Labetalol HCL (Page 4 of 4)

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 pharmacologic 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 LD50 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 & 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 to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.

When transferring patients from other antihypertensive drugs, labetalol hydrochloride tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.

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, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “041” on the other side of the tablet, bottles of 100 (NDC 49884-122-01) and 500 (NDC 49884-122-05).

Labetalol hydrochloride tablets, USP 200 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “042” on the other side of the tablet, bottles of 100 (NDC 49884-123-01) and 500 (NDC 49884-123-05).

Labetalol hydrochloride tablets, USP 300 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and “043” on the other side of the tablet, bottles of 100 (NDC 49884-124-01) and 500 (NDC 49884-124-05).

Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F)[ See USP Controlled Room Temperature].

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.


Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam — 603 103.
Made in India.

Mfg. Lic. No.: TN00002121
OS122-01-74-01Revised: 03/2017

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

labetalol
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Labetalol
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Labetalol
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Labetalol
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Labetalol
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Labetalol
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LABETALOL HCL labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-122
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (white, round, film-coated tablets) Size 8mm
Flavor Imprint Code NT;041
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-122-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49884-122-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200908 07/24/2012
LABETALOL HCL labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-123
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (white, round, film-coated tablets) Size 10mm
Flavor Imprint Code NT;042
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-123-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49884-123-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200908 07/24/2012
LABETALOL HCL labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-124
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (white, round, film-coated tablets) Size 11mm
Flavor Imprint Code NT;043
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-124-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:49884-124-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200908 07/24/2012
Labeler — Par Pharmaceutical, Inc. (092733690)

Revised: 11/2019 Par Pharmaceutical, Inc.

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