NDC 54868-4844 Labetalol Hydrochloride

NDC Product Code 54868-4844

NDC CODE: 54868-4844

Proprietary Name: Labetalol Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330)
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
8 MM
10 MM
Imprint(s):
4364;100
4365;200
Score: 2

NDC Code Structure

NDC 54868-4844-0

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC 54868-4844-1

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC 54868-4844-2

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC 54868-4844-3

Package Description: 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Labetalol Hydrochloride with NDC 54868-4844 is a product labeled by Physicians Total Care, Inc.. The generic name of Labetalol Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 08-19-2003 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Labetalol Oral

Labetalol Oral is pronounced as (la bet' a lole)

Why is labetalol oral medication prescribed?
Labetalol is used to treat high blood pressure. Labetalol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to ...
[Read More]

* Please review the disclaimer below.

Labetalol Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Labetalol HCl USP is an adrenergic receptor blocking agent that
has both selective alpha 1-and non-selective
beta-adrenergic receptor blocking actions in a single substance.Labetalol HCl USP is a racemate, chemically designated as
5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] salicylamide
monohydrochloride, and has the following structural formula:C 19H24N2O3 •HCl M.W. 364.87Labetalol HCl USP has two asymmetric centers and therefore exists as a
molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R'
stereoisomer, makes up 25% of racemic labetalol.Labetalol HCl USP is a white or off-white crystalline powder, soluble in
water.Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg of
labetalol hydrochloride, USP. In addition, each tablet contains the following
inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium
stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium
dioxide and colorants (100 mg: D&C yellow #10 aluminum lake and FD&C
yellow #6 aluminum lake; and 300 mg: D&C yellow #10 aluminum lake, FD&C
yellow #6 aluminum lake and FD&C blue #1 aluminum lake).

Clinical Pharmacology

Labetalol combines both selective, competitive alpha 1-adrenergic blocking and nonselective, competitive
beta-adrenergic blocking activity in a single substance. In man, the ratios of
alpha-to beta-blockade have been estimated to be approximately 1:3 and 1:7
following oral and intravenous administration, respectively. Beta2- agonist activity has been demonstrated in animals with
minimal beta1-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.PharmacodynamicsThe capacity of labetalol 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'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. 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 HCl contribute to a decrease in blood pressure in hypertensive
patients. Labetalol 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 HCl
dosing.Single oral doses of labetalol HCl administered in patients with coronary
artery disease had no significant effect on sinus rate, intraventricular
conduction, or QRS duration. The AV conduction time was modestly prolonged in 2
of 7 patients. In another study, intravenous labetalol slightly prolonged AV
nodal conduction time and atrial effective refractory period with only small
changes in heart rate. The effects on AV nodal refractoriness were
inconsistent.Labetalol produces dose-related falls in blood pressure without reflex
tachycardia and without significant reduction in heart rate, presumably through
a mixture of its alpha-blocking 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.Doses of labetalol HCl that controlled hypertension did not affect renal
function in mild to severe hypertensive patients with normal renal function.Due to the alpha 1-receptor blocking activity of
labetalol, 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). 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 HCl 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 HCl 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.The anti-anginal efficacy of labetalol has not been studied. In 37 patients
with hypertension and coronary artery disease, labetalol did not increase the
incidence or severity of angina attacks.Exacerbation of angina and, in some cases, myocardial infarction and
ventricular dysrhythmias have been reported after abrupt discontinuation of
therapy with beta-adrenergic blocking agents in patients with coronary artery
disease. Abrupt withdrawal of these agents in patients without coronary artery
disease has resulted in transient symptoms, including tremulousness, sweating,
palpitation, headache, and malaise. Several mechanisms have been proposed to
explain these phenomena, among them increased sensitivity to catecholamines
because of increased numbers of beta receptors.Although beta-adrenergic receptor blockade is useful in the treatment of
angina and hypertension, there are also situations in which sympathetic
stimulation is vital. For example, in patients with severely damaged hearts,
adequate ventricular function may depend on sympathetic drive. Beta-adrenergic
blockade may worsen AV block by preventing the necessary facilitating effects of
sympathetic activity on conduction. Beta 2-adrenergic
blockade results in passive bronchial constriction by interfering with
endogenous adrenergic bronchodilator activity in patients subject to
bronchospasm and may also interfere with exogenous bronchodilators in such
patients.Pharmacokinetics and MetabolismLabetalol is completely absorbed from the gastrointestinal tract
with peak plasma levels occurring 1 to 2 hours after oral administration. The
relative bioavailability of labetalol tablets compared to an oral solution is
100%. The absolute bioavailability (fraction of drug reaching systemic
circulation) of labetalol when compared to an intravenous infusion is 25%; this
is due to extensive “first-pass” metabolism. Despite “first-pass” metabolism
there is a linear relationship between oral doses of 100 to 3000 mg and peak
plasma levels. The absolute bioavailability of labetalol is increased when
administered with food.The plasma half-life of labetalol following oral administration is about 6 to
8 hours. Steady-state plasma levels of labetalol during repetitive dosing are
reached by about the third day of dosing. 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.The metabolism of labetalol is mainly through conjugation to glucuronide
metabolites. These metabolites are present in plasma and are excreted in the
urine, and via the bile, into the feces. Approximately 55% to 60% of a dose
appears in the urine as conjugates or unchanged labetalol within the first 24
hours of dosing.Labetalol has been shown to cross the placental barrier in humans. Only
negligible amounts of the drug crossed the blood-brain barrier in animal
studies. Labetalol is approximately 50% protein bound. Neither hemodialysis nor
peritoneal dialysis removes a significant amount of labetalol from the general
circulation (less than 1%).

Indications And Usage

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

Contraindications

Labetalol HCl 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 WARNINGS).Beta-blockers, even those with apparent cardioselectivity, should not be used
in patients with a history of obstructive airway disease, including asthma.

Warnings

Hepatic InjurySevere hepatocellular injury, confirmed by rechallenge in at
least one case, occurs rarely with therapy with labetalol. The hep tic injury is
usually reversible, but hepatic necrosis and death have been reported. Injury
has occurred after both short- and long-term treatment and may be slowly
progressive despite minimal symptomatology. Similar hepatic events have been
reported with a related compound, dilevalol HCl, including two deaths. Dilevalol
HCl is one of the four isomers of labetalol HCl. Thus, for patients taking
labetalol, periodic determination of suitable hepatic laboratory tests would be
appropriate. Laboratory testing should also be done at the very first symptom or
sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia,
jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms).
If the patient has jaundice or laboratory evidence of liver injury, labetalol
should be stopped and not restarted.Cardiac FailureSympathetic 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. Although beta-blockers should be avoided in
overt congestive heart failure, if necessary, labetalol can be used with caution
in patients with a history of heart failure who are well-compensated. Congestive
heart failure has been observed in patients receiving labetalol HCl. Labetalol
does not abolish the inotropic action of digitalis on heart muscle.In Patients Without a History of Cardiac FailureIn patients with latent cardiac insufficiency, continued
depression of the myocardium with beta-blocking agents over a period of time
can, in some cases, lead to cardiac failure. At the first sign or symptom of
impending cardiac failure, patients should be fully digitalized and/or be given
a diuretic, and the response observed closely. If cardiac failure continues,
despite adequate digitalization and diuretic, therapy with labetalol should be
withdrawn (gradually if possible).Exacerbation of Ischemic Heart Disease Following
Abrupt WithdrawalAngina pectoris has not been reported upon labetalol
discontinuation. However, hypersensitivity to catecholamines has been observed
in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in
some cases, myocardial infarction have occurred after abrupt discontinuation of
such therapy. When discontinuing chronically administered labetalol,
particularly in patients with ischemic heart disease, the dosage should be
gradually reduced over a period of 1 to 2 weeks and the patient should be
carefully monitored. If angina markedly worsens or acute coronary insufficiency
develops, labetalol administration should be reinstituted promptly, at least
temporarily, and other measures appropriate for the management of unstable
angina should be taken. Patients should be warned against interruption or
discontinuation of therapy without the physician's advice. Because coronary
artery disease is common and may be unrecognized, it may be prudent not to
discontinue therapy with labetalol abruptly even in patients treated only for
hypertension.Nonallergic bronchospasm (e.g., chronic bronchitis and
emphysema) patients with bronchospastic disease should, in general, not receive
beta-blockers. Labetalol may be used with caution, however, in patients
who do not respond to, or cannot tolerate, other antihypertensive agents. It is
prudent, if labetalol is used, to use the smallest effective dose, so that
inhibition of endogenous or exogenous beta-agonists is minimized.PheochromocytomaLabetalol has been shown to be effective in lowering the blood
pressure and relieving symptoms in patients with pheochromocytoma. However,
paradoxical hypertensive responses have been reported in a few patients with
this tumor; therefore, use caution when administering labetalol to patients with
pheochromocytoma.Diabetes Mellitus and HypoglycemiaBeta-adrenergic blockade may prevent the appearance of
premonitory signs and symptoms (e.g., tachycardia) of acute hypoglycemia. This
is especially important with labile diabetics. Beta-blockade also reduces the
release of insulin in response to hyperglycemia; it may therefore be necessary
to adjust the dose of antidiabetic drugs.Major SurgeryThe necessity or desirability of withdrawing beta-blocking
therapy prior to major surgery is controversial. Protracted severe hypotension
and difficulty in restarting or maintaining a heartbeat have been reported with
beta-blockers. The effect of labetalol's alpha-adrenergic activity has not been
evaluated in this setting.A synergism between labetalol and halothane anesthesia has been shown (see
PRECAUTIONS-Drug Interactions).

Precautions

GeneralImpaired Hepatic FunctionLabetalol should be used with caution in patients with impaired
hepatic function since metabolism of the drug may be diminished.Jaundice or Hepatic Dysfunction(see WARNINGS).Information for PatientsAs with all drugs with beta-blocking activity, certain advice to
patients being treated with labetalol is warranted. This information is intended
to aid in the safe and effective use of this medication. It is not a disclosure
of all possible adverse or intended effects. While no incident of the abrupt
withdrawal phenomenon (exacerbation of angina pectoris) has been reported with
labetalol, dosing with labetalol HCl tablets should not be interrupted or
discontinued without a physician's advice. Patients being treated with labetalol
HCl tablets should consult a physician at any signs or symptoms of impending
cardiac failure or hepatic dysfunction (see WARNINGS).
Also, transient scalp tingling may occur, usually when treatment with labetalol
HCl tablets is initiated (see ADVERSE REACTIONS).Laboratory TestsAs with any new drug given over prolonged periods, laboratory
parameters should be observed over regular intervals. In patients with
concomitant illnesses, such as impaired renal function, appropriate tests should
be done to monitor these conditions.Drug InteractionsIn one survey, 2.3% of patients taking labetalol in combination
with tricyclic antidepressants experienced tremor as compared to 0.7% reported
to occur with labetalol alone. The contribution of each of the treatments to
this adverse reaction is unknown but the possibility of a drug interaction
cannot be excluded.Drugs possessing beta-blocking properties can blunt the bronchodilator effect
of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses
greater than the normal anti-asthmatic dose of beta-agonist bronchodilator drugs
may be required.Cimetidine has been shown to increase the bioavailability of labetalol. Since
this could be explained either by enhanced absorption or by an alteration of
hepatic metabolism of labetalol, special care should be used in establishing the
dose required for blood pressure control in such patients.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. The anesthesiologist should be informed
when a patient is receiving labetalol.Labetalol blunts the reflex tachycardia produced by nitroglycerin without
preventing its hypotensive effect. If labetalol HCl is used with nitroglycerin
in patients with angina pectoris, additional antihypertensive effects may
occur.Care should be taken if labetalol is used concomitantly with calcium
antagonists of the verapamil type.Both digitalis glycosides and beta-blockers slow antrioventricular conduction
and decrease heart rate. Concomitant use can increase the risk of
bradycardia.Risk of Anaphylactic ReactionWhile taking beta-blockers, patients with a history of severe
anaphylactic reaction to a variety of allergens may be more reactive to repeated
challenge, either accidental, diagnostic, or therapeutic. Such patients may be
unresponsive to the usual doses of epinephrine used to treat allergic
reaction.Drug/Laboratory Test InteractionsThe 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 (e.g.,
J Chromatogr 385:241,1987) 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 Toxi-Lab A ®
(thin-layer chromatographic assay) and Emit-d.a.u.®
(radioenzymatic assay). When patients being treated with labetalol have a
positive urine test for amphetamine using these techniques, confirmation should
be made by using more specific methods, such as a gas chromatographic-mass
spectrometer technique.Carcinogenesis, Mutagenesis, Impairment of
FertilityLong-term oral dosing studies with labetalol for 18 months in
mice and for 2 years in rats showed no evidence of carcinogenesis. Studies with
labetalol, using dominant lethal assays in rats and mice, and exposing
microorganisms according to modified Ames tests, showed no evidence of
mutagenesis.Pregnancy Category CTeratogenic studies have been performed with labetalol in rats
and rabbits at oral doses up to approximately 6 and 4 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. There are no adequate and
well-controlled studies in pregnant women. Labetalol should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.Nonteratogenic EffectsHypotension, bradycardia, hypoglycemia, and respiratory
depression have been reported in infants of mothers who were treated with
labetalol for hypertension during pregnancy. Oral administration of labetalol to
rats during late gestation through weaning at doses of 2 to 4 times the MRHD
caused a decrease in neonatal survival.Labor and DeliveryLabetalol given to pregnant women with hypertension did not
appear to affect the usual course of labor and delivery.Nursing MothersSmall amounts of labetalol (approximately 0.004% of the maternal
dose) are excreted in human milk. Caution should be exercised when labetalol HCl
tablets are administered to a nursing woman.Pediatric UseSafety and effectiveness in pediatric patients have not been
established.

Adverse Reactions

Most adverse effects are mild, transient and occur early in the
course of treatment. In controlled clinical trials of 3 to 4 months duration,
discontinuation of labetalol HCl tablets due to one or more adverse effects was
required in 7% of all patients. In these same trials, beta-blocker control
agents led to discontinuation in 8% to 10% of patients, and a centrally acting
alpha-agonist in 30% of patients.The incidence rates of adverse reactions listed in the following table were
derived from multicenter controlled clinical trials, comparing labetalol,
placebo, metoprolol and propranolol over treatment periods of 3 and 4 months.
Where the frequency of adverse effects for labetalol 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.Labetalol
(N=227) %Placebo
(N=98) %Propranolol
(N=84) %Metoprolol
(N=49) %Body as a
wholefatigue501212asthenia1110headache2112Gastrointestinalnausea6112vomitingless than 1000dyspepsia3110abdominal pain0012diarrhealess than 1020taste distortion1000Central and
Peripheral Nervous Systemsdizziness11344paresthesiasless than 1000drowsinessless than 1222Autonomic Nervous
Systemnasal stuffiness3000ejaculation failure2000impotence1013increased sweatingless than 1000Cardiovascularedema1000postural hypotension1000bradycardia00512Respiratorydyspnea2012Skinrash1000Special
Sensesvision abnormality1000vertigo2100The 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 table below which depicts the entire U.S.
therapeutic trials data base for adverse reactions that are clearly or possibly
drug related.Labetalol HCl Daily Dose (mg)  200  300  400  600  800 Number of Patients522181606608503Dizziness (%)23335Fatigue21445Nausealess than 10124Vomiting00less than 1less than 1less than 1Dyspepsia10211Paresthesias20221Nasal Stuffiness11222Ejaculation Failure02123Impotence11112Edema10111Daily Dose (mg)900120016002400 Number of Patients117411242175Dizziness (%)191316Fatigue37610Nausea071119Vomiting0123Dyspepsia0224Paresthesias1255Nasal Stuffiness2456Ejaculation Failure0435Impotence4343Edema0122In addition, a number of other less common adverse events have been
reported:Body as a WholeFever.CardiovascularHypotension, and rarely, syncope, bradycardia, heart block.Central and Peripheral Nervous SystemsParesthesias, most frequently described as scalp tingling. In
most cases, it was mild, transient and usually occurred at the beginning of
treatment.Collagen DisordersSystemic lupus erythematosus; positive antinuclear factor
(ANF).EyesDry eyes.Immunological SystemAntimitochondrial antibodies.Liver and Biliary SystemHepatic necrosis; hepatitis; cholestatic jaundice, elevated liver
function tests.Musculoskeletal SystemMuscle cramps; toxic myopathy.Respiratory SystemBronchospasm.Skin and AppendagesRashes of various types, such as generalized maculopapular;
lichenoid; urticarial; bullous lichen planus; psoriaform; facial erythema;
Peyronie's disease; reversible alopecia.Urinary SystemDifficulty in micturition, including acute urinary bladder
retention.HypersensitivityRare 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.Potential Adverse EffectsIn addition, other adverse effects not listed above have been
reported with other beta-adrenergic blocking agents.Central Nervous SystemReversible mental depression progressing to catatonia; an acute
reversible syndrome characterized by disorientation for time and place,
short-term memory loss, emotional lability, slightly clouded sensorium, and
decreased performance on neuropsychometrics.CardiovascularIntensification of AV block (see CONTRAINDICATIONS).AllergicFever combined with aching and sore throat; laryngospasm;
respiratory distress.HematologicAgranulocytosis; thrombocytopenic or nonthrombocytopenic
purpura.GastrointestinalMesenteric artery thrombosis; ischemic colitis.The oculomucocutaneous syndrome associated with the beta-blocker practolol
has not been reported with labetalol.Clinical Laboratory TestsThere have been reversible increases of serum transaminases in 4%
of patients treated with labetalol and tested, and more rarely, reversible
increases in blood urea.

Overdosage

Overdosage with labetalol HCl tablets 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 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 pharmacological evidence that norepinephrine may be the
drug of choice. Bronchospasm - administer epinephrine
and/or an aerosolized beta2-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 to
10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg/hr that
can be reduced as the patient improves).Neither hemodialysis nor peritoneal dialysis removes a significant amount of
labetalol from the general circulation (less than 1%).The oral LD 50 value of labetalol HCl in the mouse is
approximately 600 mg/kg and in the rat is greater than 2 g/kg. The intravenous
LD50 in these species is 50 to 60 mg/kg.

Dosage And Administration

DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dose is
100 mg twice 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. every 2 or 3 days. The usual maintenance dosage of
labetalol HCl is between 200 and 400 mg twice daily.Since the full antihypertensive effect of labetalol 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., the same total daily
dose administered t.i.d. may improve tolerability and facilitate further
titration. Titration increments should not exceed 200 mg b.i.d.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 HCl tablets
are usually lower in patients also receiving a diuretic.When transferring patients from other antihypertensive drugs, labetalol HCl
tablets should be introduced as recommended and the dosage of the existing
therapy progressively decreased.

How Supplied

Labetalol Hydrochloride Tablets USP, 100 mg are available as yellow, round, film-coated
tablets, debossed with a bisect, “4364” and on one side and “TEVA” on the other containing 100 mg of labetalol
hydrochloride USP, packaged in Bottles of 30NDC 54868-4921-0Bottles of 60NDC 54868-4921-2Bottles of 100Bottles of 120NDC 54868-4921-1NDC 54868-4921-4Bottles of 180NDC 54868-4921-3Labetalol Hydrochloride Tablets USP, 200 mg are available as white, round,
film-coated tablets, debossed with a bisect, “4365” and on one side and “TEVA” on the other containing 200 mg of labetalol
hydrochloride USP, packaged in Bottles of 30NDC 54868-4844-0Bottles of 60NDC 54868-4844-1Bottle sof 90NDC 54868-4844-2Bottles of 120NDC 54868-4844-3Labetalol Hydrochloride Tablets USP, 300 mg are available as green, round,
film-coated, unscored tablets, debossed with ”4366” and on one side and “TEVA” on the other containing 300 mg of labetalol
hydrochloride USP, packaged in Bottles of 30NDC 54868-4903-0Bottles of 60NDC 54868-4903-1Bottles of 100NDC 54868-4903-2Dispense in a tight, light-resistant container as defined in the
USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Rev. A 7/2008Manufactured In India By:EMCURE PHARMACEUTICALS LTD.Hinjwadi, Pune, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960Rev. D 12/2010Relabeling and Rapackaging by:Physicians Total Care, Inc.Tulsa, OK    74146

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