Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary The extensive experience with use of labetalol in pregnant women, based on published interventional and observational studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproductive studies, oral administration of labetalol to pregnant rats and rabbits during organogenesis at doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively, resulted in no fetal malformations; however, increased fetal resorptions were seen in both species at doses approximating the MRHD (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Consideration Disease-Associated Materanl and/or Embryo/Fetal Ris k Hypertension in pregnancy increase the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Labetalol crosses the placenta. Newonates born to mothers who are receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratly depression and mange accordingly. Data Human Data Data from published interventional and observational studies did not demonstrate an association between major congenital malformations and the use of labetalol in pregnancy, however, most studies reported the maternal use of intravenous labetalol occurring after 20 weeks gestation. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of labetalol during pregnancy; however, these studies have methodological limitations hindering interpretation. These studies cannot definitively establish the absence of risk during pregnancy. Animal Data Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Increased fetal resorptions were seen in both species at doses approximating the MRHD. A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the MRHD revealed no evidence of drug-related harm to the fetus. Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival. 8.2 Lactation Risk Summary Available published data report the presence of labetalol in human milk at low levels. There are no data on the effects on the breastfed infant and on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for labetalol and any potential adverse effects on the breastfed infant from labetalol or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Although elderly patients may initiate therapy at the currently recommended dosage of 100 mg twice daily, elderly patients will generally require lower maintenance dosages than nonelderly patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING Labetalol Hydrochloride Tablets USP, 100 mg, White to off-white, biconvex, film coated tablets with “ET20” debossed on one side and nonfunctional scoring on the other side, bottles of 100 (NDC 71930-035-12) and bottles of 500 (NDC 71930-035-52). Labetalol Hydrochloride Tablets USP, 200 mg, White to off-white, biconvex, film coated tablets with “ET21” debossed on one side and nonfunctional scoring on the other side, bottles of 100 (NDC 71930-036-12) and bottles of 500 (NDC 71930-036-52). Labetalol Hydrochloride Tablets USP, 300 mg, White to off-white, biconvex, film coated tablets with “ET22” debossed on one side and nonfunctional scoring on the other side, bottles of 100 (NDC 71930-037-12) and bottles of 500 (NDC 71930-037-52). Storage Store Labetalol Hydrochloride Tablets, USP between 2° and 30°C (36° and 86°F).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API