Labetalol Hydrochloride: Package Insert and Label Information (Page 3 of 3)

Body as a Whole

Fever.

Cardiovascular

Hypotension, and rarely, syncope, bradycardia, heart block.

Central and Peripheral Nervous Systems

Paresthesia, most frequently described as scalp tingling. In most cases, it was mild and transient and usually occurred at the beginning of treatment.

Collagen Disorders

Systemic lupus erythematosus, positive antinuclear factor.

Eyes

Dry eyes.

Immunological System

Antimitochondrial antibodies.

Liver and Biliary System

Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

Musculoskeletal System

Muscle cramps, toxic myopathy.

Respiratory System

Bronchospasm.

Skin and Appendages

Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie’s disease; reversible alopecia.

Urinary System

Difficulty in micturition, including acute urinary bladder retention.

Hypersensitivity

Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.

Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,800 patients was conducted for further safety and efficacy evaluation of this product. Results of this survey indicate that the type, severity, and incidence of adverse effects were comparable to those cited above.

Potential Adverse Effects

In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.

Central Nervous System

Reversible 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.

Cardiovascular

Intensification of A-V block (see CONTRAINDICATIONS).

Allergic

Fever combined with aching and sore throat, laryngospasm, respiratory distress.

Hematologic

Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.

Gastrointestinal

Mesenteric artery thrombosis, ischemic colitis.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.

Clinical Laboratory Tests

There 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 causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary:

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 per hour that can be reduced as the patient improves).

Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol HCl from the general circulation (<1%).

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

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage 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 HCl is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.

Patients with severe hypertension may require from 1,200 mg to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol 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.

Elderly Patients

As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 and 200 mg b.i.d.

HOW SUPPLIED

Labetalol Hydrochloride Tablets USP, 100 mg are available as yellow, round, film-coated tablets, debossed with a bisect, and “4364” on one side and “TEVA” on the other containing 100 mg of labetalol hydrochloride USP, packaged in blistercards of 30 tablets.

Labetalol Hydrochloride Tablets USP, 200 mg are available as white, round, film-coated tablets, debossed with a bisect, and “4365” on one side and “TEVA” on the other containing 200 mg of labetalol hydrochloride USP, packaged in blistercards of 30 tablets.

Labetalol 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 blistercards of 30 tablets.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured In India By:

EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. D 12/2010

PRINCIPAL DISPLAY PANEL

Labetalol Hydrochloride Tablets, USP 100mg

Principal Display Panel-Labetalol HCI Tablet 100mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Labetalol Hydrochloride Tabs, USP 200mg

Principal Display Panel-Labetalol HCI Tabs 200mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Labetalol Hydrochloride Tablets, USP 300mg

Principal Display Panel-Labetalol HCI Tablets 300mg
(click image for full-size original)

LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7686(NDC:0172-4364)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 4364;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7686-39 30 TABLET, FILM COATED (30 TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074787 01/01/2011
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7687(NDC:0172-4365)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 4365;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7687-39 30 TABLET, FILM COATED (30 TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074787 01/01/2011
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7688(NDC:0172-4366)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
AMMONIUM NONOXYNOL-4 SULFATE
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 4366;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-7688-39 30 TABLET, FILM COATED (30 TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074787 01/01/2011
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL (0615-7686), RELABEL (0615-7687), RELABEL (0615-7688), REPACK (0615-7686), REPACK (0615-7687), REPACK (0615-7688)

Revised: 03/2012 NCS HealthCare of KY, Inc dba Vangard Labs

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