LABETALOL HYDROCHLORIDE tablet, film coated

Labetalol Hydrochloride by

Drug Labeling and Warnings

Labetalol Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Macleods Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS & 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 may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.





  • 2 DOSAGE & ADMINISTRATION

    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.

  • 3 DOSAGE FORMS & STRENGTHS

    Labetalol Hydrochloride Tablets, USP are available in the following strengths:
     Labetalol hydrochloride tablets, USP 100 mg, White to off white colored, round shape, biconvex film coated tablets debossed with 'I 33' on one side and score line on other side.
     Labetalol hydrochloride tablets, USP 200 mg, White to off white colored, round shape, biconvex film coated tablets debossed with 'I 34' on one side and score line on other side.
     Labetalol hydrochloride tablets, USP 300 mg, White to off white colored, round shape, biconvex film coated tablets debossed with 'I 35' on one side and score line on other side.



  • 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



  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypotension


    Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments with Labetalol Hydrochloride Tablets. Elderly patients are generally more likely than younger patients to experience orthostatic symptoms [see Dosage and Administration (2.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.2)].

    5.2 Bradycardia

    Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving Labetalol Hydrochloride Tablets.

    5.3 Cardiac Failure


    Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Avoid Labetalol Hydrochloride Tablets in patients with overt congestive heart failure. If patients develop signs or symptoms of heart failure during administration, discontinue Labetalol Hydrochloride Tablets and treat appropriately.

    5.4 Ischemic Heart Disease


    Abrupt cessation of therapy with beta blocking agents in patients with coronary artery disease can cause exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, even in the absence of overt angina pectoris, after the discontinuation of Labetalol Hydrochloride Tablets observe patients for development or worsening of angina. If patient experiences angina or angina markedly worsens or if acute coronary insufficiency develops, promptly reinstitute Labetalol Hydrochloride Tablets and manage as unstable angina.

    5.5 Reactive Airway Disease and Nonallergic Bronchospasm


    Avoid use in patients with reactive airways disease. If Labetalol Hydrochloride Tablets are used, use the smallest effective dose, to minimize inhibition of endogenous or exogenous beta agonists.

    5.6 Hypoglycemia


    Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.

    5.7 Use in Patients with Pheochromocytoma


    Labetalol hydrochloride has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, blood pressure when administering labetalol hydrochloride to patients with pheochromocytoma.

    5.8 Hepatic Injury


    Severe hepatocellular injury occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause. Do not restart labetalol in patients without another explanation for the observed liver injury.

    5.9 Use in Patients at Risk of Severe Acute Hypersensitivity Reactions


    Patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic). Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions. Avoid Labetalol Hydrochloride Tablets in patients at high risk of anaphylactic reactions.

    5.10 Major Surgery


    Do not routinely withdraw chronic beta blocker therapy prior to surgery. The effect of labetalol’s  alpha adrenergic activity has not been evaluated in this setting. A synergism between labetalol hydrochloride and halothane anesthesia has been shown [see Drug Interactions (7.3)].

    5.11 Intraoperative Floppy Iris Syndrome (IFIS)


    IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. Inform the patient’s ophthalmologist to be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

  • 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)]



    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 systems
    		 
    		 
    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.


  • 7 DRUG INTERACTIONS

    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.


  • 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
    Diesase-Associated Materanl and/or Embryo/Fetal Risk 
    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.

  • 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 LD50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is >2 g/kg. The IV LD50in these species is 50 mg/kg to 60 mg/kg.



  • 11 DESCRIPTION


    Labetalol Hydrochloride Tablets contain labetalol hydrochloride, an adrenergic receptor blocking agent that has both selective alpha1 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:


    111


    Labetalol hydrochloride has the empirical formula C19H24N2O3HCl 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 contain 100 mg, 200 mg, or 300 mg of labetalol hydrochloride and are for oral administration. The tablets also contain the inactive ingredients ingredients lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, hypromellose, titanium dioxide, macrogol and polysorbate 80.
    FDA approved dissolution test specifications differ from USP.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action


    Labetalol hydrochloride combines both selective, competitive, alpha1‑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 beta1 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. Beta2 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 alpha1‑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.




  • 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.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Labetalol Hydrochloride Tablets, USP 100 mg, White to off white colored, round shape, biconvex film-coated tablets debossed with 'I 33' on one side and score line on other side.

    bottles of 100 (NDC: 33342-515-11)
    bottles of 500 (NDC: 33342-515-15).

    Labetalol Hydrochloride Tablets, USP 200 mg, White to off white colored, round shape, biconvex film-coated tablets debossed with 'I 34' on one side and score line on other side.
    bottles of 100 (NDC: 33342-516-11)
    bottles of 500 (NDC: 33342-516-15).

    Labetalol Hydrochloride Tablets, USP 300 mg, White to off white colored, round shape, biconvex film-coated tablets debossed with 'I 35' on one side and score line on other side.

    bottles of 100 (NDC: 33342-517-11)
    bottles of 500 (NDC: 33342-517-15).


    Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
    Dispense in a tight, light resistant container as defined in the USP with a child resistant closure as required.



  • 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:
    Macleods Pharma USA, Inc.
    Princeton, NJ 08540

    Manufactured by:
    Macleods Pharmaceuticals Ltd.
    Plot no: M-50 to M-54A, SEZ,
    Phase-II, Pithampur, MP-454774. INDIA

    Revised: 11/2025

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Rx only
    Labetalol Hydrochloride Tablets USP, 100 mg
    NDC: 33342-515-11
    Container 100's Tablets


    111


    Rx only
    Labetalol Hydrochloride Tablets USP, 100 mg
    NDC: 33342-515-15
    Container 500's Tablet    s


    111

    Rx only
    Labetalol Hydrochloride Tablets USP, 200 mg
    NDC: 33342-516-11
    Container 100's Tablets

    111


    Rx only
    Labetalol Hydrochloride Tablets USP, 200 mg
    NDC: 33342-516-15
    Container 500's Tablets

    111


     Rx only

    Labetalol Hydrochloride Tablets USP, 300 mg
    NDC: 33342-517-15
    Container 500's Tablets

    111

     

    Rx only
    Labetalol Hydrochloride Tablets USP, 300 mg
    NDC: 33342-517-11
    Container 100's Tablets


    111
  • INGREDIENTS AND APPEARANCE
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 33342-516
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITE ((Off White)) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code I34
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 33342-516-11100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    2NDC: 33342-516-15500 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21794909/23/2025
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 33342-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITE ((Off White)) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code I33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 33342-515-11100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    2NDC: 33342-515-15500 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21794909/23/2025
    LABETALOL HYDROCHLORIDE 
    labetalol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 33342-517
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITE ((Off White)) Score2 pieces
    ShapeROUNDSize11mm
    FlavorImprint Code I35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 33342-517-11100 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    2NDC: 33342-517-15500 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21794909/23/2025
    Labeler - Macleods Pharmaceuticals Limited (862128535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Macleods Pharmaceuticals Limited854247775ANALYSIS(33342-515, 33342-516, 33342-517) , LABEL(33342-515, 33342-516, 33342-517) , MANUFACTURE(33342-515, 33342-516, 33342-517) , PACK(33342-515, 33342-516, 33342-517)
    • © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.