Labetalol Hydrochloride (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 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 mg 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 >2g/kg. The intravenous LD50 in these species is 50 mg/kg 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 mg 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 twice daily 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 mg and 200 mg twice daily.

HOW SUPPLIED

Labetalol Hydrochloride Tablets, USP 100 mg are available as white to off-white, round biconvex tablets, debossed “AC 370” on one side and bisected on other side, packaged in bottles of 30, 100 and 500 tablets.

Bottles of 30: 70377-060-11

Bottles of 100: 70377-060-12

Bottles of 500: 70377-060-13

Labetalol Hydrochloride Tablets, USP 200 mg are available as white to off-white, round biconvex tablets, debossed “AC 371” on one side and bisected on other side, packaged in bottles of 30, 100 and 500 tablets.

Bottles of 30: 70377-061-11

Bottles of 100: 70377-061-12

Bottles of 500: 70377-061-13

Labetalol Hydrochloride Tablets, USP 300 mg are available as white to off-white, round biconvex tablets, debossed “AC 372” on one side and plain on other side, packaged in bottles of 30, 100 and 500 tablets.

Bottles of 30: 70377-062-11

Bottles of 100: 70377-062-12

Bottles of 500: 70377-062-13

Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°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).

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

To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc., at 1-866-924-6266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

Biocon Pharma Inc.,
Iselin, New Jersey,
USA

Manufactured by:

Appco Pharma LLC

Piscataway, NJ 08854

Rev. 04/2021

BPCM0128/01

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LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-060
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
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (Round Biconvex Tablet) Size 8mm
Flavor Imprint Code AC;370
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-060-11 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-060-12 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-060-13 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209603 05/27/2021
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-061
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
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND (Round Biconvex Tablet) Size 10mm
Flavor Imprint Code AC;371
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-061-11 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-061-12 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-061-13 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209603 05/27/2021
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-062
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
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape ROUND (Round Biconvex Tablet) Size 11mm
Flavor Imprint Code AC;372
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70377-062-11 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70377-062-12 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70377-062-13 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209603 05/27/2021
Labeler — Biocon Pharma Inc. (080000063)
Registrant — Appco Pharma LLC (078510186)
Establishment
Name Address ID/FEI Operations
Appco Pharma LLC 078510186 ANALYSIS (70377-060), ANALYSIS (70377-061), ANALYSIS (70377-062), MANUFACTURE (70377-060), MANUFACTURE (70377-061), MANUFACTURE (70377-062), PACK (70377-060), PACK (70377-061), PACK (70377-062)

Revised: 05/2021 Biocon Pharma Inc.

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